BQYTE CQNG HOA :xA HQI cnn NGHiA VI:t::TNAMDQc l~p - TV do - H~nh phuc

s6:5Sb IBYT-TB-CTVIv xin y kien gop y v6 huang d~n kYthuat tam thai cho kh~u trang viti phongnhi~m vi khuan, virus cho cong d6ng.

Ha N(Ji, ngay 11 thdng 02 ndm 2020

~/~S0~pnA-TO'C~///// It!\o'" . t

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n;'" u,w. n;;1 nn~y "[:~~l 1..fIN11I111I1III' ..IIUI ..... ~.~

Nham he; tro va thuc dAy cac doanh nghiep san xuat khAu trang, trang phuc phongchong dich benh do chung moi cua virus Corona (nCoV), chieu ngay 10102/2020, B9 Y t~ vaB9 Cong thuong da lam viec voi mot s6 doanh nghiep san xuc1tcac mat hang nay. Theo B9Cong thuong, ngoai khau trang y t~, con nhieu loai khau trang khac trong mroc co th~ tv chuvS cong ngh~ va san xuat diroc (khAutrang co su dung vai khang khuan) gop phan tham giacong tac phong, chong dich. Tuy nhien, cAnco tieu chuAn,quy chuAncho IO!;likhAutrang naytruac khi dua ra thi truOng.

Thvc hi~n y ki~n chi d!;locua Lanh d!;loB9 Y t~, V\l Trang thi~t bi va Cong trinh y t~ -B9 Y t~ dli ph6i hqp vai Vi~n Trang thi~t bi va Cong trinh y t~ - B9 Y t~ va cac don vi lienquan xay dvng dv thao Huang d~n kY thu~t t!;lmthai cho khAu trang vai phong nhiSm vikhuAn,virus t!;lic9ng d6ng (Ph\lI\lC kern theo) va dv ki~n sam ban hanh kern thea Quy~t dinhcua B9 truemg B9 Y t~. D~ co cO'sa tri~n khai cac buac ti~p theo, tran tn;mgxin y ki~n thealInh vvc quan ly, chuyen mon cua Quy don vi v€:

1. N9i dung va hinh thuc ban hanh Huang d~n kY thu~t t!;lmthai cho khAutrang vaiphong nhiSm vi khuAn,virus t!;lic9ng d6ng.

2. M9t s6 yeu cAuky thu~t chinh cAngop y trong huang d~n:_M\lc 3.4. Chi tieu kY thu~t cua khAutrang: Phuong phap thu thea chi tieu ky thu~t cua

khAutrang thea TCVN 8389-1 la kho khan vi cong ngh~ dli thay d6i, do do tinh kha thi cuaphuong phap thu chua dam bao trong giai dO!;lnhi~n nay, vi v~y xin y ki~n co dua m\lc 3.4vao huang d~n khong?

_M\lc 3.7. Giai h!;lncho phep cac nguyen t6 kim IO!;lin~ng co trong vai: co cAndua vaokhong vi day la giai h!;lncho phep d~ dam bao an toan cho nguai su d\lng? .

- Cac n9i dung khac cua dv thao.V\l Trang thi~t bi va Cong trinh y t~ - B9 Y t~ xin nh~n l!;liy ki~n gop y cua cac don vi

trU'CYc 16hOO ngay 13/02/2020. Trong qua trinh thvc hi~n, n~u co vuang m~c, xin lien h~ ongDoan Quang Minh, chuyen vien V\l Trang thi~t bi va Cong trinh y t~, SDT:024.62732272/0912727895, file m€m gui truac vS dia chi email:minhdq.ttbct@moh.gov.vn d~ t6ng hqp, bao cao.

Kinh gui: ..........................................................................................

Tran tf(;mgcam on sv ph6i hqp cua Quy Don vi./.

Noi nhfjn:- Nhu tren (thea danh Sikh);- D/c Bi thu BCSD BYT (dS b/c);- Cae dlc Thu truang (dS b/e);- Luu: VT, TB-CT.

TL. BQ TRUONG ~.VVTRUONG

.JJiiIIMIIIlll.o.PJ vA CONG TRiNH Y TE

Phu luc kern theo

(Kern thea C6ng van s6596 IBYT-TB-CT ngay AAthang 2 nam 2020 ella B(J Y d)

DV'THAo 3HU'ONGDAN KY THU~T T~M THOI

CHO KHAu TRANG vAl PHONGNHIEMVI KHUAN, VI RUT

T~I CQNG£lONG

1. Pham vi ap dl,mg

HU'cYngdan nay ap dl,mg d6i voi khau trang vai phong nhiem vi khuan, vi rut tai cQng d6ng

(khau trang val), c6 tac dl,mg ngan can cac hat dich chua vi khuan, vi rut phat tan trong

khong khi, c6 chuc nang khLr khuan.

