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European Commission publishes new list of harmonized standards

New list of harmonized standars has been published.

The new list of harmonized standars has been published by the commission in November 2017. Please click here to see copy of the Official Journal.

We highlight the important news:

  • EN ISO 13485:2016 is now harmonized. What are the changes from a non-harmonized to a harmonized standard? You might like to refresh it and you'll find it in the Blue Guide (paragraph 4.1.2). Former version, EN ISO 13485:2012, will be out of date (date of cessation of presumption of conformity of superseded standard) on the 31st March 2019.
  • Labelling and symbols: this controversial item has now a harmonized standard reference.

EN ISO 15223-1:2016 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03).

Please take a look at the Annex ZA, as the ER cross reference have changed slightly.

  • Corrigendum 2011 for the EN ISO 14155 has been published. The corrigendum is on technical definitions. 
  • Then, for the electromedical devices, some more "part 2" and some corrigendum have been added.