1、ICS 11. 040. 10 C 46 yy YY 0671. 1-2009Nt O u,& tm 1 jf:tfi , B7t: Ntou,&tm1jf:tfiiSleep apnoea breathing therapy-Part 1:Sleep apnoea breathing therapy devices(ISO 17510-1:2002,MOD) 2009-06-16 2010-12-01 YY 0671.1-2009 -mr 11 NIII1 moo 12 ;f:iil-:fPJ:E)( . . . . 13 :iNffl* 34 iJ!lZ iJ :iN ffl * . .
2、. . . . . . . . . . . . . . . . . . . . . . . . . . . 35 7t 36 iJtJ1j ,f,ji2:fP X If:. . . . . 37 AJ;!$ 58 * 59 PI :jJffEl iJ Wtp :I: . . . . . . . . . . . . . . . . . . . . . . . . . . . 510 fFlf: 511 /F*ffl . . . . . . . . . . . . . . . . . . . . . . . . 612 /F*ffl . . . . . . . . 613 lI3t 614 *7t
3、iJ* 615 ft!. ffi:fP (:!1,x;) il:I: iJ ijjIJ . . . . . . . . . . . . . . . . . . . . . . . . . 616 j 3t :fP1!iJ tp J:j . . . . . . . . . . . . . . . . . . . . . . . . . . 617 1Wi 618 Wtp:It!LJ;!ilt1Jt!1.:fPft!.ftjf 619 J!tift!.iE:fPl1!fwWJft!.iE . . . . . . . . . . . . . . . . . . . 620 ft!.1r liJt!J
4、.!atll . 621 mtilx3.!atll . . . . . . . . . . . . . . . . . . 622 illlrmHlf: . . . . . . . . . . . . . 723 00 ,Jg:fP.itI 724 IE 1it1tffl atiJ1ifflJ:EI1: . . . . . . . . . . . . . . . . . . . . . . . . . . 725 lStzJ . . 726 jE 727 9:fPffij . 728 :f!tzJ . 729 x MmM . . 730 a,A 9rmM:fPJt:m*11FmM 831 1*
5、IlmM 832 JtmM(gllSJt) . . . . . . . . . . . . . . . . . . . . . . 833 njmM . 834 jmM835 jEil( gt!l1ljE) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 836 ft!.WJ;*I1: 8I-YY 0671.1-2009 37 ft.l:;fIl2js:.3ft: 838 t;G;,/l:i!m)(14 839 xf AP m!;fIl APG m!ilit*rJ3ft: , 840 X1 AP m!ilit* lizJt:g
6、M4;fIl j;14 3ft: ;fIliJt JJsit , . . . 841 X1 APG ilit*R;$14;f1lj;143ft:;fIliJtJJsit 842 Miiffil. . . 843 f%tfj( 944 H1Lf*m:m,Wttlti 3:1t ,iZt ,tJt , ,xm;fll;f?iftl: 945 ffj?ifff;fllstff$14. . . . . . . . . . . 946 .F*m . . . . . . . . 947 .j 948 !f?1J;f?if.I1: 949 1q:tWT . . . . . . . . . . . . 950
7、 IfF!&f!iIiftjjffl11: 1051 fe; Il&fi tB f%tf 11:. . . . . . . . . . . . . . . . . . . . 1052 .FiE1itjg1i;flliJ.x$ 1053 ffiJtJJsit . . . . . . 1054 iIl!t 1055 7r%;fIljJ . 1156 j;ff14;f1lg1l.14 . . . . 1157 1XXl$?t,j;ff14;f1l;fjJ . . . . . . . . . . . 1258 W1PtJ!J.-JlffijT;fIlJi1259 fkJ;fIl;fjJ . . .
