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9/20/2000
Radio Approvals for Europe:the R&TTE Directive and theUS-EU MRA
Presented by:
Todd RobinsonCKC Laboratories, Inc.
October 3, 20002001 RMCEMC Symposium on
Electromagnetic Compatibility
10/23/2000 2
Background - The New Deal
• In April 2000, Directive 99/5/EC (the Radioand Telecommunications TerminalEquipment Directive - R&TTE) drasticallychanged the manner in which radioequipment was placed on the Europeanmarket.
10/23/2000 3
Background - The New Deal
Notified Body and CABProvision of US/EU MRA• In January 2001 (actually began May
2001), Conformity Assessment Bodies(CABs), began the Phase 2 of the MutualRecognition Agreement between the UnitedStates and the European Union (US-EUMRA).
2
10/23/2000 4
Background - The New Deal
Open Area Area Test Site(OATS) performing RFEmissions Testing in
Tillamook, OR
Therefore, a ConformityAssessment Body(CAB), that is properlyaccredited, can act as aNotified Body under theprovisions of the R&TTEDirective
10/23/2000 5
Overview
In the Directive• Essential
Requirements.• Testing and
EvaluationRequirements.
• EU Agency andNational AgencyNotificationRequirements.
Specialized Test Set forRadio Equipment
10/23/2000 6
Overview
How It’s Working• Shortage of
HarmonizedStandards
• “Extra”Requirements ofNationalAuthorities.
• Certification ProjectExamples
RF Immunity Testing Facilityfor Radio Equipment
3
10/23/2000 7
R&TTE Essential Requirements
Article 3 -• 3.1(a) Protection of the health and safety of
the user or any other person, including thesafety objectives of the Low VoltageDirective, 73/23/EEC, but with no voltagelimit.
• 3.1(b) Protection requirements of the EMCDirective, 89/336/EEC (emissions andimmunity).
10/23/2000 8
R&TTE Essential Requirements
• 3.2 Radio equipment must effectively usethe spectrum allocated to terrestrial, spaceradio communications and orbital resourcesas to avoid harmful interference.
• 3.3 (a-b) Essential requirements forTelecom Terminal Equipment (TTE).
• 3.3 (c-f) Potentially applies to all R&TTEequipment for personal privacy, fraudprotection, access to emergency servicesand disabled user access.
10/23/2000 9
Placing on the Market
• In addition to the essential requirements,Article 6 of the R&TTE Directive puts thefollowing obligations on the manufacturer,his authorised representative or the personresponsible for placing the product on themarket:
1 Apply the conformity assessment procedures(Annexes II - V) of the Directive.
2 Add Declaration of Conformity (DoC) to theproduct.
4
10/23/2000 10
Placing on the Market
• Article 6 Requirements (continued):3 Affix the appropriate CE marking.4 The destination of the apparatus indicated so the
the product is used for its intended purpose.5 Information shall be given on the installation and
maintenance (Article 6 (1) of the Directive).6 Identification of the apparatus by means of type,
batch and/or serial numbers.7 The name of the manufacturer (Article 12 (4) of the
Directive).
10/23/2000 11
Placing on the Market
• Article 6 Requirements (continued):8 For radio equipment:
i information about the intended purpose must beon the packaging and in the instructions.
i this information shall be sufficient to identifywhere the equipment is intended to be used
9 The marking on the apparatus shall identify:i potential restrictions of usei potential requirements to hold a ministerial
licence.
10/23/2000 12
Placing on the Market
Article 6 Requirements (continued):Letters of Notification . . .iWhen using frequency bands that are not
harmonized, the manufacturer must notifyeach Member State of the intention to placeradio equipment on its national market.
iImportant radio characteristics aredescribed the letter of Notification and theidentification number of the CAB (NotifiedBody) referred to in Annex IV or V.
