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ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 1 页 共 91 页
Name: Sichuan Testing Center for Biomaterials and Medical Devices
Address: Sichuan University Biomaterials Building, No.29, Wangjiang Road, Chengdu, Sichuan, China
Registration No. CNAS L3940
Accreditation Criteria: ISO/IEC 17025:2017 and relevant requirements of CNAS
Effective Date: 2019-08-01 Expiry Date:2024-04-11
SCHEDULE 3 ACCREDITED TESTING SCOPE
Item/Parameter№ Test Object
№ Item/ ParameterStandard or Method Note
Biological evaluation of medical devices--Part 5:Test for in vitro cytotoxicity GB/T 16886.5-2017
Biological evaluation of medical devices--Part 5:Test for in vitro cytotoxicity ISO 10993-5: 2009
Organic silicon material for medical use- Biological evaluation test methods GB/T 16175-2008
Test methods for infusion, transfusion, injection equipment for medical use-Part 2:Biological test methods GB/T 14233.2-2005
1 Test for in vitro cytotoxicity
Biological evaluation of medical devices used in dentistry-Part 2:Test method-Cytotoxicity tests:Agar diffusion test and filter diffusion test YY/T 0127.9-2009
Biological evaluation of medical devices - Part 10:Tests for irritation and delayed-type hypersensitivity GB/T 16886.10-2017
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization ISO 10993-10:2010
1 Medical Devices & Materials
2Tests for sensitization(delayed-type hypersensitivity) Test for hypersensitivity of medical devices Part 2:Murine Local Lymph Node
Assay (LLNA):BrdU-ELISA method YY/T 0879.2-2015
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 2 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
Organic silicon material for medical use- Biological evaluation test methods GB/T 16175-2008
Test methods for infusion, transfusion, injection equipment for medical use-Part 2:Biological test methods GB/T 14233.2-2005
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity GB/T 16886.10-2017
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization ISO 10993-10:2010
Test methods for infusion, transfusion, injection equipment for medical use-Part 2:Biological test methods GB/T 14233.2-2005
3 Irritation test
Organic silicon material for medical use- Biological evaluation test methods GB/T 16175-2008
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity GB/T 16886.10-2017
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization ISO 10993-10:2010
Test methods for infusion, transfusion, injection equipment for medical use-Part 2:Biological test methods GB/T 14233.2-2005
4Intracutaneous (intradermal) reactivity test
Organic silicon material for medical use- Biological evaluation test methods GB/T 16175-2008
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity GB/T 16886.10-2017
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization ISO 10993-10:2010 5 Oral irritation test
Biological evaluation of medical devices used in dentistry-Part 13:Test method-Oral mucous membrane irritation test YY/T 0127.13-2018
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity GB/T 16886.10-2017
6 Ocular irritation test Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization ISO 10993-10:2010
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 3 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
Organic silicon material for medical use- Biological evaluation test methods GB/T 16175-2008
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity GB/T 16886.10-2017
7 Vaginal irritation test Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization ISO 10993-10:2010
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity GB/T 16886.10-2017
8 Rectal irritation test Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization ISO 10993-10:2010
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity GB/T 16886.10-2017
9 Penile irritation test Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization ISO 10993-10:2010
Biological evaluation of medical devices - Part 11:Tests for systemic toxicity GB/T 16886.11-2011
Biological evaluation of medical devices - Part 11:Tests for systemic toxicity ISO 10993-11:2017
Organic silicon material for medical use- Biological evaluation test methods GB/T 16175-2008
10 Acute systemic toxicity test
Test methods for infusion, transfusion, injection equipment for medical use-Part 2:Biological test methods GB/T 14233.2-2005
Biological evaluation of medical devices used in dentistry-Part 2:Test method-Acute oral toxicity test YY/T 0127.14-2009
Biological evaluation of medical devices - Part 11:Tests for systemic toxicity GB/T 16886.11-2011 11
Short term systemic toxicity test: oral route Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ISO 10993-11:2017
12 Pyrogenicity test Biological evaluation of medical devices - Part 11: Tests for systemic toxicity GB/T 16886.11-2011
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 4 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity ISO 10993-11:2017
Organic silicon material for medical use- Biological evaluation test methods GB/T 16175-2008
Test methods for infusion, transfusion, injection equipment for medical use-Part 2:Biological test methods GB/T 14233.2-2005
China pharmacopoeia 2015 1142 Pyrogenicity test China pharmacopoeia 2015
Test methods for infusion, transfusion, injection equipment for medical use-Part 2:Biological test methods GB/T 14233.2-2005
13 Bacterial endotoxin China pharmacopoeia 2015 1143 Pyrogenicity test of endotoxin China pharmacopoeia 2015
Test methods for infusion, transfusion, injection equipment for medical use-Part 2:Biological test methods GB/T 14233.2-2005
14 Sterility testChina pharmacopoeia 2015 1101 Sterility test China pharmacopoeia 2015
Biological evaluation of medical devices - Part 11:Tests for systemic toxicity GB/T 16886.11-2011
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity ISO 10993-11:2017
Organic silicon material for medical use- Biological evaluation test methods GB/T 16175-2008
Biological evaluation of medical devices used in dentistry Part 15: Test method Subacute and subchronic systemic toxicity test: oral route YY/T 0127.15-2018
15 Subacute systemic toxicity
Test methods for infusion, transfusion, injection equipment for medical use-Part 2:Biological test methods GB/T 14233.2-2005
16 Subchronic systemic toxicity
Biological evaluation of medical devices - Part 11:Tests for systemic toxicity GB/T 16886.11-2011
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 5 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity ISO 10993-11:2017
Organic silicon material for medical use- Biological evaluation test methods GB/T 16175-2008
Biological evaluation of medical devices used in dentistry-Part 15: Test method- Subacute and subchronic systemic toxicity test: oral route YY/T 0127.15-2018
Test methods for infusion, transfusion, injection equipment for medical use-Part 2:Biological test methods GB/T 14233.2-2005
Biological evaluation of medical devices - Part 11:Tests for systemic toxicity GB/T 16886.11-2011
17 Chronic systemic toxicity Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ISO 10993-11:2017
Biological evaluation of medical devices - Part 11:Tests for systemic toxicity GB/T 16886.11-2011
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity ISO 10993-11:2017 18 Systemic toxicity:
inhalation routeBiological evaluation of medical devices used in dentistry Part 5:Inhalation toxicity test YY/T 0127.5-2014
Biological evaluation of medical devices - Part 3: Test for genotoxicity, carcinogenicity and reproductive toxicity GB/T 16886.3-2008
In vitro mammalian chromosome aberration test OECD 473:2016
Biological evaluation of medical devices - Part 3: Test for genotoxicity, carcinogenicity and reproductive toxicity ISO 10993-3:2014
Test for genotoxicity of medical devices-Part 2:In vitro mammalian chromosome aberration test YY/T0870.2-2013
19Mammalian cells chromosome aberration test
Test for genotoxicity of medical devices- Part 5:Mammalian bone marrow chromosome aberration test YY/T 0870.5-2014
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 6 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
Biological evaluation of medical devices used in dentistry-Part 2: Test method-In Vitro mammalian chromosome aberration test YY/T 0127.16-2009
Biological evaluation of medical devices - Part 3: Test for genotoxicity, carcinogenicity and reproductive toxicity GB/T 16886.3-2008
Biological evaluation of medical devices - Part 3: Test for genotoxicity, carcinogenicity and reproductive toxicity ISO 10993-3:2014 20 Micronucleus test of
bone marrow cellTest for genotoxicity of medical devices- Part 4: Mammalian bone marrow erythocyte micronucleus test YY/T 0870.4-2014
Biological evaluation of medical devices - Part 3: Test for genotoxicity, carcinogenicity and reproductive toxicity GB/T 16886.3-2008
Biological evaluation of medical devices - Part 3: Test for genotoxicity,carcinogenicity and reproductive toxicity ISO 10993-3:2014
In Vitro Mammalian Cell Gene Mutation Test OECD 490:2016
Test for genotoxicity of medical devices-Part 3: In vitro mammalian cell gene mutation test using mouse lymphoma cells YY/T0870.3-2013
21In Vitro Mammalian Cell Gene Mutation Test
Biological evaluation of medical devices used in dentistry Part 17: Mouse lymphoma cells (TK) gene mutation test YY/T 0127.17-2014
Biological evaluation of medical devices - Part 3: Test for genotoxicity, carcinogenicity and reproductive toxicity GB/T 16886.3-2008
Biological evaluation of medical devices - Part 3: Test for genotoxicity, carcinogenicity and reproductive toxicity ISO 10993-3:2014
Bacterial Reverse Mutation Test OECD 471:1997
Test for genotoxicity of medical devices- Part 1:Bacterial reverse mutation test YY/T0870.1-2013
22Salmonella typhimurium reverse mutation assay
Biological evaluation of medical devices used in dentistry-Part 2:Test method-Salmonella typhimurium reverse mutation assay (Ames mutagenicity test) YY/T 0127.10-2009
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 7 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
Biological evaluation of medical devices - Part 6: Test for local effects after implantation GB/T 16886.6-2015
Biological evaluation of medical devices - Part 6: Test for local effects after implantation ISO 10993-6:2016
Test methods for infusion, transfusion, injection equipment for medical use-Part 2:Biological test methods GB/T 14233.2-2005
23 Local effects after implantation
Organic silicon material for medical use- Biological evaluation test methods GB/T 16175-2008
24 Subcutaneous implant test
Biological evaluation of dental materials-Part 2:Biological evaluation test method of dental materials-Subcutancous implant test YY/T 0127.8-2001
25 Bone implant test Biological evaluation of dental materials-Part 2:Biological evaluation test method of dental materials-Bone implant test YY/T 0127.4-2009
Biological evaluation of medical devices-Part 4: Selection of tests for interactions with blood GB/T 16886.4-2003
Biological evaluation of medical devices- Part 4: Selection of tests for interactions with blood ISO 10993-4:2017 26 In vivo thrombosis
testTest methods for infusion, transfusion, injection equipment for medical use-Part 2:Biological test methods GB/T 14233.2-2005
Biological evaluation of medical devices-Part 4: Selection of tests for interactions with blood GB/T 16886.4-2003
Biological evaluation of medical devices- Part 4: Selection of tests for interactions with blood ISO 10993-4:2017 27 In vitro thrombosis
testTest methods for infusion, transfusion, injection equipment for medical use-Part 2:Biological test methods GB/T 14233.2-2005
Biological evaluation of medical devices-Part 4: Selection of tests for interactions with blood GB/T 16886.4-2003
Biological evaluation of medical devices- Part 4: Selection of tests for interactions with blood ISO 10993-4:2017 28 Haemolysis test
Test methods for infusion, transfusion, injection equipment for medical use-Part 2:Biological test methods GB/T 14233.2-2005
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 8 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
Organic silicon material for medical use- Biological evaluation test methods GB/T 16175-2008
Biological evaluation of dental materials-Unit 1: Haemolysis test YY/T 0127.1-1993
Biological evaluation of medical devices-Part 4: Selection of tests for interactions with blood GB/T 16886.4-2003
Accredited only for CT,PT,PTT,TT
Biological evaluation of medical devices-Part 4: Selection of tests for interactions with blood ISO 10993-4:2017
29 In vitro coagulation relative test
Test methods for infusion, transfusion, injection equipment for medical use-Part 2:Biological test methods GB/T 14233.2-2005
Biological evaluation of medical devices-Part 4: Selection of tests for interactions with blood GB/T 16886.4-2003
Biological evaluation of medical devices-Part 4: Selection of tests for interactions with blood ISO 10993-4:2017 30 Platetet function test
Test methods for infusion, transfusion, injection equipment for medical use-Part 2:Biological test methods GB/T 14233.2-2005
Biological evaluation of medical devices-Part 4: Selection of tests for interactions with blood GB/T 16886.4-2003
Biological evaluation of medical devices-Part 4: Selection of tests for interactions with blood ISO 10993-4:2017 31 Haematology test
Test methods for infusion, transfusion, injection equipment for medical use-Part 2:Biological test methods GB/T 14233.2-2005
Biological evaluation of medical devices-Part 4: Selection of tests for interactions with blood GB/T 16886.4-2003
Biological evaluation of medical devices-Part 4: Selection of tests for interactions with blood ISO 10993-4:2017 32 Complement system
testTest for complement activation of medical devices-Part 1:Serum whole complement activation YY/T0878.1-2013
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 9 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
Test for complement activation of medical devices-Part 2:Serum alternative pathway complement activation YY/T 0878.2-2015
Test methods for infusion, transfusion, injection equipment for medical use-Part 2:Biological test methods GB/T 14233.2-2005
Biological evaluation of medical devices-Part 13: Identifition and quantification of degradation products from polymeric medical devices GB/T 16886.13-2017
Except for degraded production identification33
Bio-degrade test of polymeric medical devices Biological evaluation of medical devices-Part 13: Identifition and
quantification of degradation products from polymeric medical devices ISO 10993-13:2010
Except for degraded production identification
Biological evaluation of medical devices- Part 14:Identification and quantification of degradation products from ceramics GB/T 16886.14-2003
Accredited only for the extractable components34 Bio-degrade test of
ceramics
Biological evaluation of medical devices- Part 14:Identification and quantification of degradation products from ceramics ISO 10993-14:2001
Accredited only for the extractable components
Biological evaluation of medical devices-Part 20: Principles and methods for immunotoxicology testing of medical devices ISO/TS 10993-20:2006
35
Principles and methods for immunotoxicology testing
Biological evaluation of medical devices-Part 20: Principles and methods for immunotoxicology testing of medical devices GB/T 16886.20-2015
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 10 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
Tissue engineered medical product-Part 14:Standard Practice for Evaluation of Immune Responsesof Substrate and Scaffolds Products: ELISA Tests YY/T 0606.14-2014