8、. . . . . . . . . . . . 12/l#3.j AA (Jf411:/l#:B) 2js:.ll:f!ll. 13/l#:B BB (*411:/l#3.j) *i.g.* 16:;!f)(iWI: 17II YY 0671.1-2009 YY 0671 Ij IIf IlHg nHJ ) , EE rU $ :5H. JiZ :- 1 $:5t: IjIIfJlitrti1ffi&i:*;- 2 $:5t: oo;fOJ)Ifflmf!L*$:5t YY 0671 E8 1 $:5to *$:5t &*ffl 00 IWt* ISO 17510-1: 2002 IIf Jl
9、i 1!fti1ff 1 $:5t: IIf Jli 1!fti1ff i&i:*) 0 *$:5t!: ISO 17510-1:2002 E8#.t(Qr: *$:5t ISO 17510-1 :2002 2 m:tEi7lfflxtt1lf 1. 1011; 3 *itt;fOJ5C1lf 2 :!if,!:Jmfflt*%1*t-3L *$:5tj:f GB 9706.1-2007l2iffl9:.i&i:* 1 $:5t:g(Jmffl*)(Jmffltj*)E8fflt fiE,!: GB 9706.1-2007 DC-Jl!S-&!ffl 0 *$:5t 36 :!ifliiHft
10、!: YY 0505-2005CIEC 60601-1-2:2001,IDT)l2iffl9:.i&i:* 1-2 $ :5t: g(Jmffl*-*ut*: 1I!*-*;fOW;)IPJw.JJJffi: 0 *$:5t 56 :!ifi7lffl EN 556( I2iffx 1fxmt E8l2iff*), PrEN 737-6: 1998 ( I2i ffl =C 1*If llt * 6 $:5t: ff I2i ffl9:.1*;fO :2: YW i&i:* jatd ,EN 739 ( I2i ffl =C 1*ffl iff: ffmItt ttX IflHtt), EN
11、ISO 8185( I2ifflj j mE8Jmffl*), EN ISO 9360-1 ( J#Iff;fO 1IfJli i&i: * ffl f 1tlIIfJli9:.1*J3J5l: 1 $:5t: JVN=Cii 250 mL J3J5l:),tE:J:t* OO*B*IPJMJJffi:,*tEmoomo *$:5tE8m AA ;fOm BB t!g!6H4tEm0 *$:5tEEOOJ#m;fOIIfJlii&i:*1ttt*ili*oo *$:5tJl!S1Jtlji1il: fpJlff3Wl2iff1fIlLH_P ,g*1fJtt*3fL5t1f0P 0 *$:5t
12、Jl!S1JtA:7tlf,at,5* ,ft 0 ill YY 0671.1-200951 yy 06711f(*:m5tTGB 9706.1-2007(JtJft!=(.i&t* 1 :m5t:3(illlJtJ*)If(JtJtfitE ,GB 9706. 1-2007 :fElltffJj;:iimtf-tl 0 :iiJtJtf-ffEm:1f:fE - fffP, 1!rYFr E8.g- Afl;, 13! mIf(mft!=(.i&t*3(OOIf(ffE,Billm-:1f*3(If(*o illlJtJ*tlJtJ.g-*13!mo*ffEmtt*/If(*,*JtJTm
13、:1f J:iiZmi&t* .:tmff*LEMC-$T Xi&t*If(Mijjtp ,lj:o JtJitEmTtif9JKi&t* ,J Qm ft!r:bOJ!H, rJft!J ,m*o a: 3HiJtfU!l1? mtlfEBt89*#*,YY 0671 89 * $ * * m rWiJ !JJQ IIJjttJ rPf i1&. tfL rWiJ !JlHl1f rPf i1&. tJLYY 0671 89 2 $*:XfOO:fOJ1UfHf;tlj:J:1tll T*, YY 0671 89*$*/fmr GB/T 4999-2003 9=tEJrWiJ891*.&rr
