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EN ISO 11138-2:2017

Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2017) EN ISO 11138-2:2017

Publication date:   Jul 12, 2017

General information

60.60 Standard published   Mar 29, 2017

CEN

CEN/TC 102 Sterilizers and associated equipment for processing of medical devices

European Norm

11.080.20   Disinfectants and antiseptics

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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WITHDRAWN
EN ISO 11138-2:2009

NOW

PUBLISHED
EN ISO 11138-2:2017
60.60 Standard published
Mar 29, 2017