YY T 0287-2017 医疗器械质量管理体系用于法规的要求-ISO 13485-2016.pdf

May 5, 2017 | Author: 楊宗棠 | Category: N/A
Share Embed Donate


Short Description

Download YY T 0287-2017 医疗器械质量管理体系用于...

Description

I C S 11 . 0 4 0 . 0; 01 3 .1 2 01. 0 c30

YY

+ +/\ R+fn EXEwtT{r{ttrie YY/T 0287-2017/rSO 13485,2016

,ft# YY/T ozBT-2003

trtrEFftTtrEtrIE{AA ,HT'E*NH!g* Medical devices-Quality

management systems-

Requirements for regulatory purposes

( I S O 1 3 4 85 . 2 0 1 6, I D T )

2017-01-1e fr.fr

2017-05-01 * ffi

tr^AffifrF"HgHru,H.E fr.fr

+!#

RJqruEtr.fr '41 iL &r t&

E'?€FftI EEHTEtrA H T)ts*4HtE* YY /T 0287-201,7/ISO 13485:2016

.)€ + E ffi I& H Hnii fr HnETt It6fi# FEtrfr+Efl:{frry 2 +Qoooze> 16€ ( 10004s ) JtHfi Efi tr = EiFJIL;tfr Fltrt www.sPc.net.cn , K f f i E: ( 0 1 0 ) 6 8 5 3 3 5n3f3t + , L ' : ( 0 1 0 ) 5 1 7 8 0 2 3 8 1*# nV.*# : ( o1o) 68523e46 + Et,nlEfrffit|F^4.,$ Epffi{rqrEll

&fr,*fr+frtEgt4'H )e

ffA aaoxr23o 1/t6 EplK2.5 +w 68 ++ 2or7+2 EH--ffi. 2or7+2 Effi--Ik€lrffii! * . 2-31256Efl| 43.00n fl€, 155066

gsFEll#tfH HA+Efi +,1'iEl4 fiF+X€€' ,fF+T,2.f; ' + + R Ei f r ,( 0 1 0 ) 6 8 5 1 0 1 0 7

YY/T 0287-2A17/rSO 13485,2016

H V VI I

1 1 i

+ /l T

tr tr tr

6 o o

6 n ,7 I

n I

7 7 I

7 nI I I

7 I

j I

8 B B B B B B 9 9 o 9 9

YY/T 0287-2017 /rSO 13485.2016

e 10 10

7.r Fffi*q,ffiffinlj 7.2 SEnEHXF'lSfg 7 . 2 . r F f f i t > RH \ f f i F nt .oL .qL

o ot r' t4r * H t i + H '

10

)

10

7.2.3 ?4iE

7.s witflTF .........

10 .....q...

7. 3 . r , H . I U

10

10 11

7.3.2 Ei+fflfrnffir/l 7.3.3 Eif rufraffi ^ 7.3.4 1ftitffiffifcffifr 7.3.sEif il TnwF 7.3.6 iAi+fi frH.hiE T.z.T 1kltffifrEffii 7.3.8 iAit filTffr.W+ft 7.3.e iAi+ffi+Hwekfit+aftlj ......... 7.3.10 jftitffifrn_x.t\ 7.4 xWT 7.+.r f-wailfE 7.4.2 x[b{H,H, 7.4.3 *WAtrffiH,l&in ... 7.5 +.F.ffinF.*W{* .7tr1 '**flER++ftt*H!+4ft{ -rt ,.u.r LrIJI nr . rr .oL

11 72 rz 12 1,

13 13 13

* ' 'n' EF 0 i F i H

14

)

7. 5 . 3 x # f f i i ) J . : . . . . . . . 7.5.4 nvhffi6n... 7.s.s [cffiEr?#$ffi H!€H4>R T.s.6 +.r.frEEF.+W{*Sfg tuIffii,^

.........

14

14

',2', u:iTTll:,TTT :,:::::::::::::::::::::::,:: 1: #fi.-TiiTT 7. 5 . s E I € i F i ' l t .h. . . . . . . . . . .

7.5.10FnBrnr. ,7tr11

t.r.Lr

g

15

) ffiD'fF

g-1k&H'l+Aftll 7.6 H?4,ruUtJ

.."""'

B ar ur

I

E m r l. . .

16

/llJ\i^i!

... 8.2 Hifl,ffiiflljE 8.2.1 Effi

.........

16 i6 T7

8.2.3 IAH€ilLM+V.E 8.2.4 Ft*+HU, 8 . 2 . 5i $ f E H t H i n f H u l.|.t.r. . . . . . . . . . . . . . . 8.2.6 trffi Htffi]flffiU1Jtr "':""' 8.3 ;Fa^ffiffi+Aftlj I

t7 1,7

. . . . . . . . . . . . .L.7. I7 r.r....ii 1 8

YY/T 0287-2017/rSO13485t2016 ......... 8.3.1 ,H.fl|J 8.3.2 T,f{EfrH flAAA+&ffiffi UHDffiffi 8.3.3 X.|ttrts-fA6#ffiffi H0qAfrffiFft 8.3.4 EI

8.4 wffi1.+ffi 8.5 tnfr.

18 18 .q.......

. . .. . . . . . . .... . . . . 8.5.1 ,H.IIJ ......... .............o.... 8.5.2 4Ll]Effiffi ......... ......... 8.5.3 ffiD'ffiffi......... pFf * A (KF[,ISFfS*) YY/T 0287-20175 yy/T 0287-200sfi6xf bV... pFf B (FFl,l*pff*) Yv/r ......... *tYffi.

18

.........

0287-20t2f GB/T 1e001-20r0xfE *.A .........

18 1e .........

19 19 19

......... 20 23 30

YV/r 0287-2017 /rSO 13485 ,2016

-r4-

HU

FI

AffiIfi,ftE"Yv /T 0287-zoos( Er?*$ffi EE€rs I#6 2003tHhL+F&7FM.(N_,gnT fr T**4,4*klE4,E; ATiEffi?EE;

--turE TF[h€]84*;

HTy*fl,ffig*), 5 yy/T 0287-

-19/fl 7 5H€ +JLMW)Hffi ffi€ +JLFEfiU#frIF>F r".J ; -fu'& TIfiEHB€}EPIF>R; finTMffiX.l+friEftH!F* " rso 13485:2016( ^ffirE{FHffii+E+IFJXH tr pZ5t,T/& trft*$ffi Etr trrtrWa HT}**4,pt 4*)" iFit H 4 r {+fl H ,}rA 6 E[frEwN.t friJ T &frilfriJ[ ,tj€ f[ ffJfr it " " A r f+ffrH.fr trL+6 Affi ruH tr A€' F,t6ffiHH €IE,H.EFS . AffiG HAE Etr+$ffitr8€}trfiliEH4*T6l& 4L,#.fr+fiA(SAC/TC227) /J tr " A&r/EroHS{n,JL,R EEffi+ X^ilEHFRAA. Atfir&+gEHA ,l( * jE,H,f*.XF-ffi,+S,9 FS.+fift. - + j€. mffiEil. 'ffi ++stEFfi,ft # +fr/EffJE tLffi,+E fr tfr,h, -YY

/T 0287-1996.YYIT 0287-2003"

YY/T 0287-2017/rSO13485,2016

-rf

5l

.+

=

0.1 ,8,[U

jt ++,r,W*ntr.T ffi.tr_trrF|+RF* ,WN-Eff#Sffi +.ftFttr kl-f EI4+YlF9.#JneAftVW.ffiW>R 11Eft +#ffiH!tr it frnfr F..4 F .nF ffiyfriE. q *, flv+ffie.%tr ffi&.rLE, ril&.iHxtfrdr6\tne ^ i ++)HliAi+frsfrts-fr,E,f*. AtfrtEH-lg>Re,FEHT E BffitH4RE,f*F Fn@IgnlilttN,eE"l+.*F{+. E)? #$ffi,X.ffiEF.h ,&.tBnft,*. ifrtrfFf ,%IFilF.*)H!'f*i-elH{&tl.*Ftr.1ai{nfr,tl.# rtfrVHEift #f+ A 4tffi t&klg I 4 & A E 4 rFff A +{,n/EPtF >R. -$r€+sxx'jtr)?#$ffi{*Df#++Elt&ffihg trJtE zArfiH EE trrtrWaa-rti4,4* " tr rrt,Am 18ffii44tr2A: -& EE - + fi,* t ffi@,; gfl4Atu! i.x, tr H ffirA*4,g >R 5lJ TTPI* *I,4 >R; tsl}-h ffi&.ilRN]JE H T1lI,4Affi - ft ,H1lA ffi,tr tr TET+ A + HA B $JE H Pi* *4,F >R. tr H H!rE*r,4 >R+ H!€ -l(E tr lEtr xffi tu]XHFfiT FJ. ttrLAffi 4& n€E,? A$ffiE H H!€ +#X H,t +* y-ffiiq4lffi il, + tuIfr. i&H!E _X. . 4f6/fttrfrVffiT A*FfrE't.*F&t(Effii^infl+a)Wfr.n4TffiE JEIF4*.iE,HTtrE€'E{4 F.tul f*i4,4ftt2A H94>RffUr " €t+5EiEflE,+t$ttFfff,fHtE€€tE{AR4>FExfFf&^g B'l?Fn' B xff ErEnEr>R l:te.x + fn'l+.fatH plj6H f rxf, g * E z,'F pl " - rnfinffiR ffi . - + rE"9A t HE tr €'E t+A E tELF,ffi ilIffiEtr I.trW A {trlftlt ffiq frftE DJT tr fi Ht *vnft, a) tY4\Wffi.,fiffi,M.4Y,ffi91"tAf4.ffixf Etr+$ffi?++'lkfuIffin(q ; b) 2tr2A6WM.4t H!ffi>R; c) ,trtAH!^E,fA EItr; d) t\r\tfr+ftl[ffJFff ; e) ttr4\Ffr*ffi Htdffi; f ) AtrgAfi\*4,+Hffi 2Eg,?"t4; e) trH TttrzAffiihWfE*4,g* " g /&# 6,e.* * rfi4 +,n ffiE ffi h 6 lEtr E € rg,faa tuI* +a,ffi- r {+fr,MFI5 4 t,nW* #^#t6 f H

-w.tuTx_l+.

E )?#$ffi tuIffi+IP 4, +&r /&+ FfrNAEF!- :}g€ H 4 * .R,i6 H T ffi E H!E tr +$ffi X friJ"4 4F/& ffi 3 -+.1$,:H TXr&+51;FttX. HEfiX,T 0.2 IFJ

xfA+,r/& h\TrtJ^iF4ffiiEHtii,ry , -TF E H ffiIg" i6 E EI" IbTfr F >Rnt',iEH 1,A i B'N4 >R E iEE #J,W,lF+E'Afr? WSH {EA'g }E H " inR*rnq*xf ur 4rH-48 'r'ffifi!,q{ilN infi9.f-ti6 E Ht, -Fffiiffi,Btr*; EH frll**r,4>Jt ; -282N

*frE4LlEffiffi ;

YY /T 0287-2017 /rSO 13485: 20I 6

€rgt(ffi. EH^iE,'D(h"Hf,infii9&446/EfEE^ filDHt*T trft*$ffik?frA41ltavE>F4ffi8 i6ffiH!**r4* " Y -rng.>FffiE" MFII {+" E{,H&ffi g en . *trfifi 'ffr++" H!4 4 >FH!ffi S fr,P ffiq IT'tr fE E H A iE" P ffi''H{,H& Hffi" flV*" " F ffiiEffiT FNE-ffiE fitdr,ffiltfTffi#lmfr . ,*lnJ @tJtnl*|f#.Y**I #tul[tlTr*erE*I, Effi^i$"y**49*"Hf ,HiBffiTi6ffiTA+firE{Fffi " PlD H FR T E E € IE{46W>Fffi E ft +$ffi WXA 4'|Il 6E EIfF+ ) H!g >F" lt iF" l* *n9.>R F*. ] aaffi/&+{FHfiT WAr' _u -.. -u

Iii,,tarF>R; H"tml#i.L; Ft"*.mJti?;