5
10/23/2000 13
Placing on the Market
Article 6 Requirements (continued)Letters of Notification . . .iRoughly 1/2 of the Member States are
requiring additional applications to besubmitted with the ‘Letter of Notification.’
iImportant Note: manufactures aresubmitting Member State ‘Letters ofNotification’ after receiving the ‘Letter ofOpinion’ (Annex IV) from a CAB (NotifiedBody).
10/23/2000 14
Placing on the Market
Article 6 Requirements (continued):Letters of Notification . . .i ‘Letters of Notification’ shall be given no
less than four weeks in advance of the startof placing on the market.
i A Member State may, in certain cases,prevent these products from being placedon its market. (e.g. Article 3.3).
10/23/2000 15
Conformity Assessment
Article 10: The manufacturer must applyan adequate and permissible conformityassessment procedure whichdemonstrates compliance of the apparatuswith all relevant requirements in theR&TTE Directive. These procedures areidentical in all Member States andConformity Assessment Bodies (CABs)functioning as Notified Bodies, such asCKC Laboratories.
6
10/23/2000 16
Conformity Assessment
Article 10 describes equipment categories andtells manufactures which procedural Annexescan be used to demonstrated compliance.
Open Area Test Site(OATS) for EMC andTransmitter Testing
10/23/2000 17
Conformity Assessment
iThe provisions of the Low Voltage andEMC Directives no longer apply directly toradio apparatus.
iHowever, for receivers, the procedures ofthe LVD and EMC Directives can be usedas an alternative to the conformityprocedures of the R&TTE Directive.
10/23/2000 18
Conformity Assessment
iReceiving parts of radio equipment aresubject to the procedures outlined inAnnexes II, IV or V.
iSpecial Note: Article 10.5 of the EMCDirective no longer applies to radioequipment: a notified body is no longerneeded for EMC approval or receivers.EMC Directive Article 10.2 can be used analternative compliance route for R&TTEDEssential Requirement, Article 3.1(b).
7
10/23/2000 19
Conformity Assessment
• Transmitters, where harmonizedstandards can be utilized, shouldfollow the procedures outlined inAnnexes III, IV or V at the choice ofthe manufacturer.
• Transmitters, where harmonizedstandards cannot be applied or onlyutilized in part, should follow theprocedures outlined in Annexes IV orV at the choice of the manufacturer.
10/23/2000 20
Conformity Assessment
Annex II - Internal Production Control• This procedure is the easiest and less
stringent procedure that can be used fortelecommunications terminal equipment notcontaining any radio transmitter and forradio receivers .
Transmitters:“Not Applicable”
10/23/2000 21
Conformity Assessment
Annex III - Specific Apparatus TestsAnnex III includes Annex II, plus:• All essential radio tests relevant to the
product, typically including: power output,antenna terminal conducted bandwidth,temperature and spurious emissionsmeasurements.
• If harmonized standards cannot be appliedin full, then a notified body must be involvedto create a test plan to comply with Article3.2, “Use of Spectrum” requirements.
8
10/23/2000 22
Conformity Assessment
Annex III (continued):• In creating the test plan or making other
judgements, the notified body mustconsider any of previous decisions made byany notified body.
• The manufacturer then declares thatrelevant radio tests have been carried outand that the apparatus complies with theessential requirements. If a notified bodyhas been used, the notified body numbermust to be affixed to the marketed product.
10/23/2000 23
Conformity Assessment
Annex IV Technical Construction Filei Can be used for transmitters that do not
have any applicable harmonized standardsor that cannot fully apply Harmonisedstandards (Example: applicable,harmonized EMC standard but noapplicable, harmonized “Use of Spectrum”standard).
i Annex III Requirements (previous slides).
10/23/2000 24
Conformity Assessment
Annex IV (continued)i TCF Consisting of - Annex II, point 4
technical documentation, the Declaration ofConformity to the specific radio tests.
i The manufacturer must present this file toone or more notified bodies.
i If the Notified Body (or CAB) considers thatthe requirements of the Directive have notbeen met, then they can issue a letter ofopinion stating such within 4 weeks.
