Are there Summaries for Sterilization Standards?

B

Broccoli

#1
Hi,

I am in the process of procuring sterilization standards for one of my R&D projects. In order to get a head start on meeting these standards and to maybe point me to the most important areas so my reading load is initially a bit lighter I was wondering if there is such a thing as "Cole's Notes" or a summary for sterilization standards (specifically ISO 11137-1:2006, ANSI/AAMI/ISO 17665-1:2006 and ANSI/AAMI ST58:2005)?

I have found some short summaries or tables of contents, but I was wondering if anyone has other resources they could share.

Thanks!
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
I'm not a medical device person, but I'm not aware of any 'summaries' of standards off hand.

Is anyone else here aware of any?
 
K

Kees Fremery

#5
I have developped some documents which can be used as a checklist for Validation of Medical Devices according to ISO 11137-2. If you are interested I can mail them.

With kind regards,
Kees Fremery
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#6
Any chance you can share them here by attaching the file(s) to a post? In that way you can help hundreds of people.
 
F

freelovefest

#8
I would LOVE a copy of this document. I have recently been tasked with auditing sterilization and am not sure where is the best place to start or what is important.
 
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