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

glork98

Involved In Discussions
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 Right away I noticed the checklist was out-of-date so I updated it.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
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

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
 

glork98

Involved In Discussions
IEC 62304:2006 Amd 2015 Checklist

Here's the updated checklist for the 62304 Amd 1.1 2015 (IEC 62304:2006/AMD1:2015)

Well, someones gotta ensure the SOPs are in-line with the latest version.

Please post fixes or comments.
 

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Marc

Fully vaccinated are you?
Leader
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!
 

Drazenka

Registered
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 :)
 

Rgoel

Registered
IEC 62304:2006 Amd 2015 Checklist

Here's the updated checklist for the 62304 Amd 1.1 2015 (IEC 62304:2006/AMD1:2015)

Well, someones gotta ensure the SOPs are in-line with the latest version.

Please post fixes or comments.

What do the asterisk's mean on some of the sections?
 

yodon

Leader
Super Moderator
The original post was from 2010 and the last update was 2017 ... so this is pretty old. I didn't see any asterisks in the attachment in post #5 so I'm not sure what you're referring to. (NOTE: I did not review that attachment for accuracy so be sure it's accurate and complete if you use it)
 
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