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

Ronen E

Problem Solver
Staff member
Moderator
#11
ISO13485:2012 & 21 CFR 820
I will assume that you mean the EU and the USA regulations.

Generally speaking, none of them mandates compliance with specific ISO standards.

As of now, ISO 11135:2014 is on the FDA's recognized consensus standards list (since 4.4.2016), and previous versions are not recognized.

In the EU, EN ISO 11135-1:2007 is currently harmonized and ISO 11135:2014 is not. ISO 11135-2 is also not harmonized.
 
Last edited:
Elsmar Forum Sponsor

planB

Super Moderator
#13
Hi,

the transition period was 3 years and ended in July 2017, as the standard revision was released in July 2014.

However

- EN ISO 11135-1:2007 is still the harmonised European standard
- If you already comply with ISO 11135-1:2007, it should not be too hard to demonstrate also compliance to ISO 11135:2014. Refer also to AAMI TIR74:2016, Change summary for ISO 11135:2014, for an official gap analysis.

HTH,

Gerhard
 

big boss

Posts Moderated
#15
ear all
i have aquestion ,as per the iso 11135:2014 in OQ part
1- do we need to run humidity mapping ?? as in this phrase in standarad it refer to table C1 which releate to number of data logger for temp only , also is it make sense as humidity injected to be 60 % as an example so in empty chamber this not suposed to be decreased or increased !!!so can any one help to clearify this point
2- also i need to understand ((
In empty chamber OQ exercises, the recorded temperature range, within the usable chamber
volume during EO or inert gas exposure, of ± 3 °C of the average recorded chamber temperature
at each time point should be obtained after an equilibration period)) as this not clear for me
also do any one can provide copies of AAMI TRI16 and 28
 
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