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EN ISO 11137-1:2015 Standard

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  Keywords:

#requirements #part #specifies #sterilization #may

  Directive

In vitro diagnostic medical devices Directive (98/79/EC)

  Last Official Journal reference

Friday 17th of November 2017

  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

This part of ISO 11137 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. NOTE Although the scope of this part of ISO 11137 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment.

  Publication

Friday 17th of November 2017

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