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

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  Keywords:

#devices #medical #process #sterilization #control

  Directive

Medical devices Directive (93/42/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)

  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

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EN ISO 5359:2008

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EN ISO 4135:2001

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Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001)

EN ISO 3826-4:2015

Medical devices Directive (93/42/EEC)

Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated featur...

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