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EN ISO 11737-2:2009

Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009) EN ISO 11737-2:2009

Publication date:   Aug 20, 2010

General information

99.60 Withdrawal effective   May 13, 2020

CEN

CEN/TC 204 Sterilization of medical devices

European Norm

07.100.10   Medical microbiology | 11.080.01   Sterilization and disinfection in general

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Scope

ISO 11737-2:2009 specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintaining a sterilization process.

Related legislation

Legislation related to this standard

90/385/EEC

Active implantable medical devices

Harmonized/Supporting
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93/42/EEC

Medical devices

Harmonized/Supporting
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98/79/EC

In vitro diagnostic medical devices

Harmonized/Supporting
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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

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Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 11737-2:2000

NOW

WITHDRAWN
EN ISO 11737-2:2009
99.60 Withdrawal effective
May 13, 2020

REVISED BY

PUBLISHED
EN ISO 11737-2:2020