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European versions of standards - ISO 10993-1 and ISO 11607-1

Philip B

Involved In Discussions
#1
Standards 10993-1 and 11607-1 have been re-issued recently but only as ISO standards, not EN. As a European manufacturer are we ok to hold out for the EN versions or will NBs expect us to have obtained the ISO version one published? Standards are expensive and we don't really want to buy them twice.
 

Marcelo

Inactive Registered Visitor
#2
If you are talking about CE Marking, you can apply any solution you want to fulfill the regulatory requirements. IF you want to gain presumption of conformity (which is a regulatory option that CE Marking has), you need to use harmonized standards (which are European Standards who have passes the harmonization process). If you do not use an harmonized standard, your solution will need to be further evaluated.But then again, it's your choice.

Just a reminder, right now, we do not have harmonized standards for the MDR, and there will be a delay in having them available.
 
#3
Philip,

the normative part EN versions of the respective ISO standards are typically identical; they typically only differ in the informative "Z Annexes" related to harmonisation as Marcelo pointed out.

However, the process of harmonisation has practically come to a standstill for the past couple of years be it MDD, AIMD or MDR. Therefore, to my experience notified bodies have switched to holding you accountable for the "state of the art", i.e. the latest ISO standard revisions, typically about 1 year after standard publication.

Specifically for biocompatibility, you should comply to ISO 10993-1:2018 by now and ISO 11607-1:2019 by somewhen next year to be on the safe side.

HTH,
 
#4
From my personal experience, it also depends on individual auditors of NB. They respect use of harmonized standards, but personally prefer use of new ISO standards. So were trying to keep up with the current state of art. But this can differ from person to person.
 

Philip B

Involved In Discussions
#5
I've just looked in the EU Journal and they list 11607-1:2009 as a harmonised standard not 11607-1:2017. The newer standard has an annex ZA, so does anyone know why isn't it listed in the journal?
 

Ronen E

Problem Solver
Staff member
Super Moderator
#6
I've just looked in the EU Journal and they list 11607-1:2009 as a harmonised standard not 11607-1:2017. The newer standard has an annex ZA, so does anyone know why isn't it listed in the journal?
The official publication date of EN ISO 11607-1:2017 was 31-JAN-2018.
The latest harmonized standards list under the MDD was published on 17-NOV-2017.
 
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