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 (info@document-center.com). 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!