IEC 60812 or ISO 14971 for PFMEA? What should we use?

[irfank]

Hi all,
We (medical device company) are working on a manufacturing process FMEA. The question has come up whether to follow IEC 60812 or ISO 14971. Our current pFMEA does not discuss harm at all. I know 14971 use to have a reference to 60812 but no longer does?

Looking for some overall guidance on what to do or how to think about this. Thank you!

 

[yodon]

Risk management for medical devices should be done in context of effects on the patient / user. I don't have 60812 but it looks like it gives a good framework for PFMEAs; as long as the right focus is maintained. 14971 doesn't prescribe any specific approaches.

 

[Tidge]

14971 is considered 'foundational' for 60601-1 (electrical devices) and 62304 (devices that include software) so I wouldn't eschew it if your device falls into either category.

 

[Ronen E]

Hi all,
We (medical device company) are working on a manufacturing process FMEA. The question has come up whether to follow IEC 60812 or ISO 14971. Our current pFMEA does not discuss harm at all. I know 14971 use to have a reference to 60812 but no longer does?

Looking for some overall guidance on what to do or how to think about this. Thank you!

IMO these are two separate aspects of risk management.

Assuming that "medical device company" means a finished medical devices legal Manufacturer (bearing the top level regulatory responsibility in e.g. the USA or the EU), I'd highly recommend applying ISO 14971 in full, regardless of your current, specific pFMEA endeavour. Such application is in principle technique-free, so you can use different published standards (or none) in support of it, as long as you follow the normative (binding) parts of 14971.

If you feel IEC 60812 might be helpful in your pFMEA (and not too onerous for your purposes) then go ahead and apply it; however, there's no regulatory obligation that I'm aware of to use it (or any other FMEA published standard, for that matter).