|
Generally, it includes two test requirements, say, Non-clinical tests and Clinical test; ' k- T8 c) t# d! l) J
3 }1 @& e7 L2 S: KFor non-clinical test, the sphygmoomanometer shall be verified acc. to below standards7 a8 M( H* m- u, p8 O6 T
1 .Electrical safety: IEC 60601-1 or UL 60601-1 x) r3 X" t/ ^1 ] M" I
2. EMC: IEC 60601-1-24 r$ W3 K: Z8 z* W
3. FCC : FCC part 15
9 s9 w5 V ~3 Y+ S4. safety and performance characteristics: ANSI/AAMI SP10! j! M+ f. M" \
5 T& K l; m6 `( N6 mFor Clinical test,
9 d5 U: c0 k& f" i& ]/ tIn compliance with the essential requirements of ANSI/AAMI SP10. 9 Z; C5 L' ^$ U, D; Z
6 @7 d. m3 }: q! {: ~# `
Hope it helps a bit! |
|