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EVS-EN ISO 11137-1:2006/A1:2013

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/Amd 1:2013)

General information

Withdrawn from 02.07.2015
Base Documents
ISO 11137-1:2006/Amd 1:2013; EN ISO 11137-1:2006/A1:2013
ICS Groups
11.080.01 Sterilization and disinfection in general
Directives or regulations
None

Standard history

Status
Date
Type
Name
02.07.2015
Main
EVS-EN ISO 11137-1:2015
09.09.2013
Amendment
EVS-EN ISO 11137-1:2006/A1:2013
06.06.2006
Main
EVS-EN ISO 11137-1:2006
This part of ISO 11137 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. NOTE Although the scope of this part of ISO 11137 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment.

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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