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60.60 Standard published May 6, 2009
CEN
CEN/TC 102 Sterilizers and associated equipment for processing of medical devices
European Norm
11.080.01 Sterilization and disinfection in general
Published
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.
Legislation related to this standard
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
PUBLISHED
EN ISO 11140-3:2009
60.60
Standard published
May 6, 2009
IN_DEVELOPMENT
prEN ISO 11140-3 rev