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EN ISO 14161:2009

Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results (ISO 14161:2009)

Publication date:   Aug 20, 2010

General information

99.60 Withdrawal effective   Apr 17, 2019

CEN

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

European Norm

11.080.01   Sterilization and disinfection in general

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Scope

ISO 14161:2009 provides guidance for the selection, use and interpretation of results from application of biological indicators when used in the development, validation and routine monitoring of sterilization processes.
ISO 14161:2009 applies to biological indicators for which International Standards exist.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Legislation 93/42/EEC

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 14161:2000

NOW

WITHDRAWN
EN ISO 14161:2009
99.60 Withdrawal effective
Apr 17, 2019

REVISED BY

PUBLISHED
EN ISO 11138-7:2019