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ILNAS-EN ISO 11140-3:2009 Edition 05/2009
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)
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Abstract

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.

Status

Standard - Active

Origin

Technical Committee :
CEN/TC 102 : Sterilizers for medical purposes

Directives

93/42/EEC : Medical devices
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

Implementation

start of the vote on the project      date of ratification (dor)    19/04/2009
end of the vote on the project      date of anouncement (doa)    31/08/2009
start of the vote on the final project    18/12/2008   date of publication (dop)    30/11/2009
end of the vote on the final project    18/03/2009   date of withdrawal (dow)    21/03/2010


Publication Official Journal
of the Grand-Duchy of Luxembourg
14/03/2011
Reference Mémorial A N° 47

Relations

Evolutions

Relations to older standards
ILNAS-EN ISO 11140-3:2007/AC:2008
ILNAS-EN ISO 11140-3:2007

International Classification for Standards (ICS codes) :

11.080.01 : Sterilization and disinfection in general

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