Tissue engineered medical products-Part 15:Standard Practice for Evaluation of Immune Responses of substrate and scaffolds products: Lymphocyte proliferation tests YY/T 0606.15-2014
Tissue engineered medical products-Part 20:Standard Practice for Evaluation of Immune Responses of subatrates and scaffold products: Cell Migration tests. YY/T 0606.20-2014
Biological evaluation of medical devices-Part 9: Framework for identification and quantification of potential degradation products GB/T16886.9-2017
Accredited only for gravimetric analysis
Biological evaluation of medical devices-Part 9: Framework for identification and quantification of potential degradation products ISO 10993-9:2009
Accredited only for gravimetric analysis
Biological evaluation of medical devices - Part 6: Test for local effects after implantation GB/T 16886.6-2015
Biological evaluation of medical devices - Part 6: Test for local effects after implantation ISO 10993-6:2016
Biogical evaluation of medical devices-Part 13:Identification and quantification of degradation products from polymeric medical devices GB/T 16886.13-2017
Accredited only for gravimetric analysis
36 Test in vivo degradation
Biological evaluation of medical devices-Part 14:Identification and quantificaton of degradation products from ceramics GB/T16886.14-2003
Accredited only for gravimetric analysis
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 11 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
Biological eveluation of medical devices-Part 15:Inentificatoin and quantificatoin of degradation products from metals and alloys GB/T16886.15-2003
Accredited only for gravimetric analysis
Biological evaluation of medical devices- Part 16: Toxicokinetic study design for degradation products and leachables GB/T 16886.16-2013
Biological evaluation of medical devices- Part 15: Identification and quantification of degradation products from metals and alloys GB/T 16886.15-2003
37
Identification and quantification of degradation products from metals and alloys
Biological evaluation of medical devices- Part 15: Identification and quantification of degradation products from metals and alloys ISO 10993-15:2000
Biological evaluation of medical devices- Part 16: Toxicokinetic study design for degradation products and leachables GB/T 16886.16-2013
38
Toxicokinetic study design for degradation products and leachables
Biological evaluation of medical devices- Part 16: Toxicokinetic study design for degradation products and leachables ISO 10993-16:2017
Biological evaluation of medical devices used in dentistry Part 3: Endodontic usage test YY/T 0127.3-2014
39 Endodonic usage test Dentistry - evaluation of biocompatibility of medical devices used in dentistry ISO 7405:2018
Biological evaluation of dental materials-Part 7:Biological evaluation test method of dental materials-Pulp and dentine usage test YY/T 0127.7-2017
40 Pulp and dentine usage test Dentistry - evaluation of biocompatibility of medical devices used in dentistry
ISO 7405:2018
Biological evaluation of medical devices used in dentistry Part 11:pulp capping test YY/T0127.11-2014
41 Pulp capping test Dentistry - evaluation of biocompatibility of medical devices used in dentistry ISO 7405:2018
42 Residues DNA Tissue engineered medical product -Part 25:Quantification of remnant DNA in biological materials utilizing animal tissues and and their derivatives and
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 12 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
fluorescence method YY/T 0606.25-2014
Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 3407 Detection of exogenous DNA residues by second fluorescence staining
Test for reproductive and developmental toxicity of medical devices Part 1: Screening test YY/T 1292.1-2015
43
Test for reproductive and developmental toxicity of medical devices
Test for reproductive and developmental toxicity of medical devices Part 2: Prenatal developmental toxicity test YY/T 1292.2-2015
44
Biological evaluation of medical devices-Nanamaterial: In vitro cytotoxicity test (MTT assay and LDH assay)
Biological evaluation of medical devices-Nanamaterial: In vitro cytotoxicity test (MTT assay and LDH assay) YY/T 0993-2015
45
Biological evaluation of medical devices-Nanamaterial: Endotoxin test
Biological evaluation of medical devices-Nanamaterial: Endotoxin test YYT1295-2015
46
Immunogenic evaluation method of medical devices - Part 1: T Lymphocyte transformation test in vitro
Immunogenic evaluation method of medical devices - Part 1: T Lymphocyte transformation test in vitro YY/T 1465.1-2016
47
Immunogenic evaluation method of medical devices - Part 2: Serum immunoglobulin and complement
Immunogenic evaluation method of medical devices - Part 2: Serum immunoglobulin and complement component detection Enzyme-linked immunoadsordent assay YY/T 1465.2-2016
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 13 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
component detection Enzyme-linked immunoadsordent assay
48
Immunogenic evaluation method of medical devices Part 3:Plaque forming cellsassay Agar gel solid-phase method
Immunogenic evaluation method of medical devices Part 3:Plaque forming cellsassay Agar gel solid-phase method YY/T 1465.3-2016
49
Immunogenic evaluation method of medical devices - Part 5: Determination ofα-Gal antigen clearance in medical devices utilizing animal tissues and theirderivatives with M86 antibody
Immunogenic evaluation method of medical devices - Part 5: Determination ofα-Gal antigen clearance in medical devices utilizing animal tissues and theirderivatives with M86 antibody YY/T 1465.5-2016
50
Tissue engineering medical device products - remnant alpha1,3-Gal antigen determination in scaffold materials utilizing animal tissues and their derivatives
Tissue engineering medical device products - remnant alpha1,3-Gal antigen determination in scaffold materials utilizing animal tissues and their derivatives YY/T 1561-2017
51 Biological evaluation Biological evaluation of medical devices-Nanamaterial: Haemolysis test
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 14 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
of medical devices-Nanamaterial: Haemolysis test
YY/T 1532-2017
52
Immunogenic evaluation method of medical devices Part 4: Phagocytosis of mouse peritoneal macrophages on chicken erythrocytes:Ex vivo method
Immunogenic evaluation method of medical devices Part 4: Phagocytosis of mouse peritoneal macrophages on chicken erythrocytes:Ex vivo method YY/T 1465.4-2017
53 In vitro mouse embryo assay
Medical devices for human in vitro assisted reproductive technology ―In vitro mouse embryo assay YY/T 1434-2016
Chinese pharmacopoeia 2015 version Vol Ⅳ General chapters 1105 Microbial limit test for non-sterile products: microbial count
54 microbial limit
Chinese pharmacopoeia 2015 version Vol Ⅳ General chapters 1106 Microbial limit test for non-sterile products: method of controlled bacteria test
2 Hip joint prostheses 1 Part of Parameters Hip joint prostheses YY 0118-2016
Except for fatigue property, total artificial hip abrasion, EO residual, X-ray detection,C,H,O,N,Si,
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 15 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
Clˉ
2 Hip joint prostheses YY 0118-2016 7.2.1 Except for C,H,O,N
3 Hip joint prostheses YY 0118-2016 7.2.2
4 Hip joint prostheses YY 0118-2016 7.2.3
5 Hip joint prostheses YY 0118-2016 7.2.4
6 Hip joint prostheses YY 0118-2016 7.3.1
7 Hip joint prostheses YY 0118-2016 7.3.1
8 Hip joint prostheses YY 0118-2016 7.3.1
9 Hip joint prostheses YY 0118-2016 7.3.1
10 Hip joint prostheses YY 0118-2016 7.3.1
11 Hip joint prostheses YY 0118-2016 7.3.1 Except for Clˉ
12 Hip joint prostheses YY 0118-2016 7.4
13 Hip joint prostheses YY 0118-2016 7.5.1
14 Hip joint prostheses YY 0118-2016 7.5.1
15 Hip joint prostheses YY 0118-2016 7.5.1
16 Hip joint prostheses YY 0118-2016 7.5.1
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 16 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
17 Hip joint prostheses YY 0118-2016 7.5.1
18 Hip joint prostheses YY 0118-2016 7.5.2.1
19 Hip joint prostheses YY 0118-2016 7.5.2.2
20 Hip joint prostheses YY 0118-2016 7.5.2.3.2
21 Hip joint prostheses YY 0118-2016 7.5.2.3.3
22 Hip joint prostheses YY 0118-2016 8.2.1
23 Hip joint prostheses YY 0118-2016 8.2.2
24 Hip joint prostheses YY 0118-2016 8.2.3
25 Hip joint prostheses YY 0118-2016 8.3
26 Hip joint prostheses YY 0118-2016 8.4.1
27 Hip joint prostheses YY 0118-2016 8.4.2
28 Hip joint prostheses YY 0118-2016 8.5.4
29 Hip joint prostheses YY 0118-2016 8.5.5
30 Hip joint prostheses YY 0118-2016 10.2
1 Part of Parameters Implant for surgery-forgings and castings for bone joint prosthesis-forgings with titanium 6-aluminium 4-vanadium alloy YY0117.1-2005
Except for C,H,O,N3
Implant for surgery-forgings and castings for bone joint 2 Implant for surgery-forgings and castings for bone joint prosthesis-forgings
with titanium 6-aluminium 4-vanadium alloy YY0117.1-2005 3.1.2Except for C,H,O,N
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 17 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
Implant for surgery-forgings and castings for bone joint prosthesis-forgings with titanium 6-aluminium 4-vanadium alloy YY0117.1-2005 3.4
3 Mechanical properties (tensile strength) Metallic materials - Tensile testing - Part 1 : Method of test at room
temperature GB/T 228.1-2010
4 Implant for surgery-forgings and castings for bone joint prosthesis-forgings with titanium 6-aluminium 4-vanadium alloy YY0117.1-2005 3.4
5 Implant for surgery-forgings and castings for bone joint prosthesis-forgings with titanium 6-aluminium 5-vanadium alloy YY0117.1-2005 3.4
6 Implant for surgery-forgings and castings for bone joint prosthesis-forgings with titanium 6-aluminium 7-vanadium alloy YY0117.1-2005 3.5
7 Implant for surgery-forgings and castings for bone joint prosthesis-forgings with titanium 6-aluminium 8-vanadium alloy YY0117.1-2005 3.5
8 Implant for surgery-forgings and castings for bone joint prosthesis-forgings with titanium 6-aluminium 8-vanadium alloy YY0117.1-2005 3.5
Implant for surgery-forgings and castings for bone joint prosthesis-forgings with titanium 6-aluminium 8-vanadium alloy YY0117.1-2005 3.6
9 Internal quality macrostructure) Microstructure and macrostructure examination for α-β titanium alloys GB/T
5168-2008
10 Implant for surgery-forgings and castings for bone joint prosthesis-forgings with titanium 6-aluminium 8-vanadium alloy YY0117.1-2005 3.6
Implant for surgery-forgings and castings for bone joint prosthesis-forgings with titanium 6-aluminium 8-vanadium alloy YY0117.1-2005 3.6
11 Internal quality microstructure) Microstructure and macrostructure examination for α-β titanium alloys GB/T
5168-2008
prosthesis-forgings with titanium 6-aluminium 4-vanadium alloy
12 Implant for surgery-forgings and castings for bone joint prosthesis-forgings with titanium 6-aluminium 8-vanadium alloy YY0117.1-2005 3.7
4
Implant for surgery-forgings and castings for bone joint
1 Part of Parameters Implant for surgery-forgings and castings for bone joint prosthesis-castings with titanium 6-aluminium 4-vanadium alloy YY 0117.2-2005
Except for C,H,O,N,internal quality
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 18 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
2 Implant for surgery-forgings and castings for bone joint prosthesis-castings with titanium 6-aluminium 4-vanadium alloy YY 0117.2-2005 3.1
Except for C,H,O,N
3 Implant for surgery-forgings and castings for bone joint prosthesis-castings with titanium 6-aluminium 4-vanadium alloy YY 0117.2-2005 3.2
Except for C,H,O,N
4 Implant for surgery-forgings and castings for bone joint prosthesis-castings with titanium 6-aluminium 4-vanadium alloy YY 0117.2-2005 3.5
5 Implant for surgery-forgings and castings for bone joint prosthesis-castings with titanium 6-aluminium 4-vanadium alloy YY 0117.2-2005 3.5
6 Implant for surgery-forgings and castings for bone joint prosthesis-castings with titanium 6-aluminium 4-vanadium alloy YY 0117.2-2005 3.5
7 Implant for surgery-forgings and castings for bone joint prosthesis-castings with titanium 6-aluminium 4-vanadium alloy YY 0117.2-2005 3.5
8 Implant for surgery-forgings and castings for bone joint prosthesis-castings with titanium 6-aluminium 4-vanadium alloy YY 0117.2-2005 3.6
9 Implant for surgery-forgings and castings for bone joint prosthesis-castings with titanium 6-aluminium 4-vanadium alloy YY 0117.2-2005 3.6
10 Implant for surgery-forgings and castings for bone joint prosthesis-castings with titanium 6-aluminium 4-vanadium alloy YY 0117.2-2005 3.6
prosthesis-castings with titanium 6-aluminium 4-vanadium alloy
11 Implant for surgery-forgings and castings for bone joint prosthesis-castings with titanium 6-aluminium 4-vanadium alloy YY 0117.2-2005 3.8
1 Part of Parameters Implant for surgery-forgings and castings for bone joint prosthesis-castings cobalt-chrimium-molybdenumalloy YY0117.3-2005
Except for C,Si,internal quality
2 Implant for surgery-forgings and castings for bone joint prosthesis-castings cobalt-chrimium-molybdenumalloy YY0117.3-2005 3.1
Except for C,Si
3 Implant for surgery-forgings and castings for bone joint prosthesis-castings cobalt-chrimium-molybdenumalloy YY0117.3-2005 3.1
Except for C,Si
5
Implant for surgery-forgings and castings for bone joint prosthesis-castings cobalt-chrimium-molybdenumalloy 4 Implant for surgery-forgings and castings for bone joint prosthesis-castings
cobalt-chrimium-molybdenumalloy YY0117.3-2005 3.4
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 19 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
5 Implant for surgery-forgings and castings for bone joint prosthesis-castings cobalt-chrimium-molybdenumalloy YY0117.3-2005 3.4
6 Implant for surgery-forgings and castings for bone joint prosthesis-castings cobalt-chrimium-molybdenumalloy YY0117.3-2005 3.4
Implant for surgery-forgings and castings for bone joint prosthesis-castings cobalt-chrimium-molybdenumalloy YY0117.3-2005 3.4 limitation
7 Mechanical properties (Rockwell hardness) Metallic materials—Rockwell hardness test—Part 1:Test method GB/T 230.1-
2018
8 Implant for surgery-forgings and castings for bone joint prosthesis-castings cobalt-chrimium-molybdenumalloy YY0117.3-2005 3.5.1
9 Implant for surgery-forgings and castings for bone joint prosthesis-castings cobalt-chrimium-molybdenumalloy YY0117.3-2005 3.5.2
10 Implant for surgery-forgings and castings for bone joint prosthesis-castings cobalt-chrimium-molybdenumalloy YY0117.3-2005 3.5.3
11 Implant for surgery-forgings and castings for bone joint prosthesis-castings cobalt-chrimium-molybdenumalloy YY0117.3-2005 3.5.4
12 Implant for surgery-forgings and castings for bone joint prosthesis-castings cobalt-chrimium-molybdenumalloy YY0117.3-2005 3.7
1 Part of Parameters Implants for osteosynthesis-Metallic bone plates YY 0017-2016
Except for C,H,O,N,Corrosion resistence fatigue properties
2 Implants for osteosynthesis-Metallic bone plates YY 0017-2016 4.1.2
3 Implants for osteosynthesis-Metallic bone plates YY 0017-2016 4.1.3
6
Implants for osteosynthesis-Metallic bone plates
4 Hardness Implants for osteosynthesis-Metallic bone plates YY 0017-2016 4.2.1
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 20 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
Metallic materials - Vickers hardness test - Part 1: Test method GB/T 4340.1-2009
5 Implants for osteosynthesis-Metallic bone plates YY 0017-2016 4.2.2
6 Implants for osteosynthesis-Metallic bone plates YY 0017-2016 4.4.1
