EN ISO 11137-2:2015

Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions, and abbreviated terms
4 Definition and maintenance of product families for dose
   setting, dose substantiation, and sterilization
   dose auditing
5 Selection and testing of product for establishing the
   sterilization dose
6 Methods of dose establishment
7 Method 1: dose setting using bioburden information
8 Method 2: Dose setting using fraction positive information
   from incremental dosing to determine an extrapolation factor
9 Method VD[max] - Substantiation of 25 kGy or 15 kGy
   as the sterilization dose
10 Sterilization dose audit
11 Worked examples
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of
         EU Directive 90/385/EEC on active implantable
         medical devices
Annex ZB (informative) - Relationship between this European
         Standard and the Essential Requirements of
         EU Directive 93/42/EEC on medical devices
Annex ZC (informative) - Relationship between this European
         Standard and the Essential Requirements of
         EU Directive 98/79/EC on in vitro diagnostic
         medical devices
Bibliography

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.