2. Tai Ii~uvi~n dan

Cac tai li$u vien dan sau la r~t can thiet cho hU'cYngdan nay:

TCVN 8389-1 :2010 Khau trang y te - Phan 1: Khau trang y te thong thU'6'ng

TCVN 8389-2:2010 Khau trang y te - Phan 2: Khau trang y te phonq nhiem khuan

3. Yeu cau ky thuat

3.1. Quy djnh chung

_ Khong dU'Q'Cgay d] ung da cho ngU'6'i dec;

_ Be m~t phai sach se, khong con dau chi XO'vai va khong c6 loi nqoal quan;

_ Day dec duoc ket cau chao chan;

_ Cac mep khau trang vai phai om khit khuon mat ngU'6'i deo.

3.2. cau truc

3.2.1. Khau trang vai g6m cac bQph~n:

_ C6 t6i thi~u 2 IcYpd~ng ph~ng c6 g~p nep ho~c d~ng mom; IcYpngoai cung phai la IcYpc6

tinh khang nU'cYcho~c ket hQ'p khang nU'cYc,khang khuan; IcYpkhang khuan la vai khang

khuan ho~c v~t li$u chua nano b~c, ho~c than ho~t tinh ho~c tU'O'ngdU'O'ng;

- Thanh n~p mOi;

- £)$m mOi, day dec;

_ Kh6a dieu chinh day dec (neu can);

3.2.2. Ki~u dang, kich thU'cYc

Ki~u dang kich thU'cYckhong bat bUQCnhU'ng phai dam bao che kin mOi va mi$ng.

1

3.3. Yeu cau d6i v&i v~t li~u

3.3.1. Lop ngoai cung co b~ m~t nhan, co co thoang khf, khang nuoc va co kha nang ngancan cac hat dich chua vi khu~n, vi rut phat tan trong kh6ng khi.

3.3.2. Lop khang khu~n co tac dl,mgdiljl!tkhu~n.

3.3.3. Thanh nep mCri:lam b~ng vat liljl!ucam bao de uen, gill' nguyen hlnh danq sau khi uon.

3.3.4. Dljl!mmCri:rnern, kh6ng gay klch ung da.

3.3.5. Day ceo: dung 10G1ivat lieu giup cho viec ceo, thao kh~u trang de dang.

3.3.S.Khoa ci~u chlnh day ceo (n~u can).

3.4. Chi tieu ky thu~t cua kh~u trang

- Hiljl!usuat Ioc coi voi hat svonq & ch~ co thoi khi 301/phUtkh6ng nhe hon 90%;

- Tr& h,J'ch6 hap & ch~ co thoi khi 301/phUtkh6ng Ion hon 9 mm nuoc:- Gioi han trU'O'ngnhln kh6ng Ion hon 6%;

(Theo TCVN 8389-1, Di~u 3.4).

3.5. Kha nang bao v~ ch6ng nhi~m khuan

- Kha nang bao vljl!chong nhiem khu~n cua kh~u trang vai cU'Q'cxac cjnh theo c6ng bo cuanha san xuat.

3.S.Dc;,vo khuan

- Theo khuy~n cao cua nha san xuat.

3.7. Gi&i h~n cho phep cac nguyen t6 kim lo~i n~ng co trong vai

Nguyen t6 Gi&i h~n cho phep

Asen (As) 0,17

Chi (Pb) 1,0

Thuyngan(Hg) 0,12

Antimon(Sb) 0,1

Cadimi(Cd) 0,1

(Theo TCVN 8389-1. Di~u 3.5).

4. PhU'O'ngphap thLP

4.1. Ki~m tra k~t CaU,yeu cau d6i v&i v~t li~u

KiE§mtra k~t cau, yeu c~u coi voi v~t liljl!ub~ngm~t thU'O'ng.