7 Implants for osteosynthesis-Metallic bone plates YY 0017-2016 4.4.2
8 Implants for osteosynthesis-Metallic bone plates YY 0017-2016 4.4.3
9 Implants for osteosynthesis-Metallic bone plates YY 0017-2016 4.4.4
10 Implants for osteosynthesis-Metallic bone plates YY 0017-2016 4.5
1 Part of Parameters Implants for Osteosyn- thesis-Metallic bone screws YY 0018-2016 Except for C,H,O,N
2 Implants for Osteosyn- thesis-Metallic bone screws YY 0018-2016 4.1 Except for C,H,O,N
3 Implants for Osteosyn- thesis-Metallic bone screws YY 0018-2016 4.1 Except for C,H,O,N
4 Implants for Osteosyn- thesis-Metallic bone screws YY 0018-2016 4.2.1
5 Implants for Osteosyn- thesis-Metallic bone screws YY 0018-2016 4.3
6 Implants for Osteosyn- thesis-Metallic bone screws YY 0018-2016 4.4.1
7 Implants for Osteosyn- thesis-Metallic bone screws YY 0018-2016 4.4.2
8 Implants for Osteosyn- thesis-Metallic bone screws YY 0018-2016 4.4.3
7
Implants for Osteosyn- thesis-Metallic bone screws
9 Implants for Osteosyn- thesis-Metallic bone screws YY 0018-2016 4.5
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 21 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
1 Part of Parameters Implants for ostesynthesis part 2-Metallic intramedullary nailing YY/T0019.2-2011
Except for C,H,O,N
2 Implants for ostesynthesis part 2-Metallic intramedullary nailing YY/T0019.2-2011 3
Except for C,H,O,N
3 Implants for ostesynthesis part 2-Metallic intramedullary nailing YY/T0019.2-2011 4
4 Implants for ostesynthesis part 2-Metallic intramedullary nailing YY/T0019.2-2011 5
8
Implants for ostesynthesis part 2-Metallic intramedullary nailing
5 Implants for ostesynthesis part 2-Metallic intramedullary nailing YY/T0019.2-2011 6
All Parameters Implants for surgery-Hydroxyapatite-Part 2:Coating of hydroxyapatite GB23101.2-2008
Implants for surgery-Hydroxyapatite-Part 2:Coating of hydroxyapatite ISO13779.2-2008 4.1
Implants for surgery-Hydroxyapatite-Part 2:Coating of hydroxyapatite GB23101.2-2008 4.1
Implants for surgery―Hydroxyapatite―Part 3:Chemical analysis and characterization of crystallinity and phase purity GB 23101.3-2010 10
1
Calcium to phosphorus molar ratio(Chemical analysis)
Implants for surgery―Hydroxyapatite―Part 3:Chemical analysis and characterization of crystallinity and phase purity ISO13779-3:2008 10
Implants for surgery-Hydroxyapatite-Part 2:Coating of hydroxyapatite GB23101.2-2008 4.2
Implants for surgery-Hydroxyapatite-Part 2:Coating of hydroxyapatite ISO13779.2-2008 4.2
Implants for surgery―Hydroxyapatite―Part 3:Chemical analysis and characterization of crystallinity and phase purity GB 23101.3-2010 9
2
As,Cd,Hg,Pb(trace elements) and the total amount of heavy metals
Implants for surgery―Hydroxyapatite―Part 3:Chemical analysis and characterization of crystallinity and phase purity ISO13779-3:2008 9
9
Implants for surgery-Hydroxyapatite-Part 2:Coating of hydroxyapatite
3 Crystalline phase compositions
Implants for surgery-Hydroxyapatite-Part 2:Coating of hydroxyapatite GB23101.2-2008 4.3
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 22 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
Implants for surgery-Hydroxyapatite-Part 2:Coating of hydroxyapatite ISO13779.2-2008 4.3
Implants for surgery―Hydroxyapatite―Part 3:Chemical analysis and characterization of crystallinity and phase purity GB 23101.3-2010 11
Implants for surgery―Hydroxyapatite―Part 3:Chemical analysis and characterization of crystallinity and phase purity GB 23101.3-2010 12
Implants for surgery―Hydroxyapatite―Part 3:Chemical analysis and characterization of crystallinity and phase purity ISO13779-3:2008 11
Implants for surgery―Hydroxyapatite―Part 3:Chemical analysis and characterization of crystallinity and phase purity ISO13779-3:2008 12
Implants for surgery-Hydroxyapatite-Part 2:Coating of hydroxyapatite GB23101.2-2008 4.4
Implants for surgery-Hydroxyapatite-Part 2:Coating of hydroxyapatite ISO13779.2-2008 4.4
Implants for surgery―Hydroxyapatite―Part 4:Determination of coating adhesion strength GB/T 23101.4-2008
4 Coating adhesion strength
Implants for surgery―Hydroxyapatite―Part 4:Determination of coating adhesion strength ISO13779-4:2002
All Parameters Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation ASTM F1088-04a(Reapproved 2010)/YY/T 0683-2008
1 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation ASTM F1088-04a(Reapproved 2010) 3.3
2 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation ASTM F1088-04a(Reapproved 2010) 3.3
3 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation ASTM F1088-04a(Reapproved 2010) 3.3
10
Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
4 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation ASTM F1088-04a(Reapproved 2010) 3.3
11 Ceramics All Parameters Implants for surgery-Hydroxyapatite-Part 1:Ceramics hydroxyapatite
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 23 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
GB23101.1-2008/ISO13779-1:2008
1 Implants for surgery-Hydroxyapatite-Part 1:Ceramics hydroxyapatite GB23101.1-2008 4.1.1.1
2 Implants for surgery-Hydroxyapatite-Part 1:Ceramics hydroxyapatite ISO13779-1:2008 4.1.1.1
3 Implants for surgery-Hydroxyapatite-Part 1:Ceramics hydroxyapatite GB23101.1-2008 4.1.1.2
4 Implants for surgery-Hydroxyapatite-Part 1:Ceramics hydroxyapatite ISO13779-1:2008 4.1.1.2
5 Hydroxyapatite Bioactive Ceramics YY 0305-1998 4.1.1.3
6 Hydroxyapatite Bioactive Ceramics YY 0305-1998 4.1.1.4
7 Hydroxyapatite Bioactive Ceramics YY 0305-1998 4.1.2.1
8 Hydroxyapatite Bioactive Ceramics YY 0305-1998 4.1.2.2
9 Hydroxyapatite Bioactive Ceramics YY 0305-1998 4.1.2.3
10 Hydroxyapatite Bioactive Ceramics YY 0305-1998 4.1.2.4
11 Hydroxyapatite Bioactive Ceramics YY 0305-1998 4.1.2.5
hydroxyapatite
12 Hydroxyapatite Bioactive Ceramics YY 0305-1998 4.2
All Parameters Hydroxyapatite Powder YY 0303-1998
1 Hydroxyapatite Powder YY 0303-1998 4.2 12 Hydroxyapatite Powder
2 Particle sizes Hydroxyapatite Powder YY 0303-1998 4.3
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 24 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
Metallic powders - Determination of particle size by dry sieving GB/T 1480-2012
Hydroxyapatite Powder YY 0303-1998 4.4 3 Hydroxyapatite
content Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0451 X-ray diffraction
Hydroxyapatite Powder YY 0303-1998 4.5
Phosphate rock and concentrate--Determination of calcium oxide content--Volumetric methods GB/T 1871.4-1995 4
Calcium to phosphorus molar ratio Phosphate rock and concentrate--Determination of phosphrous pentoxide
content--Quinoline phosphomolybdate gravimetric and volumetric methods GB/T 1871.1-1995
5 Hydroxyapatite Powder YY 0303-1998 4.6
Hydroxyapatite Powder YY 0303-1998 4.7
Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0821 Heavy metal inspection
6
As,Cd,Hg,Pb(trace elements) and the total amount of heavy metals Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0822 Arsenic
salt test
All Parameters Standard Specification for Composition of Anorganic Bone for Surgical Implants ASTM F1581-2008
1 Standard Specification for Composition of Anorganic Bone for Surgical Implants ASTM F1581-2008 4.1
2 Standard Specification for Composition of Anorganic Bone for Surgical Implants ASTM F1581-2008 4.2
13
Standard Specification for Composition of Anorganic Bone for Surgical Implants 3 Standard Specification for Composition of Anorganic Bone for Surgical
Implants ASTM F1581-2008 4.3
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 25 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
4 Standard Specification for Composition of Anorganic Bone for Surgical Implants ASTM F1581-2008 4.4
5 Standard Specification for Composition of Anorganic Bone for Surgical Implants ASTM F1581-2008 4.5
6 Standard Specification for Composition of Anorganic Bone for Surgical Implants ASTM F1581-2008 4.6
7 Standard Specification for Composition of Anorganic Bone for Surgical Implants ASTM F1581-2008 4.7
8 Standard Specification for Composition of Anorganic Bone for Surgical Implants ASTM F1581-2008 4.8
9 Standard Specification for Composition of Anorganic Bone for Surgical Implants ASTM F1581-2008 4.9
All Parameters Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation ASTM F1538-2003
1 Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation ASTM F1538-2003 4.1
2 Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation ASTM F1538-2003 4.2
3 Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation ASTM F1538-2003 4.2
4 Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation ASTM F1538-2003 4.2
5 Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation ASTM F1538-2003 4.2
6 Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation ASTM F1538-2003 4.2
7 Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation ASTM F1538-2003 5.1.1
14
Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation
8 Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation ASTM F1538-2003 5.1.2
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 26 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
9 Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation ASTM F1538-2003 5.1.3
10 Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation ASTM F1538-2003 5.1.4
11 Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation ASTM F1538-2003 5.1.5
12 Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation ASTM F1538-2003 5.1.6
13 Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation ASTM F1538-2003 5.1.7
14 Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation ASTM F1538-2003 5.1.8
15 Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation ASTM F1538-2003 5.1.9
16 Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation ASTM F1538-2003 6
All Parameters General specification for surgical implants made of silicone elastomer YY0334-2002
1 General specification for surgical implants made of silicone elastomer YY0334-2002 4
2 General specification for surgical implants made of silicone elastomer YY0334-2002 5.2
3 General specification for surgical implants made of silicone elastomer YY0334-2002 5.3.1
4 General specification for surgical implants made of silicone elastomer YY0334-2002 5.3.2
5 General specification for surgical implants made of silicone elastomer YY0334-2002 5.4.1
15 silicone elastomer
6 General specification for surgical implants made of silicone elastomer YY0334-2002 5.4.2
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 27 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
7 General specification for surgical implants made of silicone elastomer YY0334-2002 5.4.3
8 General specification for surgical implants made of silicone elastomer YY0334-2002 5.4.4
9 General specification for surgical implants made of silicone elastomer YY0334-2002 5.4.5
10 General specification for surgical implants made of silicone elastomer YY0334-2002 5.4.6
11 General specification for surgical implants made of silicone elastomer YY0334-2002 6
All Parameters General technique requirements for orthopaedics clamp(scissor) YY 1122-2005
1 General technique requirements for orthopaedics clamp(scissor) YY 1122-2005 4.1
2 General technique requirements for orthopaedics clamp(scissor) YY 1122-2005 4.2
3 General technique requirements for orthopaedics clamp(scissor) YY 1122-2005 4.3
16 orthopaedics clamp(scissor)
4 General technique requirements for orthopaedics clamp(scissor) YY 1122-2005 4.4
All Parameters General technique requirements for orthopaedics saw YY 1137-2005
1 General technique requirements for orthopaedics saw YY 1137-2005 4.1
2 General technique requirements for orthopaedics saw YY 1137-2005 4.2
3 General technique requirements for orthopaedics saw YY 1137-2005 4.3
17 orthopaedics saw
4 General technique requirements for orthopaedics saw YY 1137-2005 4.4
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 28 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
5 General technique requirements for orthopaedics saw YY 1137-2005 4.5
6 General technique requirements for orthopaedics saw YY 1137-2005 4.6
7 General technique requirements for orthopaedics saw YY 1137-2005 4.7
All Parameters Medical forceps YY/T0686-2008
1 Medical forceps YY/T0686-2008 4.1
2 Medical forceps YY/T0686-2008 4.2
3 Medical forceps YY/T0686-2008 4.3
4 Medical forceps YY/T0686-2008 4.4
5 Medical forceps YY/T0686-2008 4.4
6 Medical forceps YY/T0686-2008 4.4
18 Medical forceps
7 Medical forceps YY/T0686-2008 4.4
All Parameters General technique requirements for orthopedic chisel YY/T 91141-1999
1 General technique requirements for orthopedic chisel YY/T 91141-1999 1.1
2 General technique requirements for orthopedic chisel YY/T 91141-1999 1.2
3 General technique requirements for orthopedic chisel YY/T 91141-1999 1.3
19
General technique requirements for orthopedic chisel
4 General technique requirements for orthopedic chisel YY/T 91141-1999 1.4
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 29 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
5 General technique requirements for orthopedic chisel YY/T 91141-1999 1.5
6 General technique requirements for orthopedic chisel YY/T 91141-1999 1.6
7 General technique requirements for orthopedic chisel YY/T 91141-1999 1.7
8 General technique requirements for orthopedic chisel YY/T 91141-1999 1.8
9 General technique requirements for orthopedic chisel YY/T 91141-1999 1.9
10 General technique requirements for orthopedic chisel YY/T 91141-1999 1.10
Part of Parameters Peritoneal dialysis tube YY 0030-2004
Except for radiation detectability
1 Peritoneal dialysis tube YY 0030-2004 5.1
2 Peritoneal dialysis tube YY 0030-2004 5.2
3 Peritoneal dialysis tube YY 0030-2004 5.3
4 Peritoneal dialysis tube YY 0030-2004 5.4
5 Peritoneal dialysis tube YY 0030-2004 5.5
6 Peritoneal dialysis tube YY 0030-2004 5.6
7 Peritoneal dialysis tube YY 0030-2004 5.7
20 Peritoneal dialysis tube
8 Peritoneal dialysis tube YY 0030-2004 5.9
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 30 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
9 Peritoneal dialysis tube YY 0030-2004 6
10 Peritoneal dialysis tube YY 0030-2004 7
All Parameters Silicone tubes and elastomeric parts for infusion and transfusion YY/T 0031-2008
1 Silicone tubes and elastomeric parts for infusion and transfusion YY/T 0031-2008 4.1
Silicone tubes and elastomeric parts for infusion and transfusion YY/T 0031-2008 4.2
2 Shore hardness Rubber, vulcanized or thermoplastic - Determination of indentation hardness - Part 1:Duromerer method (Shore hardness) GB/T 531.1-2008
3 Silicone tubes and elastomeric parts for infusion and transfusion YY/T 0031-2008 4.2
4 Silicone tubes and elastomeric parts for infusion and transfusion YY/T 0031-2008 4.2
5 Silicone tubes and elastomeric parts for infusion and transfusion YY/T 0031-2008 4.2
Silicone tubes and elastomeric parts for infusion and transfusion YY/T 0031-2008 4.2
6 Tear strength Rubber,vulcanized or thermoplastic - Determination of tear strength(Trouser,angle and crescent test pieces) GB/T 529-2008
7 Silicone tubes and elastomeric parts for infusion and transfusion YY/T 0031-2008 4.2
8 Silicone tubes and elastomeric parts for infusion and transfusion YY/T 0031-2008 4.2
9 Silicone tubes and elastomeric parts for infusion and transfusion YY/T 0031-2008 4.2
21
Silicone tubes and elastomeric parts for infusion and transfusion
10 Silicone tubes and elastomeric parts for infusion and transfusion YY/T 0031-2008 4.2
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 31 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
11 Silicone tubes and elastomeric parts for infusion and transfusion YY/T 0031-2008 4.3.2
