IEC 60601 Compliance

#1
We have some modifications to the product design, and we are going to verify the spec by using the IEC60601 standard, I wonder can we write an IEC60601 compliance report by ourselves?
When the product was initially introduced, we did get a report from a third party, so my question is because we only make changes to the product this time.
Appreciate your help in advance.
 
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Peter Selvey

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#2
In general anyone can do as long as they are qualified (suitably experienced to understand the content of the standard), and if tests are required, have the necessary calibrated equipment, and keep the records of any tests/evaluations.

Exceptions would be some regulations like China and Brazil which require third party testing, and if there is a product certification mark involved (UL, CSA, TUV etc.)

A change report should include a description of the changes, analysis, re-assessment of any areas of compliance impacted by the change (listing up each affected clause and re-assessment verdict), linkage or inclusion of tests if required, and a statement that apart from the items re-assessed, the previous test results are representative of the latest version of the product.
 
#3
Hi Peter, I love what you said, thank you very much for the reply.
In general anyone can do as long as they are qualified (suitably experienced to understand the content of the standard), and if tests are required, have the necessary calibrated equipment, and keep the records of any tests/evaluations.

Exceptions would be some regulations like China and Brazil which require third party testing, and if there is a product certification mark involved (UL, CSA, TUV etc.)

A change report should include a description of the changes, analysis, re-assessment of any areas of compliance impacted by the change (listing up each affected clause and re-assessment verdict), linkage or inclusion of tests if required, and a statement that apart from the items re-assessed, the previous test results are representative of the latest version of the product.
 
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