Particulate On Final Implantable Devices

[Mikea]

Does anyone know of guidance documents or literature that discuss particulate size and what is considered acceptable on an implantable medical device?

 

[Marc]

I don't off hand. You might try www.iest.org

Anyone here know off hand?

 

[Aaron Lupo]

My suggestion would be to try EN 46001 or ISO EN 13485.

 

[QualPro]

There several ISO standards for implantable devices, organized by the type of device, i.e., vascular grafts, active implantables, etc.

The site I like best for standards is the AAMI site, at www.aami.org. Go to "search standards" and search for "implants".

 

[Alf Gulford]

This is way outside of my field but IHS just sent me a catalog for books that included one called "Control of Particulate Matter Contamination in Healthcare Manufacturing" by Thomas A. Barber. From the description it sounds like it may cover some of your questions.

Try *** DEAD LINK REMOVED ***

Not a recommendation, just an observation. Good luck.

Alf