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EN ISO 11138-1:2006

Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2006) EN ISO 11138-1:2006

Publication date:   Dec 27, 2006

General information

99.60 Withdrawal effective   Mar 29, 2017

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 11138-1:2006 provides general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes.ISO 11138-1:2006 specifies basic and common requirements that are applicable to all subsequent parts of ISO 11138. Requirements for biological indicators for particular specified processes are provided in the subsequent parts of ISO 11138. If no specific subsequent part is provided, this part applies.

Related legislation

Legislation related to this standard

90/385/EEC

Active implantable medical devices

Legislation 90/385/EEC
93/42/EEC

Medical devices

Legislation 93/42/EEC

Life cycle

PREVIOUSLY

WITHDRAWN
EN 866-1:1997

NOW

WITHDRAWN
EN ISO 11138-1:2006
99.60 Withdrawal effective
Mar 29, 2017

REVISED BY

PUBLISHED
EN ISO 11138-1:2017