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

Philip B

Involved In Discussions
#1
I understand that this revised standard was published last year but it doesn't appear to be available in Europe. Does anyone know why this is or when it is likely to be published in Europe?
 
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Pads38

Trusted Information Resource
#4
Before an international standard becomes available as a 'national' standard (such as a BSi BS standard) it has to be approved by the European agency, CEN.
10993-1:2018 is currently listed part of the work programme at CEN (committee TC 206). I can not find any information on progress or expected dates of publication / approval.

See here:
CEN - Technical Bodies -
 

Philip B

Involved In Discussions
#5
T
Before an international standard becomes available as a 'national' standard (such as a BSi BS standard) it has to be approved by the European agency, CEN.
10993-1:2018 is currently listed part of the work programme at CEN (committee TC 206). I can not find any information on progress or expected dates of publication / approval.

See here:
CEN - Technical Bodies -
Thanks Pads. We have a technical file audit coming up, presumably we cannot be expected to be meeting the requirements of the 2018 standard if it isn't published yet? (We are in the UK.)
 

Pads38

Trusted Information Resource
#6
Officially the standards you should be using are those that are published in the Official Journal (search MDD OJ) but that has not been updated since 2017 - and is unlikely to be updated as everything is now heading to MDR, which will need it's own list of 'Harmonised Standards'.
 

Ronen E

Problem Solver
Staff member
Moderator
#7
Thanks Pads. We have a technical file audit coming up, presumably we cannot be expected to be meeting the requirements of the 2018 standard if it isn't published yet? (We are in the UK.)
No, you're not expected to meet ISO 10993-1:2018. If you meet ISO 10993-1:2009 your NB must grant you the presumption of conformity because that version is currently harmonized (included in the latest list on the OJ). However, if you did meet ISO 10993-1:2018 (and didn't have evidence of meeting ISO 10993-1:2009) that might still have been in compliance, because ISO 10993-1:2018 can now be argued to be "state of the art". Argued, because your NB could argue back that since CEN hasn't endorsed it yet there's no broad consensus (in the EU) about it actually representing the state of the art. Such a stance wouldn't make too much sense to me, but lately I hear a lot about "pigheadedness" in auditing, and strictly legally speaking they'd have a point.
 

Philip B

Involved In Discussions
#9
I've now updated our biological evaluation report to include the 2018 requirements. 2018 is pretty much 2009 plus some new bits (eg material mediated pyrogens) so hopefully we are covered from both a 'harmonised' and 'state of the art' viewpoint.
 
#10
We have a technical file audit next month. Our Biological safety assessment is still under old version iso19033:2009. We have not updated it to 19033:2018 version.
What is the transition period for ISo19033:2018? will we be critisised for not updating for Biological safety assessment report to 2018 version
 
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