12 Silicone tubes and elastomeric parts for infusion and transfusion YY/T 0031-2008 4.3.3
13 Silicone tubes and elastomeric parts for infusion and transfusion YY/T 0031-2008 4.4
14 Silicone tubes and elastomeric parts for infusion and transfusion YY/T 0031-2008 4.4
15 Silicone tubes and elastomeric parts for infusion and transfusion YY/T 0031-2008 4.4
16 Silicone tubes and elastomeric parts for infusion and transfusion YY/T 0031-2008 4.4
17 Silicone tubes and elastomeric parts for infusion and transfusion YY/T 0031-2008 4.4
18 Silicone tubes and elastomeric parts for infusion and transfusion YY/T 0031-2008 4.4
19 Silicone tubes and elastomeric parts for infusion and transfusion YY/T 0031-2008 4.5
All Parameters U.S. Food and Drug Administration (FDA) [Web site]. InFUSEBone Graft/LT-CAGELumbar Tapered Fusion Devices FDA P000058
22
InFUSEBone Graft/LT-CAGELumbar Tapered Fusion Devices
1 U.S. Food and Drug Administration (FDA) [Web site]. InFUSEBone Graft/LT-CAGELumbar Tapered Fusion Devices FDA P000058 4
1 Part of Parameters Tissue engineered medical products part 6: type Ⅰcollagen YY/T 0606.6
Except for the struction analysis23 type Ⅰcollagen
2 Tissue engineered medical products part 6: type Ⅰcollagen YY/T 0606.6 5.1
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 32 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
3 Tissue engineered medical products part 6: type Ⅰcollagen YY/T 0606.6 5.3
4 Tissue engineered medical products part 6: type Ⅰcollagen YY/T 0606.6 5.4
5 Tissue engineered medical products part 6: type Ⅰcollagen YY/T 0606.6 5.5
6 Tissue engineered medical products part 6: type Ⅰcollagen YY/T 0606.6 5.6
7 Tissue engineered medical products part 6: type Ⅰcollagen YY/T 0606.6 5.7
8 Tissue engineered medical products part 6: type Ⅰcollagen YY/T 0606.6 5.8
9 Tissue engineered medical products part 6: type Ⅰcollagen YY/T 0606.6 5.9
10 Tissue engineered medical products part 6: type Ⅰcollagen YY/T 0606.6 5.10
11 Tissue engineered medical products part 6: type Ⅰcollagen YY/T 0606.6 5.11
12 Tissue engineered medical products part 6: type Ⅰcollagen YY/T 0606.6 5.12
13 Tissue engineered medical products part 6: type Ⅰcollagen YY/T 0606.6 5.13
14 Tissue engineered medical products part 6: type Ⅰcollagen YY/T 0606.6 5.14
All Parameters Tissue engineered medical products part 7: chitosan YY/T 0606.7-2008 24 chitosan
1 Tissue engineered medical products part 7: chitosan YY/T 0606.7-2008 6.1
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 33 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
2 Tissue engineered medical products part 7: chitosan YY/T 0606.7-2008 6.2
3 Tissue engineered medical products part 7: chitosan YY/T 0606.7-2008 6.3
4 Tissue engineered medical products part 7: chitosan YY/T 0606.7-2008 6.4
5 Tissue engineered medical products part 7: chitosan YY/T 0606.7-2008 6.5
6 Tissue engineered medical products part 7: chitosan YY/T 0606.7-2008 6.6
7 Tissue engineered medical products part 7: chitosan YY/T 0606.7-2008 6.7
8 Tissue engineered medical products part 7: chitosan YY/T 0606.7-2008 6.8
9 Tissue engineered medical products part 7: chitosan YY/T 0606.7-2008 6.9
10 Tissue engineered medical products part 7: chitosan YY/T 0606.7-2008 6.10
11 Tissue engineered medical products part 7: chitosan YY/T 0606.7-2008 6.11
12 Tissue engineered medical products part 7: chitosan YY/T 0606.7-2008 6.12
13 Tissue engineered medical products part 7: chitosan YY/T 0606.7-2008 6.14
25 alginate 1 Part of Parameters Tissue engineered medical products part 8: alginate YY/T 0606.8-2008
Except for NMR,The average molecular weight and molecular
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 34 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
weight distribution,Microbial Limit
2 Tissue engineered medical products part 8: alginate YY/T 0606.8-2008 4.1
3 Tissue engineered medical products part 8: alginate YY/T 0606.8-2008 4.2
4 Tissue engineered medical products part 8: alginate YY/T 0606.8-2008 4.5
5 Tissue engineered medical products part 8: alginate YY/T 0606.8-2008 4.6
6 Tissue engineered medical products part 8: alginate YY/T 0606.8-2008 4.7
7 Tissue engineered medical products part 8: alginate YY/T 0606.8-2008 4.8
8 Tissue engineered medical products part 8: alginate YY/T 0606.8-2008 4.9
9 Tissue engineered medical products part 8: alginate YY/T 0606.8-2008 4.11
Tissue engineered medical products part 8: alginate YY/T 0606.8-2008 4.10
Chinese pharmacopoeia 2015 version Vol Ⅳ General chapters 1105 Microbial limit test for non-sterile products: microbial count
10 microbial limit
Chinese pharmacopoeia 2015 version Vol Ⅳ General chapters 1106 Microbial limit test for non-sterile products: method of controlled bacteria test
All Parameters Tissue engineered medical products part 9: sodium hyaluronate YY/T 0606.9-2007
26 sodium hyaluronate
1 Tissue engineered medical products part 9: sodium hyaluronate YY/T 0606.9-2007 5.1
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 35 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
2 Tissue engineered medical products part 9: sodium hyaluronate YY/T 0606.9-2007 5.2
3 Tissue engineered medical products part 9: sodium hyaluronate YY/T 0606.9-2007 5.3
4 Tissue engineered medical products part 9: sodium hyaluronate YY/T 0606.9-2007 5.4
5 Tissue engineered medical products part 9: sodium hyaluronate YY/T 0606.9-2007 5.5
6 Tissue engineered medical products part 9: sodium hyaluronate YY/T 0606.9-2007 5.6
7 Tissue engineered medical products part 9: sodium hyaluronate YY/T 0606.9-2007 5.7
8 Tissue engineered medical products part 9: sodium hyaluronate YY/T 0606.9-2007 5.8
9 Tissue engineered medical products part 9: sodium hyaluronate YY/T 0606.9-2007 5.9
10 Tissue engineered medical products part 9: sodium hyaluronate YY/T 0606.9-2007 5.10
11 Tissue engineered medical products part 9: sodium hyaluronate YY/T 0606.9-2007 5.11
12 Tissue engineered medical products part 9: sodium hyaluronate YY/T 0606.9-2007 5.12
13 Tissue engineered medical products part 9: sodium hyaluronate YY/T 0606.9-2007 5.13
14 Tissue engineered medical products part 9: sodium hyaluronate YY/T 0606.9-2007 5.14
15 Tissue engineered medical products part 9: sodium hyaluronate YY/T 0606.9-2007 5.15
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 36 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
16 Tissue engineered medical products part 9: sodium hyaluronate YY/T 0606.9-2007 5.16
All Parameters Wrought titanium and titanium dental implant YY 0315-2016Except for Fatigue Limit
1 Wrought titanium and titanium dental implant YY 0315-2016 5.1
2 Wrought titanium and titanium dental implant YY 0315-2016 5.2
3 Wrought titanium and titanium dental implant YY 0315-2016 5.3.1
4 Wrought titanium and titanium dental implant YY 0315-2016 5.3.2.1
5 Wrought titanium and titanium dental implant YY 0315-2016 5.3.2.2
6 Wrought titanium and titanium dental implant YY 0315-2016 5.3.2.3
7 Wrought titanium and titanium dental implant YY 0315-2016 5.4.1
Wrought titanium and titanium dental implant YY 0315-2016 5.4.2 8 Surface defect
Liquid penetrant inspection of metallic surgical implants YY/T 0343-2002
9 Wrought titanium and titanium dental implant YY 0315-2016 5.4.3
10 Wrought titanium and titanium dental implant YY 0315-2016 5.5
11 Wrought titanium and titanium dental implant YY 0315-2016 5.6.1
27
Wrought titanium and titanium dental implant
12 Wrought titanium and titanium dental implant YY 0315-2016 5.6.2
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 37 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
13 Wrought titanium and titanium dental implant YY 0315-2016 5.7
Wrought titanium and titanium dental implant YY 0315-2016 5.6.3 14 Fatigue limit Dentistry-Implants-Dynamic fatigue test for endosseous dental implants YY/T
0521-2018
15 Wrought titanium and titanium dental implant YY 0315-2016 5.8
16 Wrought titanium and titanium dental implant YY 0315-2016 5.9
All Parameters Plasma sprayed hydroxyapatite coated titanium dental implant YY0304-2009Except for Fatigue limit
1 Plasma sprayed hydroxyapatite coated titanium dental implant YY0304-2009 4.2.1
2 Plasma sprayed hydroxyapatite coated titanium dental implant YY0304-2009 4.2.2
3 Plasma sprayed hydroxyapatite coated titanium dental implant YY0304-2009 4.2.3
4 Plasma sprayed hydroxyapatite coated titanium dental implant YY0304-2009 4.2.4
5 Plasma sprayed hydroxyapatite coated titanium dental implant YY0304-2009 4.2.5
6 Plasma sprayed hydroxyapatite coated titanium dental implant YY0304-2009 4.2.6
7 Plasma sprayed hydroxyapatite coated titanium dental implant YY0304-2009 4.3.1
8 Plasma sprayed hydroxyapatite coated titanium dental implant YY0304-2009 4.3.2.1.1
28
Plasma sprayed hydroxyapatite coated titanium dental implant
9 Plasma sprayed hydroxyapatite coated titanium dental implant YY0304-2009 4.3.2.1.2
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 38 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
10 Plasma sprayed hydroxyapatite coated titanium dental implant YY0304-2009 4.3.2.1.3
11 Plasma sprayed hydroxyapatite coated titanium dental implant YY0304-2009 4.3.2.2
12 Plasma sprayed hydroxyapatite coated titanium dental implant YY0304-2009 4.3.3
13 Plasma sprayed hydroxyapatite coated titanium dental implant YY0304-2009 4.4
Plasma sprayed hydroxyapatite coated titanium dental implant YY0304-2009 4.3.4
14 Dynamic fatigue test Dentistry-Implants-Dynamic fatigue test for endosseous dental implants YY/T 0521-2018
15 Plasma sprayed hydroxyapatite coated titanium dental implant YY0304-2009 4.5
All Parameters Dentistry-polymer-based crown and bridge materials YY 0710-2009
1 Dentistry-polymer-based crown and bridge materials YY 0710-2009 5.1
2 Dentistry-polymer-based crown and bridge materials ISO 10477:2004 5.1
3 Dentistry-polymer-based crown and bridge materials YY 0710-2009 5.2
4 Dentistry-polymer-based crown and bridge materials ISO 10477:2004 5.2
5 Dentistry-polymer-based crown and bridge materials YY 0710-2009 5.3
6 Dentistry-polymer-based crown and bridge materials ISO 10477:2004 5.3
29polymer-based crown and bridge materials
7 Dentistry-polymer-based crown and bridge materials YY 0710-2009 5.4
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 39 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
8 Dentistry-polymer-based crown and bridge materials ISO 10477:2004 5.4
9 Dentistry-polymer-based crown and bridge materials YY 0710-2009 5.5
10 Dentistry-polymer-based crown and bridge materials ISO 10477:2004 5.5
11 Dentistry-polymer-based crown and bridge materials YY 0710-2009 5.6
12 Dentistry-polymer-based crown and bridge materials ISO 10477:2004 5.6
13 Dentistry-polymer-based crown and bridge materials YY 0710-2009 5.7
14 Dentistry-polymer-based crown and bridge materials ISO 10477:2004 5.7
15 Dentistry-polymer-based crown and bridge materials YY 0710-2009 5.8
16 Dentistry-polymer-based crown and bridge materials ISO 10477:2004 5.8
17 Dentistry-polymer-based crown and bridge materials YY 0710-2009 5.9
18 Dentistry-polymer-based crown and bridge materials ISO 10477:2004 5.9
19 Dentistry-polymer-based crown and bridge materials YY 0710-2009 5.10
20 Dentistry-polymer-based crown and bridge materials ISO 10477:2004 5.10
part of Parameters Dentistry-Artificial teeth for dental prostheses YY 0300-2009Except for radioactivity30
Artificial teeth for dental prostheses 1 Dentistry-Artificial teeth for dental prostheses YY 0300-2009 5.1.1
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 40 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
2 Dentistry-Artificial teeth for dental prostheses YY 0300-2009 5.1.2
3 Dentistry-Artificial teeth for dental prostheses YY 0300-2009 5.1.3
4 Dentistry-Artificial teeth for dental prostheses YY 0300-2009 5.1.4
5 Dentistry-Artificial teeth for dental prostheses YY 0300-2009 5.1.5
6 Dentistry-Artificial teeth for dental prostheses YY 0300-2009 5.2.2
7 Dentistry-Artificial teeth for dental prostheses YY 0300-2009 5.2.3
8 Dentistry-Artificial teeth for dental prostheses YY 0300-2009 5.3.1
9 Dentistry-Artificial teeth for dental prostheses YY 0300-2009 5.3.2
10 Dentistry-Artificial teeth for dental prostheses YY 0300-2009 5.3.3
11 Dentistry-Artificial teeth for dental prostheses YY 0300-2009 5.3.4
1 All of Parameters Dentistry-Base polymers-Part 1:Denture base polymers YY 0270.1-2011
Except for Maximum flexural strength and Total work of fracture
2 Dentistry-Base polymers-Part 1:Denture base polymers YY 0270.1-2011 5.1.1
31 Denture base polymers
3 Dentistry-Base polymers-Part 1:Denture base polymers YY 0270.1-2011 5.1.2
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 41 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
4 Dentistry-Base polymers-Part 1:Denture base polymers YY 0270.1-2011 5.1.3
5 Dentistry-Base polymers-Part 1:Denture base polymers YY 0270.1-2011 5.2.2
6 Dentistry-Base polymers-Part 1:Denture base polymers YY 0270.1-2011 5.2.3
7 Dentistry-Base polymers-Part 1:Denture base polymers YY 0270.1-2011 5.2.4
8 Dentistry-Base polymers-Part 1:Denture base polymers YY 0270.1-2011 5.2.5
9 Dentistry-Base polymers-Part 1:Denture base polymers YY 0270.1-2011 5.2.6
10 Dentistry-Base polymers-Part 1:Denture base polymers YY 0270.1-2011 5.2.7
11 Dentistry-Base polymers-Part 1:Denture base polymers YY 0270.1-2011 5.2.8
12 Dentistry-Base polymers-Part 1:Denture base polymers YY 0270.1-2011 5.2.9
13 Dentistry-Base polymers-Part 1:Denture base polymers YY 0270.1-2011 5.2.12
14 Maximum stress intensity factor
Dentistry-Base polymers-Part 1:Denture base polymers YY 0270.1-2011 5.2.10
15 Dentistry-Base polymers-Part 1:Denture base polymers YY 0270.1-2011 5.2.13
16 Total fracture work Dentistry-Base polymers-Part 1:Denture base polymers YY 0270.1-2011 5.2.11
17 Dentistry-Base polymers-Part 1:Denture base polymers YY 0270.1-2011 5.2.14
18 Dentistry-Base polymers-Part 1:Denture base polymers YY 0270.1-2011 5.2.15
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 42 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
1 All of Parameters Dentistry-Base polymers-Part 2:Orthodontic base polymers YY/T 0270.2-2011
Except for Maximum flexural strength and Total work of fracture
2 Dentistry-Base polymers-Part 2:Orthodontic base polymers YY/T 0270.2-2011 5.1.1
3 Dentistry-Base polymers-Part 2:Orthodontic base polymers YY/T 0270.2-2011 5.1.2
4 Dentistry-Base polymers-Part 2:Orthodontic base polymers YY/T 0270.2-2011 5.2.1
5 Dentistry-Base polymers-Part 2:Orthodontic base polymers YY/T 0270.2-2011 5.2.2
6 Dentistry-Base polymers-Part 2:Orthodontic base polymers YY/T 0270.2-2011 5.2.3
7 Dentistry-Base polymers-Part 2:Orthodontic base polymers YY/T 0270.2-2011 5.2.4
8 Dentistry-Base polymers-Part 2:Orthodontic base polymers YY/T 0270.2-2011 5.2.5
9 Dentistry-Base polymers-Part 2:Orthodontic base polymers YY/T 0270.2-2011 5.2.6
10 Dentistry-Base polymers-Part 2:Orthodontic base polymers YY/T 0270.2-2011 5.2.7
11 Dentistry-Base polymers-Part 2:Orthodontic base polymers YY/T 0270.2-2011 5.2.10
32 Orthodontic base polymers
12 Maximum stress intensity factor
Dentistry-Base polymers-Part 2:Orthodontic base polymers YY/T 0270.2-2011 5.2.8
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 43 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
13 Dentistry-Base polymers-Part 2:Orthodontic base polymers YY/T 0270.2-2011 5.2.11
14 Total fracture work Dentistry-Base polymers-Part 1:Denture base polymers YY 0270.2-2011 5.2.9
15 Dentistry-Base polymers-Part 2:Orthodontic base polymers YY/T 0270.2-2011 5.2.12
16 Dentistry-Base polymers-Part 2:Orthodontic base polymers YY/T 0270.2-2011 5.2.13
Part of Parameters Dental root canal sealing materials YY 0717-2009Except for Microbial hazard
