Product Instruction for Use Manual (IFU) - Obligation to list the standard used

QAengineer13

Quite Involved in Discussions
I would like to know whether is there any legal or regulatory obligation to list the standard used in the development of a product in the instruction for use manual.

Is it ok if its listed in a Design History file document and in the DOC. Does the standard used in the product D&D need to be listed in a user facing document like IFU etc..any suggestion/input to this discussion, will be greatly appreciated.

Thank you, Cove members
 

Sam Lazzara

Trusted Information Resource
No.

Yes for DHF, but standards are not required to be listed in the Declaration of Conformity (DoC).

No. The only standards I typically see in IFUs are IEC/EN 60601-X standards for electromedical devices; and ASTM or other standards related to MRI compatibility test data that is provided.
 
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