Developing the Essential Requirements Checklist - Identifying Requirements

[endlesslovehv]

For the product Automatic external defribillator, How can I identify if a requirement is applicable (A or N/A), and identify the possible standard/spec that can help show compliance to the requirement.

 

[MIREGMGR]

The Essential Requirements Checklist should be completed by a team that includes a product-use Subject Matter Expert, a regulatory expert, and others involved with design, production, etc. The answers to that series of questions should be self evident to one or the other of those individuals.

I'd think that if you individually don't know the basic answers, you'd be unable to complete the document in a manner that would stand up to audit.

 

[Adele]

I would get the standard ANSI/AAMI/ISO TIR16142 Medical devices — Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices.

It list every Essential Principle and the standards they would use to meet that Principle. It shouldn't be taken as gospel but for someone unsure of what to do you should be able to follow the patterns of what standards they have used where and see a pattern develop. Do not simply cut and paste that standard - you still need to apply your device-specific standards.

 

[SteveK]

For the product Automatic external defribillator, How can I identify if a requirement is applicable (A or N/A), and identify the possible standard/spec that can help show compliance to the requirement.

A good starting point might be competitor literature e.g. find downloads at:

http://www.zollaed.co.uk/

Also Wiki AED

http://en.wikipedia.org/wiki/Automated_external_defibrillator

In Europe EN 60601-1 (safety) and IEC 60601-1-2 (EMC) are a given in Standards requirements (as will other parts of the 60601 Standard family, EN 60601-2-4 is specific to defibs).

Checkout Harmonised Standards:

http://ec.europa.eu/enterprise/poli.../list-references/medical-devices/index_en.htm

However, as has been indicated you need the knowledge by a team/expert etc. Note in the ER if a n/a is identified - put a statement in the ER as to why not (audit experience!).

Hope this helps - could be information overload!

Steve