14、Pfi1&.i&*, 1. 101 Ji!m11sl ffl :xf4= rJIJJclj:9=t89jj;i1 YY 0671 89*$*89iJlfflITffJ&jg*$*89, fLti: BAA89iJlmJclj:, Jt:llJfV EJrff 89i&-!f!.C/ftlSlbi89 PJ ).!1X:iT Jt&:f:)/fm r*$*,?&ITff ,IiitJJ1lJltH*$*it:J&wiR 89*1r1iJfJEPI 15I!mM:Jclj:89!UT Jt&*, fL/fti: BAA 89iJl mJclj: ,Jt:ldT Jt&*m r*$*, GB/T 3
15、767-1996 % %Uid!iliJJEIIAtFfmt%:9J$ &MOOl:jfj gj EE89I?! Ccqv ISO 3744-94) GB/T 3785-1983 %it89 ,%!f:Eltni!tliJjf?! GB/T 4999-2003 JJ*mrPfi1&.* *i-!(lSO 4135:2001,IDT) GB/T 5332-2007 PI1?!.1*:fO1*iJl1?!.iffiLJjiJJijf?!(lEC 60079-4 :1975, IDT) GB 7144-1999 mLw!-.t;G; GB 9706.1-2007 m* 1 $*:1(JNm*(lEC
16、 60601-1:1988,IDT) GB 18278-2000 rr1*lfFr1!J( Ii iA:fO 1ItmilJIJ* I.ill:tlH!J(if(idt ISO 11134: 1994) GB 18279-2000 rr:wx; PFZ,!J(1i iA:f01ItmilJIJCidt ISO 11135 :1994) GB 18280-2000 rr1*1itFJfb!J(1i iA:f01ItmilJIJ* mM!J(licidt ISO 11137: 1995) YY 1040.1-2003 JJ*m:fOrPfi1&.* l1IDffHt:!k 1 $*:flt:!kl
17、:5flt(lSO 5356-1:1996) YY 1040.2-2008 JJ*m:fOrPfi1&.* l1IDflttt:!k 2 $*:tt7.:mtt:!k(lSO 5356-2:2006, IDT) YY 0505-2005 ffl* 1-2 $*:1(JNffl* *Jtlt*: *:fOiJJi (lEC 60601-1-2:2001,IDT) YY 0466-2003 rr:wx; 15223:2000,IDT)mrrr:wx;t1Ltic:fO:J:1tjHL,89%(lSOEN 556 rr:WX;!J(if ff!J(Iit89 rr:wx;* PrEN 737-6:
18、1998 m1*1fJlAU1E 6 $*:ff.m1*:fO!flllM*m:!k EN 739 m1*mff.m!f:E!tX1fm lj: EN ISO 8185 ffl;/JoM ;/JOM*m89jjffl* EN ISO 9360-1 JJ*m;fQrPfi1&.* mrM1tirPfi1&.1*89:Jt.Mx 1 $*:lVN:!I jg 250 7I-89:Jt.Mx *;jtFJtl*i-!;fQJE5(fflr YY 0671 89*$*, ;/JO: 2 YY 0671.1-2009 2. 1. 5 * Ell ffl alHt applied part :I1o l;
19、FfJi! : -m*$*o 2. 101 Zl*.IJI9;j!iEffii9: bi-level positive airway pressure devices 1i1&m ,m1J! DF1:WJ:ftltiEffJ1c1fLi&t*o 2.102 9;*1E breathing system Ui1&tgWr1ff2)i&t*,k-lffWAD, Wi1&A D;f!1 Itjg D1J Jif., :tm!ff jfw:iZ!: D;f!1 ili D,J1-E!.1iSwrjfw:iZ!: D;f!1 ili Do :*,ftW*ffiTQffWo 2.103 :M9;j!iEf