-'(AA" tziEJ frYitfrYW; ffi " " it "t tEffifr;nl16 X9.* B!+H 0.3 isfEf,r* S trlffid|frfrV'4nhitf5.lE L+WHW4N-,*rffi ++,ftLuffi.B.trrgHli$fgfrAt#rfr. ltltrtt*Llf.ffi -f fi E ffim . H, -f i$E H!ffifr H.+*MFIT 6ffi& *tHExFxPljgfg. i*+tjffitr #R, fi idffizEFIH! hlfr.2n"2Af,-*,gtF,ffig.ilfrtJfr€'gA j.AttJ itEtY*"" ErtjiSffitutrtrrE,fisZ}r" LtrLAFJ HiMffi,iSlEingi$ffiH! ffiffiE.rcffi,D)&.xf affi.atrT'EKa+ {FffiB ffiff ffi}' i* 5EiEDJT i E friE 41IE' a) IEffi+'ffiE.F>R; b) ,,r.rg€tuIffiEttsi$tr; *h'Will#R ; c) tf {+i$ffiffi"'*.ffiH d) ftE\ninlJ€ffi 4rstPtiEffffi . 0.4 E rsogool#JXR tBrSHlrAit, /&. trfiEIfr.HH' Fff* B hfr TAtFIEffi A&ni,Et-f t))GB/T1e001-2008 GB/T1e001-2008) HtXf Dx6. cB/T 1e001-2016(,ft# I So 13485J 076 A E ftA I'*ffi 8 6 {,Eit H T tr E E,trW A H0iE E fA*I't >FtuIVJ'iEt- 49''V WA M ffi+w&.8)?*$ffieftIflH H!-f *,*+Ff e ffintF'. 4tfr7&E AT fiW&-E'?+$ffie'ftJFIwill4tra1 fiTiIDJtrtJ}d,ffi.E_trWwa kl-$ €HE>F,ff{trfiTISOe001+6i6TtFhyx*I,F>FB!fl|3r}iF>F" frv+.tTr+a ISo e001 f6 /8, lh lFH tr E E rtrW6ffi tr ISOe001 tuIFfrH W>F. r++ +hnww gELAZ^ 0.5 5H{UHIEfFAH!fH#{!I

ffiEE + tr r'trtul &gR E X +tr rglfi,tM F *, ln &ffi,trr8 4RiL +txt?l{.',f.rtrW1'lPl AffiiEnE+fr gA z\z\h r FtRfHVliH4 " A 5 tHxillETEWa EH VIffi.E€Itr'ff * " f ffiat6 tEIF-n4AfrTWWH q g >FH!E € E wW4, frA kl f EI4 + tr rtrWR " + eh4..Hil41 eEn rcAA t;n7&

YY/T 0287-2017/rSO 13485,2016

EtrESTrrT trEHIETfiR HT'T*4HIE* rffiE +W F 4 >Frui6 H Htv**I'F * HtE,? # ffi fil fHX EE ++Bttrrrffi 4 i[ q HH H frAJr Wl*++s*iffiE JpI e'ftI#J ffiWr-f 4 4+WEk,@+frtr,?*sffi ,trtlfr,F.Tffi.:Etrrg{4 6 g>F. d'€t1 4AAVW Vtr1ftit ffifr E. 4 F,tBFffilffi iE . f,3t&t6EHTf{i*+tHLRW hlF Hfrffi*I'F--'^f,r

ffii6H T281'.'.trffituT xfT#trrWFfi rufaft{Bl}-bsffi fiRiEH

44'*Ff . 5ffiT trtr *Sffiffr*>RIEJ -%F iEi$ffi,ifl,

|tffilfrfifI

H. #EJl-sy* AAtiffiffJ{

,?*sffiH! ltl#-*rfr.,n

4tfr/& ++,finr6i6 +.2.2 ,A&,FR 2 *4ffi'ltEl

iEHf 4I

TttJt./t+ I+" ILEAE E G B / T 1 9 0 0 0 -i

3 ^iFfEEy, cB/T 1e000-2016 rFE H!pJ 3.1 ,S#t*iE*[

advisorYnotice

F.fr #JA E u T fr Wh S ?I'R {H,gEI1+i.LE *E\ffi tr6H!iEf;E' E Eft **ffit,f{ tr fr ,8"2R -*ft+$ffiHt{€H i -8ft*SffiffJe4.dr i -Wtr #$ffiiE ELE"F';iX -Etr+$ffiffr+H$." H!i**rF>R. It , ,ts#,1+iErrffJnfrE[fiEF>FtrAiEH 3.2 ffitl'ftt

authorizedrepresentative

8 ffJl*'E t ff{E H 4T{H E Xfi,H +-H E H'fl H ffifx,& FRi^ E frrJ A E xfr.tr WE fr ffifr.T WJ,f* "ft 1

YV/r

0287-2017 /tSo 13485,2016

5 HXtr H XWffifr.lt* ilI H/*/\4 */\ "

t*ffi ' GHTF/SGI/N055 : zoog, EX s.z;

3.3 llfiFFi+{/} clinicalevatuation 1YE ffi //l tfi E E tr #$ffi H * fr\tffitB&.ffiDJ& iE i4 +Effi&ffiI E ffi H0ffi .q {EH Ft'B!ffi ^ q A ffi ,Et6E. cHTF/scs/N4 ' tXffi z2oro,ffi4 Fl 3.4 complaint

fgiF

HtrrE^rtr4Rfi!+afr|J +nk4lPlEr?#$ffitrE5&nj,A.EE,ffif ,H1tt.ElI#,El.qH,ltL.EA4,ltL fr?,A XffJttrF4r Lb *,8 frs*Rtrft B E )?f$ffi'ls6E#JEF.h E E 6 E F!fl F . E T d H* plt6iE" E, "&irF"H!JILEX 6 Ge/r lET

1e000-20 16 JFEHtE_!( o

3.5 tT+Hffi distributor

'f*DaE +{t*H EHWE)?+$ffi w+Hhe{'ffiF w H/*.AErr*.A " E 2,{*D fS+,ftt trrJ E ffi'. ff tr ffi4 4 fHffiWtFN.i#in[iF fntr ffiyfrdrnn E 6 €4E x + trr4 ffiffi " t*iF ' GHTF/SGI/N055 , EX 5.31 3.6 +H,\''lSE r? 3F{XI implantabte medicaldevice

.R, fEEt 8 tr fr.^Fl+^x h plEtr+$ffi, ffi#EH, - rR+s[ fr gTA fffi {afr Hf* ffiiE+, Erff ,ftt # R.*,HR t ffi i -+trEBe,)30x.

ts, fH ,t4Ef #$ffiffiE_X.AAAiFfH,^.,tr EF+$ffi. 3.7 ifi tr ffi

importer

ftI*Ifr+fr+{FH'fe Fxfi,tr+gxftueH!Er?#$ ffiftFfrgtft'w+x&,€+sxq rHEtuIffi-f Hfr AeA+*/t. t*ffi , cHTF/scl/Nob5 : zoo9 , EX s.al 3.8 f,riE

labetling

5 trF#$ffi,fu\|,RfrU'&^ii,ryE .ms$H6fiflEffilfr.HH EAfrfinlilil XffJ+,r#,{FHii, ^g't|o,ti,H,lE Effitr]6l{+" t*ffi : GHTF/sGI/NZ6 z2orr,m 4 Ff 3.9 SftEIH

life-cycle

#-8 ft #ffi e'ft +, ^4x th4Bf a FlJ e.%t+ Hfr 4LH ffrFfrH th F90 t * f f i , Y Y/ T 0 3 1 6 - 2r0G, f r - Xz . r 1 3.r0 ftlJE H

manufacturer

u H trX ffi|J € rmtr ET H ffJtr ft ##ffi,+f\H tr tr #ffi iAit ffi/ fi,friJE fr ,ffH!Hf /r d[E , fiit ttrE tr##ffi,ffJ1ki+fiil/fi,ftiJEE fri^E/* EIr*)uttT-rfr,frfr %H!-+EI*+H f*/td[rE/t{tt Hfrl1" E 1' fL" HftI4E L"fim9+f+#8ft**ffirf

HElHEIfHeH'!E xfi,trHe.ffJFfiHrtH ffE*IF *frlH n%W '&ftlt ,W,1liztr+# X H,lH€trlfa(RA)EAffiWihftltt&JnT fr_ Hf*/\dy*/\.

2

YY/T 0287-2017/rSO 13485,2016 tr 2, 4H'f&Gurn'ffiffiI{++ii,EETftlEffiH!ff{r.B$-bfr,ff 4ffiffi/E,LfiHt4>FfiIfitr4>F,b?fin6R.S t++w.Effirqfrffitr6iEfn . tr 3, iidEx+ Ffr+Effi"iki+frlEtft{E"EI€,ffiEtr#$ffiH!*4,ffiffiJE.eF.fi|JE ,tE#-.rfir.A#.8+f ts*.tr ( trI id,. tr # tr its. r( 6 . E # EIF ftt|E ; fi,rr T E ft tr ffJffiW* ++Sffi 6EA ffi4,ft'F ffi) n+ ft - tu " 'fHfit1"#*,lbrh.T1i..*.E;ff E 4, ,i4Eft**ffi"e,%frn- Hf*,,\EIl*,,\&f€{Fffiif.Hfrfrftt*h+ +$ffiffiffiHffir8 l#ffi.#,fr.#&,lbtlEf +SffihtJl+M Hf*,,\Etr*;\ZiEft|Effi. E s' Z.EDJtrft!|EffiWAyEef..Etr**ffiH!ffitrH64ztitEf+$ffiF!,ff,f4Hf /\4rX/\,,fF#$ffiuH&XF,f+ {FH, H.i^h ftrhjstr HtE tr #$ffiHtft{E ffi " E6' 6H#4ut4t[Atnid'F.WH-ffiruilfi4X6]rtlnEtrtr*#ffi"tfr,A#t.H!&fx,ftf,.,%+HffiEIittrffi', TW.i^hftff||Effi'. ;I7 , 4fr^tr,?*$ffit**4,F*ffJrd.tt+,fr\ftjfti+fBlfrffUE1aYttt+tulH f*,,\4t* /..W.i^rlftfrtJEffi" t * u n , G H T F / S G 1 / N o :szso o eE, X s . r 1 'l 3.1 Er?€F+rI medicaldevice

ffiT;\4H!{X#F,W&.rF.dlm.+$F,tH.^+tJ.{4t|.jfrilJ,*Rl+.fff+4Ele€M .,ffiX+rJffi,^H ffiH{FHHfitI€ffiffire.,T.'ih+trfr,fFH *,tEAffi.m,D)bftjTFIJ-+*.*+++E ffJtr.trFlkl , -9 ffi*1i\W. mm.,HfF.lhft fi,4Bffi ; -ffi ffiwibw. H +F. Y6)t?,98ffifr,41 H; -& rE#+6fr,+rEisfSB!a & . 6,ft . iEi54 i {#; -e,ftH!{++EI LEt*; -ffiiFfAfrJ; -E)?+$ffiH0iF5E; xfry H,,\{4H!ffiA i[ 41t+rF&A Pltrrt* ffi,f*{H,H. . g (F trt ^H H T {4{+^ EI{6t, + ffiH frV6EiEff 4 }E+, ft,8 + 4,ft i4fB!tr rt * '[, {EX s-h } rt EnT*tI,ffi 4A ffitrfrV" E' E -'!.'bB xq,tuX trI^ i E E l? #$ffi 'fE& fr - JL-b E xfi,tutr 6 i,. z E E f +Sffi WP FnAW{E6 FFT, -{Et

,.^la -.

rfr,

*11/J t

H,,t+H!ffiFi#tr; -@edwJffi tfiJ\ {f etrgRfr!?stfi,; -H T,fa4.Effi&ffiEn+.ffi"&^Ht*$ffi " t x u n : G H T F / S G 1 / N o\ z7 2 o r 2 , E XS .r 1 3.12 Er?€Ftfitffi medicaldevicefamily

fi lE-rtr 21d.,hil-rl"q,ffit|€ ill^g.HH*4A.Tf,HHlfrffififrlf,lfHlEkl4AiAitf,r'ElfiE++'lt Ht ffitlE_ft#$ffi. 3.13 'EtBEi+{l} performanceevaluation

ifE ffi/rltfrW.ffi!ilffin4& iEWrli>B[trf #Sffiqt[,^H1f,HHi8Ht frYir" 3 .1 4 -b.ffi'trHg

post-marketsurveillance

g,s-frtJF.4"frffi. \Y€ffi4,a.ffi ^e% -LfrH!E,?#$ffiff{+tul13 .1 5 Ffr

Product

trf5tuT#R"

