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

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - Amendment 1 (ISO 11137-2:2013/Amd 1:2022)

General information

Valid from 02.05.2023
Base Documents
ISO 11137-2:2013/Amd 1:2022; EN ISO 11137-2:2015/A1:2023
ICS Groups
11.080.01 Sterilization and disinfection in general
Directives or regulations
2017/745 Medical devices (MDR) 2017/746 In vitro diagnostic medical devices (IVDMDR)

Standard history

Status
Date
Type
Name
02.05.2023
Amendment
EVS-EN ISO 11137-2:2015/A1:2023
02.05.2023
Main + amendment
EVS-EN ISO 11137-2:2015+A1:2023
02.07.2015
Main
EVS-EN ISO 11137-2:2015

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

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Related products

Main + amendment

EVS-EN ISO 11137-2:2015+A1:2023

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013 + ISO 11137-2:2013/Amd 1:2022)
Newest version Valid from 02.05.2023
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 11737-2:2020

Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)
Newest version Valid from 02.06.2020
Main

EVS-EN ISO 11135:2014

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
Newest version Valid from 04.08.2014

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Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English