|
Generally, it includes two test requirements, say, Non-clinical tests and Clinical test; y0 C' Y6 u0 L" @
# {) i4 u6 F% Y6 ?For non-clinical test, the sphygmoomanometer shall be verified acc. to below standards
0 A. G- J c# u- F. E1 .Electrical safety: IEC 60601-1 or UL 60601-1 ~4 @& T# ^$ I; x- n
2. EMC: IEC 60601-1-24 \( H3 }7 k! l: ^, X+ w( }
3. FCC : FCC part 151 M$ ]8 F8 N }6 j, Y% k7 {! J
4. safety and performance characteristics: ANSI/AAMI SP10
" [- a% @' r) |& P: q: W+ E7 k, r$ q) Z* [5 F
For Clinical test, $ k" C j* u% a
In compliance with the essential requirements of ANSI/AAMI SP10. / H8 O- m7 b2 h1 Y. Z$ F& s
2 @" L. I* x+ n+ m2 x% ]. E
Hope it helps a bit! |
|