ISO 11135:2014 cancels and replaces ISO 11135-1:2007 and ISO/TS 11135-2:2008

R

rickbert

How big are the technical changes (other than consolidating the two -n standards)? A consultant wants to charge us $2000 to do a gap analysis with our validation. If there are significant changes, it's worth it. If the changes are simply updated references (like the recent ISO 11607 changes) I can probably figure it out myself. Thoughts?

Thanks!

Rick
 
planB

planB

Super Moderator
Since you should be in control of your sterilization processes, I would suggest you take also the ownership of this gap analysis by comparing the documents side by side and evaluate the impact on your sterilization programme.

I am not yet completely through with my gap analysis yet, but once I am done I can post my 2 cents.

HTH,

Gerhard
 
E

evilchilli_420

Does anyone have or performed a gap analysis between the two versions? Can you please share it?


Thank you.
 
A

Angelucci

Good day,

Do you have a gap analysis between the two versions of ISO 11135: 2007 and ISO 11135: 2014?

Thank you!
 
planB

planB

Super Moderator
Hi,

sorry - no free lunch. My gap analysis is the property of the company I am working for and cannot be shared. And as I pointed out previously, in the end only you can really evaluate the impact of the standard changes to your sterilization programme - therefore, I would suggest you take also the ownership of this gap analysis tailored to your specific process.

However, some public reading is out there:

A first look at ISO 11135:2014
beuth.de (in German)

and AAMI is currently developing some generic guidance doc that could also serve your purposes:

AAMI TIR74


HTH,

Gerhard
 
T

toffeeman

Starting to get Involved
What is the implementation date for this? I have been told that it is 7th July 2017 by some and 31st December 2016 by others.

Apologies for asking, but I have previously worked mainly in bulk non-sterile medical devices.
 
Ronen E

Ronen E

Problem Solver
Moderator
toffeeman said:
What is the implementation date for this? I have been told that it is 7th July 2017 by some and 31st December 2016 by others.

Apologies for asking, but I have previously worked mainly in bulk non-sterile medical devices.
Click to expand...

Under what regulatory scheme?
 
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