9
10/23/2000 25
Conformity Assessment
Annex IV (continued)i Upon receipt of the Letter of Opinion or if
the CAB (Notified Body) doesn’t issue aLetter of Opinion within 4 weeks, themanufacture can place on the market.
i In reality, many CABs and Notified Bodiesare issuing Letters of Opinion as a normalcourse of action, whether negative orpositive.
i Files kept for 10 years after last production.
10/23/2000 26
Conformity Assessment
Annex V Full Quality Assurancei This procedure can be applied to all R&TTE
equipment.i This procedure can only be used by
manufacturers operating an approved qualitysystem for design, manufacture, finalproduct inspection and testing.
i Not yet a popular R&TTE conformity route.
10/23/2000 27
Marking the Product
Annex VIIi To remain in proportion with the Directive’s
renderings.i No less than 5 mm unless not possible on
the apparatus.i Should be on data plate and packaging.i Frequency information where applicable.i Notified Body number (per Annex IV).i Class 2 “alert symbol” if applicable.
10
10/23/2000 28
Marking the Product
Class 2 Alert Symboli Article 12.1: radio equipment needs a class
identifier where it has been assigned.i The EC established the identifier 4-6-2000.i Class 2 devices, those operating with
restriction, shall be identified with the alertsymbol. Many Class 2 devices operate atfrequencies not usable in all countries. A listof Class 2 devices can be found at:
Http://europa.eu.int/comm/enterprise/ rtte/listreq.htm
10/23/2000 29
Marking the Product
Example Equipment Marking
CE, Notified Body Number, Class 2 Alert.
10/23/2000 30
Example Conformity Steps
Typical R&TTE Radio Certification• CAB (Notified Body) constructs test plan
using harmonized EMC and non-harmonized TX characteristics standards.
• Testing performed at a qualified laboratoryand results submitted to CAB (NotifiedBody). Note: many CABs (Notified Bodies)may require that testing is performed by aproperly accredited laboratory.
11
10/23/2000 31
Example Conformity Steps
Typical R&TTE Radio Certification(continued)• A Letter of Opinion issued by CAB (Notified
Body) within 4 weeks (usually within 1week).
• Letters of Notification sent to MemberStates along with any applications requiredby given Member States.
• The Device is place on the EU market.
10/23/2000 32
Current R&TTE Issues
• Publication 2001/C 105/02 lists standardsthat are currently harmonized under theR&TTE Directive.
• GSM Cellular devices is the only “major”device category that can fully applyharmonized standards. Many moreharmonized EMC and “Use of Spectrum”standards are in the works!
• Most devices have applicable harmonizedstandards only for EMC and therefore musthave the involvement of a Notified body perAnnexes III, IV or V.
10/23/2000 33
Current R&TTE Issues
• Many Existing EMC standards for RadioEquipment have been replaced by a single,multi-part standard, EN 301 489-xx, with“dates of withdraw” during 2002 and 2003.
• SAR/MPE Exposure requirements are beingdeveloped to meet the health aspects ofArticle 3.19(a). The EC produced CouncilRecommendation 99-519 on EMF between 0Hz and 300GHz and has also producedprEN50371 concerning exposure limits in thefrequency range between 10 MHz and 300GHz.
12
10/23/2000 34
References
• “Directive 1999/45/EC of the European Parliamentand of the Council of 9 March 1999” (R&TTEDirective).
• “ETSI EG 201 450 v1.1.1 (2000-09), Guidance forthe identification of Harmonized Standards and/orother technical specifications for Radio Equipmentand Telecommunications Terminal Equipment(R&TTE) covering requirements under Article 3.1of Directive 1999/5/EC.”
