60.60 Standard published Jun 10, 2015
CEN
CEN/TC 204 Sterilization of medical devices
European Norm
11.080.01 Sterilization and disinfection in general
ISO 11137-2:2013 specifies methods for 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 11137-2:2013 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.
ISO 11137-2:2013 defines product families for sterilization dose establishment and sterilization dose audit.
Legislation related to this standard
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
Harmonized/SupportingRegulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
Harmonized/Supporting
WITHDRAWN
EN ISO 11137-2:2013
PUBLISHED
EN ISO 11137-2:2015
60.60
Standard published
Jun 10, 2015
PUBLISHED
EN ISO 11137-2:2015/A1:2023
IN_DEVELOPMENT
prEN ISO 11137-2 rev