YY/T 0287-2017 /rSO 13485,2016

E 1' ATttJEf+lEffiPlFffi4fU' -ilft-* (in:affi); GBi+HULfEJi.?4) ; --69.l+ GnE attntlLffi,ElD ; -ffie,HMH3nili}Bif; ) " i+9Pffi HAtrT6lEltrffi+5lJtu,FX4}+AFI,tstr'y tftfrV.*.+RI+.{E{+EI}fiffi,lsfr#f F'RTFffi H0+.+rt h" Irtin,Fffi"l\+"ftH68{+(fiftffi).iftfg,l+fr#t(iB,l*#4.s*tri&),yxl+(tn,E.ttuL?tfri.+M+,4 + ilS) frEEF. X (iEfHe ,,\R Ffififr.ffJ FptFinHHFfitEFt" ,).-l f.'tfrt)Jffr#R"Btr..+fr\Wt*trItb&,MIgn, ii.2, hF..+:trHEftVHt 'Jf ,H.EEt*fiffifpntrl,*fr*,ffiLffiFfrFIE (inffiWffilbfi!it+ +ftL*ffJHMFffi ) LFfiftFtffiyfrdt; -ET\NETftHfrtJfiMFff (i[ ) t-FfrfrF1,tu1.ffit)1; --fr,MP ffiHtt,fi(iE -hlpf

EdtJEfi

#.1+frl;,etl

ffi , Jf E.IUt W. +F#ElfEJi Ht

rE{+JEHE E'WMIf+ ) E3 , " F f t "

it& B!++,t* E ^E.A +tN e H EH M "'tfr.ffi'l+

Hre&E0++,t+ " 6F.4+ffi,n

ET GB/Tleooo-2o16 rFEF!E_J["

[xyF, 3 .1 6

*[6

frttr *, i€ 3.17

Kffi:

,xtt3fr thE E r

t',Xt ,fuh

[*i,n, 3 .1 8

M]6HIg

rtF ffitr }trfr Ft,ffiFxE H * & F! ffi{ffiH ?q,

HTFthA t*ilH ' YYIT o

€X 2.22)

3 .1 9

fiffiEHF-4fr,

sterile

TiHT.++'JfrA+HE{EFffi FN

ffiry

r-2or5,EX 3.221 t*Un ,GB/T1e633. 3.20 fiHEr?€Ftf,i

sterilemedicaldevice

ffitrffi,8fiH9* H!tr)?#$ffi"

E 1, x,fF.'ft+#ffi,fiffiH!4 *, q & Ff;i6H H!y**LF g d ffr/&#r4i " ' ,t'l

4 ffiEffIE{SE 4.1 ,_ts,F*

4.1.1 AtrAAM.tEflR4\f,n/& F!4rFffiEHH!fS*Lg*,14trE ErtrWRMFXX.|++{*++^H H-lf..,W " 1) W .GB /T l e o o o -2 0 1 6,ft# .

YY/T 0287-2017 /rSO 13485 ,2016

tHzAM^&flRAffi /fiEIE ffi HtrA*LF * e n . g i&ffi ifrf+ffi WMfi I l+ tuIFfiHg rF. fEF . ffi A El afiF o

tHtAIfrW^H tr iEH h.l* *4,F rRT r[ F(+trFt- + fi,& + ffiAfrt FxXI+"

iL, tE"q., Ffi&+EffJffitr q frA @+fr ftUE ffi . & in,ftt . ff tr H'EX 4 6HH . 4.1.2 AltArfi^,

a) 4 ffi'ttrr1A+E jtf5 trW+4HLA+H!DH tuTffitr Xbfrfr.nFtrrtrWKtfrffiHttffi&B$r ; gtrfs i b) DHETFI.IOffi}rAtAtrt|EE€]sWAFfrffiHtE c) fftfr ts:}jilfgHlJtmJF finffiE-tEffi . 4.1.3 xfT€+trE€Itr l+Aitf5 ,4,t1rfr., a) ffiEFfiffiH!/&Itl fnfrI*,t))

b) nhLxtrItftl€,r,9-ffJw c) gtrfid'FH!ffiffi d) Xfi,ifl, iflU E(

e) rgnffiLft 4.1.4 ztreArfi.&

fffgPlH?L; I,tJkl#R+tFF

,EI;

tsejsf5; y**4,9 ilq rch+bn/&+ffi,Ei6H H0 ft DJ >Fffi E H F!* *4,4 >F€'E X Wffi,Etr eHWATf5:

*-hfffED '

a) iY+Jl b) i+tJf c)& 4.1.5 #28

H!4>R

tHzAM.'XW tl'*FFffirg

r+a+

*Mn(iJP

4.1.6 2H2A

+R(+M.ffi)t 5#ff D{frHB 4.2 t{+E* 4.2.1 ,_ts,nU

trE€'Et+KI{+( a) MFI:y.l+trrffi.Efr b) ,lFESIft;

c) +ffitEFfr*>&ffrMFXX(+ ffrtEHfiiilt d) tltRbhfr-ffJ h ffi lxHff fga'if ffi tll . ia ?Tfn+aftiJ ffrffiHtI{+, @Tf; iE* ; plt{&I{+ e) iEH ffJt*ffiW>F*I,E " 4.2.2 f E+ffr

ttrqv ffiffi{ tr€+ ffi,ffi.E+ffi€'tfr, a) trtr€'E ld?.frlffiffi ,E+tltlttrulddniEHtu|l+rlinEEfrrEH ; b) trE€rtr4+4tu1V ffi,X.t+tu1ffiF4xf49 IH ; c) trE€tE t+Ki$fE2.lplH!fHEtEffiB!tit "

tr E + flftD 4Bt i6tr tr € IE{+6 ffrX.l+ro+q"

fiT:+AfttJ. H'lfit lbfr

H EfrDX{

YY/T 0287-2017 /rSO 134852016

4.2.3 E,?€Sftt1fg 2H2A M.h -E+tr )?*$ffi4 4 4 tr'? #$ffiffiten +,f+f+- f fi,4+ r fg, r +\@,a4 I IH M FXF! r ftuffqEf+6++6/eg*ruEH Ht*A*I,F*" Ifg H!A6D E+frIEAFRT, a) tr)?+$ffipltBf 6 . rrHHr6 /ffiffi HH,l ffi&nie,@+frFfiH l€.ffiifr,w ; b) Fffi*Iffi; c) ftUE.€,#,tEE.4lEffiifiiEH,liLffiEIfEJi ; d) iltj€ffiXfi,il,fEF; e) EgBt',E*4*; f) EEBt',flRfffiJi. 4.2.4 * {+f* #l|

EE€Itr ffiRffiE>F fl y.t+DT1AftU. iE*E-ffi Wr/"+4H,lII+, rfr^Wffi 4.2.sffJry.>&it4+aftll. Mffi.X.T+H!fEJSD }fl,fr.DjT}EFfiffi H!+Aftll , a) h lp-X.l+fi|?ffifrtr,X.1+fr.68fr4+F|Jif F' ffitt1,tE ; b) rz,ryBfxfJc{+trtTi+F'58*f ,*HrRtfttF; c) 6hlf.X.t+tu11nft lbiTfi# ffiFtht+fUiAFIJ ; d) 6?R|*'IP.H4LE-J#'+Effi I{+ PfrH *ffr.# ; e) 4hlilX-l+{*f-r*i#ffi , D TiF,ft\; f ) BhlxrE ry,FfiEh€ H'lffitlj frE:6'r1ffi.E€rg{A ?FfiffiH04'Xrt+4+g\8frlJ ,+f,tfriJ ^Hilfr.; g) D'rhI{+H!+fi4rI *R.; h) Frt ]L(FIE.X.T+frTIFffitr{FH ,XfEJ}-bIT+fr'4fi.Eg H,I&rii,A, " zHtAM.fihIXX-(+tu1Feh4FSUtrH'+lt*FllEItu"EH'l^H4eH'+lt*Ffl Pli+H'ru +W,W,&.+Eft-HtB'+lt*F DFEtfEtHf ,ffifiFE H!fHreHFK#f . x{TE4'rfr.lR#-It}WtFEX.l+ g.2Atfr*tlfrWa, ,2HLArfr.*tAF='HlXftH FR ffi1xF.,}--ft.1" tfrffipRD ft+#Mi"+fFs9A 'El{+F[E$jtr)?#$ffiH!fftlEflifr&H'lI{+,m,H-[ 4.z.s)dEHH! lfrZ^,]-TiErt(-tL 4.2.5 ie*#ftll D'ffr++id * tll+E,f* f+A 4 * ffitr E € rtrW4 H ^r,.,e4i F!itrm " 4flzl'rfrggnfEj++MFXX.I+ ,U*r,fr.tEftH!&niA ,f+tffi.EAffiftH11t.fd*,lfrHEf14ffift.H.tfiffi H!+AffU. & flREH H!7**r,4* ,nzArfr.xf iE* + a A f,tJ RM rcR{H,H, *r,E+ * fr64il+Ft t* " iEfr D,f+++ifrw, n T j.x, 5{ffi& H " id * H!E EID {X++4 tA,5lJ" ttr4Arfilft&ie*HlHpRer'htytAFfi*r,Ept4EHffir**l,F*tfrNAfrH!Er?+$ffiFt#ftffi, m^_Et 6 M.MtHLAijf..41 E )?# fit ffiT,'- T E + 5

H#$tr,F

5.1 HIE?E(iH

ftH EItrE M.tril DJ Tif;A ' xf^Hei. *ifiEE€Itr{A R+lX++^HH-,*:y+.il18RU EiAHH! H0 rEiI,F>R EF'E ; b) ft{EtrEfrE|; c) EfrlPftitEE FlFr;

d) fr?-trwisfr'; e) ffilYWffiB!4tf,{+{It. 5.2 DIJFFF *rXEfrFft H tr TE#Ifrffi MFN&4* f[ JEH H!rA*I,4 >R{+SU ffi fril ffi ,8 " 5.3 EEttf

ftH€Is#M.ffitxffi.afr+r, a) fttfr.AtrL\H\R E'; b) E,+fr xfiffiE.g* ffi{*f+EE€}9446H -*,'l+Ht AiH ; c) nfrilEffii+F'trEHffifE{*tE4€; d) E'HAAA'+gUY6iEffiTEffi ; e) |aI+&iEH'l4FH4+SUi+H' . 5.4 ffitlj 5.4.'t EE E tfr fr H € TtrE lfrffi IXtr.'E"4AfrI fHJE4RfrAffiE TA.LE N tr E H&N,ffi.E Hf6 ts,+fiffi tr E H ffi rXil. g * ffi r ffig 8 ff ffi H,tA 6 . E E H&n& E 4 il|JE H!,+ 5 ffi.Efr +t,ffr++- # . 5.4.2 EEffIg{fiaffilil ftH€}E#lfrffi'X pJffiE 4.1H!F>FUN-ffi.EFl&n; a) xf E'E€rEI+R#:41ffifr,lJ,

b) ftffin1fiqr6 ffi.EtrrtrwaAEBttR++H ftM,y*"

5.5 4,trf;.trFR5t6iE 5.5.1 qRHfETT.FR ft H € IEH trvffi4R4X {+SU fr rufXFR fl, E, W FXX. l+ + E 9E2AFti4 iE . *R' fifi R H € ItrE I-VW Ffi€' A + Xfffi.trH H!€ 19,T\,Ttffi h.iET (FH! fi F!f HE X A W FXX. ff , * N frh4+XftFI B $-b,ff * Ffril,E kl rAv'14ru4xFR" 5.5.2 Hrs#ft* R H E TEEIfrftEi'EEF f"O E -^ tr ffi,fr , Irjib,i^il,frAH{t, T ffiH'I 4Afi iN{4, D {F^H^HAUT' E H!4RfiflfXFR, A) ffiLXWffi,E€Ttr{A AFfrffifulfrTEMFTI{+ ) -,*.,Y+.frNffIEIIAff b) E RH € WE TF.EE€€TEWA ffJH fI ffi * ; c) ohlFftW+e\q^ aCHffiEi6H H0i**I,E>Ffitrtrtrw4+6H>RflHi.X " 5.5.3 FJffFtAiE

ftH€IEEMffiffrtr9H9F,^eniEEH'lYAiEitf5,#ffiL+xttrE€tEl+?il\H-,rh,'P+.fr.'4-WE"

YY/T 0287-2017 /rso 13485 :2016 5.6 HIgi+F' 5.6.1 ,H,nlj

2tr2AV>w€'triTH'tiltrfit$xyl+" ftH Ew#M.ww.Mlkxt+F!ffin{FlEf r{rEffix{ttrzAv,rffi.EE tgFKtrfri+H' ,UffilXH++4F!i6H'fS ,frl''l!frfrHllh'l$.. i+H'DEtfri+Ufrh-frffJtl.+frEffi€€ruff(N 4.2.D M.IRH€}EirF,HOiEft " 5.6.2 i+F.ftt^' € Ig itr H',Plffi D €, +6{EZi pR a) E-ffi; b) &}FAH; c) %M.EUL

d) FM,; e) ilfE r)

f

g)

ALI

h)

i) j)

t)

k) l)

5.6.3 i+

€'triT a) {X++

Rfrruffitrfi,

b) 5vntr c) rtfuDiEH d) Kffiffi*" 6 fi'HHIE 6.1

fr ilHfE{* ttr4A |fr.ffiE if F{* tfiffiffJW{R,t)), a) *ffi trE trWt+A+{+f+HH -,$"'lL ; b) ffitr i6H #JyEfnW>Fffi DfBFt.

