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血糖仪( f* K W% R$ L9 u6 {: n, o# D. r
1 f2 |; M, f- q1 ^) n5 i& e要求符合以下标准
$ T/ x# n" h. o$ ?8 b0 D" S4 h
& V* x {8 x. o% `5 eIEC 61010-1 :2001(safety) GB4793.1-2007
/ N4 F2 `( s+ mIEC 61010-2-101:2002 (safety) YY 0648-20081 U; q1 z% p/ O" x; E
IEC 61326-1 :2006 (EMC)
8 h: t4 r: V1 tIEC 61326-2-6 :2006 (EMC)
; k+ U, V: I! H' }7 TISO 15197:2003 (performance) GB 19634-2005* ]; Q- H# ~) |: G1 F" Y @) L8 ^
IEC 62304:2006 (software) YY/T 0648-2008
3 G B' p u9 V6 I4 ~IEC 62366:2008 (Usibility)
) j0 i8 N7 O( f! P) _
; A5 U$ h n1 m: N; c4 V7 c nISO 14971:2007 (RM) YY0316-2008
' c, z4 R) }4 s, ]3 V+ E) ?% y% Z: z) l( V0 i
EN 980:2008 (symbol)1 w. |4 v( R6 s5 k' q* R- B$ t
EN 592:2002 (IFU) |
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