ࡱ> y{x5@ R@rbjbj222XX -,Lr6Lrrl85555555$9Rp;>5-5,65555555555@ l 055B60r65;u5 ;5;5,"85Pd555 DN8 N!k'`O(ulhVwQNTlQb/g[gc[SR N0MR ,gc[SRe(W.^RTc[3u/uNON[N!k'`lhVwQNTlQ3ubDeۏLQY Nnb/g[ċvW,gBl0 Te gRN[ċ:gg[{|NTۏLyf[ĉv[ċ cؚ[ċ]\Ov(ϑTHes0 ,gc[SR/f[N!k'`O(ulhVwQNTlQ3ubDevN,Bl 3u/uNON^OncwQSONTvyr'`[lQ3ubDevQ[ۏLEQ[T~S v^OncwQSONTvyr'`nx[vQ-NvwQSOQ[/f&T(u0 ,gc[SR/f[uNONT[gNXTvc['`eN, FO NSblQ[yb@bmSvL?eNy N N\O:Nlĉ:_6RgbL, Yg gYnvsQlĉBlvvQNel _NSNǑ(u FO/fcO~vxvzDeTDe0^(Wu_vsQlĉvMRc NO(u,gc[SR0 ,gc[SR/f(WsLlĉThQSO|NSS_MRw4ls^ N6R[v @wlĉThQv Ne[U NSyf[b/gv NeSU\ ,gc[SRvsQQ[_N\ۏLevte0 N0(uV 4N^luNʋeeN!k'`O(u (uN\[hVQvmSOǏceQY v4Yb[{eQ`@{vhVhS(uN\mSOleQNSOTbSNSOSOmvhVwQSvQ~N~y:NN!k'`O(ulhVwQ0 N!k'`O(ulhVwQSbN!k'`O(umhV0N!k'`O(u@hV0N!k'`O(un[{_mhV0N!k'`O(uY m0N!k'`O(u|[ǏnmhV0N!k'`O(u_mhV0N!k'`O(umޏc{0N!k'`O(ull0N!k'`O(uẽl\hV0N!k'`O(uẽl\0N!k'`O(uẽ\ }l\hV0N!k'`O(uV[BRϑuׂl\hV0N!k'`O(uؚS q_l\hV0N!k'`O(uk_l\hVI{NT _NSbW,g~gTg(uN NNTvkۏLۏ'h0 ^fnxPge-Nvё^\bR V:Nё^\bRSOq_ThVh(W8hxsX-Nv[hQ'`0S_Pge-N+T gSq_ThVh(W8hxsX-Nv[hQ'`vё^\bRe 3ubON^cOhVh(W8hxsX-Nv[hQ'`vDe0 ^fnxkySPge SbmRBR0mnBR0|~BRbvQNmRirYremRBR0hir0 N\~vir( vbR0O(uϑ0nQir0NDEHPXQXvZ/lYNpPVC \O:NSev fDEHPv+Tϑ cNNT-NDEHPʑ>eϑVvxvzbJTNSNSOScSvBRϑVTOnc0(uNhKmDEHPʑ>eϑvKmՋm0ՋagN0hKmelI{^S_Ǒ(u~Ǐyf[vel0YǑ(uNSMNODEHPʑ>ev]z ^S_ۏLvsQv0 [Ng(uNloirvhVwQ ONcN@bloirNhVwQvv['`xvzbJT \^Sb@b3ubvhVwQ[@bloirv8TD`Qv[xvzvpencN~0 Te cNVQYsQN@b3ubhVwQ[oir8TD`Qv~bJT0 [N!k(uN;SuhVhebvePge ^cOPgeT(uNNSOvgO(uMOvvsQxvzDe0 5uN]z ~fNTuN]zǏ zSvQnx[vOnc0(ϑc6RhQSvQS`'`nxsQ.]zpv^fvQ[NTirt'`0Sf['`0:gh'`0uir'`vq_TnxuN]zv3z['`0[uNR]Ǐ z-N@bO(uv@b gBR0RBR0|TBRI{mRBRGW^fO(uBRϑ0[kYuϑvc6RceTcShQNS[hQ'`bJT0 6NTSň NTSňSOnc gsQVQ0VEhQۏLYGB/T196330ISO116070ASTM D-4169I{ cNNTvSňbJT0SňPgev b^\QN NV }SňPgevirtSf['`SňPgevktf[yr'`SňPgeNNTv^'`SňPgeNbWT[\Ǐ zv^'`SňPgeNmp̃Ǐ zv^'`SňPge@bcOvirt0Sf[T_uirO\ObSňPgeNO(uO(uevBlYẽ_/T v^'`SňPgeNh~{|~v^'`SňPgeN.X[ЏǏ zvT'`0 7NTmp̃ cNNTmp̃elv bOncSbJT0hVhvmp̃^ǏGB 182780GB18279bGB18280nxv^ۏL8^ĉc6R ẽO4ls^^OSAL 0R110 60mp̃Ǐ zv b^QN NV }NTNmp̃Ǐ zv^'`SňPgeNmp̃Ǐ zv^'`0 8NT3z['`Bl gHeg SbNT