Need help?

EN 13612:2002 Standard

wave
Save  

  Keywords:

#ivd #manufacturer #performance #mds #design

This standard can be totally or partially supervised by:
  •   EN 13612:2002/AC:2002
  •   Directive

    In vitro diagnostic medical devices Directive (98/79/EC)

      Last Official Journal reference

    Thursday 15th of April 2021

      Description:

    Performance evaluation of in vitro diagnostic medical devices

      Purpose

    EN 13612 applies to the performance evaluation of in vitro diagnostic medical devices (IVD MDs) including IVD MDs for self-testing. It specifies the responsibilities and general requirements for the planning, conduct, assessment and documentation of a performance evaluation study by the manufacturer. It does not apply to specific evaluation plans for certain IVD MDs or specific use. Where a manufacturer maintains a quality system EN 13612 addresses compliance with "design validation" and "design changes" as described in EN ISO 9001, EN 46001 and EN 928. EN 13612 helps to: – show evidence to notified bodies and national authorities by results of a performance evaluation that the IVD MD performs as claimed by the manufacturer, – establish adequate performance evaluation data originating from appropriate studies or resulting from available literature, and to – satisfy the requirements of a quality system for design validation.

      Publication

    Friday 17th of November 2017

      Related Standards

    EN 12322:1999

    In vitro diagnostic medical devices Directive (98/79/EC)

    In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media

    EN ISO 14971:2012

    In vitro diagnostic medical devices Directive (98/79/EC)

    Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

    EN 61010-2-101:2002

    In vitro diagnostic medical devices Directive (98/79/EC)

    Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements fo...

    EN ISO 23640:2015

    In vitro diagnostic medical devices Directive (98/79/EC)

    In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)

    EN ISO 20776-1:2006

    In vitro diagnostic medical devices Directive (98/79/EC)

    Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of p...

    EN ISO 18153:2003

    In vitro diagnostic medical devices Directive (98/79/EC)

    In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for ca...

      Stay up to date

      ACCESS

    Search for a standard
    GO

    Register

    Already a member?
    Login

      OTHER APPLICATIONS

    If you are interested in DO160 tests, you can give a try to our other free of charge software:
    CE-Marking assistant, Version: 1.3.0