• “2001/C 105/02 Publication of titles and referencesof harmonised standards under the Directive”(1999/45/EC)
1
9/20/2000
Radio Approvals for Europe:the R&TTE Directive and theUS-EU MRA
Presented by:
Todd RobinsonCKC Laboratories, Inc.
October 3, 20002001 RMCEMC Symposium on
Electromagnetic Compatibility
10/23/2000 2
Background - The New Deal
• In April 2000, Directive 99/5/EC (the Radioand Telecommunications TerminalEquipment Directive - R&TTE) drasticallychanged the manner in which radioequipment was placed on the Europeanmarket.
10/23/2000 3
Background - The New Deal
Notified Body and CABProvision of US/EU MRA• In January 2001 (actually began May
2001), Conformity Assessment Bodies(CABs), began the Phase 2 of the MutualRecognition Agreement between the UnitedStates and the European Union (US-EUMRA).
2
10/23/2000 4
Background - The New Deal
Open Area Area Test Site(OATS) performing RFEmissions Testing in
Tillamook, OR
Therefore, a ConformityAssessment Body(CAB), that is properlyaccredited, can act as aNotified Body under theprovisions of the R&TTEDirective
10/23/2000 5
Overview
In the Directive• Essential
Requirements.• Testing and
EvaluationRequirements.
• EU Agency andNational AgencyNotificationRequirements.
Specialized Test Set forRadio Equipment
10/23/2000 6
Overview
How It’s Working• Shortage of
HarmonizedStandards
• “Extra”Requirements ofNationalAuthorities.
• Certification ProjectExamples
RF Immunity Testing Facilityfor Radio Equipment
3
10/23/2000 7
R&TTE Essential Requirements
Article 3 -• 3.1(a) Protection of the health and safety of
the user or any other person, including thesafety objectives of the Low VoltageDirective, 73/23/EEC, but with no voltagelimit.
• 3.1(b) Protection requirements of the EMCDirective, 89/336/EEC (emissions andimmunity).
10/23/2000 8
R&TTE Essential Requirements
• 3.2 Radio equipment must effectively usethe spectrum allocated to terrestrial, spaceradio communications and orbital resourcesas to avoid harmful interference.
• 3.3 (a-b) Essential requirements forTelecom Terminal Equipment (TTE).
• 3.3 (c-f) Potentially applies to all R&TTEequipment for personal privacy, fraudprotection, access to emergency servicesand disabled user access.
10/23/2000 9
Placing on the Market
• In addition to the essential requirements,Article 6 of the R&TTE Directive puts thefollowing obligations on the manufacturer,his authorised representative or the personresponsible for placing the product on themarket:
1 Apply the conformity assessment procedures(Annexes II - V) of the Directive.
2 Add Declaration of Conformity (DoC) to theproduct.
4
10/23/2000 10
Placing on the Market
• Article 6 Requirements (continued):3 Affix the appropriate CE marking.4 The destination of the apparatus indicated so the
the product is used for its intended purpose.5 Information shall be given on the installation and
maintenance (Article 6 (1) of the Directive).6 Identification of the apparatus by means of type,
batch and/or serial numbers.7 The name of the manufacturer (Article 12 (4) of the
Directive).
10/23/2000 11
Placing on the Market
• Article 6 Requirements (continued):8 For radio equipment:
i information about the intended purpose must beon the packaging and in the instructions.
i this information shall be sufficient to identifywhere the equipment is intended to be used
9 The marking on the apparatus shall identify:i potential restrictions of usei potential requirements to hold a ministerial
licence.
10/23/2000 12
Placing on the Market
Article 6 Requirements (continued):Letters of Notification . . .iWhen using frequency bands that are not
harmonized, the manufacturer must notifyeach Member State of the intention to placeradio equipment on its national market.
iImportant radio characteristics aredescribed the letter of Notification and theidentification number of the CAB (NotifiedBody) referred to in Annex IV or V.
