EN ISO 15225, “Medical devices. Quality management. Medical device nomenclature data structure,” has been updated and the 2016 Edition is available from Document Center Inc. in a number of national editions. This new update adopts the ISO 15225 3rd Edition from 3/2016. It replaces the previous 2010 Ediiton which is now obsolete.
Because EN ISO 15225 is not part of the harmonized standards list for any of the EU Directives, there are no Annexes and no “transition time.” However, according to the usual EU protocol, all of the European Union nations must adopt this new revision as a national standard by October 2016. This means that all identical or conflicting national standards must be withdrawn by October 2016 as well.
Further, should you purchase a copy of this document in English, French or German, the text will be the official text as issued by the EU. All other language editions are actually translated by the European nation releasing the adoption. However, those translated editions, if properly notified to CEN and/or CENELEC, do have the same status as the official versions.
Since this is an adoption of an ISO standard, the core content is the ISO standard itself. This standard defines the Global Medical Device Nomenclature (GMDN). If you are not familiar with the major changes in the ISO 15225 3rd Edition, here are the highlights:
- Template terms have been removed as the hierarchy within the GMDN is now managed with the use of ‘collective terms’
- ‘Device category’ has been removed and replaced by the use of ‘collective terms’
- The prefix ‘preferred’ has been removed from term in the document and the word ‘term’ now denotes the primary identifier for generic device groups of medical devices
- ‘Collective terms’ can now be used by medical device regulators and other users to select larger groups of medical devices and analize larger sets of data. ‘Terms’ however remain the only way to identify generic device groups of medical devices
- ‘Device type’ data specification has been removed as it is outside the scope of the GMDN dataset, but remains a concept to which GMDN data are linked
When it comes to getting a copy of the new European standard, you have a wide range of choices. Here at Document Center Inc., we provide authorized copies of the BS EN ISO 15225 and of the SS EN ISO 15225. Of course, you can also search for and order European standards at our webstore, www.document-center.com. And if you have questions (as many people do), please contact our staff by phone (650-591-7600) or email (info@document-center.com). We’re your Standards Experts!