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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)

General information

Valid from 02.12.2019
Base Documents
ISO 11135:2014/Amd 1:2018; EN ISO 11135:2014/A1:2019
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
02.12.2019
Amendment
EVS-EN ISO 11135:2014/A1:2019
04.08.2014
Main
EVS-EN ISO 11135:2014

ISO 11135 describes requirements for the ethylene oxide sterilization process for medical devices in both industrial and healthcare facility settings. Compliance with ISO 11135 ensures products that meet the defined requirements for sterile products with a high degree of confidence. EN ISO 11135:2014/A1:2019 modifies the European standard EN ISO 11135:2014. The main text and the amendment can be found in the standard’s history.

In this amendment you can find the following:

— Relationship between EN ISO 11135 and the Essential Requirements of EU Directive 90/385/EEC on active implantable medical devices,
— Relationship between EN ISO 11135 and the Essential Requirements of EU Directive 93/42/EEC on medical devices,
— Relationship between EN ISO 11135 and the Essential Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices,
— Relationship between EN ISO 11135 and the General Safety and Performance Requirements of Regulation (EU) 2017/745,
— Relationship between EN ISO 11135 and the General Safety and Performance Requirements of Regulation (EU) 2017/746,
— Annex E (which specifies the release of a product from a single batch sterilization process).

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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