1 Dental root canal sealing materials YY 0717-2009 4.1
2 Dental root canal sealing materials YY 0717-2009 4.2
3 Dental root canal sealing materials YY 0717-2009 4.3.1
4 Dental root canal sealing materials YY 0717-2009 4.3.2
5 Dental root canal sealing materials YY 0717-2009 4.3.3
6 Dental root canal sealing materials YY 0717-2009 4.3.4
7 Dental root canal sealing materials YY 0717-2009 4.3.5
8 Dental root canal sealing materials YY 0717-2009 4.3.6
33Dental root canal sealing materials
9 Dental root canal sealing materials YY 0717-2009 4.3.7
34 Casting gold alloys Part of Parameters Dentistry-Casting gold alloys YY 0620-2008
Except for Melting range,
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 44 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
electrochemical properties
1 Dentistry-Casting gold alloys YY 0620-2008 5.1
2 Dentistry-Casting gold alloys YY 0620-2008 5.2
3 Dentistry-Casting gold alloys YY 0620-2008 5.3
4 Dentistry-Casting gold alloys YY 0620-2008 5.3
5 Dentistry-Casting gold alloys YY 0620-2008 5.4
6 Dentistry-Casting gold alloys YY 0620-2008 5.6
7 Dentistry-Casting gold alloys YY 0620-2008 5.7
8 Dentistry-Casting gold alloys YY 0620-2008 5.8
Part of Parameters Matal-ceramic dental restorative systems YY 0621-2008
Exept for Solidus and liquidus temperature
1 Matal-ceramic dental restorative systems YY 0621-2008 4.1.1
2 Matal-ceramic dental restorative systems YY 0621-2008 4.2
35
Mental-ceramic dental restorative systems
3 Matal-ceramic dental restorative systems YY 0621-2008 4.3.1
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 45 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
4 Matal-ceramic dental restorative systems YY 0621-2008 4.3.1
5 Matal-ceramic dental restorative systems YY 0621-2008 4.3.1
6 Matal-ceramic dental restorative systems YY 0621-2008 4.3.1
7 Matal-ceramic dental restorative systems YY 0621-2008 4.3.3
All Parameters Matal-ceramic dental restorative systems YY 0621-2008
1 Matal-ceramic dental restorative systems YY 0621-2008 4.1.2.1
2 Matal-ceramic dental restorative systems YY 0621-2008 4.1.2.2
3 Matal-ceramic dental restorative systems YY 0621-2008 4.2
4 Matal-ceramic dental restorative systems YY 0621-2008 4.3.2
5 Matal-ceramic dental restorative systems YY 0621-2008 4.3.2
6 Matal-ceramic dental restorative systems YY 0621-2008 4.3.2
7 Matal-ceramic dental restorative systems YY 0621-2008 4.3.2
36
Mental-ceramic dental restorative systems
8 Matal-ceramic dental restorative systems YY 0621-2008 4.3.3
Part of Parameters Dental-Ceramic YY 0716-2009Except for radioactivity37 Dental-Ceramic
1 Dental-Ceramic YY 0716-2009 5.1
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 46 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
2 Dental-Ceramic YY 0716-2009 5.2.1
3 Dental-Ceramic YY 0716-2009 5.3
4 Dental-Ceramic YY 0716-2009 5.4.1
5 Dental-Ceramic YY 0716-2009 5.4.2
6 Dental-Ceramic YY 0716-2009 5.4.3
7 Dental-Ceramic YY 0716-2009 5.4.4
8 Dental-Ceramic YY 0716-2009 5.5
All Parameters Elastomeric impression materials YY0493-2011
1 Elastomeric impression materials YY0493-2011 6.1
2 Elastomeric impression materials YY0493-2011 6.2
3 Elastomeric impression materials YY0493-2011 6.3
4 Elastomeric impression materials YY0493-2011 6.4
5 Elastomeric impression materials YY0493-2011 6.5
6 Elastomeric impression materials YY0493-2011 6.6
7 Elastomeric impression materials YY0493-2011 6.7
38Elastomeric impression materials
8 Elastomeric impression materials YY0493-2011 6.8
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 47 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
9 Elastomeric impression materials YY0493-2011 6.9
All Parameters Dental alginate impression materials YY1027-2001
1 Dental alginate impression materials YY1027-2001 4.2
2 Dental alginate impression materials YY1027-2001 4.3
3 Dental alginate impression materials YY1027-2001 4.4
4 Dental alginate impression materials YY1027-2001 4.5
5 Dental alginate impression materials YY1027-2001 4.6
6 Dental alginate impression materials YY1027-2001 4.7
7 Dental alginate impression materials YY1027-2001 4.8
8 Dental alginate impression materials YY1027-2001 4.9
39Dental alginate impression materials
9 Dental alginate impression materials YY1027-2001 4.10
1 Part ofParameters Dentistry-Water-based cements-Part 1:Powder/liquid acid-base cements YY0271.1-2016
2 Dentistry-Water-based cements-Part 1:Powder/liquid acid-base cements YY0271.1-2016 5.2.1
3 Dentistry-Water-based cements-Part 1:Powder/liquid acid-base cements YY0271.1-2016 5.2.2
4 Dentistry-Water-based cements-Part 1:Powder/liquid acid-base cements YY0271.1-2016 5.3
40Powder/liquid acid-base cements
5 Dentistry-Water-based cements-Part 1:Powder/liquid acid-base cements YY0271.1-2016 8.1
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 48 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
6 Dentistry-Water-based cements-Part 1:Powder/liquid acid-base cements YY0271.1-2016 8.2
7 Dentistry-Water-based cements-Part 1:Powder/liquid acid-base cements YY0271.1-2016 8.3
8 Dentistry-Water-based cements-Part 1:Powder/liquid acid-base cements YY0271.1-2016 8.4
9 Dentistry-Water-based cements-Part 1:Powder/liquid acid-base cements YY0271.1-2016 8.6.1
10 Dentistry-Water-based cements-Part 1:Powder/liquid acid-base cements YY0271.1-2016 8.6.2
11 Dentistry-Water-based cements-Part 1:Powder/liquid acid-base cements YY0271.1-2016 8.7
All Parameters Dental water-based cements-Part 2:Resin-modified cements YY0271.2-2016
1 Dental water-based cements-Part 2:Resin-modified cements YY0271.2-2016 5.1
2 Dental water-based cements-Part 2:Resin-modified cements YY0271.2-2016 5.2
3 Dental water-based cements-Part 2:Resin-modified cements YY0271.2-2016 5.3
4 Dental water-based cements-Part 2:Resin-modified cements YY0271.2-2016 5.4
5 Dental water-based cements-Part 2:Resin-modified cements YY0271.2-2016 5.5
6 Dental water-based cements-Part 2:Resin-modified cements YY0271.2-2016 5.6
41 Resin-modified cements
7 Dental water-based cements-Part 2:Resin-modified cements YY0271.2-2016 5.7
42
Zinc oxide/eugenol All Parameters Dentistry-Zinc oxide/eugenol and zinc oxide/non-eugenol cements YY 0272-
2009
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 49 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
1 Dentistry-Zinc oxide/eugenol and zinc oxide/non-eugenol cements YY 0272-2009 4.1
2 Dentistry-Zinc oxide/eugenol and zinc oxide/non-eugenol cements YY 0272-2009 4.1
3 Dentistry-Zinc oxide/eugenol and zinc oxide/non-eugenol cements YY 0272-2009 4.1
4 Dentistry-Zinc oxide/eugenol and zinc oxide/non-eugenol cements YY 0272-2009 4.1
5 Dentistry-Zinc oxide/eugenol and zinc oxide/non-eugenol cements YY 0272-2009 4.1
and zinc oxide/non-eugenol cements
6 Dentistry-Zinc oxide/eugenol and zinc oxide/non-eugenol cements YY 0272-2009 4.2
All Parameters Dental prefabricated root post YY/T 0517-2009
1 Dental prefabricated root post YY/T 0517-2009 5.1
2 Dental prefabricated root post YY/T 0517-2009 5.2
3 Dental prefabricated root post YY/T 0517-2009 5.3
4 Dental prefabricated root post YY/T 0517-2009 5.4
5 Dental prefabricated root post YY/T 0517-2009 5.5
6 Dental prefabricated root post YY/T 0517-2009 5.6
43Dental prefabricated root post
7 Dental prefabricated root post YY/T 0517-2009 5.7
All Parameters Dentistry-Polymer-based restorative materials YY 1042-2011 44
Polymer-based restorative materials 1 Dentistry-Polymer-based restorative materials YY 1042-2011 5.2.2
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 50 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
2 Dentistry-Polymer-based restorative materials YY 1042-2011 5.2.3
3 Dentistry-Polymer-based restorative materials YY 1042-2011 5.2.4
4 Dentistry-Polymer-based restorative materials YY 1042-2011 5.2.5
5 Dentistry-Polymer-based restorative materials YY 1042-2011 5.2.6
6 Dentistry-Polymer-based restorative materials YY 1042-2011 5.2.7
7 Dentistry-Polymer-based restorative materials YY 1042-2011 5.2.8
8 Dentistry-Polymer-based restorative materials YY 1042-2011 5.2.9
9 Dentistry-Polymer-based restorative materials YY 1042-2011 5.2.10
10 Dentistry-Polymer-based restorative materials YY 1042-2011 5.3
11 Dentistry-Polymer-based restorative materials YY 1042-2011 5.4
12 Dentistry-Polymer-based restorative materials YY 1042-2011 5.5
All Parameters Dental-Orthodontic bracket adhesive materials YY/T 0269-2009
1 Dental-Orthodontic bracket adhesive materials YY/T 0269-2009 4.1
2 Dental-Orthodontic bracket adhesive materials YY/T 0269-2009 4.2
3 Dental-Orthodontic bracket adhesive materials YY/T 0269-2009 4.3
45Orthodontic bracket adhesive materials
4 Dental-Orthodontic bracket adhesive materials YY/T 0269-2009 4.4
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 51 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
5 Dental-Orthodontic bracket adhesive materials YY/T 0269-2009 4.5
6 Dental-Orthodontic bracket adhesive materials YY/T 0269-2009 4.6
All Parameters Dental pluggers YY/T 0275-2011
1 Dental pluggers YY/T 0275-2011 4.1
2 Dental pluggers YY/T 0275-2011 4.2
3 Dental pluggers YY/T 0275-2011 4.3
4 Dental pluggers YY/T 0275-2011 4.4
5 Dental pluggers YY/T 0275-2011 4.5
6 Dental pluggers YY/T 0275-2011 4.6
46 Dental pluggers
7 Dental pluggers YY/T 0275-2011 4.7
All Parameters Dental gypsum products YY 0462-2003
1 Dental gypsum products YY 0462-2003 4.1
2 Dental gypsum products YY 0462-2003 4.2
3 Dental gypsum products YY 0462-2003 4.3
4 Dental gypsum products YY 0462-2003 4.4
47 Dental gypsum products
5 Dental gypsum products YY 0462-2003 4.5
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 52 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
6 Dental gypsum products YY 0462-2003 4.6
7 Dental gypsum products YY 0462-2003 4.7
All Parameters Dentistry - Casting investments and refractory die materials YY/T 0463-2011
1 Dentistry - Casting investments and refractory die materials YY/T 0463-2011 5.2
2 Dentistry - Casting investments and refractory die materials YY/T 0463-2011 5.3
3 Dentistry - Casting investments and refractory die materials YY/T 0463-2011 5.4
4 Dentistry - Casting investments and refractory die materials YY/T 0463-2011 5.5
5 Dentistry - Casting investments and refractory die materials YY/T 0463-2011 5.6
6 Dentistry - Casting investments and refractory die materials YY/T 0463-2011 5.7
48
Casting investments and refractory die materials
7 Dentistry - Casting investments and refractory die materials YY/T 0463-2011 5.8
All Parameters Dental aqueous impression materials based on agar YY 0494-2004
1 Dental aqueous impression materials based on agar YY 0494-2004 5.1
2 Dental aqueous impression materials based on agar YY 0494-2004 5.2
3 Dental aqueous impression materials based on agar YY 0494-2004 5.3
49
Dental aqueous impression materials based on agar
4 Dental aqueous impression materials based on agar YY 0494-2004 5.4
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 53 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
5 Dental aqueous impression materials based on agar YY 0494-2004 8.4
6 Dental aqueous impression materials based on agar YY 0494-2004 8.5
7 Dental aqueous impression materials based on agar YY 0494-2004 8.6
8 Dental aqueous impression materials based on agar YY 0494-2004 8.7
9 Dental aqueous impression materials based on agar YY 0494-2004 8.8
10 Dental aqueous impression materials based on agar YY 0494-2004 8.9
11 Dental aqueous impression materials based on agar YY 0494-2004 8.10
All Parameters Dental root-canal obturating points YY 0495-2009
1 Dental root-canal obturating points YY 0495-2009 4.1
2 Dental root-canal obturating points YY 0495-2009 4.2
3 Dental root-canal obturating points YY 0495-2009 4.3
4 Dental root-canal obturating points YY 0495-2009 4.4
5 Dental root-canal obturating points YY 0495-2009 4.5
6 Dental root-canal obturating points YY 0495-2009 4.6
50Dental root-canal obturating points
7 Dental root-canal obturating points YY 0495-2009 4.7
51 Titanium and titanium alloy 1 All Parameters Titanium and titanium alloy dental implant attachments YY/T 0520-2009 Except for
Fatigue
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 54 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
limitation
2 Titanium and titanium alloy dental implant attachments YY/T 0520-2009 5.1
3 Titanium and titanium alloy dental implant attachments YY/T 0520-2009 5.2
4 Titanium and titanium alloy dental implant attachments YY/T 0520-2009 5.3
5 Titanium and titanium alloy dental implant attachments YY/T 0520-2009 5.4
6 Titanium and titanium alloy dental implant attachments YY/T 0520-2009 5.5
7 Titanium and titanium alloy dental implant attachments YY/T 0520-2009 5.6
8 Titanium and titanium alloy dental implant attachments YY/T 0520-2009 5.8
Titanium and titanium alloy dental implant attachments YY/T 0520-2009 5.6 9 Fatigue limit Dentistry-Implants-Dynamic fatigue test for endosseous dental implants YY/T
0521-2018
10 Titanium and titanium alloy dental implant attachments YY/T 0520-2009 5.9
dental implant attachments
11 Titanium and titanium alloy dental implant attachments YY/T 0520-2009 5.10
Part of Parameters Mental-ceramic dental restorative systems YY 0621-2008
Except for liquidus and solidus temperature
52
Mental-ceramic dental restorative systems
1 Mental-ceramic dental restorative systems YY 0621-2008 4.1.1
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 55 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
2 Mental-ceramic dental restorative systems YY 0621-2008 4.1.2.1
3 Mental-ceramic dental restorative systems YY 0621-2008 4.1.2.2
4 Mental-ceramic dental restorative systems YY 0621-2008 4.2
5 Mental-ceramic dental restorative systems YY 0621-2008 4.3.1
6 Mental-ceramic dental restorative systems YY 0621-2008 4.3.1
7 Mental-ceramic dental restorative systems YY 0621-2008 4.3.1
8 Mental-ceramic dental restorative systems YY 0621-2008 4.3.1
9 Mental-ceramic dental restorative systems YY 0621-2008 4.3.2
10 Mental-ceramic dental restorative systems YY 0621-2008 4.3.2
11 Mental-ceramic dental restorative systems YY 0621-2008 4.3.2
12 Mental-ceramic dental restorative systems YY 0621-2008 4.3.2
13 Mental-ceramic dental restorative systems YY 0621-2008 4.3.3
All Parameters Dental resin-based pit and fissure sealants YY 0622-2008
1 Dental resin-based pit and fissure sealants YY 0622-2008 4.2
2 Dental resin-based pit and fissure sealants YY 0622-2008 4.3 53
Dental resin-based pit and fissure sealants
3 Dental resin-based pit and fissure sealants YY 0622-2008 4.4.1
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 56 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
4 Dental resin-based pit and fissure sealants YY 0622-2008 4.4.2
5 Dental resin-based pit and fissure sealants YY 0622-2008 4.4.3
6 Dental resin-based pit and fissure sealants YY 0622-2008 4.4.4
7 Dental resin-based pit and fissure sealants YY 0622-2008 4.4.5
8 Dental resin-based pit and fissure sealants YY 0622-2008 4.4.6
9 Dental resin-based pit and fissure sealants YY 0622-2008 4.4.7
54
Test method of soluble fluoride of dental materials
All Parameters Test method of soluble fluoride of dental materials YY 0623-2008
All Parameters Dentistry-Orthodontic products-Orthodontic elastomeric auxiliaries YY/T 0624-2016
1 Dentistry-Orthodontic products-Orthodontic elastomeric auxiliaries YY/T 0624-2016 4.2
2 Dentistry-Orthodontic products-Orthodontic elastomeric auxiliaries YY/T 0624-2016 4.3.1
3 Dentistry-Orthodontic products-Orthodontic elastomeric auxiliaries YY/T 0624-2016 4.3.2
55
Dentistry-Orthodontic products-Orthodontic elastomeric auxiliaries
4 Dentistry-Orthodontic products-Orthodontic elastomeric auxiliaries YY/T 0624-2016 4.3.3
