IEC 60601 3.1 edition Gap Analysis wanted

[Talichek]

Hello

Happily get some help.

I have to make Gap analysis between 60601-1 3rd and 3.1 editions.
Any body have a GAP template or a format?

Any useful direction would be highly appreciated.

 

[Pads38]

If you get edition 3.1 as a 'redline' version all the changes are, effectively, highlighted.

For a quick overview try here:-

IEC 60601-1 Edition 3.1 Introduces New Product Safety Requirements for Medical Electrical Equipment - MET Laboratories, Inc.

 

[tazer]

Hi All
You can also look at:
http://www.medteq.info/med/files/Articles/IEC 60601-1 Amendment 1.pdf

 

[tazer]

There is also the web site: IEC 60601-1 Medical Equipment Testing, Reports, Help (MECA)
where you can found alot of ressources on the labelling and risk management checklists.

Hope will help.