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

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  Keywords:

#amd #iso #devices #medical #process

  Directive

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

  Last Official Journal reference

Wednesday 25th of March 2020

  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)

  Publication

Wednesday 25th of March 2020

  Amendment

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

  Related Standards

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 556-1:2001/AC:2006

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

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminal...

EN 45502-2-2:2008

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

Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat ta...

EN 45502-2-2:2008/AC:2009

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

Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat ta...

EN 45502-2-3:2010

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

Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems

EN 60601-1:2006

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

Medical electrical equipment - Part 1: General requirements for basic safety and essential performanceIEC 60601-1:2005

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