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BS EN 60601 or IEC 60601 or GB9706 - Our product is going to various markets

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lisawxf80

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#1
#1
Dear All,

I have this question currently, as our product is going to various market including EU and US. Which standard we should refer then, BS EN60601 version or IEC 60601, or any other version if go to other region.

Thanks & Regards,

Lisa
 
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Ronen E

Ronen E

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#2
#2
lisawxf80 said:
Dear All,

I have this question currently, as our product is going to various market including EU and US. Which standard we should refer then, BS EN60601 version or IEC 60601, or any other version if go to other region.

Thanks & Regards,

Lisa
Click to expand...
Hi,

To benefit the presumption of conformity in the EC, it has to be a version including "EN". For FDA recognition it has to be the IEC/AAMI ANSI version. Please note that the contents are not necessarily identical.

Other regions - you'd have to be specific to get specific answers, as requirements vary.

Cheers,
Ronen.
 
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