|
Generally, it includes two test requirements, say, Non-clinical tests and Clinical test; - n# V6 }" S: b( v) b2 c- F6 q& _
( v- ]3 L- s1 \
For non-clinical test, the sphygmoomanometer shall be verified acc. to below standards6 ]& Z9 |& D" n$ v; K
1 .Electrical safety: IEC 60601-1 or UL 60601-1. o+ K8 i6 O% L% q- _2 q8 L g
2. EMC: IEC 60601-1-2
( D6 @( N2 G( y5 F4 U3. FCC : FCC part 15# G% I1 w L. u' i' h1 U: q0 H! D
4. safety and performance characteristics: ANSI/AAMI SP10
6 N8 p4 g8 @ w! x" c4 o
8 S# |8 ]/ a3 |2 ]9 o0 _# CFor Clinical test,
4 _! `% g: g7 N% XIn compliance with the essential requirements of ANSI/AAMI SP10.
* X0 b9 }) X1 I; l- |
+ B# {. l$ {3 W1 P5 Y$ h3 C. pHope it helps a bit! |
|