Need help?

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

wave
Save  

  Keywords:

#text #requirements #can #safety #general

  Directive

In vitro diagnostic medical devices Regulation ((EU) 2017/746)

  Last Official Journal reference

Wednesday 28th of January 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"

  Related Standards

EN ISO 20916:2024

In vitro diagnostic medical devices Regulation ((EU) 2017/746)

In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO ...

EN ISO 18113-1:2024

In vitro diagnostic medical devices Regulation ((EU) 2017/746)

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and gener...

EN ISO 13485:2016/A11:2021

In vitro diagnostic medical devices Regulation ((EU) 2017/746)

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

EN ISO 13408-6:2021

In vitro diagnostic medical devices Regulation ((EU) 2017/746)

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)

EN ISO 11737-2:2020

In vitro diagnostic medical devices Regulation ((EU) 2017/746)

Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validati...

EN ISO 18113-5:2024

In vitro diagnostic medical devices Regulation ((EU) 2017/746)

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instrumen...

  Stay up to date

  ACCESS

Search for a standard
GO

Register

Already a member?
Login

  OTHER APPLICATIONS

If you are interested in DO160 tests, you can give a try to our other free of charge software:
CE-Marking assistant, Version: 1.3.0