6 . 2 LJJ'frilF.

4T16 *ffJ+\H.ffiijl|.&FE rtAFffiE€r tFffJ^ftD€ffi,ffF! fir?fr]d*,^#*R " tHrAIfr.W ffi n EA )r, +Et* Ffiffi B!1SiJIIfiilnfrIRLE F.tH i.A+ _ + *, 4 $!ffiM FLX.I+ " 2H2A1fr., a) ffifr.^#ffi sf,JPffi trE:r tF#J^ fr FfrffiH& ffifrUt;

YY/T 0287-201 7/rSO13485,2016

b) E{*iBijll 4X4xH {,tuffiffiuffi4+*,lK++ Ffiffi f,\frY h ; c) 1+ffrffi XE(ffiffi ffiHi;d..'y+. t q,kll\F d) bhIfrt1 NWFfr ^Sif; drHlXffi,14 f,ilEg,El,U N.tnlTh *fln ffi,EHfm,ffi fr Fffi ; ( e) IF'W+f-H.f.Bijll .&68ffi%WHti6 EiE+ n 4.2.5) . E' xtT E,f*1SiJIIEtX E{^H{effirEffrA "*'lt ffJthafr y*D 5 r fFfHieF!t( h tEiED " 6.3 Efiiligffi T B SU f+hP ffi4* . D.rtF ffiYEffi ffi 6fr1*FF,H trtEIE,zlzF'il\TFfiffiH!46SiATE H!4* M FXX-

I+" trgHt',xriliAfrEa+fr, a) lejfr"+rJ,TlFLhFfrfrfH*iAtfi ; b) sfEiA6 tGp.t+ffiHil\); c)

#W+fffiAdfft,)-# Fffitr€,4traAMWrtL >R H!B{HHWMFII{+. D i6H + + P 1ft&,ItFfiH +AfitI M'ffrHrL#-ffi f t + . 2 . 5. )

>FA,ffittt/t1#Wtfrr't

EW&"

6.4 r{€ffrH 6.4.1 r,ff s

'E"aAM inRr tu?ffitrMFX 2Eqlfr^,

I(F14.ffi

FIfE *otsfiJ

a)W

Eft b) 6h4R

T(F " i+.,H_*tr,9n

fiHBT fB ISO 14698"

6.4.2 tE*fSftU i6EFt',tTb'rhxfl

r,\+>wfrHFfrtffi,x.l+ "

XfTfi ffi E )?+$ffi ,1ltra1lfrWfA ftl|

ffiPlYs* ,AHLA

WP ffi H!+Afttj M.fi,r1ffi

,f+.28 M FXX.I+ #fr,ts,*iSfE+'f*++

FfiE>FKIi#IfrHO 7 Ffi*IB 7.1 FFO*IEHIffiIU

ttrtF,M.ffinJffift E.F ffi*il,Ffrffi fili$fg. F ffig ILtuIffiil|D 5 ffi.E€jtr{+ RBlfi;t fEtu1-8fH

-w.

2tr2\[fr.&Fffi* 9[tr E tr, :14 FtpO € rtrfrl-_f 4 4 + frtEM FXX. I+. D,f+ffix, b € ]trffi dr0id* (n 4 . 2 . 5" ) f*-ffir,\Pffi* I4,H!trfE +, iEg Bt',4trLArfrffiF-UT i ffiH!FJ6,

YY/T 0287-2017 /rSO 1348522016

a) Fffi H!trtrH&rfr4>R; b) ft xfF ffitgn fi fE. I {+( n 4.2.D ffi+EI*W WHtffi>F,€,+f;# 6il1ftffiffi T(F6 B.; c) ftxfF ffiEn*>R H0hitr,mi .,H,lfl .U|J€,tfi&ffi ifr&. 4lH,WE. rfiE fild Eiff ,Elffi6htilE Fffi1*4t/&H; d) t*4trffie-HF-ffi iffi,94**€,f*iEffi FfiffiHtiefr (n 4.2.5) " q€t1tfrHtfilfr MitX.l+ Mffi.rtJtu'1ffi Htr DJEATstr "

tso 74eTI. ii., E*{E,H.-|L 7.2 SMAHj€ HiiJfE 7.2.1 Fn?g*HiffiE 'HlRIfrohF_

a) b) c) d) e)

rpntrfI"E H!tr*, €,+f;xfttt e-i.Htrffi aH\4>R; 'r,ffifl4>R; rvn# E*tgd ry,5,Iilfr,fr.H'lffi 6Er E f;rH!ffiHffi6,Ffr SFffiAJeffiiEHH'li*iI4>R ; bhlFE)?f$ffi trl#E'l+ fraffi x +(fr.HrnffiffJiilE HF i*ijrr; ?H4TBfrre-Pl[tlEFlf ln4* " 7.2.2Fffig*Hti+F 2H2A M.i+H'5 P ffiA JeH!4 * " i+F'D f tELAA fvntrffii.frrc,f+F F,tultsi#( fi +Et & t6fl . t* E A lEEIiT+ u &-&*A E 4 iT+ tulFef)ffifr 4i+ M6hlfr: a) Ffi g* e4+sJilnF.+VnXX"l4 ; b) 5 D_lBf ts6-4H0Ald4iT+4>R e 4#f]rJffiF-; c) iffireEHPIE*LF*; d) 'f&fl€ T.z.riAfil|#rltlltnF l*rrl -_trI#t+Hld&itilltnJ# 44frq ; e) 4HLAH frVhffi E*LF.H04>F. (n 4.2.il. D'ffrH1+Ff"Reif F'FfillfuH'lffif€ffiiE* # FntrI*.HWffiMFII {+H!F *, 4E"1' '.ftt* * tvnBg*Hfr D xf,En B 4 * fr 41ffii " >F g >R # P ffi4 E hE.e\.,zEtAfr.ffi{*f Hx I ff 1+fliJ lbrh,+ ffi4xffi* fi fi iEe,F.eh.frt " 7.2.3 tAiE 4trqrfi-EkDJ T f E 5 EnEH'f i4iEi441ffikll+ >W X flFfttFl t {+, a) Fffi{H,H.; b) 4LrEt{ if,l. A lElEIi,T+ , €'tfrH9k; c) rvntrn_ffi,atfrw.ift; d) ,t,g,EliEff. e#Arfr.&flR iEH WW*nry-*5 Xf,€ tr"tqi6iB. 7.3 ifii.ffnfrE 7.3.1 BnlJ

ttrA\M.W1ftitffi* ft.tEtr V fixt.(+" 7.3.2 ifii,tfnftEffitil ttr4\M.xtFffituIiftlt ffi+ ft.fr 41ffinUffi*4fttJ . i6 g H{,reE iAit rufr E H0 iSE, D {fr+++ E # iAif 10

YY/T 0287-2017 /rso 13485 ,2016

frlfrft-ffitUI{+. Etft rt rtnfrts-ffifrlJtr DJT tr E WFXX.I+: lf, , tHtAMW a) 1f-itffifrk#J&+WFk; b) E+1fti+frEfrEhBktfiffiHt-f 4 44,iyF ; c) EAT€+&itru * E WFpF!&ljE,Ehi^frr1k itwffirfrdt; d) 1ft:ltffi]IEH04Rfr firfnFR ; e) EfrR1k1ttnfrfrffis FuiAitffifr Hffi plET€#iv'1rt* ; 'T'*HO E fr\rt. f) Ffrffi frtJWW, @,ffi 7.3.3 i{i.tfnfrfr.ffi,\ MffiE5Pffi4>F€*H!ffi ,+IftHidfr(n 4.2.5) ,Br!_bm ^M.@,+fr, a) &ffifiH ffitrffinhtH'lrhftA,ftFg, trf,H,ltlf[fiAEF>& ; b) EH H,l}t*4,9>Rfr+6rE i c) iEHH![tlh€]EH!-fd'3tffifr ; d) tEg Bt',xffiT pJEfr# lD)1ft1.tfi1{H,H, ; e) F ffiffitrffi tullkitfinfrEfn,yffiplH,feg*. D xfE &3ffi^ f i1i+H',U ffi lXffi^ Bfi,hfi E H H!,+ gi+tLrE . XD'bI M.f,W. ?F^6, f2W&WiE&fi, + H6fAE_tE* t "

rec 62366-1" i*., H.4IE,H._fL

7.3.4 ifii.ffnTr&ffiH 1k:'tffifrHffifrD, a) if,EEitffEf

gfH,H. b) h fr*ra .4 F fr8nft.+w,f*H0i6 , c) €'ffifr,91HFffif*4tIEIU; d) fnapffi ++?tr,ih++'y+xtTF ffiHtga frEE ffi{FHEZ,,ffi F!. lkit ffi,l Fffi fr Plf rt tr E A T xfflR gtJ iAii fiEff E ffi^ fr 'rl hitr, iAit ffifr n ffi H D fr E fr ffi '4+ +TLW " D{frffitftttfrnfrnffifrfrlidrt(i[, 4.2.s) . 7.3.5 igif fnfrfr.i+F

I I

M.ffiffitfrffir'\+ WFtI {+H!q fiF,A E H PlthFixf lktt fnfi fr.Wtl 4 ^W H, D), a) iY+Jt1ft:ltffifr H.H!4Riffi E F>FtuIfrYh ; b) iP'frrJ++ftiyrz,wH0ffirft . if H'Frtr * )nE ffi.E +fr5 r[ iYF'H'liAi+fi + E Y]Eg.H X ffJExftAFt,ft t u X.^Hifi,€iL E . M.lRffii+H?"Rfrff{qd.'4ffirfiH0iE *,@,ffiFfii+FHoiAi+ ,wk.Ft't4)n#ruffH'H H( IL 4.2.il. 7.3.6 ifiif fnfrfr.ffiiE h ffilxwi+ffifr fr.ffiH iffi,E1kltfrnfr E ffi^Fl g >R,N.ffi.ffiFnffiflI+ MEII {+ffrgfl FxfE if ffi+ h.fr'tthit " ttrr\Ifrw&ifri+tllM FXX.I+, &itri+tl| & tfrl rA.+*qy.tFrlJ , iEE EfE tfrEeffi + E tr }gpl,fr,it

+i^ "

fi R IfrH H 1A4 t E,? #$ffi i€+*E 4 iEi$f* tr E +*8 4 {&Ht- + 4 4 + 8 ft #$ffi , & itrD €,+frifr 11

YV/r 0287-2017 /rso 13485,2016

q E s f+is f* EriEis +*n e f* Ht'& if ffi H iffi E E i+ffi H0 F rR. M-lxw wiE# Rffi# it D.rz,F.wtrfi ( F!iE* _t't4.2.4 ffi 4.2.5 )" 7.3.7 ifiitfn fiEf'fri^

hEhlRPF'frEWffi,E*4'EHlr[ffi4>R4tf$H6g>F,M.+kffiffi.r,tJ+frtFXX.I+tuIEflF frEtT ft.fr116fri" zTz\M-wffiiitfrilV ffi'r{+,6hi .'tftUa{frfr*. i* Ltr..rtrnlj , E g nf@,+fr€ a#aEtrrg wfr,it &^, lftit Ehi Mifrt+H'ftt'l& F F,frii. A'ft *'ltl F fi €,+f;ft in frrJ + p H.n +tL R d[H + lElffi " D id *H Tffi il HTFffiEf+ HIIEHii, qE(N 4.2.5 ) ^tFh jft.itffi* h.Eh^Ht-*F &fl€iEHHtrS Eft #$ffitffiRt*tJrEI,Et frU,i++Jt " H T rlfrRi*tJr&,'WftAffur inRlfrHH6s* €EItrtrf* tr iS&eH{& ,?#$ffi,ffii rfia+f;itr gEEffiis+*4iEi f E iffiE i4,fr H,l g>R DH

EfrLAM.E.IEJ

D{ftWffii

4 'f, H H 6 .

