SR EN ISO 11138-2:2009

Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006)

ISO 11138-2:2006 provides specific 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.

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General information

Status : Withdrawn
Approval date : 10/30/2009
Publish date : 11/1/2009
Withdrawal date : 8/31/2017
Number of pages : 14
ICS : 11.080.01 Sterilization and desinfectation
Technical Committee : 377 - Medical devices

Relations with other standards:

Replaces SR EN ISO 11138-2:2006
Normative reference SR EN ISO 18472:2006
Normative reference SR EN ISO 11138-1:2007
Replaced by SR EN ISO 11138-2:2017