amjadrana
Involved - Posts
CE mark and harmonized standards
I have come upon another similar regulatory issue for which I seek guidance from the forum.
We are a manufacturer of a hearing diagnostic and screeing product. We are testing our product according to safety standard IEC 60601-1 and relevant EMC standards. A particular standard IEC 60601-2-40 is also applicable to us. According to the standard IEC 60601-1, a particular standard takes precendence over the relevant clauses of the general standard.
Question: Does it mean that compliance to IEC 60601-2-40 is also mandatory in addition to IEC 60601-1?
I have another question. If we have submitted our product for regulatory testing, can we market our product, when we receive test report from the testing authority that our product has passed the requirements of the standard or do we have to wait until the actual certificate is in our hands.
Thanks for your inputs
I have come upon another similar regulatory issue for which I seek guidance from the forum.
We are a manufacturer of a hearing diagnostic and screeing product. We are testing our product according to safety standard IEC 60601-1 and relevant EMC standards. A particular standard IEC 60601-2-40 is also applicable to us. According to the standard IEC 60601-1, a particular standard takes precendence over the relevant clauses of the general standard.
Question: Does it mean that compliance to IEC 60601-2-40 is also mandatory in addition to IEC 60601-1?
I have another question. If we have submitted our product for regulatory testing, can we market our product, when we receive test report from the testing authority that our product has passed the requirements of the standard or do we have to wait until the actual certificate is in our hands.
Thanks for your inputs