gHegTNTSň gHeg0NT3z['`SǑ(uRSb[eSvxvz [eSvxvz/f/UNYS fNT(Wĉ[PX[agN N[E3z['`Blvel0RSxvzՋvwQSOBlSSASTM F19800(WۏLRSՋxvze^laNT(W bvsXagNvS:g6R^N(W[eck8^O(usXSagN Nw[SuNTSv:g6RN0[!klQ*gcN[eSxvzDev ON(W͑elQvDe-N^cN[eSxvzDeNnx[NTv[E3z['`0 9N,'`Bl ;NSbirt'`0Sf['`0uir'`I{ebvBlSvQ6R[Onc0^SbFO NPNN NQ[ 1 irt'` l\hV{|NT;NSbNTY‰0~g0T~Nvr0:\[Q_0Y_0^0[ϑI{ 0mnBR(uϑ/cm2 0h:\0h:\v;R^[ϑ~0h:\vϑpeW[0h:\vpS7R0 cKbݍ0;m^X0%4Y0nR'`0hV[T'`0[ϑAQ]0kYu[ϑ0bSSR l\\gW0R'`0'`0P'`0W%c4Y0^vr0ޏcbrV'`0Eu'`0ObWYI{0 mhV{|NT;NSbY‰0~g0T~Nvr0:\[Q_0Y_0^0[ϑ 0EQ[ϑ0npe/ml0n[{[ϑ0_|alg0lo0b8O:_^0f^0z:Re=Q\0{^0ǏnhVT[_0nds0mAm0~mSpe0kYumSOSOy0AmϑNevf~Vll 0l\N0W%c4Y0mAmϑ0mnBR0mgW0z:RR0rh0ObWYI{0 2 Sf['` ;NSbxx^0؏Sir(f'lSir 0ё^\yP[0Sk#n0+}Y8TIQ^0s'lYNpkYuϑ0nQir0N/lYN0Slnir0Pgeh_I{0 3 uir'` uirf['`^&{TGB/T 168861[vsQ(u0O(uMOScevwQSOBl0NTce/f勧NT[NSOvg'Y/}y\O(ue0lhVwQ{|NTvuirf[ċNyvN,^Sbẽ0pS0~ހk'`0Oe0:RobvQS^0%`'`hQk'`0@mv['`I{0 10yrk'`Bl 1 k'` [N:Nk'`vl\{|NT 3ubON^[vQk'`NN0k'`vuHeeSNV N T ;N gN NQy`Q  = 1 \* GB3 `$Nl\_Yew kyr'`ꁨRuHev^Oc gHe;  = 2 \* GB3 a$S_[[vV[BRϑv50%e kyr'`ꁨRuHev^Oc gHe;  = 3 \* GB3 b$S_[[vV[BRϑe kyr'`ꁨRuHe0 (W@b g`Q N kyr'`NeuHe l\hVT1\ N͑ YO(u0 2 el|~ el|~SOXR`ag_uirvΘi V:NNTv gS[_uirۏeQẽvmSO0ON^[dk_U\xvz [ُ{|hVhۏL_uirOeQՋ Ջ^S_!jb4N^ N͑ YY!kO(uv`Q0 ^S_(W!jb4N^O(uvr` NۏLՋ YՋ-N@bO(uv_uirvy{|Tpeϑ^S_T4N^ N@bO(uhVhceQMOSag_uirvr`v ƶt^tH2*hXhNh<CJOJPJQJ\^JaJo(*hXhNh<CJOJPJQJ\^JaJo(*hXhNh<CJOJPJQJ\^JaJo(#hXhNh<CJOJPJQJaJo(3hXhNh<B*CJOJPJQJ\^JaJo(ph*hXhNh<CJOJPJQJ\^JaJo(hXhNh<5CJOJPJo("hXhNh<5CJOJPJQJo( hNh<aJ$hXhNh<5OJPJaJ$o("hXhNh<5CJOJPJaJo( 68B 0 > | dWD`gdNh< 0dWD`0gdNh<$%dWD^`%a$gdNh<dhWD=^`gdNh<$dhWD=^`a$gdNh<@r4DX`  \!" dWDd`gdNh<$0dWD`0a$gdNh< 0dWD`0gdNh<pt| ~ $$$$$$&%(%@%B%D%F%%%%%%%4(6(N(P(R(T(`(b(z(|(~(())))))***** *2*4*L*N*P*R*j*l********ϸϸϞϞϞϞϞϞϞϞϞϞϞϞϞϞϞϞϞϞϞϞϞϞϞϞϞϞϞϞ3jhXhNh<CJOJPJQJU\^JaJo(-hXhNh<CJH*OJPJQJ\^JaJo(*hXhNh<CJOJPJQJ\^JaJo(3hXhNh<B*CJOJPJQJ\^JaJo(ph>""6#F#:$N$^$$&%%%&&&&4(`()*2*j**d+++,,, 0dWD`0gdNh< dWD`gdNh<****++d+f+~++++++++++^-x-111111 3"3:3<3>3304244444555555555555556HHٰ>ϸϢϠϢϢ*󱷳<CJOJPJQJ\^JaJo(-hXhNh<CJH*OJPJQJ\^JaJo(*hXhNh<CJOJPJQJ\^JaJo(3jhXhNh<CJOJPJQJU\^JaJo(>,^-x-../0>000^1~11 