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SSH EN ISO 11138-4:2017

Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2017)

Oct 23, 2017

General information

60.60     Jul 17, 2017

DPS

DPS/KT 206

European Norm

11.080.01     11.080.20  

English  

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Scope

ISO 11138-4:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing dry heat as the sterilizing agent at sterilizing temperatures within the range of 120 °C to 180 °C.
NOTE 1 Requirements for validation and control of dry heat sterilization processes are provided by ISO 20857.
NOTE 2 Requirements for work place safety can be provided by national or regional regulations.

Life cycle

PREVIOUSLY

WITHDRAWN
SSH EN ISO 11138-4:2006

NOW

PUBLISHED
SSH EN ISO 11138-4:2017
60.60 Standard published
Jul 17, 2017

Related project

Adopted from EN ISO 11138-4:2017

Adopted from ISO 11138-4:2017