The EN 45502-1, “Implants for surgery. Active implantable medical devices. General requirements for safety, marking and for information to be provided by the manufacturer,” has just been updated. The new 2015 Edition replaces the previous 1998 Edition which is now obsolete. European nations have until 4/20/2016 to adopt the new revision. All conflicting or duplicating national standards must be withdrawn by 4/20/2018.
EN 45502-1 is the European standard for general requirements for the basic safety of active implantable medical devices. To reduce the risks of mishandling and/or misuse, the standard also provides users with comprehensive information on markings, instructions, and other documentation requirements to be supplied by manufacturers for their customers. At this time, there are three additional parts of the series. One is for bradyarrhythmia devices (cardiac pacemakers).The second specifies additional requirements for devices for tachyarrhythmia (like implantable defibrillators). And the third covers implantable devices for cochlear and auditory brainstem implant systems.
What’s new in the 2015 Edition of EN 45502-1?
- It’s been updated to meet the requirements of the modified definition of AIMD (Active Implantable Medical Device) which now includes “software.”
- The definition of “state of the art” has been updated.
- Some usability issues are now addressed.
- Links to information security have been implemented.
- The elements of the standard have been harmonized to match EN 14971 from 2012.
- Clause 14 has been updated and improved.
- Clause 20 has also be updated and improved.
- Clause 22 has been updated and improved, particularly for ultrasonic diagnostic devices.
You will also want to note that the Annexes A and B from the 1998 edition have now been consolidated and updated as the new Annex ZZ. This Annex is important as it provides you with the information required to map the clauses of the EN 45502-1 with the essential requirements of Directive 90/385/EEC (as modified by amendment 2007/47/EC) on implantable medical devices. You’ll use this ZZ mapping to insure that your device meets the legal requirements for selling it in Europe.
Where can you get a copy of the EN 45502-1? You’ll want to purchase your copy of this copyright publication from an authorized dealer like Document Center Inc. You’ll have choices, since legal copies are published by each country in Europe. Right now you’ll be able to get the EN 45502-1 in paper format as BS EN 45502-1 (Here’s the link to the order page for BS EN 45502-1). You can get it in both paper format and as a pdf download in the SS EN 45502-1 Edition (Here’s the link to order SS EN 45502-1). It’s also available for multi-user access using our Standards Online service. Contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com) for more information.
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