SS-EN-ISO-11138-2 › Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2017)
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ISO 11138-2:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxide gas or mixtures of this gas with diluent gases, at sterilizing temperatures within the range of 29 °C to 65 °C. NOTE 1 Requirements for validation and control of ethylene oxide sterilization processes are provided by ISO 11135 and ISO 14937. NOTE 2 National or regional regulations can provide requirements for work place safety.
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11.080 (Sterilization and disinfection)
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Designation Name
SS-EN ISO 11138-2:2017
Revision Level
2017 EDITION
Status
Current
Publication Date
April 5, 2017
Language(s)
English
Page Count
24
International Equivalent
EN ISO 11138-2:2017(IDT); ISO 11138-2:2017(IDT)