IEC 62366-1 Corrigendum

A new Corrigendum 1 has been released for the IEC 62366-1 Edition 1.0.  This standard is titled “Medical devices – Part 1: Application of usability engineering to medical devices.”  It is a widely used standard in the medical device industry.  But what exactly does this new Corrigendum do?

Many of our customers have questions when a corrigendum is released for an international standard.  So let’s take a look at what a corrigendum is and why it is issued for a given document.

Basically, a corrigendum is a change notice.  Similar updates are issued for other standards as errata, changes notices, and so on.  This type of change is too small to warrant an amendment.  But it is a change that affects the technical content of the publication.

You will find the true definition of a technical corrigendum in the ISO/IEC Directive 1.  These directives provide you with the administrative information for understanding the standards process.  They also define many of the document types ISO and IEC use.

Some things to note about a technical corrigendum.  It is issued when the change has a material affect on the techical content.  So it will always address an error or ambiguity that could “lead to incorrect or unsafe application of the publication.”   And it is not usually issued for a publication that is over 3 years old.

Now to the technical corrigendum for IEC 62366-1.  This correction sheet has been issued because of an error in numbering the references to a particular paragraph within the standard.  And it’s true, using the  wrong paragraph can lead to errors.  So the change fits the requirements for issuing a corrigendum.

There are 2 sections of the standard that have been affected by this inadvertent error in referencing,  Section C.1 (General) and Section C.2.4 (Risk control).    Your new corrigendum will give you the correct information.  You should keep the corrigendum with the document it affects.  And you might also like to make “pen and ink” changes to the body of the document so there’s no change of confusion.

How do you find out when a corrigendum has been issued?  Rely on Document Center Inc.’s notification service.  We track all components of the standards we sell.  And our notification service provides you with timely emails when changes to your collection have been made.  As I have noted above, technical corrigenda provide you with information the committee deems to be critical to the correct use of the standard.  You will want to make sure that when a corrigendum is issued for any of the standards you use, you are informed and get a copy promptly.

Just get in touch with our staff to get your copy.  You can  reach us by phone (650-591-7600) or email (  We are happy to help you understand the standards you use, how they are issued, and what you need in order to be current.  Make us your Standards Experts!

Correction issued to BS EN ISO 13485:2012 Edition for Medical devices. Quality management systems. Requirements for regulatory purposes

It seems like the 2012 of BS EN ISO 13485,”Medical devices. Quality management systems. Requirements for regulatory purposes,” was just released.  But a few corrections have been found so the consolidated BS EN ISO 13485:2012 with Corrigendum 1 is now available from Document Center Inc.  A Corrigendum is a technical correction sheet and the EN standards are released as interfiled reprints of the original document.

The CENELEC corrigendum is from July 2012, but the integration into the BS Edition is dated 9/30/2012.  There are two corrections:  the title was altered and Table ZC.3 (Relationship with Annex IV of Directive 98/79/EC) was updated.

If you bought your copy of the BS EN ISO 13485:2012 from Document Center Inc., we’ll provide you with a corrected copy for a modest printing fee.  If not, you’ll need to purchase the new copy in its entirety.  You can order the document on our website,   Otherwise, contact us by phone (650-591-7600), fax (650-591-7617) or email ( for more information.