ffi{frHBfr frFi. 4.2.4ffi +.2.s)" V&-'I,g-ffirfiF,lid*(_t'1,

7.3.8 igi+ NzAN. %+.F.NA DiE

F"Rffi

7.3.9 ig

E'f H!

frAFInft

itri6A

'trAAM ,EI.qA.E

. ,l!fFE. q"m

Ifr.iF.fril1k a) rYF; b) hitr; c) Egnt,Ehi

d) +LLW. lk:'tffiTfts-W.thHiiYH' €IEH!ffi 4ffiS ffiFffig'4[fE

l+ffiF ffi ffJWB(iJ, D),&xf [t &

D{+HFekx.Hi+F'ffililil,)z,trH,lffiDft mie,*rn, 4.2.5) " 7.3.10 iqif fnfrfr.itg tHzA Mh € f tr )t # ffi4 4 fr E )?# ffifeiF^giAi+ffifr n \.+\ . laX.+*D€,A eAi I H M FXftt iE;t tltitr EA f+a 1ftitruf E F *, 1ax.+\6 N.@,a wit ffiT f,-H.tfr.H! iEfr " 7.4 *m6 7.4.1 *n6idfE

zHrArfr.>WffiIR*ry8HlFffi r++ffl,F.HtJ*nqH H,HlfgFfitffi,x.t+(n4.2.4) . 2T2Alfr.r€.n1++Jtffiftt+l*t H!/&flJ . /EI{r[ , 12

YY/T 0287-2017/rSO 13485,2016

a) #T'f*i-t€{*ffi,8 tH1.-''9-*-H!P FotulHEh ; b) eTIxfrffi4fi,-,*,; c) HTXIAFffix'ftr)?#$ffiEtrtu1**n(4; d) 5 E)?#$ffifHJ€Fl.hfHED " -x[aP tHrAM.xttxfr H!Hi{,fnFirfftr41ffiril" DH,m,f*niffiE ffiHt4>Ftr\ffi-^\," M4nffi*fix ,f*z-F ir f/rrsffi E,f*ffi . xf * If x [aF >Ft1Hn f 4LH M5 tf NrAF f A X F!Ftb fHiED, * t+A 1ff H!rX*4,4 >R. F"R e, Htsr]-,b D {frHl*fr frV h fr,trtNWi+ t|f. j6f+. H i[ ffiF i+6ttu1 if;dJFfr4lruH'l,ff{4M,ryffiffi il1 iEfr(n 4.2.5) " 7.4.2 *n6{=,F. H!x[6{H,H. +uxrffaP''ffi a) trffiiIffi; b) Fffif*qf. 1k&Pl4>R;

c) t#.fr^ d) ffi,EE ilHLAM6fr

ilTfrUrtullI

EHH{,

{4ErIg16 tEffizf+fHre*ffi

) frrJfrtrt,ffr

7.4.3 *[A LH4Affi.

?HED#T{* E'8 AAfr,

trtrft|,-ffi"&.%

ftrl Ftro /

#tEqfi,HlDr tFfrIflfr."

fuIq,rh*trft & itr, 2tr2A I"nE*IM{H,H.+ xf +t{

ffiF FrW'nfr.#,

M.LRShitrid*(jt 4: 7.5 ftFfnEE#fE.f,.lr 7.5.1 *.FfEEE#fE{+HOHftlJ D)ffi IR* Fotr++ *LiE . iEEFf ,4F+AftilM.EffiIEA +.P ffi hft. + ffi.{+D T ffi trJ. q ffi . H i[ ffi +AftiJ a) rFfr[eF+Afi{fEFffi fAfilIfrt*.illt.l+ ( n 4.2.D; b) #E#'1kffi,AE; c) qf6jif5 *WffiPffi ++4tHtHiI,ruiI!|E; d) tft1Ffil{EHH,ifl,frifl|J ft.fr.& ; e) xfffiiEfr€,#gffi Ifl,F-'ffiWtF ; f) *ffiF Frffij:.t,f'Ifflt,f{Fffidl " ,H4AIfr.hE-6EI€-+ftE)?+$ffien+ RHiE* (n 4.2.s),ihie*fE,f* T 7.5.e*nre_H! 4 E iFi 13

YV/t 0287-2017 /rso 13485 ,2016

'EfyfiE ruf5trH'l {H,H,++6 ryE fttl€ft€ fiE+w,rLrTg&€ ffi+w,t\1aiE 't " " N.M,w 7.5.2 FponHIHH

fT r\'lFA,T, ttrrAM.\4FffiH!iFi#d i5* +AtrU E *M FXy{+, a) Fffi EN,HEI{F,H ffifr tlel.fflriHi#; b) F ffiF-X11nffiMrt'€{+trffi trEx.ffi EI{FHEftrtT?Fi#A}tr; c) tr ffitr x-ffiEI{FHBf6 6Etr fTiFiS4l}tr,{F,HHt'H iFi#E e ie E ggH0; d) a€{*ffrPFnh1lfiffifFH,{FHBt'HiFi#EexEEffi ; e) AftU€trf5+rt Ffi +th* frffivftfin4/ . ffRFffiE&flRt18a)d b) WF-*it4tffii#,I|J6.4.r+EAffJq>FZrtrHTiFi#ALItrEf H! [fE. 7.5.3F#rEil i6 g Ht,tH2AM.,t4 Eft ##ffi* # 4 >Fffiq # & itr1*4tw wlM FXr{+ " lnR%EH ffJl,ntrF'FJ.,i.+|h ttrLlfi,HlxfrriltFffJ'4^#)-q#8tr#$ffi ,fliJtlllrfr.wlxrcf+$ffi E#fr rfr.lR H h 2tr2A4 H,f*i- fr,t\H! E r?#$ffiq H rut * & itrH,t id fr uil,4.2.5) . 7.5.4 E&.*ffidl

inFxf Etr+#.ffi,flft.+A*nEHtE* ,,)Z,F.E| ,1lE"tAN.>WflF.+ffiF ,FfrWe-ffJ+nNffiFfiWh-frtJfl\E qifi FII {+,H T EF.+ ffiil +WitrF fi F >Ft+FU ffi,e. tHzA M.htfitutTzAdH {* f g DfiWflft.+ffi driE+, a) y)6frfr.th,fH,H,86 tFhW.ififr.,ai FLEt b) EEHt',-}ETtrtrffiMFXMA" M Ifrffituttr21&H{*}g}fttu1flF.*ffidrfrrJie* (_r'1 4.2.s) " 7.5.5fi HE,?€F+rIHf€H g* zEzAM'fftHtr*ry.ffi+ltHlXHittE4W.PliEfr (n 4.2.5) XHiE*DE jE tfr:eiJntr#$ffi trJE"

+-f'+Lr, "

7.5.6 trFfnEE*fE,f*itfEF!ffi i E4FfrFflF.-++ftf*ilf5H'lffiH6fEdz.E frtr.ryfi,lHifi,dirrlEitnD-r&iE,+Er rr*lfr.taJffilxftFffi fFHtr 4 flft.#*.tttr t eIfl Ft',tELArfr xt{f{qi*F F,lilfgtr,41nfti. nh^ M.iEE B D-b it ffiHH tREje* IqFfiffi ftiJ ffJ*"R w ftah. 'HAA M.,W frffiffi iAffiE M FXT{+, fiffiffi ,AETT, a) )Vi$fsHti+Fruff/EFfrflAE.pti&IU ; b) jft&#Efr/\E Wffi#Ei : c) {FH++Etull tX.fEJifr+*r|ti&I|J d) i6 g Bt'€,ffi@AFAEtrTE tr,Jfrj+#fi, e) iE*H!4* (n 4.2.D; f) HffiiA,E+frHffi]/'#J/ETU; g) xttrfgEEhW+W,tE" ^E4AMWHTeP ffiE[-*ft1*ffr1tHitL1sn/t+N.Hffrafti^ffitrMFXX.ff " tftXyxl+ffrrfr.HfrHrklfr. T4

YY/T 0287-2017/rSO 13485,2016

ffiEtfrT6hi^,iEgHt' 'tL4+i{+EIHDH![Dttr&,Maffii^" a x+kl+ffil^finF.nhiffJffifr.}-rxffiifi 6tM.5 #.I+ lfr-H H xH!x & (a +6xf F ffir+6 *nfdH!Buirw*RtnE )fHE D . (n 4.2.4fB4.2.D" D{* Hbhi^wr"xffi#itu&.ffi^Ffi*-F+vffJr}9-ffifrEffiiEfr 7.5.7 XHi$fErtsnHEWAzfrEfti H!€Hg* ttr4A M.>WX H i$fEfrE fiffi ffiW4 fr"tuIEfti tEF M nXX. l+(n 4.2.4)" X Hilfg ffififfiBHKr.i;fr.agifiBfr1++ltJnhi ,iEE nt',trDE tr&HlF ffieltrffiErt*ffiBfr 4+#tl fihi .

D{xHffii arJ#Rffi#itu&.6hi^Ffrx-w*tr'x,g.ffirfiH!iE*(rt 4.2.4 trn+.2.5) "

it

E*la,H.-!L lso 11607-1 ffi rSO 17607-2.

7.5.8 +niA AH'A ffi.WFffiffi J,A f5 F M FXXI+, + ft P ffig 4 H!g + J$fg + {EH i6 g HT }. rEiF,frlJFffi . j.A 2tr9A lfi.f+F ffi * r4,B'lH f i$ fg + & ,HR Hi4,fi iI|IE 4 >R ElJ F fi H0fi # " ftJ'ffi H!e F,Wft. q * ffifrft*B!AiJfE+M'fX++Fffifi#H!&niA ,UnhlfrF.AiESrf4>FH!tOSfitfrhEIgiVtxiL+nk41frlJ Fffi tfru,&.H.iE.{Effi4fi*. j.Affr?tkMFII{+. fi+AEH ffirX*4'4>F ,rHtAMWi E)?+$ffi+EErft-+$ffitfr ttrtArfire.nfEF + M FXX. I+ Uffi lXE @tTzxB!tr )?+$ffi FE?Ej.F, 5{E FE5 A ffi F,tF ffi E h fr " 7.5.9 EIiEtln'E 7.5.e.1BI|J ,H2Arfr.W4€i$n'HffitrVffi,r{+ " B$rffiJ?D,f&ffii6HH!rA*4,t**4,84€iFi,lt fflffiH ffiffiE r)) D.+URH PliE* (iil,4.2.5) " 7.s.e.2 f€,^''EE r?pSfnIHt€ H g * tnRffrl€.Hwt1l+.f/#lfnr (Ffiffi,Rl++ E F EI6E+#,wft #ffi"z^iffi,e^H*4,8 F!X+f,r,EtfrVg. >F, trI€iFi'lSrFq>R HliE*Dts +68t}-h+Hre tr R HliEft . ttr2[Iiltr-*+E{+ififfiHF.hffJHrt*,%+HH'{+ WEfr +#ffiH'lifiiEiE+DJ{EEtfit.,#&affiry., nttft4+ El}jid*

"

D'f+WtrEE #'lt{+,,\tu\tr+ffi}UitPliE*(tt 4.2.s)" 7.5.l0 ,tF€ntF zAfAfttITEI #ENEMe'E.2E ,Xtlzl,zlfFH fr4l"4ltfr.ffi H!4f6FXFffi-*FA ffirlLtru*- ,'8"2l1fr.+I)) j.Aflj.&iiE.{++F ffiFiiIF " #[rl{.DntrrnPfr.H*X,ffifrd.,fr-IflzFEH,Hn,rEzlil.rfilyfrtrtft.tr+lilW i E f t ( n 4 . 2 . 5") 7.5.11tffi tfi+F

;

E-F-ffiH'l/:nr,fliF.AlHffi,tiEtrlq,+E"tAM.whpFaff+E>F+E,f+prt+FftlfgFvixr{+. prt1lF r[EH T tr)i+$ffi,fr\4trFX*fir] " EF ffikllnr 'W|g..4LEffiifrtrSl'4 , g^H#ffiTtfrffi#.l*ffifub(itr)Et,nLNDiEtpJTtrtffi lhF Fnfr.+M4L,liF-fi,+frfr, a) iAif fifilJtEiftgH'lE,+ffitrE€.#fr?;

YY/T 0287-2017/rSO 13485:2016

b) fiFE,+ +HTAAM,* ,>WFfrffiiltrW,ART+W*WFII{+ Ffrl;F " (n 4.2.5) . fi4*ffirfrRl+,^HDE+A +A DJiE* 7.6 H,i4,fnilUEig &fr+J f*ftl| 4tr4AMEhEffiqF6 ,]rP F,f+hffiE Htg>FE{*itr+E H0HiI,ffii[|JtriA6 HtHiI,fliItJElil&-Ffrffi " trI th tt D) u 4HLA ifitj 4 fH , H iI' fl € *H! f H 4n ffiUU € lf; 1-r 5 * * Ml.H.nfEJi + M rtXXff m{fr *fft o

