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ISO 11138-2:2017

Current Revision

Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes

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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.


SDO ISO: International Organization for Standardization
Document Number ISO 11138
Publication Date Not Available
Language en - English
Page Count
Revision Level
Supercedes
Committee ISO/TC 198
Publish Date Document Id Type View
Not Available ISO 11138-2:2017 Revision