EN ISO 11138-5:2017

Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2017)

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 11138-5:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing low-temperature steam and formaldehyde as the sterilizing agent.
NOTE 1 Requirements for validation and control of low-temperature steam and formaldehyde sterilization processes are provided by ISO 14937.
NOTE 2 Requirements for work place safety can be provided by national or regional regulations.

Life cycle

PREVIOUSLY

Replaces
EN ISO 11138-5:2006

NOW

PUBLISHED
EN ISO 11138-5:2017
60.60 Standard published
Mar 29, 2017