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News and Views October 2011

Standard update (EN 60601-1:2006 referred also to the third edition of 601)

Normally MDSS does not make it part of its newsletter when a standard is being updated.  Standards are being updated all the time and manufacturers have written procedures in place to become aware of updates or new releases of standards concerning their products - in particular European harmonized standards.  EN ISO 13485 refers to the control of external documents and standards definitely fall under that definition. 

With the EN 60601-1:2006 it is somewhat different.  As can be seen from the publication date the third edition is around for quite some time but the implementation was somewhat difficult.  This was due to a number of controversial requirements.  The "date of cessation of presumption of conformity of superseded standard" as set by the European Commission is now set for June 1, 2012

What does this mean?  With the previous version of this standard the compliance can not be assumed any longer after that date.  If someone uses the standard for satisfying the essential requirements we strongly recommend as with any other standard to act quickly bringing the products into compliance.  This may be done with the new version of the standards but the directive allows also for other means of compliance which may be considered.  However, that the product is in compliance until June 1, 2012 it will be difficult to argue that the product will be in compliance after that date.  In particular for this standard because authorities made it clear that they like to see the updated version implemented.

We are also being ask whether this would apply to new designed products only and old designs with its testing is being grandfathered.  Meaning that products, if they are not being changed, can be placed on the market without the consideration of the new standard.
Unfortunately this is not how the European system works.  It is the law that the product must be in compliance to all applicable current requirements at the time when it is being physically placed on the market.  So a product developed, tested and found to be in compliance a few years back will not be considered in compliance when it is being placed on the market a day after June 1, 2012 with the previous version of the standard tested. At least a documented consideration of the new requirements and their fulfillment is obligatory.

We strongly recommend to immediately start the update process now -if not already done.  We shall see that test houses may become very busy next year.  Also keep in mind that the third edition has a number of new requirements.  Should the device not pass the test a redesign may be indicated. 

A first step could be to make yourself familiar with the update.  I would believe that a number of Seminars are being offered.  I was made aware of one from TUV SUD America Inc.  Here is the is the link to the brochure:  A TUV representative from Europe will present and will be equipped to outline the changes from the European perspectives.

The MDSS team

Ludger Moeller

President, MDSS