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prEN ISO 11135

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2025)

General information

Draft
Base Documents
ISO/DIS 11135; prEN ISO 11135
ICS Groups
11.080.01 Sterilization and disinfection in general
Directives or regulations
None
You can view draft standards in the Commenting portal🡭.

Standard history

Status
Date
Type
Name
Main
prEN ISO 11135
02.12.2019
Amendment
EVS-EN ISO 11135:2014/A1:2019
04.08.2014
Main
EVS-EN ISO 11135:2014
ISO 11135:2014 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.

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Standard monitoring

Related products

Main

EVS-EN ISO 11737-2:2020

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Amendment

EVS-EN ISO 11135:2014/A1:2019

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)
Newest version Valid from 02.12.2019
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

EVSEstonian standard
ENEuropean standard (published by an CEN or CENELEC)
EN ISOInternational standard adopted as an European standard
ISOInternational Organization for Standardization’s standard
IECInternational Electrotechnical Commission’s standard
HDCENELEC’s harmonisation document
EVS-ENEuropean standard implemented in Estonia
EVS-EN ISOInternational standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IECInternational standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IECInternational electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
 
A, AMDamedment
+Aa full standard plus the amendment
/Aonly amendment
COR, ACcorrigendum
+CORa full standard plus the corrigendum
NAnational annex
+NAa full standard plus the national annex
/NAonly national annex
TStechnical specification
TRtechnical report
CWAagreement, developed by a CEN or CENELEC
prEVS-EN (etc)draft standard
 
etthe standard is in Estonian only
enthe standard is in English only
et-enthe standard is in Parallel text Estonian-English