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EN ISO 11137-2:2015 Standard

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  Keywords:

#describes #achieve #sterility #relationship #general

This standard can be totally or partially supervised by:
  •   EN ISO 11137-2:2015/A1:2023
  •   Directive

    Medical devices Regulation ((EU) 2017/745)

      Last Official Journal reference

    Tuesday 8th of April 2025

      Description:

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

      Purpose

    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.EN-ISO 11137-2 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility. It also provides 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.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 8th of March 2024

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