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ISO 11138-2:2017

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

Publication date:   Mar 3, 2017

General information

90.93 Standard confirmed   Dec 9, 2022

ISO

ISO/TC 198 Sterilization of health care products

International Standard

11.080.01   Sterilization and disinfection in general

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Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 11138-2:2006

NOW

PUBLISHED
ISO 11138-2:2017
90.93 Standard confirmed
Dec 9, 2022