60.60 Standard published Nov 12, 2014
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 11140-1:2014 specifies general requirements and test methods for indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor the attainment of one or more of the process parameter(s) specified for a sterilization process. They are not dependent for their action on the presence or absence of a living organism.
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
WITHDRAWN
EN ISO 11140-1:2009
PUBLISHED
EN ISO 11140-1:2014
60.60
Standard published
Nov 12, 2014
