Which Medical Device Standards to Buy

[Pads38]

And as you mention an informatics standard their is a risk standard directly related to that as well (don't know the number).

Just checked and the standard I was thinking about is ISO 80001 - Application of risk management for IT-networks incorporating medical devices -- Part 1: Roles, responsibilities and activities.

Check the informatics forum for more on that.

[jradford]

I was able to pick up 62366:2007 & 62304:2006 from AAMI for much less than the IEC versions. Both are equivalent to the IEC version. You do need to be careful to check equivalencies when purchasing from other sources.