EN ISO 13408-1 Updated – Medical Device Sterility

EN ISO 13408-1, “Aseptic processing of health care products – Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013),” has just been updated.  The new 2015 Edition is available from Document Center Inc. in paper format, as a pdf download, or as part of our multi-user subscription service, Standards Online.  The EN ISO 13408-1 is a harmonized standard for the European Directives 90/385/EEC, 93/42/EEC, and 98/79/EC.  Official acceptance of this new edition is expected.  When this occurs, a notice will be published in the Official Journal and the list of harmonized standards for each of the three medical device directives will be updated.

The previous edition of this ISO adoption also was identical to the ISO 13408-1:2008, including Amd 1:2013.  So what has changed in this update?  Firstly, this edition includes the mandate that the EN ISO editions should be substituted for the use of any original ISO editions for those standards in the referenced documents section (if available).  There is a table that specifies which of the referenced documents does have an EN adoption equivalent, including issue date for both the ISO and IEC originals and the EN adoptions themselves.

Next, the Z Annexes are expanded.  Since the standard is part of the harmonized lists of three directives, there are three Z Annexes — one for each of the applicable directives.  As I’ve mentioned before, these Z Annexes give you complete information on what’s termed “presumption of conformity,” that is, how adherance to the standard will meet essential requirements of the directive in question.  This is accomplished by a direct one-to-one correlation of the clauses of the standard to specific essential requirements that will be met by using the standard.

Over the last couple of years, this understanding of how medical device standards in particular meet the essential requirements of their directives has changed, most notibly with reference to risk management.  So those of you using these standards have had something of a chore wrapping your head around this situation.  The new Z Annexes clarify this to some degree.  However, you may still be left with a few questions.

Firstly,   you need to remember that above all your products that are sold in Europe need to meet the essential requirements of all applicable Directives.  So while the use of appropriate standards can make this easier, it may still leave you with essential requirements that are unmet.

Next, you’ll need to review the applicable Z Annex against the original Directive to see if there are any essential requirements that are unmet by the standard but still apply to your product.  If any non-met essential requirements aren’t applicable, there’s no need to worry any further.  However, if there are still essential requirements that apply to your product and are not covered by the standard you’ll need to take alternative paths to prove you meet the requirement none-the-less.

Where do these Z Annexes differ from those of the past?  First there are 4 notes that are new.  Note 1 and Note 2 clarify some basic risk management concepts that were unaddressed previously.  Note 3 again reiterates that the EN adoptions of referenced documents are being used.  Note 4 reminds you that if an essential requirement is not included in the Annex, it is not met by the standard.  The Z Annex tables then have more detailed information about presumption of conformity given by adherance to this standard.

If you use this standard, you’ll want to get a copy as soon as possible to begin your gap analysis, since formal adoption as a harmonized standard is expected although no firm date on this is available yet.  You have a number of choices.  Here at Document Center Inc. we suggest purchasing the SS EN ISO 13408-1.  It is low priced and is available in paper, for pdf download and for multi-user access.  Here is the direct link to the order page for SS EN ISO 13408-1.  We also have it available as the BS EN ISO 13408-1.  However that edition is available in paper format only.  The DIN EN ISO 13408-1 has not been released in the new edition yet.  Remember, any of the European National editions are as good as any other.

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