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EN ISO 11137-2:2015 Standard

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  Keywords:

#text #requirements #can #safety #general

  Directive

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

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

  Purpose

ISO 11137-2 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility. It also provides methods to substantiate using 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10−6. EN ISO 11137-2:2015/A1:2023 modifies the European standard EN ISO 11137-2:2015. The main text and the consolidated version which consists of the main text and the amendment can be found in the standard’s history. In this amendment you can find: — Annex ZA, which describes the relationship between ISO 11137-2 and the General Safety and Performance Requirements of Regulation (EU) 2017/745 — Annex ZB, which describes the relationship between ISO 11137-2 and the General Safety and Performance Requirements of Regulation (EU) 2017/746

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes 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 13408-6:2011

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

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)

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 13408-5:2011

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

Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)

EN ISO 13408-4:2011

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

Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)

EN ISO 13408-3:2011

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

Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)

EN ISO 13408-1:2015

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

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)

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