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EN ISO 11137-1:2015/A2:2019 Standard

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  Keywords:

#devices #medical #process #sterilization #control

  Directive

Active implantable medical devices Directive (90/385/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

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)

  Purpose

Amendment for EN ISO 11137-1:2015

  Publication

Wednesday 25th of March 2020

  Amendment

This standard is an amendment for "EN ISO 11137-1:2015"

  Related Standards

EN ISO 11607-1:2009

Active implantable medical devices Directive (90/385/EEC)

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging sy...

EN 556-2:2015

Active implantable medical devices Directive (90/385/EEC)

Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptic...

EN ISO 10993-5:2009

Active implantable medical devices Directive (90/385/EEC)

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)

EN ISO 10993-4:2009

Active implantable medical devices Directive (90/385/EEC)

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd...

EN ISO 10993-3:2014

Active implantable medical devices Directive (90/385/EEC)

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:...

EN ISO 10993-1:2009/AC:2010

Active implantable medical devices Directive (90/385/EEC)

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)

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