20、fiW: CPAP device 1i1&m,m1DF1:iEffi&t*o 2.104 !T 9; fresh-gas #*Wo-E!.1iSk-$*: a) AJ12:i1&AD:iZ!:Aw; b) jj*mttiw; c) JiliWo 2.105 9; IJ& A D fresh-gas intake port J1,2:i1&ADYr, E8 i&t*,1 i1&A!ffjfwi&t*jj * wi1&A D (J7i!. 2. 102 tt*f) 0 2. 106 9; D gas exhaust port 1iE#1*tp*tt,W;f!1/J2ffjFJJ!*Jffwpw1$
21、t*VItJiffijDo 2. 107 9;l:f:l D gas output port k-i1&ffnjj*,#*WDi&t*iliJiffijDo 2. 108 9; lID ViE D gas return port k-i1&ffn*,#*WADVIti&t*Do 2.109 ffi 9; A D high pressure gas input port Affn*T100 kPa WAD0 2. 110 f;f- label fflTffftWft-E!.k*OO%mAo 2. 111 flffi9;AD low pressure gas input port A&n100 k
22、Pa WAD0 2 3 YY 0671.1-2009 2. 112 tr- iR marking $ffB%mA, 2. 113 *:fl)HIU:tJ maximum limited pressure; Plim max 0.-0r,mQmffno 2. 114 #J tl microbial filter mT*U1UPgm1i,1*t!fWJwH)IL 2. 115 ,:ii1i Q patient connection port BJ jltjjlH,UwQ 0 2. 116 Z;/JifoJ1HjJlll!&ilfwjff self-adjusting sleep apnoea br
23、eathing therapy devices mBt, BJitHHlW El $JT.ftltffn jjlw:* 0 tt:*-.$ff*o 2. 117 M!Jlll!&ilfwjff sleep apnoea breathing therapy devices mTljUJTWWl:EJTnJffw:*,mTfff*!Wn;fQ*,*/FlWA 2. 118 Jll IN ffi:h 11 stability of the respiratory pressure JTffnW:JEmIl.iliBtlil1titEI3 Tff:ltctmWt& ,*it)i&1t1lffsl;g1
24、tit 0 2. 119 p;y.1N ffi:h 3 .t variation of the respiratory pressure JTttJTffnjAW:JEmZ*o ffl* GB 9706. 1-2007 m3 :!tm 0 GB 9706. 1-2007 m4 :!tm 0 GB 9706. 1-2007 m5 :!tm 0 tt:-*m$, 6 iR j5IJ , tr- iC r1 :x: f!f: GB 9706.1-2007 m6 :!tm, PJBtfJtr1i&jo: 6. 1 gJ;i9:$f!f:a99tr-iC Dm-f&J: j) A Wi JE AJJZ
25、LV. :Utf 7F 0 3 YY 0671.1-2009 fJa (fJatE 6. 1 f TIff) : eM.mti.#,tE#kmM ;fp7j(J1$iJ=* 0 bb) YfEHiAJliiijtJ tiit GB 7144-1999 Jt!E f*1;%,tiffm:00 (kPa);fp W!Eil*:I: (L/min) * 0 cc) .tiltJliiijtJtiico JiHJ.T*i: -jfjff*Il&AtJ :jfjff*Il&A; -f*tri ll tJ :f*tri ll ; -f*1JliiijtJ :f*1til:; -l1p tJ :l1p 0