4.2. Ki~m tra hi~u suat IQcd6i vai sU'O'ngdau

2

4.2.1. Nguyen tic

4.2.2. Thi~t b], dl,mg cu4.2.2.1. Thi~t b] kiem tra hi~u su~t IQc cua phU'O'ngMn bao v$ co quan ho hap (Hlnh 1) phai

dam bao cac yeu cau sau:

_ dam bao do kin khi;

_ lU'u1U'Q'ngk~ (5) c6 dai do tu>0 lit/phdt d~n 4 lit/tren phut vai dOchinh xac ± 0,1 lit/phdt;

_ ap k~ dong ho (3) c6 dai do tu>0 KG/cm2 d~n d~n 2 KG/cm2 vai dOchinh xac 0,05 KG/cm2;

_ dau tao suonq la dau DOP tinh khi~t;

_ thi~t bi do dOdue <t>EH-58(11) hoac thi~t b] khac c6 tinh nang tU'O'ngdU'O'ng;

_ b6ng den chleu cua thi~t b] do do due <t>EH-58c6 cong suat 400 W, di$n ap 30 V;

_ bo ga I~p mau (9) dam bao do kin, kich thuoc va hlnh d<;lngphu hop vai mau kh3mtra;

_ khi nen cung cap phai kho va sach;

_ b~p di$n cua 16tao suonq (6) c6 cong suat 1000 W, di$n th~ 220 V.

4.2.2.2. Tu sAy, c6 bo ph~n dieu chTnhnhi$t do vai do chinh xac ± 0,1°C.

4.2.2.3. Can ky thu~t c6 do chinh xac ± 0,001 g.

4.2.2.4. Nhi~t k~ c6 thang chia tu>O°Cd~n 150°C.

4.2.2.5. Thi~t bl nEmkhi va cung c~p khi s~ch.

4.2.2.6. H~ thOng lam mat cho thi~t bi do do dl,lc <t>EH-58.

Khi

Chi dan

1. Ong dan khi

2. Bo IQckhong khi

3. Ap k~ dong ho

7. Thi~t bi dieu chTnhkich thU'ac h<;ltsU'O'ng(xyclon)

8. HOpIQcsU'O'ngdau

9. BOga mau killm tra

4. Van dieu chinh

5. Luu IlfQ'ng kll con chay

6. Thillt b] tao slfO'ng

Hinh 1 - SO' dO thi~t b] kit}m tra hi~u suat IQc cua phU'O'ng ti~n bao v~ co quan h6 hap

10. Mau kiem tra

11. Thillt bi do d¢ due <l>EH-58.

4.2.3. Chuan b] mau th(P va thi~t b]

- mau kiem tra phai dam bao d¢ kin khi SLrdunq, khOng b] scm rach hoac khuyet tat;

- chuan b] it n~at 03 mau thLr;

- mau kiem tra phai duoc say khO dlln khOi 1U'Q'ngkhonq dOia nhi~t d¢ tCr80°C dlln 1aaoc.Kiem tra biing each can I~p lai mot gia mot IfIn cho dlln khi chenh I~ch khOi IlfQ'nggiCfhai IfInlien tillp khong Ian hon 0,1 % ;

- mau kiem tra dU'Q'cdanh theo sOthLi'tu;

- lap mau kiem tra vao b¢ ga (9) dam bao d¢ kin. Sau khi xac dinh d¢ kin, thao mau ra khoi b¢g13;

- kiem tra SI,I'dong b¢ cLlathillt bi;

- kien tra d¢ kin cLlathillt bi;

- chuan I~i h~ thOng do quang cLlathillt bi;

- ki~m tra dau t~ci slfO'ng, cac van kh6a dieu chinh cLla h~ thOng t~o slfO'ng;

- t~o sU'O'ng,dieu chinh nang d¢ va kich thlfac h~t slfO'ng dau bang cach: dieu chinh IlfUIlfQ'ngdong khi vao thillt bi, nhi~t d¢ va xyclon (7);

- xac dinh d¢ pMn tan cLla slfO'ng dau bang phep xac dinh d¢ khuyllt pMn CI,I'C(ty I~ %) cLla

anh sang tan x~ theo hU'ang vuong g6c va song song vai m~t ph~ng pMn CI,I'C:

A=4x1OO~

trong d6:

A la d¢ khuyllt pMn CI,I'C;

Arv la d¢ pMn CI,I'CcLlaanh sang tan x~ theo hU'ang vuong g6c;

Ars la d¢ pMn CI,I'CcLlaanh sang tan x~ theo hlfang song song.

- do d¢ tan x~ rieng cLlathillt bi (Kcc);

- kiem tra h¢p IQc(8).

