IEC 62304:2006/AMD1:2015 Checklist .xls file attached

glork98

Involved In Discussions
#1
I downloaded a checklist from this site and used it as a bit of a study guide while going through IEC 62304:2006. Right away I noticed the checklist was out-of-date so I updated it. It's just a list of section headers along with the device classes (A,B,C) that the section applies to. Still a useful tool to seeing what to do.

I'm posting it to possibly help other people. If you take a look and have issue or questions, please let me know.
 
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glork98

Involved In Discussions
#2
Re: IEC 62304:2006 Checklist attached

Here's a better version...now with columns to cross-reference your SOPs and sections!

Moderator note: This checklist is old and a new version has been posted below on 3/7/2017. I've disabled this one to avoid confusion.
 
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C

cingo

#4
Re: IEC 62304:2006 Checklist .xls file attached

Thanks a lot for the checklist and other very useful information available on this forum (I'm a new member).

I noticed a little mistake in the checklist, in particular for the item 5.3.5 'Identify segregation necessary for SAFETY task'. Based on the IEC 62304:2006 this is applicable for the Class C only and not for the Classes B and C as reported in the checklist.

Thanks again,
cingo
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#6
Re: IEC 62304:2006 Checklist .xls file attached

Howste has edited the post with the obsolete file.

I have deleted some old posts in this thread in order to clean it up a bit and shorten it.

glork98 has attached an updated file. Thanks, glork98!
 
#7
Greetings.

Is somebody has the SEPT IEC 62304 CHECKLIST to upload? I finished some processes by this standard and need to check if I did them all, and this document is great. Thanks :)
 
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