搜索
ICS11.040.01;03.120.10c30YY++/\R+fnEXEwtT{r{ttrieYY/T0287-2017/rSO13485,2016,ft#YY/TozBT-2003trtrEFftTtrEtrIE{AA,HT'E*NH!g*Medicaldevices-Qualitymanagementsystems-Requirementsforregulatorypurposes(ISO13485.2016,IDT)2017-01-1efr.frtr^AffifrFHgHru,H.Efr.fr2017-05-01*ffi+!#RJqruEtr.fr'41iL&rt&E'?€FftIEEHTEtrAHT)ts*4HtE*YY/T0287-201,7/ISO13485:2016.)€+EffiI&HHniifrHnETtIt6fi#FEtrfr+Efl:{frry2+QooozeJtHfiEfitr=EiFJIL;tfr16€(10004s)Fltrt:(010)68533533nft+,L':(010)517802381*#nV.*#:(o1o)68523e46+Et,nlEfrffit|F^4.,$Epffi{rqrEll&fr,*fr+frtEgt4'H)effAaaoxr23o1/t6EplK2.5+w68++2or7+2EH--ffi.2or7+2Effi--Ik€lrffii!*fl€,155066.2-31256Efl|43.00ngsFEll#tfHHA+Efi+,1'iEl4fiF+X€€',fF+T,2.f;'++REifr,(010)68510107YY/T0287-2A17/rSO13485,2016HVVII11i+/lTtrtrtr6oo6n,7InI77I7nIII7IjI8BBBBBB99o99YY/T0287-2017/rSO13485.20167.rFffi*q,ffiffinlje7.2SEnEHXF'lSfg107.2.rFffitRH\ffiF10noqoo'4*Hti+H'10t.L.L)trtr7.2.3?4iE107.switflTF.........107.3.r,H.IU.....q...107.3.2Ei+fflfrnffir/l107.3.3Eifrufraffi^117.3.41ftitffiffifcffifr7.3.sEifilTnwF117.3.6iAi+fifrH.hiET.z.T1kltffifrEffii727.3.8iAitfilTffr.W+ftrz7.3.eiAi+ffi+Hwekfit+aftlj127.3.10jftitffifrn_x.t\.........1,7.4xWT7.+.rf-wailfE7.4.2x[b{H,H,7.4.3*WAtrffiH,l&in137.5+.F.ffinF.*W{*...13.7tr1**flER++ftt*H!+4ft{13,.u.r'-rtLrIJInro*'''F0iFiH14r.r.L)nE7.5.3x#ffii)J.:................147.5.4nvhffi6n...7.s.s[cffiEr?#$ffiH!€H4RT.s.6+.r.frEEF.+W{*SfgtuIffii,^14',2',#fi.-TiiTTu:iTTll:,TTT:,:::::::::::::::::::::::,::::::::::::::::::::::::::::1:7.5.sEI€iFi'lth............7.5.10FnBrnr.,7tr11gt.r.Lr)ffiD'fF157.6H?4,ruUtJg-1k&H'l+Aftll..'BarEmrl...urI/llJ\i^i!8.2Hifl,ffiiflljE............8.2.1Effi1616i6T7t71,7L7I7188.2.3IAH€ilLM+V.E8.2.4Ft*+HU,8.2.5i$fEHtHinfHul|tr.................................8.2.6trffiHtffi]flffiU1Jtr':'8.3;Fa^ffiffi+Aftljr.r....iiIYY/T0287-2017/rSO13485t20168.3.1,H.fl|J.........188.3.2T,f{EfrHflAAA+&ffiffiUHDffiffi8.3.3X.|ttrts-fA6#ffiffiH0qAfrffiFft188.3.4EI.q.......188.4wffi1.+ffi.........188.5tnfr.1e8.5.1,H.IIJ..................198.5.24Ll]Effiffi......................o.............198.5.3ffiD'ffiffi...........................19pFf*A(KF[,ISFfS*)YY/T0287-20175yy/T0287-200sfi6xfbV............20pFfB(FFl,l*pff*)Yv/r0287-20t2fGB/T1e001-20r0xfE*.A23*tYffi...................30YV/r0287-2017/rSO13485,2016AffiIfi,ftEYv/T0287-zoos(Er?*$ffiEE€rsI#6HTy*fl,ffig*),5yy/T0287-2003tHhL+F&7FM.