Need help?

EN 556-1:2001 Standard

wave
Save  

  Keywords:

#devices #medical #european #standard #specifies

This standard can be totally or partially supervised by:
  •   EN 556-1:2001/AC:2006
  •   Directive

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

      Last Official Journal reference

    Thursday 15th of April 2021

      Description:

    Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices

      Purpose

    This European Standard specifies the requirements for a terminally-sterilized medical device to be designated 'STERILE': Part 2 of this European Standard specifies the requirements for an aseptically processed medical device to be designated "STERILE".

      Publication

    Friday 17th of November 2017

      Reference

    This standard supersedes the "EN 556:1994 + A1:1998"

    Anyway is still possible use the "EN 556:1994 + A1:1998" until April 30th, 2002

      Related Standards

    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 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 ISO 13408-5:2011

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

    Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)

    EN ISO 13408-6:2011

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

    Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)

    EN ISO 13408-7:2015

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

    Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408...

    EN ISO 13485:2016

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

    Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

      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