Just a quickie. This link “of the IEC-TECH nesletter” gives a very good one-page overview of what is the GHTF - Global Harmonization Task Force.

A new updated list oh harmonized standards related to the european medical devices directives - MDD - has been published in the official journal and Europa website.

Harmonized standards - Medical devices - Directive 93/42/EEC concerning medical devices isthe link for the full list.

This is the link for the official journal update.

The link to the new version of the directive (i don´t remember if i have put this out before) is: Council Directive 93/42/EEC of 14 June 1993 concerning medical devices.

These links are all or related to the EUR-Lex website, the site for the european law.

Canada is one of the first countries to officialy establish a transition period to the third edition of IEC 60601. In truth, they have already adopted the new versions of IEC 60601-1 and IEC 60601-1-2, removing the previous editions from the Health Canada List of Recognized Standards. This meant that only the new versions could be used. But this position was reviewed due to the difficult in the implementaion of the new standard (the main problem is the requirement for a risk management process based on ISO 14971), so they reinserted the older editions in the list. This means that, until December 15, 2008, the old or the new version can be used for regulatory purposes. After that, only the new edition. It´s a short period, but will surely help manufacturers in the adaptation process.

More information on the original link: Inclusion of Second and Third Editions of IEC 60601-1 and IEC 60601-2 on TDP List of Recognized Standards

Thanks for Dmitry from the Elsmar Cove Forum for the tip.