99.60 Withdrawal effective Jun 5, 2013
CEN
CEN/TC 204 Sterilization of medical devices
European Norm
11.080.01 Sterilization and disinfection in general
Withdrawn
ISO 11137-2:2011 specifies methods of determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10-6. ISO 11137-2:2011 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.
ISO 11137-2:2011 defines product families for sterilization dose establishment and sterilization dose audit.
Legislation related to this standard
In vitro diagnostic medical devices
Harmonised Standard / Cited in the Official JournalActive implantable medical devices
Harmonised Standard / Cited in the Official Journal
WITHDRAWN
EN ISO 11137-2:2012
99.60
Withdrawal effective
Jun 5, 2013
WITHDRAWN
EN ISO 11137-2:2013
