Tag: Z Annexes

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.

Still have questions?  You’ll find our staff to be most helpful in assisting you with your purchasing decisions and other standards questions.  Reach them by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Want to find and order a standard from our extensive online catalog?  Head to www.document-center.com now.  We’ve been working with standards since 1982.  Make us your Standards Experts!

EN ISO 14971 and the presumption of conformity

EN ISO 14971, “Medical devices – Application of risk management to medical devices,” and it’s Annex Z’s are continuing to give medical device manufacturers heartburn!  At the root of the matter is the issue of the presumption of conformity — The concept that adherence to a harmonized EN standard provides the user with proof of conformance to the applicable Directive.  With the issuance of the Z Annexes in 2012 for EN ISO 14971, gaps were revealed and this is causing doubt about the basic tenets of the New Approach from back in the 1990’s.

However, there are sources available that can shed some light on how to bridge the gap from the EN ISO 14971’s requirements to those of the 3 relevant European Directives (90/385/EEC, 93/42/EEC and 98/79/EC).  One of the best documents I’ve found in recent months is the Team-NB’s Consensus Paper for the Interpretation and Application of Annexes Z in EN ISO 14971: 2012.

Team NB is the European Association for Medical devices of Notified Bodies, a group whose members are the Notified Bodies themselves.  These organizations do the auditing for EN certification to the various directives, and in particular in this case, the medical device directives noted above.

As with all certification to the medical device directives, the gap exposed in the “presumption of conformity” by the amended Z Annexes in 2012 has caused a great deal of confusion among medical device companies.  So Team-NB created a consensus paper to help shed light on what can reasonably be expected of medical device manufacturers needing to have product certified for sale in Europe.

This particular paper provides device makers with clean and concrete information on how to reconcile the language of EN ISO 14971 with that of the 3 directives.  Additionally, it makes recommendations to auditors and to the standards bodies responsible for both ISO 14971 and IEC 60601-1.

For industry, there is information and recommendations for all 7 of the content deviations that have been brought to light by the latest edition of the 3 Z Annexes.  This content deviations are:

  • Treatment of negligible risks
  • Discretionary power of manufacturers as to acceptability of risks
  • Risk reduction “as far as possible” versus “as low as reasonably practicable”
  • Discretion as to whether a risk-benefit analysis needs to take place
  • Discretion as to the risk control options
  • Deviation as to the first risk control option
  • Information of the users influencing the residual risk

You’ll be pleased to know that there is an explanation of each deviation as well as specific actionable recommendations for each.  Combined with the material in the first 3 Sections (Introduction, Terminology, and General Considerations), you will have a good understanding of what’s generated these issues and what you’ll need to do now that they have been raised.

Meantime, if you do not have the latest edition of EN ISO 14971, you’ll need to get a copy.  The document is covered by copyright and must be purchased from an authorized dealer like Document Center Inc.  It can only be purchased as a national edition since the EN documents are not published in any other format.  Take a look at these three options offered by Document Center:  SIS EN ISO 14971, BS EN ISO 14971, and DIN EN ISO 14971.  All three are in English, so you’ll make your buying decision based on the formats available and the price.  Remember:  Document Center Inc. is your Standards Expert!