New EN ISO 11137-1 2015 Edition available now

EN ISO 11137-1, “Sterilization of health care products. Radiation. Requirements for development, validation and routine control of a sterilization process for medical devices,” is now available as the 2015 Edition.   You’ll have a number of ordering options, as the document will be available in a national edition from each of the EU countries.  This is a new revision of the publication and replaces the 2006 Edition (as well as the 2006 Edition with Amendment A1), both of which are now obsolete.

What will you find in the new 2015 Edition of the EN ISO 11137-1?  This new edition provides you with the same core ISO standard — It’s still identical to ISO 11137-1 1st Edition (2006) with Amendment 1 (2013.)  So it’s no surprise that the changes center on those Z Annexes that have become so important, particularly for those of you in the business of medical devices.  Let’s talk about the additional language that’s been added to each of the 3 Annexes.

There are 3 Z Annexes in the EN ISO 11137-1.   As before, they correspond to the 3 Directives that include EN ISO 11137-1 as part of their Harmonized List of Standards.  ZA relates to 90/385/EEC (Active Implantable Medical Devices), ZB is for the 93/42/EEC (Medical Devices), and ZC is for the 98/79/EC (in vitro Diagnostic Medical Devices.)  In this new Edition, the basic correlation remains the same, however there are significant changes in the preliminary notes and the tabular column on remarks for each.

The first thing you’ll notice in each Annex is that 4 notes have been added.  It’s no surprise that the first two notes have to do with risk assessment.  Note 1 reaffirms that your risks have to be reduced according to the language of the various essential requirements of the directive.  Note 2 informs you that your policy for determining that risk also has to be in compliance with the essential requirements.

Another question that we often get with our Document Center Inc. customers is what edition should be choosen for compliance.  That is, should I purchase the ISO 11137-2 or the EN ISO 11137-2, for example.  There is a new table in the European forward to this ISO adoption.  This table provides you with the European equivalent for any ISO standard referenced in the text, where one is available.  Note 3 informs you that only those European adoptions of referenced ISO standards will be acceptable.

Finally, Note 4 tackles the issue of essential requirements that are not addressed in the relevant Z Annex.  You will want to remember, as noted here, that if an essential requirement is not mentioned in the Z Annex, it is not fulfilled by using the standard.  So you’ll still have work to do to meet the balance of the applicable Directive’s requirements.

As I’ve mentioned before, the use of standards to fulfill the mandates of legislation by the Europeans has been a large step towards simplifying the process of compliance in many instances.  However, with the discovery of the “gap” in the level of risk management in medical device directives and in the harmonized standards that support them has called the concept of “presumption of conformity” into question.

As industry and regulators struggle to bring the legislation and supporting standards back into harmony, we will continue to see these types of updates occurring.  With the impact that this situation has had on industry, you can bet that all parties are struggling to get the system working originally envisioned as soon as possible.

Meantime, you’ll need a copy of this new edition for any medical device products that you intend on selling in Europe.  Although the official publication of the adoption of this new Edition has not yet been made, it is expected.

There are a number of national adoptions that you can choose from for your copy.  Here at Document Center Inc., we offer the SS EN ISO 11137-1 2015 Edition in paper format, for pdf download, and as part of our Standards Online multiuser subscription service.  This is also the lowest priced edition in our catalog, so we’re glad to have it available for you.  If you prefer, you can certainly purchase the BS EN ISO 11137-1 2015 Edition.  This is available in paper format only.  There will also be a DIN EN ISO 11137-1 2015 Edition available, but it has not been released yet.

Here’s the order page for SS EN ISO 11137-1, the order page for BS EN ISO 11137-1 and the order page for DIN EN ISO 11137-1.  You’ll also want to be aware that the EN ISO 11137-2 has recently been updated as well and copies for all 3 national adoptions are available.

Remember, Document Center Inc. has been selling standards since 1982.  You’ll find an extensive catalog of standards to choose from on our website, www.document-center.com.  If you have questions, you can work with one of our sales staff by contacting them by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re your Standards Experts!