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EVS-EN ISO 11138-4:2017

Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2017)

General information
Valid from 18.04.2017
Base Documents
EN ISO 11138-4:2017; ISO 11138-4:2017
Directives or regulations
None
Standard history
Status
Date
Type
Name
18.04.2017
Main
07.09.2006
Main
This document specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing dry heat as the sterilizing agent at sterilizing temperatures within the range of 120 °C to 180 °C. NOTE 1 Requirements for validation and control of dry heat sterilization processes are provided by ISO 20857. NOTE 2 Requirements for work place safety can be provided by national or regional regulations.
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