33304555FfW'`4ls^0xvzbc^NS4N^Ջkv{|Wegnx[0^(W4N^ՋeHh-Nfnx~QwQSOv{lQ_SvQQY f{Ǐ z-N@bǑ(uv@b gSpeSvQ0Ofvh_:SR v^ňbQ03ubvTyQ[^[te0nZi N_m9e03ubDev YpSN^S_[te0npf v^NSN[hQN03ubDevpenc^S`0(uĉ0ыQnx03ubDe-NvxvzbJT_{~cxvzvv0xvzagN0@b(uY0[gq0Ջel0‰[ch0~el0pencRg0~T0uNON^\@b gxvzDeYUO{v^R_ch0[N3ubDe-N_(uvSe.s0vsQhQTpenc ON^cNُNDevSeb YpSN0 N {|NT^OncsL gHelĉY 0N!k'`O(uẽ;SuhVhNTl0hVwQ uN[e~R 00 0;SuhVhuN(ϑ{tĉẽ;SuhVh[e~RՋL 0I{ ۏL(ϑSO|8h cNSO|8hbJT0Y gY-~N {cNY-OSS;SuhVhNTlQ0  N (ϑߍ*bJT\^SbN NQ[NTv.U`QON[NTv(ϑc6RceNSQ萡[8h-N[NT(ϑv[g`QvfNThTgh0e8^hS(ϑvcwb`Q(WNTO(uǏ z-N (u7b[NT(ϑvS`QNT N^TONgbL NoNNvKm6R^S NoNNvKm`QbJTON6eƖvsQNNTvvsQ(ϑOo`0 N0 T͋ʑ 1el|~el|~/fc:NSN N:R S YTm{bbSmSOvN{|hVh dk|~S[smSOvUSTbSTAmR mSOvSTAmRAQO(uRobVbmSO0 22:RchVhvN*N~NbDNwQ g2bkO(uNXTS0Rl\/maY:R$OvNy 募Rvo;me_eSN/f;NRv _NSN/fRv0 mQ0Se.s 1 0;SuhVhvcw{tagO 0-NNSNlqQTVVRbN,{276S 2 0;SuhVhlQ{tRl 0V[ߘToTvcw{t@\N,{16S 3 0;SuhVh4N^Ջĉ[ 0V[ߘToTvcw{t@\N,{5S 4 0;SuhVhffN0h~{TSňhƋ{tĉ[ 0V[ߘToTvcw{t@\N,{10S 5 0@{Q[{vsQagv2NlucWS(2007) 0-NNS;Sf[O͑u;Sf[RO 6Intravascular Administration Sets Premarket Notification Submissions;510(k)=July 11, 2008 CDRH FDA 7Submissions for Piston Syringes[510(K)]April 1993 CDRH FDA 8Submissions for Hypodermic Single Lumen Needles[510(K)]April 1993 CDRH FDA 9Medical Devices with Sharps Injury Prevention FeaturesAugust 9, 2005 CDRH FDA 10ASTM F1980 07 Standard Guide for Accelerated Aging of Sterile Medical Device Packages 11Submissions for External Infusion Pumps[510(K)]March 1993 CDRH FDA 12Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and TestingMay 1 1995 CDRH FDA 4GFGGGHHtIJ^KtK*L>LMMNNOOP(PbPvPSTT (dWD`(gdNh< dWD`gdNh< 0dWD`0gdNh<>MNNRRRRRR\ccc̱ccccccccٻٱҼңңҊҊҊҳZZZZZZZZZZ3󱷳<CJOJPJQJU\^JaJo(*h`hNh<CJOJPJQJ\^JaJo(0 jbhXhNh<CJOJPJQJ\^JaJo(0 jahXhNh<CJOJPJQJ\^JaJo(*hXhNh<CJOJPJQJ\^JaJo(*hXhNh<CJOJPJQJ\^JaJo(.hXhNh<@CJOJPJQJ\^JaJo(#TRUdUV*VVVWXXfYxYY^ZrZ [ [`[n[[[\\\]x]] dWD`gdNh< 0dWD`0gdNh<]^^___`H```a^aaa:bb6cncccBddde$eBeze dWD`gdNh< 0dWD`0gdNh<De\e^e`ebeze|eeeeeeeeeee8fNfPfjjjkkl>꾨꾨꾨*`󱷳<CJOJPJQJ\^JaJo(#h`hNh<CJOJPJQJaJo(3jhXhNh<CJOJPJQJU\^JaJo(*hXhNh<CJOJPJQJ\^JaJo(zee8fPfhijjdkklBlllmjm6nn,$ 2( Px 4 #\'*.25@9d1$WD`a$gdNh<$ h6td7$8$H$WD`a$gdNh< dWD`gdNh< 0dWD`0gdNh<nNoop0q@rgdNh<$d7$8$H$WD`a$gdNh<,$ 2( Px 4 #\'*.25@9d1$WD`a$gdNh<0182P. A!"