99.60 Withdrawal effective May 13, 2020
CEN
CEN/TC 204 Sterilization of medical devices
European Norm
07.100.10 Medical microbiology | 11.080.01 Sterilization and disinfection in general
Withdrawn
ISO 11737-2:2009 specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintaining a sterilization process.
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WITHDRAWN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 11737-2:2000
WITHDRAWN
EN ISO 11737-2:2009
99.60
Withdrawal effective
May 13, 2020
PUBLISHED
EN ISO 11737-2:2020