All Parameters Dentistry-Orthodontic products: Wires YY/T 0625-2016 56
Dentistry-Orthodontic products: Wires 1 Dentistry-Orthodontic products: Wires YY/T 0625-2016 5.2
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 57 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
2 Dentistry-Orthodontic products: Wires YY/T 0625-2016 5.3
3 Dentistry-Orthodontic products: Wires YY/T 0625-2016 5.4.1
4 Dentistry-Orthodontic products: Wires YY/T 0625-2016 5.4.1
5 Dentistry-Orthodontic products: Wires YY/T 0625-2016 5.4.1
6 Dentistry-Orthodontic products: Wires YY/T 0625-2016 5.4.1
7 Dentistry-Orthodontic products: Wires YY/T 0625-2016 5.4.2
8 Dentistry-Orthodontic products: Wires YY/T 0625-2016 5.4.2
9 Dentistry-Orthodontic products: Wires YY/T 0625-2016 5.5
Part of Parameters Dental casting alloys with noble metal content of at least 25% but less than 75% YY 0626-2008
Except for Melting range
1 Dental casting alloys with noble metal content of at least 25% but less than 75% YY 0626-2008 4.1
2 Dental casting alloys with noble metal content of at least 25% but less than 75% YY 0626-2008 4.2
3 Dental casting alloys with noble metal content of at least 25% but less than 75% YY 0626-2008 4.3
4 Dental casting alloys with noble metal content of at least 25% but less than 75% YY 0626-2008 4.3
5 Dental casting alloys with noble metal content of at least 25% but less than 75% YY 0626-2008 4.4
57
Dental casting alloys with noble metal content of at least 25% but less than 75%
6 Dental casting alloys with noble metal content of at least 25% but less than 75% YY 0626-2008 4.5
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 58 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
7 Dental casting alloys with noble metal content of at least 25% but less than 75% YY 0626-2008 4.7
8 Dental casting alloys with noble metal content of at least 25% but less than 75% YY 0626-2008 4.8
58
Dental bleach materials-Test method of perioxide component
All Parameters Dental bleach materials-Test method of perioxide component YY/T 0632-2008
All Parameters Root-canal lubricating &cleaning agent with EDTA YY/T 0516-2009
1 Root-canal lubricating &cleaning agent with EDTA YY/T 0516-2009 4.1
2 Root-canal lubricating &cleaning agent with EDTA YY/T 0516-2009 4.2
3 Root-canal lubricating &cleaning agent with EDTA YY/T 0516-2009 4.3
4 Root-canal lubricating &cleaning agent with EDTA YY/T 0516-2009 4.4
59
Root-canal lubricating &cleaning agent with EDTA
5 Root-canal lubricating &cleaning agent with EDTA YY/T 0516-2009 4.5
All Parameters Dental polymer based adhesives for restoratives YY/T 0518-2009
1 Dental polymer based adhesives for restoratives YY/T 0518-2009 4.1
2 Dental polymer based adhesives for restoratives YY/T 0518-2009 4.2
3 Dental polymer based adhesives for restoratives YY/T 0518-2009 4.3
60Dental polymer based adhesives for restoratives
4 Dental polymer based adhesives for restoratives YY/T 0518-2009 4.4
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 59 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
5 Dental polymer based adhesives for restoratives YY/T 0518-2009 4.5
6 Dental polymer based adhesives for restoratives YY/T 0518-2009 4.6
7 Dental polymer based adhesives for restoratives YY/T 0518-2009 4.7
All Parameters Phosphoric etching gel YY 0769-2009
1 Phosphoric etching gel YY 0769-2009 3.1
2 Phosphoric etching gel YY 0769-2009 3.2 61 Phosphoric
etching gel
3 Phosphoric etching gel YY 0769-2009 3.3
1 Part of Parameters Medical sodium hyaluronate gel YY/T 0308-2015
Except for Shear Viscosity, Flexibility,Refractive index
Medical sodium hyaluronate gel YY/T 0308-2015 5.1 2 Appearance Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0904 Visible
foreign body inspection
3 Medical sodium hyaluronate gel YY/T 0308-2015 5.2
4 Medical sodium hyaluronate gel YY/T 0308-2015 5.3
5 Medical sodium hyaluronate gel YY/T 0308-2015 5.4
62 Medical sodium hyaluronate gel
6 Transmittance Medical sodium hyaluronate gel YY/T 0308-2015 5.5
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 60 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0401 Ultraviolet-visible spectrophotometry
Medical sodium hyaluronate gel YY/T 0308-2015 5.6 7 pH value Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0631 pH
measurement
Medical sodium hyaluronate gel YY/T 0308-2015 5.7 8 Osmotic pressure Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0632 method
of osmolality determination
9 Shear viscosity Medical sodium hyaluronate gel YY/T 0308-2015 5.8
10 Elasticity Medical sodium hyaluronate gel YY/T 0308-2015 5.9
Medical sodium hyaluronate gel YY/T 0308-2015 5.10.1 11 Intrinsic viscosity
(molecular weight) Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0633 Viscosity measurement
12 Medical sodium hyaluronate gel YY/T 0308-2015 5.11
13 Medical sodium hyaluronate gel YY/T 0308-2015 5.12
Medical sodium hyaluronate gel YY/T 0308-2015 5.14 14 Heavy metal content Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0821 Heavy
metal inspection
Medical sodium hyaluronate gel YY/T 0308-2015 5.15 15 Ethanol residue Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0861
Residual solvent assay
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 61 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
16 Medical sodium hyaluronate gel YY/T 0308-2015 5.16
17 Medical sodium hyaluronate gel YY/T 0308-2015 5.17
18 Medical sodium hyaluronate gel YY/T 0308-2015 5.19
19 Medical sodium hyaluronate gel YY/T 0308-2015 5.18
All Parameters Medical devices Symbols to be used with medical device labels, labelling and information to be supplied-Part 1:General requirements YY/T 0466.1-2016
1 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied-Part 1:General requirements YY/T 0466.1-2016 4.1
63
Medical devices Symbols to be used with medical device labels, labelling and information to be supplied-Part 1:General requirements
2 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied-Part 1:General requirements YY/T 0466.1-2016 4.2
All Parameters Dentistry-Polymer-based die materials YY/T0911-2014
1 Dentistry-Polymer-based die materials YY/T0911-2014 4.1
2 Dentistry-Polymer-based die materials YY/T0911-2014 4.2
3 Dentistry-Polymer-based die materials YY/T0911-2014 4.3
4 Dentistry-Polymer-based die materials YY/T0911-2014 4.4
5 Dentistry-Polymer-based die materials YY/T0911-2014 4.5
64Dentistry-Polymer-based die materials
6 Dentistry-Polymer-based die materials YY/T0911-2014 4.6
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 62 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
All Parameters Cross-linked sodium hyaluronate gel for plastic Surgery YY/T 0962-2014
1 Cross-linked sodium hyaluronate gel for plastic Surgery YY/T 0962-2014 5.1
2 Cross-linked sodium hyaluronate gel for plastic Surgery YY/T 0962-2014 5.2
3 Cross-linked sodium hyaluronate gel for plastic Surgery YY/T 0962-2014 5.3
4 Cross-linked sodium hyaluronate gel for plastic Surgery YY/T 0962-2014 5.4
5 Cross-linked sodium hyaluronate gel for plastic Surgery YY/T 0962-2014 5.5
6 Cross-linked sodium hyaluronate gel for plastic Surgery YY/T 0962-2014 5.6
7 Cross-linked sodium hyaluronate gel for plastic Surgery YY/T 0962-2014 5.7
8 Cross-linked sodium hyaluronate gel for plastic Surgery YY/T 0962-2014 5.8
9 Cross-linked sodium hyaluronate gel for plastic Surgery YY/T 0962-2014 5.9
10 Cross-linked sodium hyaluronate gel for plastic Surgery YY/T 0962-2014 5.10
11 Cross-linked sodium hyaluronate gel for plastic Surgery YY/T 0962-2014 5.11
Cross-linked sodium hyaluronate gel for plastic Surgery YY/T 0962-2014 5.12
Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0521 Gas chromatography
65
Cross-linked sodium hyaluronate gel for plastic Surgery
12 The residual amount of crosslinking agent
Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0405 Fluorescence spectrophotometry
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 63 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
13 Cross-linked sodium hyaluronate gel for plastic Surgery YY/T 0962-2014 5.13
14 Cross-linked sodium hyaluronate gel for plastic Surgery YY/T 0962-2014 5.14
15 Cross-linked sodium hyaluronate gel for plastic Surgery YY/T 0962-2014 5.15
16 Cross-linked sodium hyaluronate gel for plastic Surgery YY/T 0962-2014 5.16
17 Cross-linked sodium hyaluronate gel for plastic Surgery YY/T 0962-2014 5.17
18 Cross-linked sodium hyaluronate gel for plastic Surgery YY/T 0962-2014 5.18
All Parameters Implants for Surgery Bioglass and glass ceramic biomaterials YY/T 0964-2014
1 Implants for Surgery Bioglass and glass ceramic biomaterials YY/T 0964-2014 4.1
2 Implants for Surgery Bioglass and glass ceramic biomaterials YY/T 0964-2014 4.2
3 Implants for Surgery Bioglass and glass ceramic biomaterials YY/T 0964-2014 5 a)
4 Implants for Surgery Bioglass and glass ceramic biomaterials YY/T 0964-2014 5 b)
5 Implants for Surgery Bioglass and glass ceramic biomaterials YY/T 0964-2014 5 c)
Implants for Surgery Bioglass and glass ceramic biomaterials YY/T 0964-2014 5 d)
66
Implants for Surgery Bioglass and glass ceramic biomaterials
6 Hardness Fine ceramics(advanced ceramics,advanced technical ceramics)- Test method for hardness of monolithic ceramics at room temperature GB/T 16534-2009
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 64 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
7 Implants for Surgery Bioglass and glass ceramic biomaterials YY/T 0964-2014 5 e)
8 Implants for Surgery Bioglass and glass ceramic biomaterials YY/T 0964-2014 5 f)
9 Implants for Surgery Bioglass and glass ceramic biomaterials YY/T 0964-2014 5 g)
Implants for Surgery Bioglass and glass ceramic biomaterials YY/T 0964-2014 5 h)
10 Thermal expansion coefficient Fine ceramics (advanced ceramics, advanced technical ceramics) - Test
method for linear thermal expansion of monolithic ceramics by push-rod technique GB/T 16535-2008
11 Implants for Surgery Bioglass and glass ceramic biomaterials YY/T 0964-2014 5 i)
12 Implants for Surgery Bioglass and glass ceramic biomaterials YY/T 0964-2014 6
All Parameters Dental temporary polymer-based crown and bridge materials YY/T 0826-2011
1 Dental temporary polymer-based crown and bridge materials YY/T 0826-2011 5.1
2 Dental temporary polymer-based crown and bridge materials YY/T 0826-2011 5.2
3 Dental temporary polymer-based crown and bridge materials YY/T 0826-2011 5.3
4 Dental temporary polymer-based crown and bridge materials YY/T 0826-2011 5.4
5 Dental temporary polymer-based crown and bridge materials YY/T 0826-2011 5.5
67
Dental temporary polymer-based crown and bridge materials
6 Dental temporary polymer-based crown and bridge materials YY/T 0826-2011 5.6
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 65 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
7 Dental temporary polymer-based crown and bridge materials YY/T 0826-2011 5.7
8 Dental temporary polymer-based crown and bridge materials YY/T 0826-2011 5.8
9 Dental temporary polymer-based crown and bridge materials YY/T 0826-2011 5.9
10 Dental temporary polymer-based crown and bridge materials YY/T 0826-2011 5.10
11 Dental temporary polymer-based crown and bridge materials YY/T 0826-2011 5.11
All Parameters Implants for Surgery -Acrylic resin cements YY 0459-2003
1 Implants for Surgery -Acrylic resin cements YY 0459-2003 3.1
2 Implants for Surgery -Acrylic resin cements YY 0459-2003 3.2
3 Implants for Surgery -Acrylic resin cements YY 0459-2003 3.3
4 Implants for Surgery -Acrylic resin cements YY 0459-2003 4.2
5 Implants for Surgery -Acrylic resin cements YY 0459-2003 4.3
6 Implants for Surgery -Acrylic resin cements YY 0459-2003 5
7 Implants for Surgery -Acrylic resin cements YY 0459-2003 5
8 Implants for Surgery -Acrylic resin cements YY 0459-2003 5
9 Implants for Surgery -Acrylic resin cements YY 0459-2003 5
68Implants for Surgery -Acrylic resin cements
10 Implants for Surgery -Acrylic resin cements YY 0459-2003 5
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 66 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
11 Implants for Surgery -Acrylic resin cements YY 0459-2003 5
12 Implants for Surgery -Acrylic resin cements YY 0459-2003 6.1
13 Implants for Surgery -Acrylic resin cements YY 0459-2003 6.2
14 Implants for Surgery -Acrylic resin cements YY 0459-2003 7
15 Implants for Surgery -Acrylic resin cements YY 0459-2003 7
16 Implants for Surgery -Acrylic resin cements YY 0459-2003 7
1 Part of Parameters Dentistry-Metallic materials for fixed and romovable restorations and appliances GB 17168-2013
Except for solidus and liquidus temperature or melting point
2 Dentistry-Metallic materials for fixed and romovable restorations and appliances GB 17168-2013 5.1
3 Dentistry-Metallic materials for fixed and romovable restorations and appliances GB 17168-2013 5.2
4 Dentistry-Metallic materials for fixed and romovable restorations and appliances GB 17168-2013 5.3
5 Dentistry-Metallic materials for fixed and romovable restorations and appliances GB 17168-2013 5.4.2
6 Dentistry-Metallic materials for fixed and romovable restorations and appliances GB 17168-2013 5.4.3
69
Dentistry-Metallic materials for fixed and romovable restorations and appliances
7 Dentistry-Metallic materials for fixed and romovable restorations and appliances GB 17168-2013 5.4.4
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 67 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
Dentistry-Metallic materials for fixed and romovable restorations and appliances GB 17168-2013 5.5
8 Density Method of measurement of density for precious metals and their alloys GB/T 1423-1996
Dentistry-Metallic materials for fixed and romovable restorations and appliances GB 17168-2013 5.6
9 Corrosion resistanceChinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0411 Inductively Coupled Plasma Atomic Emission Spectrometry
10 Dentistry-Metallic materials for fixed and romovable restorations and appliances GB 17168-2013 5.7
11 Dentistry-Metallic materials for fixed and romovable restorations and appliances GB 17168-2013 5.9
1 Part of Parameters Dentistry-Ceramic materials GB 30367-2013Except for radioactivity
2 Dentistry-Ceramic materials GB 30367-2013 5.1
3 Dentistry-Ceramic materials GB 30367-2013 5.2.1
4 Dentistry-Ceramic materials GB 30367-2013 5.2.3
5 Dentistry-Ceramic materials GB 30367-2013 5.3
6 Dentistry-Ceramic materials GB 30367-2013 5.4
7 Dentistry-Ceramic materials GB 30367-2013 5.4
8 Dentistry-Ceramic materials GB 30367-2013 5.4
70Dentistry-Ceramic materials
9 Dentistry-Ceramic materials GB 30367-2013 5.4
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 68 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
10 Dentistry-Ceramic materials GB 30367-2013 5.5
All Parameters Dentistry-Soft lining materials for removable dentures-Part1:Materials for short-term use YY 0714.1-2009
1 Dentistry-Soft lining materials for removable dentures-Part1:Materials for short-term use YY 0714.1-2009 5.1 71
Dentistry-Soft lining materials for removable dentures-Part1:Materials for short-term use
2 Dentistry-Soft lining materials for removable dentures-Part1:Materials for short-term use YY 0714.1-2009 5.2
All Parameters Dentistry-Soft lining materials for removable dentures-Part2:Materials for long-term use YY 0714.2-2016
1 Dentistry-Soft lining materials for removable dentures-Part2:Materials for long-term use YY 0714.2-2016 5.1 72
Dentistry-Soft lining materials for removable dentures-Part2:Materials for long-term use
2 Dentistry-Soft lining materials for removable dentures-Part2:Materials for long-term use YY 0714.2-2016 5.2
1 Part of Parameters Medical carboxymethylchitosan YY 0953-2015
Except for Weight-average molecular weight and molecular weight distribution,and microbial limit
