99.60 Withdrawal effective 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
Withdrawn
ISO 11140-1:2005 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 variables required for a sterilization process. They are not dependent for their action on the presence or absence of a living organism.
The requirements and test methods of ISO 11140-1:2005 apply to all indicators specified in subsequent parts of ISO 11140, unless the requirement is modified or added to by a subsequent part, in which case the requirement of that particular part will apply.
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WITHDRAWN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 11140-1:2005
WITHDRAWN
EN ISO 11140-1:2009
99.60
Withdrawal effective
Nov 12, 2014
PUBLISHED
EN ISO 11140-1:2014
