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ISO 11138-1:2006

Sterilization of health care products -- Biological indicators -- Part 1: General requirements

General information

Withdrawn from 03.03.2017
ICS Groups
11.080.01 Sterilization and disinfection in general
Directives or regulations
None

Standard history

Status
Date
Type
Name
03.03.2017
Main
ISO 11138-1:2017
Main
ISO 11138-1:2006
Main
ISO 11138-1:1994
ISO 11138-1:2006 provides general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes.ISO 11138-1:2006 specifies basic and common requirements that are applicable to all subsequent parts of ISO 11138. Requirements for biological indicators for particular specified processes are provided in the subsequent parts of ISO 11138. If no specific subsequent part is provided, this part applies.

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Standard monitoring
English (PDF 210 KB)

Related products

Main

ISO 11138-1:2017

Sterilization of health care products -- Biological indicators -- Part 1: General requirements
Newest version Valid from 03.03.2017
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
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

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