EN ISO 15882:2008

Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results (ISO 15882:2008)

Publication date:   Mar 27, 2009

General information

60.60   Standard published   Sep 1, 2008

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 15882:2008 provides guidance for the selection, use and interpretation of results of chemical indicators used in process definition, validation and routine monitoring and overall control of sterilization processes.
ISO 15882:2008 applies to indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor one or more of the variables required for a sterilization process. These chemical indicators are not dependent for their action on the presence or absence of a living organism.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 15882:2003

NOW

PUBLISHED
EN ISO 15882:2008
60.60 Standard published
Sep 1, 2008