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EN ISO 14937:2009 Standard

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  Keywords:

#process #medical #devices #sterilization #control

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)

  Purpose

This International Standard specifies general requirements for the characterization of a sterilizing agent and for the development, validation and routine monitoring and control of a sterilization process for medical devices.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN ISO 14937:2000"

Anyway is still possible use the "EN ISO 14937:2000" until April 30th, 2010

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EN ISO 10079-1:2009

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EN ISO 10079-2:2009

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EN ISO 10079-3:2009

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

EN ISO 10328:2016

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

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