26、:J2IfJil JiHiff=* nrrA tJ ,tlX;ftiic 0 l!tjr ,:tm=*Jintif!.*i,% ,fJQl;J.i.rt ,*k I a dd) * *ltmtt:tie:tmJm*mmtt:) ti ffffig tiHJ. T pg : -:ila =* * JJJl MJRi:Xf r.fF *i. /F rt 1IQ. , Jt ffl tt: g pg ffliiH. rt ttmYf ffl i. rt 45 ; -J ;jJ1;jJti kJ.ltjg:l1l:; -*tiiJ;fppg!lo/rfbi.rt ; -:ilUffl,ft( YY 0
27、466-2003 Jt!EtiiJXt1STERILE;fpxjJ?!; -:iluffl,ft( YY 0466-2003 tii1ttVz(LOT)ffjU%; -:ilOffl,*ltmtt:ffl,kJ.,Jj *; -:iluffl ,E:rt-Vzjj:ffl/F:m:ffl (SINGLE USE ONLY); tt: ISO 7000 9=N% 1051 flj(m YY 0466-2003L -f:Mtm=1;fp/jgiJl.rt; -f:Mt1!f;fp/JJJlrwmJJf ; -1mtffftE:rtflJ!J;ffi,E3. 6.1dd) 6 JJrIfi5Gjr;
28、 tt: itJ;U!PJ1tt%JjU%9=0 -:iloffl ,ji#ffl7t,r;fpxt1?!o tit A rP:%* g;fp/tik R7t;f rlJfp;fp ;fPJ.f rfb ,gMX ;fppxfrfb a :ila=*ll&mtt: EE Jif-1t!;fJ*4JJVZ ,Jtg!lo/ kMti rt Jif-It! m.It! a ee) :ilU=*EJf1*ffltil:I:Jfflfflf*ti ,it GB 7144-1999 * 0 6. 8. 2 ire JfJ lt )H fJa : aa) fflw.rt 45gMkJ. Tpg: -lm
29、tJ %;fpR i.w, 56. 3ee) J; -:iloffl , MifjHLj:* 0 bb) tEjf1lt;fp.-ti9:$T ,l.lJ.tj; tJ :I: ffj (JJi!. 51. 101) a 1*.,llllm.7t#am:OO;fp.o cc) :Xfr I *,ll1!fjj:FaA :ffllt!1*tpjj:mjg., kJ.1iffl1* .o d =*mll&ffj .,;jJFrttE.#.tp1*gZffj.!Etto tt:xffhffirr,J;U!mmo ee) tE.#:.lJ.;fp*;f3UiL.,ft( 26 jfrtaljJ?!ff
30、l:l:* A ;f;ZF ffiJtF 0 4 YY 0671.1-2009 ff) t&ilffijlfF14:(WJR.10.102) 0 gg) :alE 1t;j;!;fQ.-tJ!l:i!1t;j;!T ,:l1Iiit:ff1r:=1tJIl&A:I:&VJ 0 6.8.3* 1.R*t)B)H jm:1m ffl ,rt*iJ?, 9=t J1L:iJn T PJ?iI-:-:f&Ifi&t:* lE 1iJfl , lit ;fQ lE 1iJfl I fF t W1.Lf:# &, 1 ,Ij!, ;- ii:ktlHltElS.iJ (PEmmax);-M:1J:J; -
31、ER:# IJnmJ :I:;fQ1&I ,7Crr;JJX;ri&t:* J: IJttffliJJi!m#PIffl ri&t:*5$IJ, iJ?,A ffl:i&LL m OO;fQ1tIJi, A;fQfFJj!. WiJ?, ; -W;IJi!i!rJ:I:;fQ1&:a ATPD 14:TJtt1-T1J,!M ,J1LtaIiti!i!rJi;i14:(1m BTPS) ; B: ATPD:.f:%i1ffi.OCfllEJJ ,T1*; BTPS:1*i1ffi.ocfllEJJ ,tfgfll*fto-XJ*W ,:f&l!rJ 3:!IL :9J imlJ i;i:1J?