Medical carboxymethylchitosan YY 0953-2015 5.1
73Medical carboxymethylchitosan
2 Appearance Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0904 Visible foreign body inspection
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 69 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0901 Solution color inspection
Medical carboxymethylchitosan YY 0953-2015 5.2 3 Qualitative test
(identification test) Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0402 Infrared spectrophotometry
4 Medical carboxymethylchitosan YY 0953-2015 5.3
5 Medical carboxymethylchitosan YY 0953-2015 5.4
Medical carboxymethylchitosan YY 0953-2015 5.5 6 Loss on drying Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0831
Determination of drying weightlessness
7 Medical carboxymethylchitosan YY 0953-2015 5.6
8 Medical carboxymethylchitosan YY 0953-2015 5.7
9 Medical carboxymethylchitosan YY 0953-2015 5.9
Medical carboxymethylchitosan YY 0953-2015 5.10 10 Carboxymethyl
chitosan purity Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0704 Nitrogen assay
11 Medical carboxymethylchitosan YY 0953-2015 5.11
Medical carboxymethylchitosan YY 0953-2015 5.12.1 12 Heavy metal content Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0821 Heavy
metal inspection
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 70 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
13 Medical carboxymethylchitosan YY 0953-2015 5.12.2
Medical carboxymethylchitosan YY 0953-2015 5.13 14 Residue on ignition Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0841
Inspection method for residue on ignition
15 Medical carboxymethylchitosan YY 0953-2015 5.14
Medical carboxymethylchitosan YY 0953-2015 5.15.1 16 Ethanol residue Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0521 Gas
chromatography
17 Medical carboxymethylchitosan YY 0953-2015 5.15.2
18 Medical carboxymethylchitosan YY 0953-2015 5.15.3
19 Medical carboxymethylchitosan YY 0953-2015 5.16
20 Medical carboxymethylchitosan YY 0953-2015 5.17
Medical carboxymethylchitosan YY 0953-2015 5.16.2
Chinese pharmacopoeia 2015 version Vol Ⅳ General chapters 1105 Microbial limit test for non-sterile products: microbial count
21 microbial limit
Chinese pharmacopoeia 2015 version Vol Ⅳ General chapters 1106 Microbial limit test for non-sterile products: method of controlled bacteria test
22 Medical carboxymethylchitosan YY 0953-2015 5.18
74Nonactive surgical implas-Type I collagen
1 Part of Parameters Nonactive surgical implas-Type I collagen implants-Specific requirements YY 0954-2015
Except for Acid hydrolyzat
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 71 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
e, collagen content (amino acid analyzer method)
2 Nonactive surgical implas-Type I collagen implants-Specific requirements YY 0954-2015 7.2.2
Nonactive surgical implas-Type I collagen implants-Specific requirements YY 0954-2015 7.2.3
3 LoadingChinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0942 Minimum loading inspection
4 Nonactive surgical implas-Type I collagen implants-Specific requirements YY 0954-2015 7.2.4
5 Nonactive surgical implas-Type I collagen implants-Specific requirements YY 0954-2015 7.3.1
Nonactive surgical implas-Type I collagen implants-Specific requirements YY 0954-2015 7.3.3
6 Hybrid protein analysis Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0541
Electrophoresis
7 Nonactive surgical implas-Type I collagen implants-Specific requirements YY 0954-2015 7.3.4
8 Nonactive surgical implas-Type I collagen implants-Specific requirements YY 0954-2015 7.3.5
9 Nonactive surgical implas-Type I collagen implants-Specific requirements YY 0954-2015 7.3.6.1
Nonactive surgical implas-Type I collagen implants-Specific requirements YY 0954-2015 7.3.6.2
implants-Specific requirements
10As,Cd,Hg,Pb,Cr,Cu,Fe,Ni,Mo(trace elements) Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0406
Atomic absorption spectrophotometry
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 72 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0411 Inductively Coupled Plasma Atomic Emission Spectrometry
11 Nonactive surgical implas-Type I collagen implants-Specific requirements YY 0954-2015 7.3.7
12 Nonactive surgical implas-Type I collagen implants-Specific requirements YY 0954-2015 7.3.9
13 Nonactive surgical implas-Type I collagen implants-Specific requirements YY 0954-2015 7.3.10
14 Nonactive surgical implas-Type I collagen implants-Specific requirements YY 0954-2015 7.4.1
15 Nonactive surgical implas-Type I collagen implants-Specific requirements YY 0954-2015 7.4.2
1 Part of Parameters Medical instruments of stainless steel-Test methods of corrosion resistance YY/T 0149-2006
Except for Pressure steam method
2 Medical instruments of stainless steel-Test methods of corrosion resistance YY/T 0149-2006 5
3 Medical instruments of stainless steel-Test methods of corrosion resistance YY/T 0149-2006 6
4 Medical instruments of stainless steel-Test methods of corrosion resistance YY/T 0149-2006 7
5 Medical instruments of stainless steel-Test methods of corrosion resistance YY/T 0149-2006 8
75
Medical instruments of stainless steel-Test methods of corrosion resistance
6 Medical instruments of stainless steel-Test methods of corrosion resistance YY/T 0149-2006 10
All Parameters Test method for primary wound dressing-Part1: Aspects of absorbency YY/T 0471.1-2004
76
Test method for primary wound dressing-Part1: Aspects of 1 Test method for primary wound dressing-Part1: Aspects of absorbency YY/T
0471.1-2004 3.2
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The scope of the accreditation in Chinese remains the definitive version.
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№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
2 Test method for primary wound dressing-Part1: Aspects of absorbency YY/T 0471.1-2004 3.3
3 Test method for primary wound dressing-Part1: Aspects of absorbency YY/T 0471.1-2004 3.4
4 Test method for primary wound dressing-Part1: Aspects of absorbency YY/T 0471.1-2004 3.5
5 Test method for primary wound dressing-Part1: Aspects of absorbency YY/T 0471.1-2004 3.6
absorbency
6 Test method for primary wound dressing-Part1: Aspects of absorbency YY/T 0471.1-2004 3.7
All Parameters Test method for primary wound dressing-Part2:Moisture vapour transmission rate of permeable film dressings YY/T 0471.2-2004
1 Test method for primary wound dressing-Part2:Moisture vapour transmission rate of permeable film dressings YY/T 0471.2-2004 3.2
77
Test method for primary wound dressing-Part2:Moisture vapour transmission rate of permeable film dressings
2 Test method for primary wound dressing-Part2:Moisture vapour transmission rate of permeable film dressings YY/T 0471.2-2004 3.3
All Parameters Test method for primary wound dressing-Part3:Waterproofness YY/T 0471.3-2004
78
Test method for primary wound dressing-Part3:Waterproofness
1 Test method for primary wound dressing-Part3:Waterproofness YY/T 0471.3-2004 3.2
All Parameters Test method for primary wound dressing-Part4:Conformability YY/T 0471.4-2004
79
Test method for primary wound dressing-Part4:Conformability
1 Test method for primary wound dressing-Part4:Conformability YY/T 0471.4-2004 3.2
80
Test method for primary wound All Parameters Test method for primary wound dressing-Part5:Bacterial barrier properties
YY/T 0471.5-2017
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 74 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
1Bacterial barrier properties(Low moisture condition)
Test method for primary wound dressing-Part5:Bacterial barrier properties YY/T 0471.5-2017 5
2
Bacterial barrier properties(semi wet condition)( External dry
Test method for primary wound dressing-Part5:Bacterial barrier properties YY/T 0471.5-2017 6
3
Bacterial barrier properties(semi wet condition) ( External wet)
Test method for primary wound dressing-Part5:Bacterial barrier properties YY/T 0471.5-2017 7
dressing-Part5:Bacterial barrier properties
4Bacterial barrier properties(Wet condition)
Test method for primary wound dressing-Part5:Bacterial barrier properties YY/T 0471.5-2017 8
All Parameters Poly(L-lactide) resins and fabricated forms for surgical implants-In vitro degradation testing YY/T 0474-2004
1 Poly(L-lactide) resins and fabricated forms for surgical implants-In vitro degradation testing YY/T 0474-2004 5.1
Poly(L-lactide) resins and fabricated forms for surgical implants-In vitro degradation testing YY/T 0474-2004 5.2
2 Intrinsic viscosity Plastics - Determination of the viscosity of polymers in dilute solution using capillary viscometers - Part1:General principles GB/T 1632.1-2008
Poly(L-lactide) resins and fabricated forms for surgical implants-In vitro degradation testing YY/T 0474-2004 6
3 Tensile Strength Plastics - Determination of tensile properties - Part 1: General principles GB/T 1040.1-2018
4 Poly(L-lactide) resins and fabricated forms for surgical implants-In vitro degradation testing YY/T 0474-2004 6
81
Poly(L-lactide) resins and fabricated forms for surgical implants-In vitro degradation testing
5 Poly(L-lactide) resins and fabricated forms for surgical implants-In vitro degradation testing YY/T 0474-2004 6
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No. CNAS L3940
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第 75 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
All Parameters Dental materials Testing of adhesion to tooth structure YY/T 0519-2009
1 Dental materials Testing of adhesion to tooth structure YY/T 0519-2009 5.2
2 Dental materials Testing of adhesion to tooth structure YY/T 0519-2009 5.3 82
Dental materials Testing of adhesion to tooth structure
3 Dental materials Testing of adhesion to tooth structure YY/T 0519-2009 5.4
83
Dental materials-Determination of colour stability
All Parameters Dental materials-Determination of colour stability YY/T 0631-2008
1 Part of Parameters Standard specification for polyetheretherketone(PEEK) polymers for surgical implant applications YY/T 0660-2008
Except for notched impact strength
2 Standard specification for polyetheretherketone(PEEK) polymers for surgical implant applications YY/T 0660-2008 5.1
3 Standard specification for polyetheretherketone(PEEK) polymers for surgical implant applications YY/T 0660-2008 5.2
4 Standard specification for polyetheretherketone(PEEK) polymers for surgical implant applications YY/T 0660-2008 5.2
5 Standard specification for polyetheretherketone(PEEK) polymers for surgical implant applications YY/T 0660-2008 5.2
6 Standard specification for polyetheretherketone(PEEK) polymers for surgical implant applications YY/T 0660-2008 5.2
7 Standard specification for polyetheretherketone(PEEK) polymers for surgical implant applications YY/T 0660-2008 5.3
84
Standard specification for polyetheretherketone(PEEK) polymers for surgical implant applications
8 Standard specification for polyetheretherketone(PEEK) polymers for surgical implant applications YY/T 0660-2008 5.4
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 76 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
9 Standard specification for polyetheretherketone(PEEK) polymers for surgical implant applications YY/T 0660-2008 5.4
10 Standard specification for polyetheretherketone(PEEK) polymers for surgical implant applications YY/T 0660-2008 5.4
11 Standard specification for polyetheretherketone(PEEK) polymers for surgical implant applications YY/T 0660-2008 5.4
12 Standard specification for polyetheretherketone(PEEK) polymers for surgical implant applications YY/T 0660-2008 5.4
Standard specification for polyetheretherketone(PEEK) polymers for surgical implant applications YY/T 0660-2008 5.4
13 Bending strengthPlastics - Determination of flexural properties GB/T 9341-2008
14 Standard specification for polyetheretherketone(PEEK) polymers for surgical implant applications YY/T 0660-2008 5.4
1 Part of Parameters Standard specification for virgin poly(L-lactic acid) resin for surgical implants YY/T 0661-2008
Except for average molecular weight and molecular weight distribution,HNMR
2 Standard specification for virgin poly(L-lactic acid) resin for surgical implants YY/T 0661-2008 4.1
3 Standard specification for virgin poly(L-lactic acid) resin for surgical implants YY/T 0661-2008 4.2
4 Standard specification for virgin poly(L-lactic acid) resin for surgical implants YY/T 0661-2008 4.3.1
85
Standard specification for virgin poly(L-lactic acid) resin for surgical implants
5 Standard specification for virgin poly(L-lactic acid) resin for surgical implants YY/T 0661-2008 4.4
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 77 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
6 Standard specification for virgin poly(L-lactic acid) resin for surgical implants YY/T 0661-2008 4.5
7 Standard specification for virgin poly(L-lactic acid) resin for surgical implants YY/T 0661-2008 4.6
8 Standard specification for virgin poly(L-lactic acid) resin for surgical implants YY/T 0661-2008 4.6
9 Standard specification for virgin poly(L-lactic acid) resin for surgical implants YY/T 0661-2008 4.6
10 Standard specification for virgin poly(L-lactic acid) resin for surgical implants YY/T 0661-2008 4.6
11 Standard specification for virgin poly(L-lactic acid) resin for surgical implants YY/T 0661-2008 4.6
86
Test methods for boning properties of tissue adhesives-Part1: Strength in lap-shear by tension loading
All Parameters Test methods for boning properties of tissue adhesives-Part1: Strength in lap-shear by tension loading YY/T 0729.1-2009
87
Test methods for boning properties of tissue adhesives-Part2: Strength in T-peel by tension loading
All Parameters Test methods for boning properties of tissue adhesives-Part2: Strength in T-peel by tension loading YY/T 0729.2-2009
88
Test methods for boning properties of tissue adhesives-
All Parameters Test methods for boning properties of tissue adhesives-Part3:Tension strength YY/T 0729.3-2009
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 78 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
Part3:Tension strength
89
Test methods for boning properties of tissue adhesives-Part4: Wound closure strength
All Parameters Test methods for boning properties of tissue adhesives-Part4: Wound closure strength YY/T 0729.4-2009
All Parameters Dental calcium hydroxide pulp capping and lining materials YY/T 0824-2011
1 Dental calcium hydroxide pulp capping and lining materials YY/T 0824-2011 5.1.1
2 Dental calcium hydroxide pulp capping and lining materials YY/T 0824-2011 5.1.2
3 Dental calcium hydroxide pulp capping and lining materials YY/T 0824-2011 5.1.3
4 Dental calcium hydroxide pulp capping and lining materials YY/T 0824-2011 5.1.4
5 Dental calcium hydroxide pulp capping and lining materials YY/T 0824-2011 5.1.5
6 Dental calcium hydroxide pulp capping and lining materials YY/T 0824-2011 5.2
7 Dental calcium hydroxide pulp capping and lining materials YY/T 0824-2011 5.2
8 Dental calcium hydroxide pulp capping and lining materials YY/T 0824-2011 5.2
9 Dental calcium hydroxide pulp capping and lining materials YY/T 0824-2011 5.2
90
Dental calcium hydroxide pulp capping and lining materials
10 Dental calcium hydroxide pulp capping and lining materials YY/T 0824-2011 5.2
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No. CNAS L3940
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№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
All Parameters Dentistry-Brackets and tubes for use in orthodontics YY/T 0915-2015
1 Dentistry-Brackets and tubes for use in orthodontics YY/T 0915-2015 4.1
