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EVS-EN ISO 11138-5:2017

Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2017)

General information

Valid from 18.04.2017
Base Documents
ISO 11138-5:2017; EN ISO 11138-5:2017
ICS Groups
11.080.20 Disinfectants and antiseptics
Directives or regulations
None

Standard history

Status
Date
Type
Name
18.04.2017
Main
EVS-EN ISO 11138-5:2017
07.09.2006
Main
EVS-EN ISO 11138-5:2006
ISO 11138-5:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing low-temperature steam and formaldehyde as the sterilizing agent.
NOTE 1 Requirements for validation and control of low-temperature steam and formaldehyde sterilization processes are provided by ISO 14937.
NOTE 2 Requirements for work place safety can be provided by national or regional regulations.

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Standard monitoring
English (PDF 428 KB)

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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