您好,欢迎访问三七文档
当前位置:首页 > 商业/管理/HR > 信息化管理 > YY-T-0316-2016-医疗器械-风险管理对医疗器械的应用
ICSc3011.040.01YY+#/\Fe+fntrxE4iti]tl{t6;Eyy/T0316-2016/15014971,2007EE'I+E,ft#YY/T0316-2008trtrE#fiIiMrfrtrIHX{trtrEFfiIiHlEHMedicaldevices-Applicationofriskmanagementtomedicaldevices(ISOr4e7r,2007HiEHn,IDT)2016-01-26Efr2017-01-01*ffi*g$*=t'?orBq^W.ie3'r:r'.tiflaE^AffifrFffigHU,,-H.EEfryy/T0316-2016/15014971.2007FE.fiEBUF=l*?IE1ffiE2*:uEfrEEXSX&€TgtEHgR3.1X|.b€]Eilfs3.2€rEqAff3.3^frW+&3.4Fth€rtrittlJ3.5Fth€rElfg4Nb4,t'tn4.rIWl+tfri$fE4.2E)?*$ffimtrH6fi5R+HXffi?frktj.X,5lJ4.8ftW(YF)Plj.XEU4.4,ffii+€+ftw.'ffinffix&5Fthi+f/fOXIh+AftlJd.1WIfs,E1h..:......6.2Xt&faffiljn#1Atfi6.3xth+aftlIffifEHtqrfi6.4*llaxhiYf/I6.5Fth/Effittffi6.6HXb+AftUffirfiF+_WFth6.7X,h1AftUfr\ft,W'y*7%a*rJA^t(&HtEIt*E,y*i+t|f8xh€IE+EggHFffi+F.tr{H,H.Fff*A(K#[,l4Ffffr)&ryF.FBttr]qiI,EE...FfJfrB(KF[,l4Fff*)E)?*$ffiFl&€]Ej$fslBti8Ffffrc(KFl,t*ptf*)HTiAEUE)?#$ffi5x+HJe++ftrH,tftffiFff*D(Kfl,ltpFf*),ffiTE)?+$ffiH0xtblffiaFfI*E(KFI'ISFf.I*)fu&(iF).4ffi,LH!+{+JiYtJfisfr,h'Hn,rifUFtf*F(K#[,Etptf+)Fth€]si+nil...Fff*G(KFt,t4Ffffr)Fth€IsfitK#tpff*H(K#[,l4Fff*)w^iBfEf#$ffiFt&€IE+FH...itrHilNt-l44ooo77777B8BBB999I10101010T2192126404tr,=v4750.jt-i'i.t]i..ffT:f,::!x?i;_11ffsi:r..4yy/T0316-2016/15014971,2007EiEfrEpfJ*I(FFl'lSFff*)+.WJ+ftW(iF)B0D(hAffiSffi+FH'63FfffrJ(KFI,I+Fffrt)FA{H,H,fH*IIAFI&{H,H.*txffi.:'yy/T0316-2016/15014971,2007EjEffi4+6/&&fl€ce/r1.1-200ehfrPl*4,FUEH.4+fi/&{t6vv/r0316-200s(E77#$ffiFg6€Itrx1Ef#$ffiHgDffi)5yy/T0316-2008ffibv,,wmffi'y*lbth.ilt4&^M.i'LtnT,5ce/r20000.4-2003KtstF4tTt1#ffiffi4*t,h,m/€+tbEE#H!^ai)+H!^iF{fr++-ry,lbrtTTrtJsfliiFffiEx,-friElb)trh(fiE,*Ibj,TEX;-('.'ftEtibiThfe.W(yF),*lbtTfr.X;-('fu'Eft.B,lbifhfuW.'En,#lbiTEX;T*\AN&EX;TX&€XtTFt&AtFE_X';T,,XL&i+8frx;-x+'yT.lbiThx+,+$birfr.y-.ISO14e7|,2oo7(2007-10-01ErEffF),lbrtTKrFth€rE$ffiz\HKl4f,nI&{FHffii+**+IFJXHISo14e7r,2oo7(Er?#$ffiFt,&€}gxfEz?+$ffiH!DH)ErEfin.iFEH4x,t+#rHry64EIfraW&.Pfirl.4I{+ffrfr.fr$LMTE$EI.AFtlE,rrtfriJwfrIrA+,n/EHEA'A-F^frffiffiB€Ilfl,H.,8EfiAffi/&HAEE)t#$ffiEE€IgfillEHg*&nGkW.fr*fiA(sAc/rczzDEH.AAn/&EH+{n,JL.F,EEffi#Jt^i,fiAFFAAA&n#tFruH,A''EH#.XIS*ffi,X]3t€.m,SE|I.+tfttrFfr,ft#+6/&ffJmrh,ffr.+Efr'ffin*r:-yy/T0316-2000.yy/T0316-2003,yy/T0316-2008*F.g-HUyy/T0316-2016/15014971,2007ECftEEIAn/EA,AH!4*tfUEf+E,f+T-+Af,tf,M.f4W._rL.i.F,f+tJWtrE5tt#$f{FHH*t1xthH0tE44&nG€ll}{FHEenH!X1h€IEtrflUH!Elt*$ffi/4tfr,frtrffitl€ffi'ffiftrJExft{&ftUEffi,lnEH'feh\EtrL+.lf.&{tuil'4&r/&trIH(FHnffi'f+++r(b€rtr4+AruSfEtuIWN'l++Fffi.+trttrtVN-ErtrXl&H!ilfE,+gExfffi,#HtXth,lH&.@,+frxtWrcE.^H{&,,\tr,Hlbik&frn4ffi,Htxllb.tFh_fltBt{B[A,W&_+^,LELAdwJtrH!