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Collateral standard precendence over IEC60601

  • 1.  Collateral standard precendence over IEC60601

    Posted 31-Mar-2021 03:12
    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.


    Soumya Rajesh
    Quality and Regulatory Affairs Manager
    Den Haag