T Talichek May 21, 2018 #1 May 21, 2018 #1 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.
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.
P Pads38 Moderator May 29, 2018 #2 May 29, 2018 #2 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.
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.
T tazer Involved In Discussions Jul 4, 2018 #3 Jul 4, 2018 #3 Hi All You can also look at: http://www.medteq.info/med/files/Articles/IEC 60601-1 Amendment 1.pdf
T tazer Involved In Discussions Jul 4, 2018 #4 Jul 4, 2018 #4 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.
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.