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SRPS 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)

Sep 25, 2017

General information

60.60     Sep 25, 2017

ISS

Z076

European Norm

11.080.01     11.080.20  

English  

Plan 2017.

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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WITHDRAWN
SRPS EN ISO 11138-2:2011

NOW

PUBLISHED
SRPS EN ISO 11138-2:2017
60.60 Standard published
Sep 25, 2017

Related project

Adopted from EN ISO 11138-2:2017

Adopted from ISO 11138-2:2017