New EN ISO 11137-2 2015 Edition

EN ISO 11137-2, “Sterilization of health care products. Radiation. Establishing the sterilization dose,” has just been updated.  The new 2015 Edition is being released in the various national adoptions from the members of the EU now.   This update leaves the adopted ISO 11137-2 2013 Edition untouched — the changes are all to the Annex material.

What is the EN ISO 11137-2?  It is the European adoption of ISO 11137-2.  Here’s how this is phrased in the endorsement notice: “The text of ISO 11137-2:2013 has been approved by CEN as EN ISO 11137-2:2015 without any modification.”  Additionally, the EN ISO 1137-2 is on the harmonized list of standards for the 3 medical device directives: 90/385/eec, 93/42/eec, and 98/79/ec.  So it is an important part of the documentation requirements for many medical device manufacturers who sell products in Europe.

What are the changes in the 2015 Edition of EN ISO 11137-2?  First, the introductory material includes clarification of what documents should be used as referenced standards.  Then, since the document continues to adopt the ISO 11137-2 without any modifications, the balance of the changes are contained in the Annexes (ZA, ZB, and ZC — one for each of the directives it applies to).

If you are already using any of the ISO adoptions on these 3 directives’ harmonized lists, you know about the problems that risk assessment is causing at the present moment.  So it will be no surprise that this update seeks to clarify the situation as regards to the ISO 11137-2 material.  There is the addition of 4 notes at the beginning of each of the 3 Annexes.  Note 1 provides you with a straight-forward statement of the expectation of the reduction of risk.  Note 2 then expands on this with the requirements for a manufacturer’s policy regarding acceptable risk.  Note 3 confirms that the “normative references” (reference documents) in the Annex are the European adoptions as laid out in the forward and noted above.  Note 4 reminds you that any Essential Requirement of your directive is not met if it does not appear in the appropriate directive’s Annex.

The last change to each Annex is actually an update for the table that is contained in each.  The third column for each table has been expanded.  This means, in part, that only sterilization using ionized radiation is covered by the publication.  And it is now emphasized that other aspects of manufacture not relating to sterilization are not covered by this document.  The previous other notes continue to be in force.

When will it be mandatory to meet this new edition?  First, when the update is formally accepted and added to the harmonized lists, there will be the cessation date for the 2013 Edition included on the list itself.  And even though this has not yet taken place, it is expected to be processed without issue.  Secondly, the member nations of Europe have until December 2015 to adopt this document and withdraw any conflicting or duplicating standards.  So we’d make that our preliminary migration date until the new harmonized list comes out.

How do I comply with these changes to the Annexes?  Remember, standards give you the presumption of conformity to specific Essential Requirements (ER’s) of specific directives.  But there may be other ER’s that the directives do not meet.  This means that you’ll have to address these types of issues in your technical file.  The new material in the Annexes seems to indicate that your company policy with regards to risk management will be at scrutiny.  And you may also need to prove compliance in this regards for the covered device as well.

How can I get a copy of the new EN ISO 11137-2 2015 Edition?  All national adoptions are covered by copyright, so you’ll want to purchase your copy from an authorized distributor like Document Center Inc.  Order on our webstore, www.document-center.com.  Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).

What national adoption should I purchase?  Right now, the BS EN ISO 11137-2 2015 Edition is available in paper format only.  The SS EN ISO 11137-2 (in English) is expected to be released any day now and will be available in paper format, for pdf download and as part of our Standards Online multi-user subscription service.  The English language edition of the DIN EN ISO 11137-2 should also be available soon and can be purchased in paper format or for pdf download as well.  At that point, the only other difference between the 3 editions will be the price.

It is mandated that you use the EN editions of ISO adoptions when you’re meeting the requirements for directives with harmonized lists.  But if you’re like our Document Center customers, this still leaves you with many questions.  We’re here to help you navigate these waters, so make us your Standards Experts!