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Generally, it includes two test requirements, say, Non-clinical tests and Clinical test; 5 V6 L# o6 s2 A8 c w8 U: p
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For non-clinical test, the sphygmoomanometer shall be verified acc. to below standards/ J- i) ^% y" `* s0 }$ J8 S
1 .Electrical safety: IEC 60601-1 or UL 60601-1
6 x" ? n( f x2. EMC: IEC 60601-1-27 j2 X* p8 U0 n8 J! h; `- F
3. FCC : FCC part 15
$ A( @1 {- g$ G7 R3 x- }- N4. safety and performance characteristics: ANSI/AAMI SP10
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For Clinical test,
Z" M4 A f | }4 Y7 A+ O3 ZIn compliance with the essential requirements of ANSI/AAMI SP10.
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Hope it helps a bit! |
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