|
|
血糖仪
: h" b' u# {/ Z" F* `/ }6 N) G" S# v+ Y! M1 }
要求符合以下标准# c( K3 H1 I5 X! O, ]& [
; g/ Z, |) M6 [% U( D7 [
IEC 61010-1 :2001(safety) GB4793.1-2007
; w; R ]5 |: z9 T1 |IEC 61010-2-101:2002 (safety) YY 0648-2008
) v% \. [6 O9 q1 E& UIEC 61326-1 :2006 (EMC) 8 m: h# G. k. }+ P( r2 B, \4 Q+ J* Y
IEC 61326-2-6 :2006 (EMC)
) i9 g Q+ ^. K1 vISO 15197:2003 (performance) GB 19634-2005
1 O- v2 L# n$ h, [( H7 x k8 dIEC 62304:2006 (software) YY/T 0648-2008
0 o. `. \4 O5 B* W" n# l" _8 f" yIEC 62366:2008 (Usibility), i( _( K3 L, M) y) Y
3 v" _6 K" Z% J& |5 G4 G. N# k
ISO 14971:2007 (RM) YY0316-2008 F/ e9 `/ k: t/ [- `* K: z7 I1 s
W+ k7 b0 d0 B9 B* B
EN 980:2008 (symbol)
4 E/ V* H1 n1 U2 @4 VEN 592:2002 (IFU) |
|