ISO 10993-1:2018 - When will the European equivalent become a Harmonized Standard?

Philip B

Involved In Discussions
#11
Depends on your assessor! Safest bet is to update to 2018 as it could be argued to be state of the art. It's not that bad and you should be able to do it in a month (unless you need new testing of course).
 
Elsmar Forum Sponsor
#12
Depends on your assessor! Safest bet is to update to 2018 as it could be argued to be state of the art. It's not that bad and you should be able to do it in a month (unless you need new testing of course).
Thanks for advice Philip and prompt reply. Assessor will be starting tech file audit next week. I have only joined new company recently and realised they have not updated biological safety assessment report. I will have to take a hit on it :(
I will see why assessor says. Meanwhile I will ask our consultant to perform gap analysis and update the report. Thank you again
 

Philip B

Involved In Discussions
#13
You can argue that 2018 isn't harmonised and therefore strictly speaking isn't state of the art. I would also check that you have covered all of the biological end points and you are not missing any testing, that could be a bigger problem than not having updated your BER.
 
#14
Thank you Philip. That’s quite helpful. I will check the biological end points in current biological safety assessment report we have which was written in 2016.
 
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