#l}_b.ffi^i,EIEI.AEA{Ftsr&trIfl|3trfiiJffifHXfr&ffiTfulS(itr)Z+'eItrJfrExffilffiiFHXFH+ll4Htul+TJF,EFIIFX-4.,W.fr.HlF€+ftjffifnXi-,xtTH.4-lfrEtuIffif,4X.^HlEtrHHTHfr\ffiffix4,Xllh€rEE-+n-+H!iRff.^Ffr^^tulF_,Flth4BfAHHW+ttrFt*Is]1+,a)tftEfr-+.ffitK5-;b)LkEffitrR,E[Effii.E,Ein{dfiTf[ffifHr€ifr\?ff'W.,E+frtrrF.+E'f+trtrI+lLffitultl4F'.4m.trTil.,HAffi^^FXfr,A*E)?#$ffiXl.h€]sH!4ffiA++5lJE4.ffrHH'lflJffifH*fr,x'rnwffi,tr)??$ffitu11fr.H'r,*ffi*Hf+fgEH![t&tr+fr]JffifHx]-xfxt&HtFIf*EfEtrEX,hH!-L6ffi+lsFI*Fhffifi[ffifHre]H!Ft&ilNfrf.**nf4.E+frilffifg*]-trlXtbilfil+EitJ6*4r+tuIt.ttHF.+I^tAttffi+*.trHrn.,*[z.H!fifr,XHte+R{#DJE-i+*HIt',trRh\**n(qm4frY.E+#.)r.i,^\ilxtFsfilfrtd,4ftxzffi.,lF\fun,xff*ffi+ft&(iF)Ee-frfiHi.AH!.trIfrYft.F!.;\ttuI.ffkPl.HWlr^NH!trtr1lkful.EXEA-=ife+H!58#fr+/6fU,HEft+#ffi1^SfHDffiEF!il6^fEJ?HIRE,4**IJAX,hfntl55*J+H!ffiHEffitl+:&r.Bffitul+tJWtrtB.ffiafr#SffiA*F!TfiHffi6.'Et6EruX[&,t]lE-ffiilfi^fsJf4{Effi6ffi,HXBtFtlGfilEffi.RHTffiffi#+L&+Rfin,ffiffi#+/\H_rLh\HW+eF!ErF,tfrVfiffi.frH+--$_hEt+pt#ilB[ff-hfiilffifH*}-Z-'ftU€ffiD|r'*-ffi,EEf*Effie.*fiffi.fzJcYH'l'lFiXT,xftrf?$ffiF'lR+€'tfrFtlbH0EII*E'l+{tfr.H+UBf,UIF.IREE)t+$ffieHTftrHi6-Lrt'H!EHfSAtrIENAET-fjiffi,,&rltfif5,E)?#$ffiH!ft|J€ffitrIuiF,friJ5trtr#$ffiHXfrrJft,W(iF),,ffriffili+ut5x}-bfub(itr)fHxH,lFth,+AftUEEjXth+Xf,+AA-+AffiUfr4JHri9.'l+.xfT'ff'f4++EHttr)?#$ffi,H,f&trpir&rIE46Eg*DH++EH'lX,lh€Igtf*.I=yy/T0316-2016/15014971,2007EEftEEfrEFTfiI,XIFOHruXilE'?ESftTH!&HrfiEAffi/Eiftl|Effi*r,fr.T---+tfE,Ui,F,n\5E)?+$ffiaEIfr/6^DWfr(rvD)tr'?*$ffi)HXtu\fr,W(iF),,ffritfniY+Jt/IHXH!D(h,+Afttjts$rXth,*M&?tfiJH!Arit'144tt,NTEAHTIIfiftRffi.4fn/E6*4,8trI+*EH!XhzKY.Af/&n4*f{EfA-fi6*i1f.81+4/*f,X[hEjEtIriEf.E€WW4t1-f'tF\*[r]2zttiFfnEy.T'lJAiFfiEXiEHTAT,i/&2.1HEF{'J*{+accompanyingdocumentrcEtr,?#SffiA\,irE,?#$ffiX#.{F,HffiWfFH'lfrltn+ft[*l-r-,eDJ&.}rffitF-Z,fi,1*-ffi8+ftHH,H,,ffiE|J€XTqA{H,gH!r{+tr,&5HIEC60601-1:2005,EXS.+2.2IftEharmxf/\{4tu?+frLh&xf/\{+&+RF.tffig,4$MF4qiHF!+fi9.[cB/T2oooo.4-2oo3,EXs.s]2.32.4frF0(tlH)hazardEI6E+SttfiEffiI#A&UF.[GB/T2oooo.4-2oo3,EXS.S1fr[HH)n,hazardoussituation,,\-F.ntF.&frH*ffiT-+fr,*tfsh(iF)+V\'ffifit[ce/r2oooo.4-2oo3,E_![3.6]E,,LFffrtE+xfft&(W)ffiftp0'lFlflH{XAffJinEA.TfiHHHGintendedusetf,SHH!intendedpurpose&NRfttJ€ffiffi,f*PI*I,?E.iXEEflfil{H,g,XfFffi.itfSETEVhfr\Mtr{F,H2.52.8yy/T0316-2016/15014971:2007EIEHF2.6ffitliDffiEr?ESfitinvitrodiagnosticmedicaldeviceMEr?g$+fiIVDmedicatdeviceft{Effi'ffiHH-}&Ari.',,\,fA+ffi4xF!f+4,U+ft.i*i^B[.HilEIfHd,
本文标题:YY-T-0316-2016-医疗器械-风险管理对医疗器械的应用
链接地址:https://www.777doc.com/doc-1358616 .html