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SRPS EN ISO 11140-3:2011

Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007, including Cor 1:2007)

May 31, 2011

General information

60.60     May 31, 2011

ISS

Z076

European Norm

11.080.01  

English  

From plan 2011

Buying

Published

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Scope

ISO 11140-3:2007 specifies the requirements for chemical indicators to be used in the steam penetration test for steam sterilizers for wrapped goods, e.g. instruments and porous materials. The indicator for this purpose is a Class 2 indicator as described in ISO 11140-1.
Indicators complying with ISO 11140-3:2007 are intended for use in combination with the standard test pack as described in EN 285. ISO 11140-3:2007 does not consider the performance of the standard test pack, but does specify the performance of the indicators.

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.

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

PREVIOUSLY

WITHDRAWN
SRPS EN ISO 11140-1:2009

NOW

PUBLISHED
SRPS EN ISO 11140-3:2011
60.60 Standard published
May 31, 2011

Related project

Adopted from EN ISO 11140-3:2009

Adopted from ISO 11140-3:2007 IDENTICAL

Adopted from ISO 11140-3:2007/Cor 1:2007 IDENTICAL