32、! ;fQ fF :1J?! IJ riB it ;- xJ1g 1%!t. !W ttng :a PJIJ PIifffEjJ IJ jJi =UUjE$14: IJ taIit ;- Z9J UjE;EI 00 ;-jJi *JE 9=t 5t14: JIiI! ff IJ ffliJ ,1m xJ t:1J OJ 4f 5t14: ;-ffliJ :9J IJ ;f1LkltK;-1&m;fQmmlJ;fQmOO;B: :mocPJ r:Jffliilm.!)iUliJ:I&*i (iiiiJJ1Jo $:ociRUj ,:llOffliJs *It* 0- Et!YtP.*iP, Et
33、!YtP.IJ;fQ;EEt!nliit;- Et! $t 9=t l!IT;fQ yg i&t: * :9J mit;-:affliJJi!mJE14:T,:aii:kPIiftjlliiJ IJ 1/3 ,2/3 ;fQii:kmB1lJii:kt:l:;-:a 56. 103 JE IJnmJ iJl: 14:T IJ lliiJ / ?iI-li f!E ;fQ IlfIl&lliiJ 1t 07 Aljj GB 9706. 1-2007 7 :!jtffl 0 GB 9706. 1-2007 8 :!jtffl 0 9 RJm:a91*t? /F*ffl 0 GB 9706. 1-2
34、007 10 :!jtffl 0 jm: 10. 10 1 $. il5( Qj(; 9;il5( :aJi!JEIJEt!$t$tZ9JmooPJ,*J1Lm:aftlJftmOOPJ.flo 10. 102 * *&,1HFHj: ffliJJi!J1L%J3: fF;fQ Et!$t(Et!$t$t)tf:l TmOOIJt&m, i&A9=t-1-rm1*t#A1 :alE1tmOOB1, i&t:*fFM &J1L: -fFWfrmOO:5 c 40 C; 5 YY 0671.1-2009 -;j:Ml3till 00 :10 %95 %;-*lIjillOO :700 mbarl
35、060 mbar;-5t1Ef#1I:WUE1IiJ-15%+10%;-1i1Ef# 1I :WfJE1IiJ-15%+25%0 1B.MHB GB 9706. 1-2007 r:p 10. 2 JE ,.:tEJ:J:i:Jl1JE iJ:Eff!l () 5kLf:ill 00 Z Vg ,*Jj)zxtl ;j!f1*ft;j!fr1:.1(= 0 ti: *PI mHjH 1f ,I.Lft itH I:Lit:Js!ll5 L 12 :iF*JfL 13 m GB 9706. 1-2007 m13 :!1f:Jij 0 14 *IJ* GB 9706. 1-2007 m14 jjf:
36、Jij 0 15 mffiQ () g.m IJ lUtl GB 9706. 1-2007 m15 :!1f:Jij 0 16 9Q ryf? GB 9706. 1-2007 :f# 16 :!1f:Jij 0 17 i8.i GB 9706. 1-2007 m17 :!1f:Jij 0 18 f*t?it!LJjiIUQ mf.fl:f:1:.J GB 9706. 1-2007 m18 :!1f:Jij 0 19 j! 11ii m1m Q , $iii WJ m1m TJ$5t)7,GB 9706.1-2007 m19 :!1f:Jijo 19.4 itC h) ! ;j!ftIi lt
37、iJ nnrJ :I: :lJo: 19. 101) ,f. ;j!ftIi 1E Jj)z :tE fJf 1f JE 5( jg rrlJ iJ Jj)z Jij $ 5t nnrJ 0 T itf t!Jg /HltH? t!Jg 1tl! JIiM r J: iJ $ 5t)7, Jj)zJij $5tJj)z:tE J:itft!Jg:tE -j ,itf t!Jg/HlH? t!Jg1tl!JliMr iJ Jj)zJij $5tJj)zljLas WW iJ 0 GB 9706. 1-2007 :f# 20 :Jij 0 GB 9706. 1-2007 m21 :!1f:Jij
38、0 6 YY 0671.1-2009 22 EidJffiWI: GB 9706. 1-2007 m22 .ffl 0 23 liL 1f.I 1lll . GB 9706. 1-2007 m23 .ffl 0 24 :if* ma1Y-Hiffi: 11 GB 9706. 1-2007 m24 .ffl 0 25 iYli#J GB 9706. 1-2007 m25 .ffl 0 26 idJII,i wi*: 26.101 * El=ri&t*1IiJft,l!ltiJIlA!F(A JlHxFBdlk)1iZft(Jffi 26. 102 MfJE4:r:lL :RM.,.ff wm*msQrnm. 26. 102 19:* :iJ!Ci: T Jt!. TIff , ft( Jffi 1lJ!J : rtf m: ;Jt :Hi ;ff: iJ :1f ?id( :iIf rIf Il& W 0 - r*J 12 4 mm,-1 40 mm ;fll ttHJ 1fJ J3t 45iJ!ill. ,1J!t1HJ J!t1i: C 00 101) 0 xtW AUfE;fll ,IJ! tt: 0 !It iJ!ill.p iJ
