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Generally, it includes two test requirements, say, Non-clinical tests and Clinical test; % Q" w4 g5 D% E9 P" v! V3 r* [
H( Q- }' \+ b) wFor non-clinical test, the sphygmoomanometer shall be verified acc. to below standards
) W6 \& c6 Z9 w. e2 p4 h. {+ Y1 .Electrical safety: IEC 60601-1 or UL 60601-1
4 D9 b" D9 o7 p: g w9 a+ B9 F2. EMC: IEC 60601-1-2; @1 I: S" C5 o- l
3. FCC : FCC part 15
2 i. L$ W# i0 Y4. safety and performance characteristics: ANSI/AAMI SP10
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/ _8 {0 n q5 r3 GFor Clinical test, ) p$ _, K9 E, d$ {0 \
In compliance with the essential requirements of ANSI/AAMI SP10.
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) Y7 ]. E! U7 f5 h5 j" z1 L9 {+ l# yHope it helps a bit! |
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