#$%S  R`R Nh<cke $1$a$(CJKHOJ QJ _HaJmH nHsH tH$A@$ ؞k=W[SOBi@B nfhLDe@r!;>",4GT]zen@r ":<=?@@rly{')0=? &(5BDQ^`%' %%%%%%!&.&0&&&&&&&&&& -"""""""""""""""""""""""" _Toc233025302 _Toc233025303 _Toc233025304 _Toc233025305 _Toc233025306 _Toc233025307 _Toc233025308 _Toc233025309 _Toc233025310 _Toc233025311 _Toc233025312 _Toc216778687 _Toc233025313VRy"'U)U))"- _]"''\))-"-++"-++"-8*urn:schemas-microsoft-com:office:smarttagsdate  1120052008789DayMonthYear !01|}  MNcejkPRWXCDhrst~$%&/MNipqz{!, 8<LMr t y z _ a f g Q [   ; @ Q U Y Z &*./kz{| no()*/>?@QR[\ijst'()4CDEP_`a  jntu no  $+-.CEOP!*+,MPcgmq&'(NP_a  *.89aevwTW_`hi+/03;?@CRT]^~  02:;+,.0;>CDEHRUZ[\]^akmvw[\ >@BDJNWX  % ( C D e x .!0!8!9!!!!!!!!!!!!!A"C"F"G"x"z"""""""""""##J#L#]#a#######$$#$'$R$V$d$h$$$$$$$$$% %]%a%w%x%%%%%%%%%%%%%%% &/&0&2&D&F&V&X&Z&^&f&j&&&&&&&&&&&&&&&&&&&'''')'E(G(((U)V)\)^))))))))*** *"*=*?*A*C*^*_*a*c************++++D+E+J+K+Z+[+++++++++++,,S,T,,,,,,, - ---"-!$}GJNQPSrt  B F [ _ k o q u w | LM,/UY\_`a*,(,-1OP`ant 58dg"%)06DGHM[]/4`d V [ !######l$q$%%z'~'V(W(((b)e)i)l)"-3333333sssssssssssss3s3333333333s33sss33333ss3333ss333333s333333333s3s3333333333333s33333333333ss33"-"-N%mwm86Nh<K arT,"-@--S--( -PP*PFUnknown Gz Times New Roman5Symbol3& z Arial;5 N[_GB2312]E  eck\h[_GBKArial Unicode MS;ўSOSimHei55|8N[e[SO95  A<[SO-18030;5 wiSO_GB2312;[SOSimSun7&{ @Calibri qh;;d&Qd&Q!-!),.:;?]}    & 6"0000 0 0 00000 =@\]^([{  0 0 00000;[2 - - 3qHP)?86DN8N%mwmN%mwmOh+'0l   ( 4 @LT\d8 Normal.dotd1Microsoft Word 10.0@@H@Hd&՜.+,0 X`lt| sdaQ -A   !"#$%&'()*+,-./0123456789:;<=>?@ACDEFGHIKLMNOPQRSTUVWXYZ[\]^_`abcdefgijklmnoqrstuvwzRoot Entry Fo |Data B1TableJ;WordDocument2SummaryInformation(hDocumentSummaryInformation8pCompObjf  FMicrosoft Word ĵ MSWordDocWord.Document.89q