5
10/23/2000 13
Placing on the Market
Article 6 Requirements (continued)Letters of Notification . . .iRoughly 1/2 of the Member States are
requiring additional applications to besubmitted with the ‘Letter of Notification.’
iImportant Note: manufactures aresubmitting Member State ‘Letters ofNotification’ after receiving the ‘Letter ofOpinion’ (Annex IV) from a CAB (NotifiedBody).
10/23/2000 14
Placing on the Market
Article 6 Requirements (continued):Letters of Notification . . .i ‘Letters of Notification’ shall be given no
less than four weeks in advance of the startof placing on the market.
i A Member State may, in certain cases,prevent these products from being placedon its market. (e.g. Article 3.3).
10/23/2000 15
Conformity Assessment
Article 10: The manufacturer must applyan adequate and permissible conformityassessment procedure whichdemonstrates compliance of the apparatuswith all relevant requirements in theR&TTE Directive. These procedures areidentical in all Member States andConformity Assessment Bodies (CABs)functioning as Notified Bodies, such asCKC Laboratories.
6
10/23/2000 16
Conformity Assessment
Article 10 describes equipment categories andtells manufactures which procedural Annexescan be used to demonstrated compliance.
Open Area Test Site(OATS) for EMC andTransmitter Testing
10/23/2000 17
Conformity Assessment
iThe provisions of the Low Voltage andEMC Directives no longer apply directly toradio apparatus.
iHowever, for receivers, the procedures ofthe LVD and EMC Directives can be usedas an alternative to the conformityprocedures of the R&TTE Directive.
10/23/2000 18
Conformity Assessment
iReceiving parts of radio equipment aresubject to the procedures outlined inAnnexes II, IV or V.
iSpecial Note: Article 10.5 of the EMCDirective no longer applies to radioequipment: a notified body is no longerneeded for EMC approval or receivers.EMC Directive Article 10.2 can be used analternative compliance route for R&TTEDEssential Requirement, Article 3.1(b).
7
10/23/2000 19
Conformity Assessment
• Transmitters, where harmonizedstandards can be utilized, shouldfollow the procedures outlined inAnnexes III, IV or V at the choice ofthe manufacturer.
• Transmitters, where harmonizedstandards cannot be applied or onlyutilized in part, should follow theprocedures outlined in Annexes IV orV at the choice of the manufacturer.
10/23/2000 20
Conformity Assessment
Annex II - Internal Production Control• This procedure is the easiest and less
stringent procedure that can be used fortelecommunications terminal equipment notcontaining any radio transmitter and forradio receivers .
Transmitters:“Not Applicable”
10/23/2000 21
Conformity Assessment
Annex III - Specific Apparatus TestsAnnex III includes Annex II, plus:• All essential radio tests relevant to the
product, typically including: power output,antenna terminal conducted bandwidth,temperature and spurious emissionsmeasurements.
• If harmonized standards cannot be appliedin full, then a notified body must be involvedto create a test plan to comply with Article3.2, “Use of Spectrum” requirements.
8
10/23/2000 22
Conformity Assessment
Annex III (continued):• In creating the test plan or making other
judgements, the notified body mustconsider any of previous decisions made byany notified body.
• The manufacturer then declares thatrelevant radio tests have been carried outand that the apparatus complies with theessential requirements. If a notified bodyhas been used, the notified body numbermust to be affixed to the marketed product.
10/23/2000 23
Conformity Assessment
Annex IV Technical Construction Filei Can be used for transmitters that do not
have any applicable harmonized standardsor that cannot fully apply Harmonisedstandards (Example: applicable,harmonized EMC standard but noapplicable, harmonized “Use of Spectrum”standard).
i Annex III Requirements (previous slides).
10/23/2000 24
Conformity Assessment
Annex IV (continued)i TCF Consisting of - Annex II, point 4
technical documentation, the Declaration ofConformity to the specific radio tests.
i The manufacturer must present this file toone or more notified bodies.
i If the Notified Body (or CAB) considers thatthe requirements of the Directive have notbeen met, then they can issue a letter ofopinion stating such within 4 weeks.
