EN ISO 11138-3:2009

Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006)

Publication date:   Aug 20, 2010

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 11138-3:2006 provides specific requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing moist heat as the sterilizing agent.
Moist heat as the sterilizing agent is defined in ISO 11138-3:2006 as dry saturated steam. While air-steam mixtures may be used in moist heat sterilization processes, the methods and performance requirements of this part of ISO 11138 might not be applicable for biological indicators used in such processes.

Related legislation

Legislation related to this standard

90/385/EEC

Active implantable medical devices

Harmonized/Supporting
93/42/EEC

Medical devices

Harmonized/Supporting
2007/47/EC

Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 11138-3:2006

NOW

WITHDRAWN
EN ISO 11138-3:2009
99.60 Withdrawal effective
Mar 29, 2017

REVISED BY

PUBLISHED
EN ISO 11138-3:2017

Relations

Adopted from ISO 11138-3:2006 IDENTICAL