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SRPS EN ISO 11737-2:2011

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)

Sep 30, 2011
95.99   Withdrawal of Standard   Nov 30, 2020

General information

95.99     Nov 30, 2020

ISS

Z076

European Norm

07.100.10     11.080.01  

English  

From plan 2011

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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 directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

90/385/EEC

Active implantable medical devices

Harmonized
Directive 90/385/EEC
93/42/EEC

Medical devices

Harmonized
Directive 93/42/EEC
98/79/EC

In vitro diagnostic medical devices

Harmonized
Directive 98/79/EC
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

Directive 2007/47/EC

Life cycle

PREVIOUSLY

WITHDRAWN
SRPS EN ISO 11737-2:2008

NOW

WITHDRAWN
SRPS EN ISO 11737-2:2011
95.99 Withdrawal of Standard
Nov 30, 2020

REVISED BY

PUBLISHED
SRPS EN ISO 11737-2:2020

Related project

Adopted from EN ISO 11737-2:2009

Adopted from ISO 11737-2:2009 IDENTICAL