9
10/23/2000 25
Conformity Assessment
Annex IV (continued)i Upon receipt of the Letter of Opinion or if
the CAB (Notified Body) doesn’t issue aLetter of Opinion within 4 weeks, themanufacture can place on the market.
i In reality, many CABs and Notified Bodiesare issuing Letters of Opinion as a normalcourse of action, whether negative orpositive.
i Files kept for 10 years after last production.
10/23/2000 26
Conformity Assessment
Annex V Full Quality Assurancei This procedure can be applied to all R&TTE
equipment.i This procedure can only be used by
manufacturers operating an approved qualitysystem for design, manufacture, finalproduct inspection and testing.
i Not yet a popular R&TTE conformity route.
10/23/2000 27
Marking the Product
Annex VIIi To remain in proportion with the Directive’s
renderings.i No less than 5 mm unless not possible on
the apparatus.i Should be on data plate and packaging.i Frequency information where applicable.i Notified Body number (per Annex IV).i Class 2 “alert symbol” if applicable.
10
10/23/2000 28
Marking the Product
Class 2 Alert Symboli Article 12.1: radio equipment needs a class
identifier where it has been assigned.i The EC established the identifier 4-6-2000.i Class 2 devices, those operating with
restriction, shall be identified with the alertsymbol. Many Class 2 devices operate atfrequencies not usable in all countries. A listof Class 2 devices can be found at:
Http://europa.eu.int/comm/enterprise/ rtte/listreq.htm
10/23/2000 29
Marking the Product
Example Equipment Marking
CE, Notified Body Number, Class 2 Alert.
10/23/2000 30
Example Conformity Steps
Typical R&TTE Radio Certification• CAB (Notified Body) constructs test plan
using harmonized EMC and non-harmonized TX characteristics standards.
• Testing performed at a qualified laboratoryand results submitted to CAB (NotifiedBody). Note: many CABs (Notified Bodies)may require that testing is performed by aproperly accredited laboratory.
11
10/23/2000 31
Example Conformity Steps
Typical R&TTE Radio Certification(continued)• A Letter of Opinion issued by CAB (Notified
Body) within 4 weeks (usually within 1week).
• Letters of Notification sent to MemberStates along with any applications requiredby given Member States.
• The Device is place on the EU market.
10/23/2000 32
Current R&TTE Issues
• Publication 2001/C 105/02 lists standardsthat are currently harmonized under theR&TTE Directive.
• GSM Cellular devices is the only “major”device category that can fully applyharmonized standards. Many moreharmonized EMC and “Use of Spectrum”standards are in the works!
• Most devices have applicable harmonizedstandards only for EMC and therefore musthave the involvement of a Notified body perAnnexes III, IV or V.
10/23/2000 33
Current R&TTE Issues
• Many Existing EMC standards for RadioEquipment have been replaced by a single,multi-part standard, EN 301 489-xx, with“dates of withdraw” during 2002 and 2003.
• SAR/MPE Exposure requirements are beingdeveloped to meet the health aspects ofArticle 3.19(a). The EC produced CouncilRecommendation 99-519 on EMF between 0Hz and 300GHz and has also producedprEN50371 concerning exposure limits in thefrequency range between 10 MHz and 300GHz.
12
10/23/2000 34
References
• “Directive 1999/45/EC of the European Parliamentand of the Council of 9 March 1999” (R&TTEDirective).
• “ETSI EG 201 450 v1.1.1 (2000-09), Guidance forthe identification of Harmonized Standards and/orother technical specifications for Radio Equipmentand Telecommunications Terminal Equipment(R&TTE) covering requirements under Article 3.1of Directive 1999/5/EC.”
• “2001/C 105/02 Publication of titles and referencesof harmonised standards under the Directive”(1999/45/EC)