4.2.4. Cac ti~n hanh

4.2.4.1.Di~u ki~n th(Pnghi~m

- thillt bi kiem tra phai dam bao d¢ kin;

4

_ hru 1U'Q'ngdong sU'O'ngdau qua m~u killm tra ta 30 Iltlphut;

_ th(J'& di~u ki~n mOitrU'cmgcua phong;

_ khOngkhi cung cap cho thiE§tbi khOva sach;

_ nOngd¢ suonq dau: 0,020 mg/I- 0,025 mg/I;

_ kich thuoc hat suonq: c6 dU'cyngkinh d trong khoang tt) 2.10-5 cm dE§n4.10-5 cm (0,2 IJm

dE§n0,4 IJm)

4.2.4.2. Ti~n hanh do

_ xac dinh chi s6 do quang cua sU'O'ngdau truce m~u killm tra (sU'O'ngdau ban dau) voi luu1U'Q'ng30 Iltlphut, ghi kE§tqua do (AT) (d6i voi m6i m~u killm tra phai xac djnh it nhat 1 Ian);

_ I~p m~u killm tra vao b¢ ga (9);

_ xac dinh chi s6 do quang cua suonq dau sau m~u killm tra voi luu 1U'Q'ng30 Iltlphut, ghi k~t

qua do (As);

_ thai khi sach vao thiE§tb] do quang;

_ thao m~u ra kh6i b¢ ga (9), I~p m~u khac vao va tiE§ptuc killm tra

4.2.5. Tinh toan k~t qua

4.2.5.1. Hi~u su~t loc sU'O'ngdau cLlam~u killm tra dU'Q'ctinh theo cOngth(fc:

H=lOO-(!XlOO-x.. )trong d6:

H la hi~u su~t loc, tinh b~ng phan tram (%);

As la chi s6 do quang sU'O'ngdau sau m~u killm tra;

AT la chi s6 do quang sU'O'ngdau tmoc m~u killm tra;

Kcc la d¢ tan Xl;! rieng cLladl,lc kE§.

4.2.5.2. Hi~u su~t loc sU'O'ngdau cLla phU'O'ngti~n bao v~ cO'quan hO hap la gia tri trung blnh

cLla3 m~u killm tra trong cung m¢t di~u ki~n th(J'nghi~m.

4.2.5.3. Bao cao thw nghi~m

Bao cao th(J'nghi~m phai gOmcac n¢i dung sau:

- ten phOngthi nghi~m;

- ten khach hang;

- ten m~u killm tra;

- hi~u su~t loc (H);5

- nhan xet va k~t luan:

- ngay, thang ti~n nanh thli;

- ngU'oi thf nghi~m.

(Thea TCVN 7312:2003 , Dieu 6.3).

4.3.1. Nguyen t~c

Xac djnh d(>chenh I~ch ap suat giCrad~1Uvao va dau ra cua mau khi cho dong khf c6 luu 1U'Q'ngxac djnh di qua.

4.3.2. Thi~t b], dl,lng cu

4.3.2.1. Thi~t b] ki~m tra treYIl,I'c he)hap cua phU'O'ngtien baa v~ co quan h6 hap (Hinh 2) phaidam baa cac yeu cau sau:

- dam baa d(>kin khi;

- IUJu1U'Q'ngk~ (3) c6 dai do tli ° lit/phdt d~n 60 lit/pMt vcYid(>chinh xac 0,1 lit/phdt;

- ap k~ (5) c6 dai do ttl °mmH20 d~n 50 mmH20 vcYid(>chinh xac 0,5 mmH20;

- b(>ga I~p mau (4) dam baa d(>kin, kich thuoc va hinh dc;lngphu hop vcYimau kiem tra;

- chat long trong luu 1U'Q'ngke va ap ke: dau hoa c6 khoi 1U'Q'ngrieng 0,83 g/cm3 ± 0,01 g/cm3.

4.3.2.2. Tu say, c6 b(>ph~n dieu chinh nhi~t d(>c6 d(>chinh xac ± 10C.

4.3.2.3. Can ky thu~t, c6 d(>chinh xac ± 0,001 g.

4.3.2.4. Nhi~t k~, c6 dai do ttl O°Cden 100°C.

4.3.2.5. Thi~t bi nen khi

Chi dan

1. Gia dO> 5. Ap ke nghieng

6

2. BO toe khOng khi

3. LU'u 1U'Q'ngke

4. Ga I~p mau

6. Vit chlnh thang bang

7. Khoa dieu chlnh khOngkhi

8. Bot ruroc thang bang

Hinh 2 _ So' d6 thi~t b] ki~m tra tr6t h.fc he)hip cua phU'O'ngti~n bao v~ Co' quan hOhip

4.3.3. ChuAn bi mAu thli' va thi~t b]

Chuan b] it nhat 03 mau thLY;

_ Cac mau ki~m tra phai dam bao do kin khi SLYdunq, khOng b] san rach hoac khuyet tat;

_ Mau ki~m tra duoc danh theo s6 th(f tl,l';

_ L~p mau ki~m tra vao bo ga (4) dam bao do kin khi;

