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EN ISO 11137-2:2015 Standard

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  Keywords:

#part #methods #kgy #sterility #achieve

  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 2: Establishing the sterilization dose (ISO 11137-2:2013)

  Purpose

This part of ISO 11137 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10−6. This part of ISO 11137 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose. This part of ISO 11137 defines product families for sterilization dose establishment and sterilization dose audit.

  Publication

Friday 17th of November 2017

  Reference

This standard superseed the "EN ISO 11137-2:2013"

Anyway is still possible use the "EN ISO 11137-2:2013" until June 30th, 2016

  Related Standards

EN ISO 13408-2:2018

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

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EN ISO 11737-1:2006/AC:2009

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

Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (...

EN ISO 11137-1:2015/A2:2019

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Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a ster...

EN ISO 10993-11:2018

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

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)

EN ISO 10993-6:2009

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

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)

EN ISO 10993-7:2008

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

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)

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