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EN ISO 11137-2:2015/A1:2023 Standard

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  Keywords:

#text #requirements #can #safety #general

  Directive

Medical devices Regulation ((EU) 2017/745)

  Last Official Journal reference

Thursday 11th of June 2026

  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 8th of March 2024

  Amendment

This standard is an amendment for "EN ISO 11137-2:2015"

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