99.60 Withdrawal effective Mar 29, 2017
CEN
CEN/TC 102 Sterilizers and associated equipment for processing of medical devices
European Norm
11.080.01 Sterilization and disinfection in general
ISO 11138-3:2006 provides specific requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing moist heat as the sterilizing agent.
Moist heat as the sterilizing agent is defined in ISO 11138-3:2006 as dry saturated steam. While air-steam mixtures may be used in moist heat sterilization processes, the methods and performance requirements of this part of ISO 11138 might not be applicable for biological indicators used in such processes.
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WITHDRAWN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 11138-3:2006
WITHDRAWN
EN ISO 11138-3:2009
99.60
Withdrawal effective
Mar 29, 2017
PUBLISHED
EN ISO 11138-3:2017