Dear RAPS Members,
Do we have to test the requirements of clause 15.3 of IEC60601-1 if the collateral standard applicable for our device states compliance to 15.3 is not applicable? The collateral standard also states that it takes precedence over the corresponding requirements of IEC 60601-1 if IEC 60601-1 is applicable and differences exist.
Also, under the CB scheme is it possible for the test labs to overrule the collateral standards?
Looking forward to your valuable feedback.
Regards,
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Soumya Rajesh
Quality and Regulatory Affairs Manager
Den Haag
Netherlands
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