(N_,gnTfrT**4,4*klE4,E;ATiEffi?EE;--turETF[h€]84*;-19/fl75H€+JLMW)Hffir.Jffi€+JLFEfiU#frIFF;-fu'&TIfiEHB€}EPIFR;finTMffiX.l+friEftH!F*^ffirE{FHffii+E+IFJXHtrpZ5t,T/&rso13485:2016(trft*$ffiEtrtrrtrWaHT}**4,pt4*)iFitH4r{+flH,}rA6E[frEwN.tfriJArf+ffrH.frtrL+6T&frilfriJ[,tj€f[ffJfritAffiruHtrA€'F,t6ffiHH€IE,H.EFS.AffiGHAEEtr+$ffitr8€}trfiliEH4*T6l&4L,#.fr+fiA(SAC/TC227)/JtrA&r/EroHS{n,JL,REEffi+X^ilEHFRAA.Atfir&+gEHA,l(*jE,H,f*.XF-ffi,+S,9FS.+fift.-+j€.mffiEil.++stEFfi,ft#+fr/EffJEtLffi,+Efr'ffitfr,h,-YY/T0287-1996.YYIT0287-2003FI-r4-HUYY/T0287-2017/rSO13485,2016-rf.+5l=0.1,8,[U++,r,W*ntr.Tffi.tr_trrF|+RF*,WN-Eff#Sffi+.ftFttrkl-fEI4+YlF9.#JneAftVW.ffiWRjt11Eft+#ffiH!tritfrnfrF..4F.nFffiyfriE.q*,flv+ffie.%trffi&.rLE,ril&.iHxtfrdr6\tne^i++)HliAi+frsfrts-fr,E,f*.AtfrtEH-lgRe,FEHTEBffitH4RE,f*FFn@IgnlilttN,eEl+.*F{+.E)?#$ffi,X.ffiEF.h,&.tBnft,*.ifrtrfFf,%IFilF.*)H!'f*i-elH{&tl.*Ftr.1ai{nfr,tl.#rtfrVHEift#f+A4tffit&klgI4&AE4rFffA+{,n/EPtFR.-$r€+sxx'jtr)?#$ffi{*Df#++Elt&ffihgtrJtEzArfiHEEtrrtrWaa-rti4,4*trrrt,Am18ffii44tr2A:-&EEtrHffirA*4,gRi.x,5lJgfl4Atu!-+fi,*tffi@,;tsl}-hffi&.ilRN]JEHT1lI,4AffiTTPI**I,4R;-ft,H1lAffi,trtrTET+A+HAB$JEHPi**4,FR.trHH!rE*r,4R+H!€-l(EtrlEtrxffitu]XHFfiTFJ.ttrLAffi4&n€E,?A$ffiEHH!€+#XH,t+*il,+tuIfr.y-ffiiq4lffii&H!E_X..4f6/fttrfrVffiTA*FfrE't.*F&t(Effii^infl+a)Wfr.n4TffiEJEIF4*.iE,HTtrE€'E{4F.tulf*i4,4ftt2AH94RffUr€t+5EiEflE,+t$ttFfff,fHtE€€tE{AR4FExfFf&^gB'l?Fn'BxffErEnErRl:te.x+fn'l+.fatHplj6Hfrxf,g*Ez,'FpltHEtr€'Et+AEtELF,ffi-rnfinffiRffi.-+rE9AilIffiEtrI.trWA{trlftltffiqfrftEDJTtrfiHt*vnft,a)tY4\Wffi.,fiffi,M.4Y,ffi91tAf4.ffixfEtr+$ffi?++'lkfuIffin(q;b)2tr2A6WM.4tH!ffiR;c),trtAH!^E,fAEItr;d)t\r\tfr+ftl[ffJFff;e)ttr4\Ffr*ffiHtdffi;f)AtrgAfi\*4,+Hffi2Eg,?t4;e)trHTttrzAffiihWfE*4,g**rfi4+,n/,e.*ffiEffigh-6lEtrE€rg,faatuI*+a,ffi-r{+fr,MFI54t,nW*#^#t6fH-w.tuTx_l+.E)?#$ffituIffi+IP4,+&r/&+FfrNAEF!-:}g€H4*.R,i6HTffiEH!Etr+$ffiXfriJ44F/&ffi3-+.1$,:HTXr&+51;FttX.0.2IFJHEfiX,TxfA+,r/&h\TrtJ^iF4ffiiEHtii,ry,EHffiIgi6EEIIbTfr-TFFRnt',iEH1,AiB'N4REiEE#J,W,lF+E'Afr?WSH{EA'g}EHinR*rnq*xfur4rH-48'r'ffifi!,q{ilNinfi9.f-ti6EHt,-Fffiiffi,Btr*;EHfrll**r,4Jt;-282N*frE4LlEffiffi;YY/T0287-2017/rSO13485:20I6€rgt(ffi.EH^iE,'D(hHf,infii9&446/EfEE^filDHt*Ttrft*$ffik?frA41ltavEF4ffi8i6ffiH!**r4*Y-rng.FffiEMFII{+E{,H&ffigen.*trfifi'ffr++EHAiEPffi''H{,H&HffiflV*FffiiEffiTFNE-ffiEH!44FH!ffiSfr,PffiqIT'trfEfitdr,ffiltfTffi#lmfr.Effi^i$y**49*Hf,HiBffiTi6ffiTA+firE{Fffi#tul[tlTr*erE*I,@tJtnl*|f#.Y**I,*lnJEIfF+)H!gFltiFl**n9.RPlDHFRTEE€IE{46WFffiEft+$ffiWXA4'|Il6EF*.aaffi/&+{FHfiTWAr']_uIii,,tarFR;-..Html#i.L;-uFt*.mJti?;-'(AAtziEJfrYitfrYW;itttEffifr;nl16X9.*B!+Hffi0.3isfEf,r