_ Kiem tra tlnh trc;tngcua toan bo thiet bi nhu: dOkin cua cac m6i lien ket, do tMng bang (8), vi

trl cac diem "0" cua ap ke (5) va luu 1U'Q'ngke (3);

_ Ki~m tra be;,loc khOng khi (2): neu giay loc bul hong phal thay the, cac chat hut am bi bao

hoa thl phai say Ic;ti;

4.3.4. each ti~n hanh

4.3.4.1. Di~u ki~n thli'

_ thiet bi ki~m tra phai dam bao do kin;

_ lU'u1U'Q'ngdong khi qua mau kiem tra: 30 lIt1phut;

_ thLYadieu ki$n mOitmang cLlaphong;

_ dieu hoa mau a mOitmang cLla phong trU'cYckhi kiem tra tra Il,I'c15 phut.

4.3.4.2. Xac dlnh tr6t I,!c clia thi~t bl (P1)

- cho khi vao thiet bi;

_ dieu chlnh khoa (7) tll' tll' cho den khi dc;ttdU'Q'ClU'u1U'Q'ng30 lIt1phut, doc gia tri P1 tren ap ke

(5);

_ dong khi vao thiet bi.

4.3.4.3. Xac dlnh tr6t I,!c (P2)

_ I~p mau kiem tra vao bo ga (4);

- cho khi vao thiet bi;

_ dieu chlnh khoa (7) tll' tll' cho den khi dc;ttdU'Q'ClU'u1U'Q'ng30 litlphut, doc gia tri P2 tren ap ke

(5);

dong khi vao thiet bi;

_ thao mau khoi bo ga, I~p mau mcYitiep tl,lCkiem tra.7

4.3.5. Tinh toan k~t qua

4.3.5.1. Tro II,I'Ccua mau kiem tra a di~u ki~n thf nghi~m voi hru fU'Q'ng30 ffUphUt.

trong d6:

L\P fa tra fl,l'ccua mau kiem tra a di~u ki~n thi nghi~m, tfnh bang mmH20;

P2 fa tro fl,l'ccua thiet b] khi c6 mau kiem tra, tfnh bang mmH20;

P1 fa tra fl,l'ccua thiet b] khi kheng c6 mau kiem tra, tfnh bang mmH20.

4.3.5.2. Tra fl,l'Che hap cua phU'O'ngti~n bao v~ co quan he hap fa gia tri trung blnh cua 3 maukiem tra trong cling mot di~u ki~n thu nghi~m.

4.3.6. Bao cao thLPnghi~m

Bao cao thu nghi~m phai bao gOmcac noi dung sau:

- ten pMng thl nghi~m;

- ten knach hang;

- ten mau kiem tra;

- treyfl,l'che hap (L\P);

- nhan xet va ket tuan:

- ngay, tMng tien hanh thu;

- ngU'ai thl nghi~m.

(Theo TCVN 7312:2003 , f)i~u 6.4).

4.4. Ki~m tra giai han trll'cYng nhin

Kiem tra gioi hc;intrU'ang nhin theo TCVN 3154-1979.

5. Bao goi va ghi nhan

5.1. Bao goi

SOfU'Q'ngva quy cach d6ng g6i khau trang aU'Q'cdi~u chinh theo nhu cau Cl,lthe.

5.2. Ghi nhan

Nhan phai aU'Q'cdan tremhop cacteng voi cac thOng tin tOi thieu sau:

- Ten san pham;

- Vi~n dan hU'ong dan nay;

- Ten va dia chi nha san xuat;

- Ngay san xuat, hc;insu dl,lng;

- oau kiem tra cLla KCS;

8

_ Huang dan SlYdunq.

9

MVC LVC

1. Pharn vi ap dl,mg

2. Tai li~u vi~n dan·

3. Yeu cau ky thuat

4. Phuonq phap tht)

5. Bao g6i va ghi nhan

10

DANH sxca cAc DON VI XIN YK1EN

(Kern thea Cong van sci 59!; IBYT- TB-CT ngayA./ thang 2 nam 2020 cua B6 Y Ii)

1. BQ Cong thuong2. BQKhoa hoc va Cong nghe

3. BQ Tu phap4. T~p doan D~t may Vi~t Nam (Vinatex)

5. Cong ty C6 phan - Vi~n nghien ciru Det may

6. Cong ty TNHH MTV Det kim Dong Xuan (Doximex)7. BQY t~ (O,IC Quan ly Kham, chua benh; C\lC Y t~ du phong; Vu Phap che;

C\lC Khoa hoc Cong nghe va Dao tao)8. Dai hoc Bach khoa Ha NQi (Vien D~t may - Da gi~y va Thai trang)

9. HQi TBYT Vi~t Nam

3