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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

Friday 17th of November 2017

  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

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EN ISO 10993-18:2009

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EN ISO 11135-1:2007

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

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

EN ISO 11137-1:2015

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

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

EN ISO 11138-2:2009

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

Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization pro...

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