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

QAengineer13

Quite Involved in Discussions
#1
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
 
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Sam Lazzara

Trusted Information Resource
#2
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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