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EVS-EN ISO 11139:2018

Sterilization of health care products - Vocabulary - Terms used in sterilization and related equipment and process standards (ISO 11139:2018)

General information

Valid from 03.10.2018
Base Documents
ISO 11139:2018; EN ISO 11139:2018
Directives or regulations
None

Standard history

Status
Date
Type
Name
15.02.2024
Main + amendment
01.02.2024
Amendment
03.10.2018
Main
This document defines terms in the field of the sterilization of health care products including related equipment and processes.

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Amendment

EVS-EN ISO 11137-1:2015/A2:2019

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137-1:2006/Amd 2:2018)
Newest version Valid from 02.12.2019
Main

EVS-EN ISO 11137-3:2017

Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017)
Newest version Valid from 02.08.2017
Main

EVS-EN ISO 11137-2:2015

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
Valid from 02.07.2015
Main

EVS-EN ISO 11137-1:2015

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)
Newest version Valid from 02.07.2015