In Vitro Diagnostic Medical Devices Directive (93/42/EEC)

There is a new publications in the OJEU of standards harmonised under the In Vitro Diagnostic Medical Devices Directive:

17th November 2017               2017/C 389/04               4 standards added

  • 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 and EN ISO 13485:2016/AC:2016
    Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016)
  • 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 2017-03)

 

 

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