Implementation Schedule in EU for ISO 10993-7:2008 - Transition period?

B

bogart

#1
Does anyone know of an official source that details an implementation schedule for ISO 10993-7:2008 in the European Union? In particular, I am wondering if there is a transition period for complying with the tighter EO residual requirements.

Background:
...ISO 10993-7:2008 is listed in the Official Journal of the European Union as a harmonized standard under the MDD. However, in relevant columns in the table, no reference is made to the 2008 version superseding the 1995 version. (C41, 19.2.2009, pg. 18.)

...FDA recognized the 2008 version on 8 Sept 2009, but states "Transition Period: FDA recognition of AAMI/ANSI/ISO 10993-7:1995 (R) 2001 will be superseded by recognition of AAMI/ANSI/ISO 10993-7:2008 as of December 1, 2011." (Recognition List 22, published 8 Sept 2009. Recognition Number 14-279.) I include this FDA background information for readers' general awareness of status in USA, knowing it has no bearing on status of the standard in the EU.
 
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Marcelo

Inactive Registered Visitor
#2
In general, if there´s no date for cessation of presumption of conformity, you can use both standards..as soon as a date is implemented (via ublication in the OJ), this date will be the transition date.

This is happening right now with the series for medical electrical equipment...both versions are in the journal, with no cessation date.

However, some "sources" (related to the Cenelec) have already said that the date will be 2012, so we are now only waiting for the OJ publication.

I don´t know of similar sources for the 10993 series of standards, but the responsible commiittees from CEN or Cenelec might help.

Also, generally there´s at least some transitions years after the publication on the OJ
 
M

MIREGMGR

#3
I wouldn't use any information from the FDA regarding ISO-originated standard transition periods as necessarily indicative of the EU's stance on that same transition. The FDA is most definitely not uniformly harmonized yet, internally.
 
V

vintagebob

#4
My notified body is telling us that 10993-7:2008 will be considered to be in effect immediately and has no adoption period. Ouch.
 

Marcelo

Inactive Registered Visitor
#5
Weird...i just revised the list of harmonized standards and noted the there´s no older version of 10993-7 listes (i thought there were two versions before).

So, what i said before does not apply to this case..if there´s only one version, and there´s not date for this versions, i think this might be better interpreted that the implementation date is "now", as vintagebob mentioned.
 
C

Chris Auditor

#6
Transition periods for European harmonized standards when a new standard replaces an older one. Since the 1995 version of 10993-7 was never harmonized, this does not apply. The 2008 version of the standard is treated as a new standard and therefore has no transition period. No doubt this will be very difficult for many medical device manufacturers, as it was difficult to meet the old limits for certain devices (tubing sets).
 
B

bogart

#7
I believe the 1995 version of ISO 10993-7 was in effect harmonized as EN 30993-7, as made legally binding by listing in Official Journal of the European Union C293, 14.10.2000, pg. 10.

It is listed again as a harmonized standard under EN ISO 10993-7 in OJ C129, 2.6.2006, pg. 14.

(I tried to provide links to those documents, but I have insuffient number of posts to do so.)
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#8
(I tried to provide links to those documents, but I have insuffient number of posts to do so.)
I think the number is 5 posts to put in a live link. You should be able to put one in now as your post count (as of right now) is 7 posts. Sorry about that, the 5 post minimum keeps a lot of spam out of the forum.
 
B

bogart

#10
I've run into several sources, such as this one, indicating a 3 year transition period for the EU ending October 2011.

euro.canon-experts.com/2009/08/how-long-do-we-have-to-comply-with-the-new-iso-10993-72008-standard/

Here's the relevant text from that page:
" How long do we have to comply with the new ISO 10993-7:2008 standard?

ISO 10993-7 was published in October 2008 and has a three-year transition period, so the 1995 version will be withdrawn officially in 2011. However, any revalidation projects or assessment of ethylene oxide levels for new or existing products should be performed in accordance with the 2008 version of the standard.
In my opinion, it is important to begin assessments to ISO 10993-7:2008 as soon as possible because it may be necessary to redesign or optimise the sterilisation cycle to meet the more stringent requirements contained in the latest version of the standard." Credit for this opinion is cited to Peter Strain, VP Technology, Sterigenics.
 
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