External Standards List (Document Control)



I'm currently in the process of doing a review of our companies External standards list. I'm curious how other medical device companies out there are handling their document. When FDA recognizes the same standard sometimes 2-3 diff ways. For example FDA may recognize the ISO publication and the ASNI/AAMI publication for the same standard from the same year. Are you guys listing each one? I attached an example. There are three versions of this ISO 11737-1, in the attachment that is currently how we are listing. Any suggestions on how to clean this up.



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Re: External Standards List

Hi ryannh,
We are a small medical devise manufacturer. Our external documents list provides title, document number, and revision. Our qms procedures do not require us to list if an external document pertains to EU harmonized, FDA regulated, or Canada regulated.

Do you have to include the reference?
All the best.


Re: External Standards List

I don't actually think there is a requirement to do this. I think i might propose to my management that we remove this. It causes more headaches then help currently.

I don't know where that would leave us with the many different recognized ones. I honestly would like to list the general standards "ISO 80369-7" and than have a statement that the most recent publication would be followed (state of the art). Not sure how that would go over with the FDA & NB though.

Any opinions or guidance would be greatly appreciated.


Re: External Standards List

Hello Ryannh,

It is unnecessary to list all reference, it's a nice thing to do, but unnecessary and it can save you a lot of time.

But I have attached a document of how I would do

Hope it helps you a little

Best Regards


  • Standard Reference (1).docx
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