Hf, ifllj81ft.&N., *J6frlft# RH "^h.,'I,E a) xf FRfrV.#fritrF|J tr Pd4E,XffitEHlifl|J€

q,&ffi.ffiEtit 4T& reru( 4 ) ,& fR*4,EF!Bt'1414pffi .2.il; IE4E

&€,Y6#i*t6&s7& b) rz,F.Ft'4+4U/Fjg c)

.H+niF,,l:)

d) AUFfiTF, e) AUR

ttrzr.rfr.lil

g{Fi[[ EF^R*./*,;

HttfitrffiFlFj" ,w+FffittrEffit4 + H0fEJi+JLTt&.ffi$,&E. z\tAlfrxti41k

ttl,rf, Y &ffiIT{,'Igj

D{,R ttr4\ HBfD? thM.5+R M.tfr E, E 8

HAHWF

F--frtxruifr

ISO 10012.

il|JE.A

8.1 BI|J

ewAM.ffitll+ a) itr*P Fr*1tr+

i[.u!JE.r]ff filB[iti$f5 DJ,

b) ffiLfr.ffi.trtrtu+R c) {fr++trtrEttrl+Ail\H F." tsD A+6xtfr,t ffi.^A A H!E 3t * &.H{FHfEtr ffJEfr 8.2 H,i4,fnilUE 8.2.1 Effi

..RffiM"+n4"2A'tr-e.-tffitrlBfr&E>RklfHX ,ql| E,tE"2AM.LW rc,rxtffi.E€rtr{+4A-,*.'y+H,l-ff frlfr tXMFXr{+ M_WtftW\fi f{ ffiB fF{H,H. Wrfilfr." zHtAMWEffit fsffitr ry FXX. I+" i^ E-ffitrfED E,ffiA H F ffi+.P tr ffitt + LW.RW.ffi q g D H lFM4nfr,f+}+P ffi >RH!Ft& € le ffi# A ffi^ UN.Pffi rI,4 rfi.fr. A E ffi [ ffi + LW.Hkl {H,H, trf5F!i#Affi . a)r#H\++fr.%.W,rflJxtin14-h Lt,M+.P.trffi H'l H!i+HN.+8FXn-ffiitfg in+E ffiB,tEiI,g>&F>Rrtr -*FA" 16

YY/T 0287-2017/rso I 3485,2016 8.2.2 fgiF4[E

'Hq,M.&flRE H H,I E *4,g *,I+ X.Bt'4LE & ,trfuITEF MFTI {+" tsrl-b fgF D €,f6xf rJT i- ffi H0 ft {ftF * fi qRff , a) f*&friE *{H,H, ; b) i+,f/|{H,H, uEhF=EffipFtgFI&itr; c) /flA&itr; d) 6ftfr.F-6.ffi4 r"rtr E iltrW"trilLf6*R#{H,H, ; e) 4!85&iftHXHIFffi; f) BfrF-trEffigEA4LIE

funRH 4rf4&itr* 4iH inR-rF iflEohfr

fflqrLliE4 aLlEffiffi, "

+$ T &itr ,NtJM.tr4H4i

*F}-zt4tf4fH*{;,H, .

D{*HfAitr4tEi 8.2.3 HHH+/r inFEH HXHOH€ Ifr.lfl.W

NJ4H4AIfr.>Wfi H0f5Ji +qffi.#

8.2.4 6

ttrAAM. a) f+ NA b) 1+ 2H'AN.9E ttr4AM.ffi

D/*4,€+iE*H'.

filEH H!y*

, ffi ttJBfD t R+UF' M.ffJil fg ffi X Ej B.illtJXffi E F

TfSFxlE,AE" B'

(n 4.2.5) E.B{tf,tEpEffi}rA jfr " FM,frH!

M.IfrffiFM.tnFU,

fufrPFU,XfuIH!€ ^AtffiD.EFEl" tr&ffittu.E

f[q>F "

,,EfrIJH M,*"R "

E dHtJ-(F"

4.2.5) , €,+f;dfE.EF M

AE ffire, DJiH!tr,FfiE-fAful

EqxH,lffifrE++E

ii., F-9|E,H._!L rso 1e01i"

8.2.5 iSfEH!ffi :i4,fn ilUE 2H4AM.-)F-H iEH ftIf EXf EE €}tr ffiAtfEtrlTHiq,, +*ff.ffiE F+tr 1TU|J E . E J}Jfr IXDil q i$ fEE 14ffi fiJr" R WfrZJr . # *frz X rnffit1;# +, E * gt',D X ry tLltr rtErLIE ffilE " i 8.2.6 F noo Hts;i4 fnnUE ttrzlil-xtFffi H'l++'|4ff 4tF.4nfrni4|J€, DjhitrFffi4>R -,'i+gtfiffi,ts " IFF M.4nfrillj€D ffiffiffitrJ + frt Fxx.t+ tuIx frFffi MFtr {+H!fs F, Ep ffiq }flt fEHtE y yt Fkfr 41 " IfrlR++f+Af*'ltIE^lJH0iE+8" DiE*H+vnkftFffiHI E frrJHh,(n4.2.s) EgBt',iErtMi.AfU " jft.& HT+ '41ililEifirtHtf6r[il " tr ffi r,tJ fr M Fxxl+B!q #FE tr iffifi FtEf;Fr[ tuft pffi fnA,ft flfr+ " I7

YY/T 0287-2017/ISO13485:2016

xfT lH fhtrf +$ffi, LFzxffrtf-frl1laf'l& h 4ifr & HtAfi WIH It). 8.3 7F€'ftt frf*ftlj 9.3.'l ,-F.[lJ

en lFffiH Fl'fFHeIt'f{ . tHzAD tHLAMlrfr lftxtptr+h Pffi 4* klF ffifr.T:ilfr\fi +Aft||,D)Ffrrh r\&.E.^atf-ffij.A5lJ.iE,fr.pHH.i+flffiftEH*fllRfrfrfxFR. tEtr+Mfir{+ u*r,F=6a+&ffi}aft{ }. . A fr E f;ilft 6 A +&ft fr tuIFfiH ?IBF i+,f/IM@+fr ffiE E a-ffigtiJ4 T A +&Ht Ut,lf{FIiFlEffiRft B!}gHiXEE {'1ffiffiHtits*,€,+f;i+ M.lfrWl^Alt&ffr'l+ffiu&.WffiFfrlxEl'ftl{f ( n 4 . 2 . 5. ) 8.3.2 f .f{Hfr ar[7ieffi ffiffirfteffi ffi N.EAA T&FO 'tr4F, M,Es Tr]J- ffiEI'Lffi6',14 a) X4xffifftDJiHlh stsr['ilITdt& ; EIMH; b) XRffiffi DJffiltHtrTfiHH0{fiffi c) WtYiL*{Fffi,1k41&+*qt-. 7XT t AA iL b +*'|[. D B',l'lE nq Mnh RT e +&F,lytrW,f*lEf; . tf,{+#t/Effiffi E iEH H!rE}frW>F + / frHIrlftliE* (n 4.2.5) IXWiL+t*Ll[.ffiF&i.r " H!rltutrHffi 8.3.3 fr.Intrfr.rnZ".Afttfi

gt,f.Jtr *,fithlfr.Htrf,-ilz^fit&ffiFf ,LE"qM.-)y.E(5Z^AffiBtJ*BtrHEI|6EFln(qHtfEHfHiEMH ffirfi" D'f*wFfr*wffiffikliErt(n 4.2.5) " ',f'}i#gtr&.r-r vlf,.frffiFfl/ffiX.l+. Bl}-bfEFD6ErcBf H!r**r,4*{4,ts,g,l+iEfi tlrlrfr+frflRiEH (n 4'2'5)' 5nfr,H'€'l4iEfrfHXffiffifeH0if,ft lF.W 8.3.4 iEr

E$-bfEtrtfr-%itqlFttrtlrfrtlFlaffi,TErxfPffi WI€/-tZ^H.*ws1JFfrMif,y.t4fr1tLfxfr.11&r. Htif F' ffitt;tIE" fEJ+fHIFJ ]Erft,fil,tr,F ffiM.%W[EUBhl*Hiffi,eiEH fir**4,EF>F H'lf*&I,EIlJ " (n 4.2.5) D,ffrH trI F'lie,ft " 8.4 w.ffia^tlfr H.'W, fr h'l+ffiH iE* tr tr € tE'f+4 tufifr 6hfr.. q{R ffih tfriEY WffiilIffitr MFII {+DJ tHq rfrW ,EL ffitr WmF" nif $.*A FlH!i6*frIXD.^H{FH . A+rfgjiD@+6xf ,a ifl ffiillJE wH R t^&H l&,HX*ffi. VIWffi,+ E')-@ffit))Ti- ffiH!ffi ' w.ffih ffiD +f;* H_ffi

-$t

a) F-ffi; b) Fffi4>Fffiffd'lr; *; e-ffi%,8+fret-W.tu1tlt c) fffEfrFffi Ft++'lS d) l*fr; e) FM,; f) EEnt,EF._++E#" B.5klF*{+}t htfi# tiEH ilI ,frhfr1&Hii\.tu1,4H4AM&F'R trnfuW.ffiltltfi#Hlffi.lgtrrtrW7-

RH tqttfrHlm^" 18

r

YY/T 0287-2017 /rSO I 3485,2016

4.2.5) M.I*Hhtfi#R ffiitsrt (_ril, " 8.5 rf ifi 8.5.1 BIlJ

t\AAlfr.fiiJHffi.Efift.EE Fl&r.FV,*"R.t'fif H tr ,Wffi4dtn ,rLlEffiffi.Tf ffiffitr&ru€Igi+F' Xi.X,5|Jffi*f&'ff tE,/.9-ffJFek,uffilLffi{frf+trEtrrEWKHt++&iEH,El ,frh'y*f\H-,*:1+.til&.8ft# ffi,tula+f,r,ElFE. 8.5.2 aqE.ffiffi ttr2F,tfr.XE(ffif6iHWT# +&V,J IREtll ffi'Lt6 A +E#JH E +." eH2Arfr. * Wlt lq,I,E ffJrllE ffiffi,, rfr. fiT\ffire " tLlEffif6DSn++8ffiffin(qEEfni6& " 'Hq IfiW*I,E.DJ T }. E g * ffJffitrMEII {+, a) i+H'6.#+&@,ffiW.)F); b) ffire-6#t&tu1tfl,w; c) l+UtffilY AffiTHE+.H!ffifeffiffi*; d) fi FnffiB!ffiffiffT:ffitrJ,M fil,X.l++gFfi ,iEg Hf,€,ffiEffi\14 ; e) WiEtLliEffitrfixfffiE.iEH frl7**I 4 * ffifrUrffixt E yt f$ffi V,J R + ffi,Y*frAfi:c H.** n(q ; f) t+H FfiZ*ry tllfiffifiEffJ6i;r'fu1+" H! IfrIfrW4f14iHEffJ+"RfirFfr*Wffi ffi F!il rt (n 4.2.D" 8.5.3 ffiVfr#ffi ,H4F'Ifr.ffiEffiffiiHlhi6ETA+&klHEl IilPfirLZ^hffiV!fr.+.. mmffiffiD5itrEf"lffiffi*'ntn(iJ fgH fHiED" 'H,AIfrWilNEA PJT } H g >F#JffiE MFTT {+, a) ffifrW|a6++&eHFtr; b) i+utffi'rt64 t&E +.frlffiffifttffi>R; c) xtFfrffiffiffimif ftffinJ,Minyl+i+qr6 ,i6 g Bt',@,ffi!E #X.14; d) &ifr mffiffiffixfffiE i€H FtY**4,9>F B!frE rt finxtnr?+$ffi vtrX+fin'l+frVfiH.F/n(q t e) iEE Hf,i+F'ttrX+xklffiB'ffilEffJH-,*.,|+. M,ffrH ElatiHEffJH Rffi Fn*q\ffi rfiffiitsfr (n 4.2.5) .

