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Norm

ISO 11138-2:2017

Issue date: 2017 03 03

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

ISO 11138-2:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the per...
Valid
Publisher:
International Organization for Standardization
Format:
Digital | 6 Pages
Language:
English

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.

ISO 11138-2:2017
2017 03 03
Sterilization of health care products — Biological indicators — Part 2: Biological indicators for et...
Norm
ISO 11138-2:2006
2006 06 26
Sterilization of health care products — Biological indicators — Part 2: Biological indicators for et...
Norm
ISO 11138-2:1994
1994 10 06
Sterilization of health care products — Biological indicators — Part 2: Biological indicators for et...
Norm