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SSH EN ISO 11138-2:2009

Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006)

Dec 22, 2009
95.99 Withdrawal of Standard   May 16, 2017

General information

95.99     May 16, 2017

DPS

DPS/KT 206

European Norm

11.080.01  

English  

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Scope

ISO 11138-2:2006 provides specific requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxide gas or mixtures of this gas with diluent gases, at sterilizing temperatures within the range of 29 °C to 65 °C.

Related directives

Directives related to this standards.

90/385/EEC

Active implantable medical devices

Harmonized
93/42/EEC

Medical devices

Harmonized
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

NOW

WITHDRAWN
SSH EN ISO 11138-2:2009
95.99 Withdrawal of Standard
May 16, 2017

REVISED BY

PUBLISHED
SSH EN ISO 11138-2:2017

WITHDRAWN
SSH EN ISO 11138-2:2006

Related project

Adopted from EN ISO 11138-2:2009