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SRPS EN ISO 11138-1:2009

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

Apr 27, 2009
95.99 Withdrawal of Standard   Sep 25, 2017

General information

95.99     Sep 25, 2017

ISS

Z076

European Norm

11.080.01  

English  

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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 directives

Directives related to this standard.

90/385/EEC

Active implantable medical devices

93/42/EEC

Medical devices

Life cycle

NOW

WITHDRAWN
SRPS EN ISO 11138-1:2009
95.99 Withdrawal of Standard
Sep 25, 2017

REVISED BY

PUBLISHED
SRPS EN ISO 11138-1:2017

Related project

Adopted from EN ISO 11138-1:2006

Adopted from ISO 11138-1:2006 IDENTICAL