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EVS-EN ISO 11140-3:2009

Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test

General information
Valid from 07.08.2009
Base Documents
ISO 11140-3:2007+Cor1:2007; EN ISO 11140-3:2009
ICS Groups
11.080.01 Sterilization and disinfection in general
Directives or regulations
93/42/EEC Medical devices (MDD)

Standard history

Status
Date
Type
Name
07.08.2009
Main
EVS-EN ISO 11140-3:2009
07.10.2008
Corrigendum
EVS-EN ISO 11140-3:2007/AC:2008
Main
EVS-EN ISO 11140-3:2007
This part of ISO 11140 specifies the requirements for chemical indicators to be used in the steam penetration test for steam sterilizers for wrapped goods, e.g. instruments and porous materials. The indicator for this purpose is a Class 2 indicator as described in ISO 11140-1.
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Standard monitoring
English

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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

Contact

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Reg. code 80120020
Eesti Standardimis- ja Akrediteerimiskeskus MTÜ
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