Get our free email newsletter

EU Commission Updates List of Standards for Medical Device Directive

The Commission of the European Union (EU) has issued a revised and updated list of standards that can be used to demonstrate conformity with the essential requirements its Directive 93/42/EEC concerning medical devices.

The Directive defines a ‘medical device’ as “any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application….to be used for human beings for the purpose of: 1) diagnosis, prevention, monitoring, treatment or alleviation of disease; 2) diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap; 3) investigation, replacement or modification of the anatomy or of a physiological process; or 4) control of conception.”

The revised list of CEN and Cenelec standards was published in May 2014 in the Official Journal of the European Union, and replaces all previously published standards lists for the Directive.

- Partner Content -

Magnetic Field Conversions

This download provides a table of magnetic field conversion factors of microvolts-per meter, gauss, picotesla, microampere-per-meter, weber per-square meter, and gamma with values of either 0 db or 1 as a starting point.

Download the revised list of standards for the EU’s Medical Device Directive.

 

 

Related Articles

Digital Sponsors

Become a Sponsor

Discover new products, review technical whitepapers, read the latest compliance news, trending engineering news, and weekly recall alerts.

Get our email updates

What's New

- From Our Sponsors -

Sign up for the In Compliance Email Newsletter

Discover new products, review technical whitepapers, read the latest compliance news, trending engineering news, and weekly recall alerts.