标准解读
《YY 0671.1-2009 睡眠呼吸暂停治疗 第1部分:睡眠呼吸暂停治疗设备》是一项针对用于治疗睡眠呼吸暂停综合征的医疗设备的标准。该标准详细规定了此类设备的安全性、性能要求以及相关的测试方法,旨在确保这些设备能够安全有效地服务于患者。
标准涵盖了对睡眠呼吸暂停治疗设备的基本定义与分类,明确了适用范围包括但不限于持续正压通气(CPAP)、双水平正压通气(BiPAP)等类型的产品。对于制造商而言,需要按照标准中的指导原则设计和生产产品,以满足特定的技术规范。例如,在安全性方面,标准强调了电气安全、机械强度及生物相容性的要求;而在功能性上,则关注于压力控制精度、噪音水平等方面的具体指标。
如需获取更多详尽信息,请直接参考下方经官方授权发布的权威标准文档。
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ICS 11. 040. 10 C 46 yy YY 0671. 1-2009 Nt O u,& tm 1 jf:tfi , B7t: Ntou,&tm1jf:tfii Sleep 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 N III 1 moo 1 2 ;f:iil-:fPJ:E)( . 1 3 :iNffl* 3 4 iJ!lZ iJ :iN ffl * . . . . . . . . 3 5 7t 3 6 iJtJ1j ,f,ji2:fP X If:. . . . . 3 7 AJ;!$ 5 8 * 5 9 PI :jJffEl iJWtp :I: . . . . . . . . 5 10 fFlf: 5 11 /F*ffl . 6 12 /F*ffl . 6 13 lI3t 6 14 *7tiJ* 6 15 ft!. ffi:fP (:!1,x;) il:I: iJ ijjIJ . . . . . . . . 6 16 j 3t:fP1!iJtpJ:j . . . . . . . . 6 17 1Wi 6 18 Wtp:It!LJ;!ilt1Jt!1.:fPft!.ftjf 6 19 J!tift!.iE:fPl1!fwWJft!.iE . 6 20 ft!.1r liJt!J.!atll . 6 21 mtilx3.!atll. . 6 22 illlrmHlf: . . . . . . . . 7 23 00 ,Jg:fP.itI 7 24 IE1it1tfflatiJ1ifflJ:EI1:. . . . 7 25 lStzJ . 7 26 jE 7 27 9:fPffij . 7 28 :f!tzJ . 7 29 x MmM . . 7 30 a,A 9rmM:fPJt:m*11FmM 8 31 1*IlmM 8 32 JtmM(gllSJt) . . . . . . . . . . . . . . . . . . . . . . 8 33 njmM . 8 34 jmM8 35 jEil( gt!l1ljE). . . 8 36 ft!.WJ;*I1: 8 I -YY 0671.1-2009 37 ft.l:;fIl2js:.3ft: 8 38 t;G;,/l:i!m)(14 8 39 xf AP m!;fIl APG m!ilit*rJ3ft: , 8 40 X1 AP m!ilit* lizJt:gM4;fIlj;14 3ft:;fIliJtJJsit , . 8 41 X1 APG ilit*R;$14;f1lj;143ft:;fIliJtJJsit 8 42 Miiffil. . . 8 43 f%tfj( 9 44 H1Lf*m:m,Wttlti 3:1t ,iZt ,tJt , ,xm;fll;f?iftl: 9 45 ffj?ifff;fllstff$14. . . . . 9 46 .F*m. . . . . . 9 47 .j 9 48 !f?1J;f?if.I1: 9 49 1q:tWT . . . 9 50 IfF!&f!iIiftjjffl11: 10 51 fe; Il&fi tB f%tf 11:. . . . . . . 10 52 .FiE1itjg1i;flliJ.x$ 10 53 ffiJtJJsit . . 10 54 iIl!t 10 55 7r%;fIljJ . 11 56 j;ff14;f1lg1l.14 . 11 57 1XXl$?t,j;ff14;f1l;fjJ . . . 12 58 W1PtJ!J.-JlffijT;fIlJi12 59 fkJ;fIl;fjJ . . . . . 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: 17 II YY 0671.1-2009 YY 0671 Ij IIf IlHg nHJ ) , EE rU $ :5H. 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