The Commission publishes NEW list of harmonised standards

The European Commission published an updated list of CEN/ Cenelec harmonised standards in the framework of the implementation of the IVD Directive 98/79/EC.

The harmonised standards published for the first time in the Official Journal of the EU are:

  • EN ISO 11137-1:2015 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)

  • EN ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2016)

  • EN ISO 13485:2016/AC:2016

  • 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 2016-12- 15)

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