|
Generally, it includes two test requirements, say, Non-clinical tests and Clinical test; : e+ }& k) I6 Y( {. O" Z3 e' N
1 O% d6 s {( a9 DFor non-clinical test, the sphygmoomanometer shall be verified acc. to below standards* k P+ |8 {& ~9 k* c' I7 o$ n
1 .Electrical safety: IEC 60601-1 or UL 60601-15 @& t4 ?: q8 q
2. EMC: IEC 60601-1-2
. B5 |7 M& g. W g3. FCC : FCC part 15* b8 Q8 F0 |7 D5 P9 U/ b O }. E
4. safety and performance characteristics: ANSI/AAMI SP10% {+ B. X' m7 k- P! A6 P- N
' `$ I' u. _7 c
For Clinical test, - ?, j: V0 j/ h+ z) x' @
In compliance with the essential requirements of ANSI/AAMI SP10.
/ _4 Y) E/ Q7 K6 y3 y9 B/ |, c" ?2 p s$ f" |
Hope it helps a bit! |
|