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EN ISO 11137-2:2015 Standard

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  Keywords:

#text #requirements #can #safety #general

  Directive

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

  Last Official Journal reference

Thursday 15th 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 13408-2:2011

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EN 13641:2002

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Elimination or reduction of risk of infection related to in vitro diagnostic reagents

EN 13612:2002/AC:2002

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Performance evaluation of in vitro diagnostic medical devices

EN 13612:2002

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

Performance evaluation of in vitro diagnostic medical devices

EN 13532:2002

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

General requirements for in vitro diagnostic medical devices for self-testing

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