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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 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 60601-2-29:2008

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EN ISO 10651-2:2009

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Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilat...

EN ISO 10079-1:2009

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Medical suction equipment - Part 1: Electrically powered suction equipment - Safety requirements (ISO 10079-1:1999)

EN ISO 10079-2:2009

Medical devices Directive (93/42/EEC)

Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:1999)

EN ISO 10079-3:2009

Medical devices Directive (93/42/EEC)

Medical suction equipment - Part 3: Suction equipment powered from a vacuum or pressure source (ISO 10079-3:1999)

EN ISO 10328:2016

Medical devices Directive (93/42/EEC)

Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2016)

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