19

YY/T 0287-2017 /tSO 13485,2016

F{.J * A (iftf4'EF{,1*) yy/r 0287-20v 5 yy/T 0287-2003FJFx{tb * A.1 fST

YY/T 0287-20rT5 YY/T 0287-200sxf btfJM.4N," t A.1 yy/r 0287-2017E yy/r 0287-2003FJ#X{tb

Y Y/ T 0 2 8 7 - 2 o rR z# _xf

EU_

xf tb YY/T oz87-zoo3ffiEEIFtdWinU .Tlf AtnrEffi 3 FFt,* t! il | 7v

fan

VirEkd X.ffrH-# ffi HE {H,H." L-"r-o*

E&J HV=)JF)

\

T,tuMffir$*Nh;; 0.2 t{ EE tBt

k \81 .ttrlJrr

ozBT"trt

W >R.

ffJfllrfffiW

^ * ** *

*' €,*frxf+.* *4,R6[&f U " yE^ r

*xg>F" fl E,H?E E

fl13btr E € IE{f 6 F >RfnE F #SffiffrX +*flffi*il

0.3 i$ffir*

0.4 5 ISo eoolHtXa

\--:--=

Jf

-p

- 2 0 1z6t q f f J # f a x ; " ZlffiJl*,TYY/T 0287-2003t6/E+{FHR{A+

#.1^ffJxf GB/T 1e001-2000#J

Ert - #nA+ bi IExtlb&.E ft # ffi". 6' I#J ffi #J* + *, * + VnW.#JtE AF!jEHjS " -#EE+Aii&t FAH H tr.ft#ffi"t1l4.Wffi**ffi (€ffi588€rE,f+ 4A X.trrnft.*) B!{* r f6H

}-d4.*Fnlfr.Ho -++5{tE 1ffitlAH M.&,%+Fffi+Aft{rl.€itffiffrft[+ "

3 AiEfEEX

-'BrrT

z0

|L+ffifr-y,ffi[LT-ryWHE y

YY/T 0287-2017/rSO 13485?2016

t n . 1( & ) -zoos frlErt A 6 H0ii,q xt bf,yy / T 0zBZ

Y Y / T 0 2 8 7 - 2 o r ZR #

A1 .i. -l

- H lntngWH FfitsfEH!* + EI* + ffi@MFX}-[+H! F >R. -F trt(t R tYgtfrtsffiffJ ffitr "*ffi fr.sffi . >RD H " E T t( FdHti- y*E fUE € € IEt+4 Fff H!i6 g /t f " -,8tu5trffiE&A+ffi4rF. - JHI[ 5 H T tr € tr WWA ffJlt H TIL+K I+Wlfr.ffiffiA € JEH!F >R

ffi,EtrWWA ,H.F,R

Eft|J4>Rtr Affi Xfid * HT H fttJ. 4.2 I{+4>F

ffi*xdxw 5.6 €TEiYF' /

o.z l.JlW'tR I

f

o.o ^*rrr"{ {

/

6.4 rff$q

*ol,fAffiJ

7.7 Fffiq

il,Jffi ||

ffiHil,ffi;;W.Mi,ffi**

-===={=-\r=

7.r.2uxt;rfrfu\ 7.3.3tlt-tfffi"il

h

J F. -xt ffi+affil ffift.1*.i+ ffifr ElErI HtE g ffiH.frtt T Z R WR 7.3.10 lkltffifrEyt.Yr

7.4.1.xfla$ffi

-l*fr)ftFtftfl|JJ€it l*frffilf.xtF.tr#ffi.ffi8ffJ*Rtstil .5 E,tr+#ffi"E Jeffi& W.UD.P ff ffi,eiEHHfi**4,4*+. HtHiI,fiFWffit))&.*ffiEXftAF>FH{4X4x tuTffiffi,H XH!+f}94*. *FrdEi#fr 27

YY/T 0287-2017 /rso 13485,2016

(&) YY/T 0287-2077*Pft

7.4.2 XftA,fH,H. 7.4.3 XWAF. ffi Fl&itr

xf tL YYIT 0287-2003HtEpI6ta.fr4JinlA

-

H )rnT I*t rfr.:W X.WA P F,fr WVtW.en;e n tEtAWffiE & -}Bln T &ifrffi4 Hty*E E ffi#tTgfr,NatJ*-NAP F"VtltlotE.e\.Ffrw:xw.ffJffitLffJtfr

s*

7.5.7 +.P ffi EF.+tZH H,I+4ft{ 7.5.2 F ffi H,lt# i#

,ron* -trt\rn+18tu4>R

7.5.4 Fjft.*ffia

-trrtJry+rym 7.5.6 +.r frnEF.+ Wt* T ffiwvffi,ffiJiH!iFA,. -#.I+Ehi ffr++fr.frWM.E yxt+,fF fiffiH!rfi1.,l. ffiA JeffiX & fEi6M . -iB lrn5 afizl.iert A X H,lF >F 7.5.7 XHltffifrnftffi -_rH/nr-** ffiWAfr,ffii,^A4J+Hg>R 7.5.8 Eri,A

-Hln j.AH!F* T pft-#$ffif;n JBtrNT WP ffi &N.i,A ffi Ji M FXy-T+tN4 F + JET f6 ],Affi F ffi )It# H,I# 4 *

7.5.r7FffiB'tF 8.2.7 n-ffi

8.2.2&rF4IE

T Xt'iNIEftFXBN|lF H!4>R -

tg fu T " frl H Ft b € rEtr ffi + ffJF-ffi *ffi iI, ru,ffrf+ F ffi g * " F!F >R _+F.W#-

8.2.3 r"rH€trLf6+Ef;: -ffiH+ 8.2.6 FffiH,lW.mffi --19 tu T xf filriltl E ffiA H{&iI{ EA H{i.AF{ q* U!|€

8.3 ZKA+& ffi+Affil

-"xf ffMffi,yl+ffJfAfit| F0ffi+"mlLf F*. -f -l(.FlP*€,ffiltlElEt6tsRffi'EH. -JgfiT ELL+HXfrIF>RO -xf t,f{Hf .t,f'},trnw awffiffiiErr}5lJ€fr rq>R " -}B ln T " 5 E fr ,E#,l*iE fi € JeH!id rt " B!4*

8.4 Wffihffi

- Hiu T "A,ffixt ni+w.*trFr Fti6S h txE Hleme e tt un *r t ** " -tgtu T ffi^t\rn

8.5.2 {-.11rtffiffi

-}S -H

8.5.3 ffiFffir6

-JB INT ..&itrTfrFfiffiffifrA R.#qfu '' F!F>R

ln T " h.i$ tlliEffi tr6fi 6 H.ffinlE"fuIF>F. finT *Ex,tLIfrffi f&fi n g ffi G ffi F*

YY/T 0287-2017 /rSO 13485: 20I 6

B

Ft'J *

(6fr+'trF{'l *) -2016 Xil&*,4 yy /T 0287-2017fiEGB/r 19001 T YY/T 0287-20tt ffi Ce/T 1e001-2otaZE HtXfMJe6. ft B.t ffi*.8.2 .E/1s -20v t n. 1 yy /T 0287

rtAGB/r 19001-2016 ZlElHtx'fE X.* GB/T 19001-201b

YY /T 0287-2077

r ffiE 4.1.1(fif,iFE)

t v*68 4.3 ffift.ffi.Atrr9{6.F.H'lY*dE

+ ffi.EtrIjEI+A

4 ,Yry.frH, 4.7 'Effi91"t\D.trqiH 4.2 ttrffitl+-h F'lffi*fEtrgE 4.4 ffi.E_EW|EKeFSffi

4. I

4.4 ffiEEtEWRX-Hisffi s.+ 41.*Fffi,f* HtfiE,F ffiftEnF..*Ht+aftrj

, H. E*

4.2 I{+g*

7.5 FTIfH,H,

1.2.r ,H,qtj

7.s.r ,SXU J

A

= trE€IE,fA6X.SSffi

A

4.2.2 tr€+flfi

ffire.natrwtraH'l?'fi8

= a

/l

7 5.1

,H.A|J

4.2.3 trf #$ffiIfg

fr+6t*#i

4.2.4 I{++4ft{

T.s.z d{i+ffilg+f z.s.B FIIH,e H!1Aft|l

4.2.5 idrt+4fr|J

7.5.2 oljefnEtf 7.5.3 FTI{H,EH!fAftt|

s €IEHRfi

5 €n+{FH

5.1 EW&1#

5.1 5 . 1r

{r+fFH fr F(i.# ,H.FIJ

s.2 UfpfrEhXi+R,R

5.1.2 UFNEbXER,R

5.3 ffi.EE+t

s.z i+t s.z.r friJ€ffi.Eft+t 5.2.2wiBffi.Et+t

5.4 ffitlJ

o ffiitj

5.4.1trE Etn

6.2 tr€ HffieE*r[H!ffitlJ

s.4.2 ffi.EtrrFlfF-ffik\

o ffitrJ 6.1 Dxf FlhfEt[iE F!ffir& 6.3 gEHtffitU t2

-2017lrSO 13485:2016 YY/T 0287

# n.l (t*) GB/T 19001-2016

YY /T 0287-2077

5.5 1Rfi.+XFRfii4iE

5 SI+fFffi

5.5.1lRtrruinFR

5.3 9H9F,W Hi{i .4Rfifl fn FR

s.s.ztrW#Rt

5.3 ,trqffJH,fi,4AfrffifnFR

5.s.3 Fr*Fi4iE

7.+ i4iE

5.6 €'EitrF'

e.3 €'Ei+H',

5.6.1 ,Br,rU

--=a-

f

5.6.3irF',ffifi

6.1

6.2

Hfr

7.1 ftW

^/

6.3 H6ilifr6 6.4 T(Fj

e.3.3€rEiyER

^r'

/

\ \\

ffi'qffi$Iffi$,

A

*En'rsS,' =

7 Fffig

rF;iFEE:-^-\_

l.F

ita

^/

+

6 wwtr1tr-

rliTh\

4f€

?a

2.rffiru;aaffi ff#iffi{i^ sffi$ _€

a.,$fttMzrryS

7.rrmsnri

Y4 2.2.rrme\md\

=

r.o

1^Jrm

\

8.2.1 tvnEtME ^/

\

-uxyl_rrunZx

\

\

7.3.r HI'J

ffire|I

n;;ffir;;*w/

T.z.z -"**k\ ,.2..'-,

I

--

u.s =aatnlffi"*ry/F-

\

7.3.2 1kl+ffifr6-ffif1

-

EIfrllffifrnffivlt

7.3.3 lft:ltffifr Fffi ^

8.3.3 1ft1.+ffifrFffi/r

7.3.4 lft"t+ffifrnffifr

8.3.5 1ftitffifrtsffifr

7.s.5 1ktffifrnjF.H

8.3.4 lft'LtffifrE?EffiJ

7.3.6 iAitfi#E&itr

8.3.4 1ki+ffifr8?iffil

7.3.7 1ft'r,tffifrEani

8.3.4 lfti+I\frn?i.ftil

7.3.8 ifti+ftHTE.#tft

8.3.4 lftj+ffifrF.tEfrrJ

7.s.e lki+ffifr ts-EPIPIfAftll

8.3.6 1ft',tffifrHF.W 8.5.6 EUt+Atr|J

7.3.10 1fti+ffifrx^H!Ifg

7.5.3 FII{H,e ffi+AfttJ

^,

YY/T 0287-2017 /rSO 13485 ,2016

t n.l (&) Yv/'t 0287-2077

GB/T 19001-2016

7.4 xnq

8.4 r|'*FE'f*H!i$ffi. F F,tnEF..+H! +Affl

7.4.r X[4trffi

8.4.1 ,H.llj

8.4 tl.sFE{*H!ilffi .F F,mEn *Ft+AtrlJ 8.4.2 +4fi1+4 finffiH.

7.4.2XnoE,e

8.4.3 Wffih'F*F,f*2-H!{H.e

E--

-

LL2

2.4.s *.NqPffi pl&itr

-\--:+

8.6 Fffiffi*Bt\(

;.r +-rE ilrt.#R.',f,f ^/

8.5

7.s.1+rmHF +lfi*tr/t+,J T.s.z r.FTWWfr 7.i.3 xx'*{ I lrt z.s.+ Efta.tq

tr#$ {tr€*-*ffi

2 . s . 6+ p

flF.4

t.5.t xw

ffif!