2 Dentistry-Brackets and tubes for use in orthodontics YY/T 0915-2015 4.2.1
3 Dentistry-Brackets and tubes for use in orthodontics YY/T 0915-2015 4.2.1
4 Dentistry-Brackets and tubes for use in orthodontics YY/T 0915-2015 4.2.1
5 Dentistry-Brackets and tubes for use in orthodontics YY/T 0915-2015 4.2.1
6 Dentistry-Brackets and tubes for use in orthodontics YY/T 0915-2015 4.2.1
7 Dentistry-Brackets and tubes for use in orthodontics YY/T 0915-2015 4.2.2
8 Dentistry-Brackets and tubes for use in orthodontics YY/T 0915-2015 4.2.2
91
Dentistry-Brackets and tubes for use in orthodontics
9 Dentistry-Brackets and tubes for use in orthodontics YY/T 0915-2015 4.2.2
1 Part of Parameters Dentistry-Denture adhesives YY/T 1280-2015Except for microbial index
2 Dentistry-Denture adhesives YY/T 1280-2015 5.1.1
3 Dentistry-Denture adhesives YY/T 1280-2015 5.1.2
4 Dentistry-Denture adhesives YY/T 1280-2015 5.1.4
92Dentistry-Denture adhesives
5 Dentistry-Denture adhesives YY/T 1280-2015 5.1.5
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No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 80 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
6 Dentistry-Denture adhesives YY/T 1280-2015 5.2.1
7 Dentistry-Denture adhesives YY/T 1280-2015 5.2.2
8 Dentistry-Denture adhesives YY/T 1280-2015 5.3.1
9 Dentistry-Denture adhesives YY/T 1280-2015 5.3.2
10 Dentistry-Denture adhesives YY/T 1280-2015 5.3.3
1 Part of Parameters GB/T 14233.1-2008 Except for EO residue
GB/T 14233.1-2008 5.1 2 Turbidity and color Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0901
Solution color inspection, 0902 Clarity inspection
3 GB/T 14233.1-2008 5.2
GB/T 14233.1-2008 5.3 4 Chloride Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0801
Chloride inspection
5 GB/T 14233.1-2008 5.4
6 GB/T 14233.1-2008 5.5
7 GB/T 14233.1-2008 5.6
93
Medical transfusion, infusion and injection apparatus part1: chemical analysis methods
8 GB/T 14233.1-2008 5.7
ISO/IEC 17025 认可证书
No. CNAS L3940
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第 81 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
9 GB/T 14233.1-2008 5.8
10 GB/T 14233.1-2008 5.9
11 GB/T 14233.1-2008 6
12 GB/T 14233.1-2008 7
13 GB/T 14233.1-2008 8
1 Part of Parameters YY/T 1453-2016
Exept for peptide map,acid hydrolyzate,fat content, do not use the amino acid analyzer to determine the collagen content
2 YY/T 1453-2016 4.1
3 YY/T 1453-2016 4.2
4 YY/T 1453-2016 4.3 Limitation
94 Type I collagen
5 YY/T 1453-2016 4.4
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 82 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
6 YY/T 1453-2016 4.6
7 YY/T 1453-2016 4.7
YY/T 1453-2016 4.8
Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 2321 Lead, cadmium, arsenic, mercury, copper determination
8
As,Cd,Hg,Pb,Cr,Cu,Fe,Ni,Mo(trace elements) and the total amount of heavy metals Chinese pharmacopoeia 2015 version Vol Ⅳ general Chapters 0411
Inductively Coupled Plasma Atomic Emission Spectrometry
9 YY/T 1453-2016 4.10
10 YY/T 1453-2016 4.12
All Parameters Dentistry-Compatibility testing-Part1:Metal-ceramic systems YY 0621.1-2016
1 Dentistry-Compatibility testing-Part1:Metal-ceramic systems YY 0621.1-2016 6.1.1
2 Dentistry-Compatibility testing-Part1:Metal-ceramic systems YY 0621.1-2016 6.1.2
3 Dentistry-Compatibility testing-Part1:Metal-ceramic systems YY 0621.1-2016 6.2
4 Dentistry-Compatibility testing-Part1:Metal-ceramic systems YY 0621.1-2016 6.3
95 Metal-ceramic systems
5 Dentistry-Compatibility testing-Part1:Metal-ceramic systems YY 0621.1-2016 6.4
All Parameters Implant for surgery-Skeletal pins and wires-Part1:Material and mechanical requirems YY/T 0345.1-2011
96 skeletal pins and wires
1 Implant for surgery-Skeletal pins and wires-Part1:Material and mechanical
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 83 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
requirems YY/T 0345.1-2011 3
2 Implant for surgery-Skeletal pins and wires-Part1:Material and mechanical requirems YY/T 0345.1-2011 4
3 Implant for surgery-Skeletal pins and wires-Part1:Material and mechanical requirems YY/T 0345.1-2011 4
4 Implant for surgery-Skeletal pins and wires-Part1:Material and mechanical requirems YY/T 0345.1-2011 4
5 Implant for surgery-Skeletal pins and wires-Part2:Steinmann skeletal pins-Dimensions YY/T 0345.2-2014 2
6 Implant for surgery-Skeletal pins and wires-Part2:Steinmann skeletal pins-Dimensions YY/T 0345.2-2014 3
7 Implant for surgery-Skeletal pins and wires-Part3:kirschner skeletal wires YY/T 0345.3-2014 3
8 Implant for surgery-Skeletal pins and wires-Part3:kirschner skeletal wires YY/T 0345.3-2014 4
All Parameters Corneal cell carrier membrane STCBM/FB-001-2017
1 Appearance Corneal cell carrier membrane STCBM/FB-001-2017 4.1
2 Dimension Corneal cell carrier membrane STCBM/FB-001-2017 4.2
3 Transmittance Corneal cell carrier membrane STCBM/FB-001-2017 4.3
4 Water content Corneal cell carrier membrane STCBM/FB-001-2017 4.4
5 pH value Corneal cell carrier membrane STCBM/FB-001-2017 4.5
97Corneal cell carrier membrane
6 Heavy metal content Corneal cell carrier membrane STCBM/FB-001-2017 4.6
ISO/IEC 17025 认可证书
No. CNAS L3940
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第 84 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
7 Content Corneal cell carrier membrane STCBM/FB-001-2017 4.7
All Parameters Soft tissue repair patch STCBM/FB-002-2017
1 Dimension Soft tissue repair patch STCBM/FB-002-2017 5.1
2 Appearance Soft tissue repair patch STCBM/FB-002-2017 5.2
3 Tensile Strength Soft tissue repair patch STCBM/FB-002-2017 5.3.1
4 Elongation at break Soft tissue repair patch STCBM/FB-002-2017 5.3.2
5 Peracetic acid residual Soft tissue repair patch STCBM/FB-002-2017 5.4.1
6 Ethanol residue Soft tissue repair patch STCBM/FB-002-2017 5.4.2
7 pH value Soft tissue repair patch STCBM/FB-002-2017 5.4.3
98 Soft tissue repair patch
8 Heavy metal content Soft tissue repair patch STCBM/FB-002-2017 5.4.4
All Parameters Customised activity denture STCBM/FB-005-2017
1 Design Customised activity denture STCBM/FB-005-2017 4.1
2 Raw materials Customised activity denture STCBM/FB-005-2017 4.2
3 Polished surface Customised activity denture STCBM/FB-005-2017 4.3
4 Tissue surface Customised activity denture STCBM/FB-005-2017 4.4
99 Customised activity denture
5 Denture base Customised activity denture STCBM/FB-005-2017 4.5
ISO/IEC 17025 认可证书
No. CNAS L3940
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第 85 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
6 Colour Customised activity denture STCBM/FB-005-2017 4.6
7 Color stability Customised activity denture STCBM/FB-005-2017 4.7
8 Partial denture metal part internal mass Customised activity denture STCBM/FB-005-2017 4.8
9 Partial denture Customised activity denture STCBM/FB-005-2017 4.9
10 Full denture occlusion Customised activity denture STCBM/FB-005-2017 4.10
11 Full denture thickness Customised activity denture STCBM/FB-005-2017 4.11
All Parameters Custom fixed denture STCBM/FB-004-2017
1 Design Custom fixed denture STCBM/FB-004-2017 4.1
2 Raw materials Custom fixed denture STCBM/FB-004-2017 4.2
3 Colour Custom fixed denture STCBM/FB-004-2017 4.3
4 Appearance and surface roughness Custom fixed denture STCBM/FB-004-2017 4.4
5 Metal ceramic bonding properties Custom fixed denture STCBM/FB-004-2017 4.5
6Hot and cold-resistant performance of emergency
Custom fixed denture STCBM/FB-004-2017 4.6
7 Metal internal quality Custom fixed denture STCBM/FB-004-2017 4.7
100 Custom fixed denture
8 Porosity Custom fixed denture STCBM/FB-004-2017 4.8
ISO/IEC 17025 认可证书
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第 86 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
9 Adjacency Custom fixed denture STCBM/FB-004-2017 4.9
10 Adhesion Custom fixed denture STCBM/FB-004-2017 4.10
11 Occlusal Custom fixed denture STCBM/FB-004-2017 4.11
12 Denture morphology Custom fixed denture STCBM/FB-004-2017 4.12
1 All Parameters Custom orthodontic appliances / retainers STCBM/ FB-003-2017
2 Design Custom orthodontic appliances / retainers STCBM/ FB-003-2017 4.1
3 Appearance and structure Custom orthodontic appliances / retainers STCBM/ FB-003-2017 4.2
4 Hardness Custom orthodontic appliances / retainers STCBM/ FB-003-2017 4.3
5 Corrosion resistance Custom orthodontic appliances / retainers STCBM/ FB-003-2017 4.4
6 Surface roughness Custom orthodontic appliances / retainers STCBM/ FB-003-2017 4.5
7 Raw materials Custom orthodontic appliances / retainers STCBM/ FB-003-2017 4.6
8 Arch wire Custom orthodontic appliances / retainers STCBM/ FB-003-2017 4.7
101
Custom orthodontic appliances / retainers
9 Color stability Custom orthodontic appliances / retainers STCBM/ FB-003-2017 4.8
1 All Parameters Zirconia ceramics STCBM/FB-006-2017
2 Dimension Zirconia ceramics STCBM/FB-006-2017 4.1 102 Zirconia ceramics
3 Appearance Zirconia ceramics STCBM/FB-006-2017 4.2
ISO/IEC 17025 认可证书
No. CNAS L3940
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第 87 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
4 Pre-sintering density Zirconia ceramics STCBM/FB-006-2017 4.3
5 Sintering density Zirconia ceramics STCBM/FB-006-2017 4.4
6 Flexural strength Zirconia ceramics STCBM/FB-006-2017 4.5
7 Chemical solubility Zirconia ceramics STCBM/FB-006-2017 4.6
8 Product composition Zirconia ceramics STCBM/FB-006-2017 4.7
1 All Parameters Dentistry-Casting and Baseplate waxes YY/T 0496-2016
2 Dentistry-Casting and Baseplate waxes YY/T 0496-2016 5.1
3 Dentistry-Casting and Baseplate waxes YY/T 0496-2016 5.2
4 Dentistry-Casting and Baseplate waxes YY/T 0496-2016 5.3
5 Dentistry-Casting and Baseplate waxes YY/T 0496-2016 5.4
6 Dentistry-Casting and Baseplate waxes YY/T 0496-2016 5.5
7 Dentistry-Casting and Baseplate waxes YY/T 0496-2016 5.6
8 Dentistry-Casting and Baseplate waxes YY/T 0496-2016 5.7
9 Dentistry-Casting and Baseplate waxes YY/T 0496-2016 5.8
10 Dentistry-Casting and Baseplate waxes YY/T 0496-2016 5.9
103Dentistry-Casting and Baseplate waxes
11 Dentistry-Casting and Baseplate waxes YY/T 0496-2016 5.10
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 88 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
1 Compressive properties Plastics - Detemination of compressive properties GB/T 1041-2008
2 Specific optical rotation
Chemical reagent - General method for the determination of specific optical rotatory power(specific optical rotation) GB/T 613-2007
3 Density and apparent porostiy
Test methods for density and apparent porostiy of fine ceramics GB/T 25995-2010
4 Apparent porosity and bulk density
Test method for apparent porosity and bulk density of porous ceramic GB/T 1966-1996
5 Crystallite size and micro-strain
Determination of crystallite size and micro-strain of nano-materials - X-ray diffraction line broadening method GB/T 23413-2009
6 Static immersion test Dentistry—Corrosion test methods for metallic materials YY/T 0528-2018 4.1
7 Sulfide tarnish test(cyclic immersion)
Dentistry—Corrosion test methods for metallic materials YY/T 0528-2018 4.3
8 Sulfide tarnish test(static immersion)
Dentistry—Corrosion test methods for metallic materials YY/T 0528-2018 4.4
104 Medical Devices & Materials
9 Static immersion test with periodic analysis
Dentistry—Corrosion test methods for metallic materials YY/T 0528-2018 4.5
1 Part of ParametersDentistry— Additive manufacturing—Selective laser melting metallic materials for fixed and removable restorations and appliances STCBM/FB-007-2019
except for Solidus and liquidus temperatures or melting points
105
Dentistry— Additive manufacturing—Selective laser melting metallic materials for fixed and removable restorations and appliances 2
Chemical composition and Harmful ingredients
Dentistry— Additive manufacturing—Selective laser melting metallic materials for fixed and removable restorations and appliances STCBM/FB-007-2019 4.1.1
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 89 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
3 Powder appearanceDentistry— Additive manufacturing—Selective laser melting metallic materials for fixed and removable restorations and appliances STCBM/FB-007-2019 4.1.2
4 RoundnessDentistry— Additive manufacturing—Selective laser melting metallic materials for fixed and removable restorations and appliances STCBM/FB-007-2019 4.1.3
Dentistry— Additive manufacturing—Selective laser melting metallic materials for fixed and removable restorations and appliances STCBM/FB-007-2019 4.1.4
5 Powder size and
distributionParticle size analysis—Laser diffraction methods GB/T 19077-2016
Dentistry— Additive manufacturing—Selective laser melting metallic materials for fixed and removable restorations and appliances STCBM/FB-007-2019 4.1.5
6 Flow time
Metallic powders-Determination of flow time by means of 啊 calibrated funnel (Hall flowmeter) GB/T 1482-2010
Dentistry— Additive manufacturing—Selective laser melting metallic materials for fixed and removable restorations and appliances STCBM/FB-007-2019 4.1.6
7 Apparent density
Metallic powders-Determination of apparent density-Part1:Funnal method GB/T 1479.1-2011
Dentistry— Additive manufacturing—Selective laser melting metallic materials for fixed and removable restorations and appliances STCBM/FB-007-2019 4.1.7
8 Tap density
Metallic powders-Determination of tap density GB/T 5162-2006
9 Surface roughnessDentistry— Additive manufacturing—Selective laser melting metallic materials for fixed and removable restorations and appliances STCBM/FB-007-2019 4.2.1
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 90 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
10 sizeDentistry— Additive manufacturing—Selective laser melting metallic materials for fixed and removable restorations and appliances STCBM/FB-007-2019 4.2.2
11 Warpage deformationDentistry— Additive manufacturing—Selective laser melting metallic materials for fixed and removable restorations and appliances STCBM/FB-007-2019 4.2.3
12 HardnessDentistry— Additive manufacturing—Selective laser melting metallic materials for fixed and removable restorations and appliances STCBM/FB-007-2019 4.2.4.1
13 Tensile StrengthDentistry— Additive manufacturing—Selective laser melting metallic materials for fixed and removable restorations and appliances STCBM/FB-007-2019 4.2.4.2
14 Bending strengthDentistry— Additive manufacturing—Selective laser melting metallic materials for fixed and removable restorations and appliances STCBM/FB-007-2019 4.2.4.3
15 Inclusions and porosity
Dentistry— Additive manufacturing—Selective laser melting metallic materials for fixed and removable restorations and appliances SSTCBM/FB-007-2019 4.2.5
16 DensityDentistry— Additive manufacturing—Selective laser melting metallic materials for fixed and removable restorations and appliances STCBM/FB-007-2019 4.2.6
17 Corrosion resistanceDentistry— Additive manufacturing—Selective laser melting metallic materials for fixed and removable restorations and appliances STCBM/FB-007-2019 4.2.7
18 Tarnish resistanceDentistry— Additive manufacturing—Selective laser melting metallic materials for fixed and removable restorations and appliances STCBM/FB-007-2019 4.2.8
19 Thermal expansion coefficient
Dentistry— Additive manufacturing—Selective laser melting metallic materials for fixed and removable restorations and appliances STCBM/FB-007-2019 4.2.9
ISO/IEC 17025 认可证书
No. CNAS L3940
The scope of the accreditation in Chinese remains the definitive version.
第 91 页 共 91 页
№ Test ObjectItem/Parameter
Standard or Method Note№ Item/ Parameter
20 The debonding/crack-initiation strength
Dentistry— Additive manufacturing—Selective laser melting metallic materials for fixed and removable restorations and appliances STCBM/FB-007-2019 4.2.10