SS-EN-ISO-11138-4 › Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2017)
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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.
To find similar documents by classification:
11.080 (Sterilization and disinfection)
Medical devices
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Designation Name
SS-EN ISO 11138-4:2017
Revision Level
2017 EDITION
Status
Current
Publication Date
April 5, 2017
Language(s)
English
Page Count
24
International Equivalent
EN ISO 11138-4:2017(IDT); ISO/WD 11138-4(IDT)