T.s.sEIE#it

\

8.5.1 +.'-ffiEF,#F_f*B!H\

7-',* nffi.ft.4--E -= il

\

a\t

=

T.s.s ftffil

7.5.8 ffi j.A

+Ffi NF.#WT* \

ftffimff

? v

c,r*irffiHffi W{ffi e.s.rffiffirnrn+ffiffi't trffiFv+a@F*rffff$$ifffd ftqmlm&.€ sXffi4r'-r4g L-'"($t$$ I

s 7lI

\

tt

7.5.10fmAnt\

8.5.+Fnr

7.5.i1 -**n\\

7.6Hinfi*E,afun\

T.r.s Hi{,fili[{EKiF ^/

8 UuE,tltfrffiW)fi \> 8.1 ,H,^'J

8.2 Hir,ffitlt|E

-\

-t

::W;= 1.:

t

t /

. r , u . n lz f ffiFln'JE.*tfrffii+tt

8.2.7 E-ffi

8.5.5 fi-titrWA: e.1.2DfFffiH

8.2.2&itrAE

9.1.2 lTBffiH

8.2.3 fiMEULffiffi.E

8.5.5 t,fftrffidJ

8.2.4 frrP,FFV.

e.2 ^ErFM

8.2.5 trffiFtHi4,ffii4||E

9.1.1 ,H.[lJ

8.2.6 Fffi F,!ffiil,ftill|E

8.6 P FaffinE.+ffrnk41

8.3 TA+& ffifAffi|I

B.T Taffiffifi E0tAft||

8.3.1 ,H.4lJ

70.2

efftrfftn 25

13485 YY/T 0287-2017/rSO :2016

t n.l (&) GB/T 19001-2016

YY/T 0287-2077

8.3.2 {,fi BfrE46A+&ffiH0nEEffiffi

8.7 6A+&ffiH H!+Afr!|

8.3.3 x.It E nwT+t&ffi HtqtDffifr&

8.7 Za^ffiffiS H,l+AftlJ

8.4 W.ffij't'tn

e.1.3 h+fi5:F'ffi

8.s rfr.fr

ro tfrifr

9.5.1 ,H.n|J

10.1 ,H.n|J 10.3 f+&B[iS

B.s.z ?LlEffiffi

ro.z T#ffiffit'18ffitr6

8.5.3 Trffiffirfi

0.3.3 4Tt(h WE,W 6.1 Mxft(p0fntrliEH!ffir6 10.1 ,H.ItJ 10.3 ++*D[it

-2016 fH YY/T 0287-20tt Zl'riJ F!rilE * fr t. n.z cs/r 19001 YY/T 0287-2077

GB /T 1 e o o 1 -2 0 1 6

t

r*6H

r fEE

4 ttrqfrffi

+ ffi.8trW6F.

4.7 wffinq&.HqiH

4.r ,H.g>F

4.2 'trffitF'*frB'lffi*fnH4

L.r ,H,F>R

4,.3 ffifr.ffi.EtrtswaH!lEE

4.r ,H,4* 4.2.2 EE+flI

4.4 tr€€rs{fa&-Hfrffi

+.r ,H,48

s €f S,ff H

s €r$4Rfr

5.1 4f+fFH ffits1'#

5.1 trrL&1#

5. 1. 1 , H. I U

5.1 trWF'lH

s.7.2 UWEtr*..&R,fi

5.2 Ufvn#rrf-.ffR,R

s.z fr+i

5.3 ffiEt+t

s.z.r ffiJfr.ffi.funfr

5.3 ffi,Et+t

5.2.2 wiBffiEfr{"t

5.3 ffi.Et+t

s.4.2trE€tE,f+KffinL 5.3 ttrtAwffi{i.4Rfi f{fnpR

5.5.1 4RfifrfnFR s.s.z €IEA,ftt

o ffittj

5.4.2 ffi.AEWWflffiI1l

6.1 Dx.tFlhrufiLiEH!ffiffi

s.4.2 trE€IE,ff Rffif,tJ 8.5.3 If,ffiffirE

6.2 trE H+,fieH*rflH!ffit{

5.4.1 trE E+,i

26

YY/T 0287-2017/rSO 13485:2016

# , 8 . 2e * ) GB/T 19001-2016

YY /T 0287-2017

6.3 AEH!ffiIU

5.4.2 tr€€rE,faAffiIll

n

6 w{F.trtg

/

+I+

x-fiF

7.7 wW 7. 7. 7 , H.I[

6 WWtrTE 6.1 w{R+El*

7.7.2 /\E

6.2 L)lWW

7.7.3 E6S&tr6

6.3 #6SiAf6

7. 1. 4 iS E i A{ T q i H

6.4.1 J:(Ffiffi

7.r.5 Hl4,ffli[||EffiiF

7.6 nf,iI,tulflt|E1ft&fr4J+EftiJ

7.7.5.1,H._nU

7.6 Hil,ffiifiUE1ft&klfi#J

7.7.s.2l[||€ifitF

7.6 HiI,ruUt|Elk & {?f}ftrJ

2.7.6 4Hq,$JfiliR

6.2 \)rW{R

T.z frUr

6.2 LrtWW

7.3 Hi.A

6.2 ^hWW

7.4 i4iE

5.5.3 FJ* S i 6i E

7.5 fiI{H.H.

4.2 I{+4>R

7.5.7 ,H.flU

4.2.r ,H.IU

T.s.z AUrgfrE+f

4.2.4 I{+14ftlJ 4.2.5 its*+4ft{

7.5.3 FTI{H,H.B!+AfiJ

s

E'41

4.2.3trf #sffiIfg 4.2.4I{++4tr[ 4.2.5 idRfaft!| 7.3.10 lkrtmfrny+g 7 F"'ffig4'

8.1 E,frtulffi.ilfilAftJ

7.7 Pffi*rflffiffinll

8.2 f FaffinE.+ H'l4*

7.2 Slen&EXHtSffi

8.2.1Fn&tEin

7.2.3 16i B

8.2.2 F F,ffiEF..*F >RHtffi E

7.2,7 Fff48ffJBftft

8.2.3 P FnffiflF..+F*H,li+tr

7.2.2 Fffig>RH,iirH'

8.2.4 r F"mnn *4>F HtEzft

7.2.2 5P FaAXA!4>FH!i+F'

8.3 f FnffiflU-+ tr'J1*j+ffifth

7.3 l*.Ittr\TE

8. 3. 1 , H, ^ U

7.3.1 ,H.IU

8.3.2 ik:ltfrfrts-ffifl

7.3.2 1fti+ffifrn-ffittl

8.3.3 lfti+tnfrEffi^

2.3.3 rki+finfrN.ffi^

8.3.4 lft1fmfrny;ffiJ

3.5 3.6 7 3.7 7 3.8 7

7

1fr.ifffifrfr.WF lkitfrnfrEtrr,"iE 1ft1+firfr nahi t*.ittnfrfr.W& 27

YY/T 0287-2017 /rSO 13485,2016

t,8.2 (&) G e /T 1 e 0 0 1 -2 0 1 6

Yv/r

0287-20L7

8.3.s r9.1+frnfrts-ffifr

2.3.4 lft1+finfrnffifr

8.3.6 1ftitffifrtsg.th

7.3.e 1ft.lttnfr FEBI HttAftU

8.4 tl'*Fffi{*H!fiffi.FFamnL+ frl+Aft{

4.r ,H .4> R (4,4.1.5) 7.4.1 * mi l ffi

8.4.1 ,H,[lJ

7.4.7 * [btffi

8.4.2 +aft'J+ruffiffiH.

/ ^/j

8.4.3 wt*h^*F-F/

,;;;ru;ffi

d.5 +.f tnnF..xff t

7.5 +.rffiqft.*WtH

8s1 *"*fi-rt-G

8.5.2

s

;:

-ffi z.s.i[\-\[WtrM'.

8.5.3 mg.fr,yf#X2.s.tI1F€S'S 8.5.+ -pnrnl I 8.5.5

=

".+{

L.

1l

",$Wffililffffiffi

:

8.2.2 &tF4[El

8.5.s t,f'Jtrif;

8.5.6 lrrlfAft't

s.2.3 FrH€f/rf6ffi6 8.3.3 X.fttrn-f4',TA \

\

\

-\\

ffi

r^'^{'4*

\

i.o.v

-az-rrAn -G.rr-t2{

8.7 T#ffiffifr B!+aftlJ

8.8 ra^ffiffi#ft{

e ffifrf.W+tl

8 i[UE,tltrfrffiW.it

e.1 .H|n.n1|€,tltffrffiWffl

8

9. 1. 1 , H. I lJ

8.1 ,H.flU 8.2.5 dffiB!ffiiI,filiI||€ 8.2.6 FffiffiHU,ffiil||E

9. 1. 2 I pT B ffi H

7.2.3 i€iE 8.2.r F-ffi 8.2.2- tftiFALH

F\I i ll

YY/T 0287:2017lrSO 13485:2016

# . 8 . 2( & ) YY/T

GB/T 19001-2016

e.1.3 tltffrSN+Ul

8.4 wffihtfi

e.2 FJ*FH'&

s.2.4 FJ*FH'&

e.3 €ISi+F'

5.6 €rgi+fr',

9.3.1 ,H.fl!,|

b.6.1 ,H,qtj

e.s.z €4if H'ffiz\

s.6.2 i+H'ffiz\

e.3.3 €Itrif fi'ffiifr

5.6.3 i+H'ffiH

10 rhifr

8.5 tsti8

lo.1 ,H,flU

9.5.1 ,H.4lJ

ro.z zrh+&trE?LlEffiffi

8.3 AAMffi+Afr|| s.s.z ?-l|rtffiffi

10.3 f+4eti[

5.6.1 ,H,f|J 8.5 Bti[

0287-2017

(o 'o

YY/T 0287-2017/rSO 13485.2016

ll

ro @ s

a+nffi G B / T 1 e 0 0 1 - 2 0 1 6t r E € ' S w a

t1l

q > R ( G B / T1 e 0 0 1 - 2 0 1 6 , r SeO 001 J0r5,rDT)

ISO 10012, Measurement management systems-Requirements

12)

CA

for measurement processes

ft.%XffiE)?*$ffiA#- ffi | #Fh tt#,I6ffiffiW?fr,fi\E#4fr, t3l cB/T 1e633.1-2015 1 9 6 3 3 . 1 - 2 0 1 5 , I S O1 1 6 0 7 - 1 :2006,IDT)

m ent s f or f o rmi n g , s e a l i n g a n d a s s e mb l y processes i5]

I SO 1 4 6 4 4 (a l l p a rts ),C l e a n ro oms and associ atedcontrol l ed envi ronments

t6]

ISO 14698(all parts),Cleanrooms and associatedcontrolled environments-Biocontamination con-

trol

l 7 ) y y / T 0 3 1 6 - 2 0 1 6E t r + $ f f i t t h t r f f i X f E f t + * f f i H 0 D H ( y y / T 0 3 1 6 - 2 0 1 6 , I S O1 4 9 7 r . 2 0E0E 7HA,IDT) tB]

I S O 1 9 0 1 1 ,Gu i d e i i n e s{ o r a u d i ti ng managementsystems

t 9]

IEC 6 2 3 6 6 -1 ,M e d i c a l d e v i c es-P art 1: A ppl i cati on of usabi l i ty engi neeri ngto medi c al de-

v ic es [ 10]

GH T F /SG1 /N O S S .2 0 0 9 2 ,D ) e{ i ni ti on Terms " Manu{ acturer" ," A uthori zed representat ive",

"Distributor" and "Importer" [ 11]

GH T F /SGs /X+ .2 0 1 0 3 ),P o s t-Market C l i ni cal Fol l ow -U p S tudi es

l12l

GHTF/SG1/N20.20114),Label and Instructions for Use for Medical Devices

GH T F /SG1 /N 0 7 I.2 0 I2 5 ),D efi ni ti on [ 13] ( IVD) Medical Device"-

2)

EI H mifi #R,

of terms " Medi cal D evi ce" and " In V i tro D i ag nost ic

http: / / www.imdrf.org/documents/doc-ghtf-sg1.asp

3)

EI f; 14tfi fi 4X, http' / / www.irndrf.orgldocuments/doc-ghtf-sg5.asp

4)

trI H IUN ifi #4X' http, / / www.imdrf.orgldocuments/doc-ghtf-sg1.asp

5)

nI H ru v-fitf ifi'' http : / / www.imdrf.orgldocuments/doc-ghtf-sg1.asp

f.c

il1ilil| Illlllll lll llllll lllll|l YY/T 0287-2017

a o N I

I S O 1 7 6 0 7 -2 ,Pa c k a g i n gfo r termi nal l y steri l i zedmedi cal devi ces-P art 2:V al i dati on requir e-

i4]

v

N

and measuring equipment

HtF*(GB/T

A

ftEf!€€'

Efr,d'f; t(

S€,155066 .2-31.256

fr.U\,

43.00)tr

@

c\l o Fr

View more...

Comments

Copyright ©2017 KUPDF Inc.
SUPPORT KUPDF