NEN EN ISO 11137-2 : 2015

Foreword
Introduction
1 Scope
2 Normative references
3 Abbreviations, terms and definitions
   3.1 Abbreviations
   3.2 Terms
4 Definition and maintenance of product families for dose
   setting, dose substantiation and sterilization dose auditing
   4.1 General
   4.2 Defining product families
   4.3 Designation of product to represent a product family for
        performance of a verification dose experiment or
        sterilization dose audit
   4.4 Maintaining product families
   4.5 Effect of failure of establishment of sterilization dose
        or of a sterilization dose audit on a product family
5 Selection and testing of product for establishing and verifying
   the sterilization dose
   5.1 Nature of product
   5.2 Sample item portion (SIP)
   5.3 Manner of sampling
   5.4 Microbiological testing
   5.5 Irradiation
6 Methods of dose establishment
7 Method 1: dose setting using bioburden information
   7.1 Rationale
   7.2 Procedure for Method 1 for product with an average
        bioburden >= 1,0 for multiple production batches
   7.3 Procedure for Method 1 for product with an average
        bioburden >= 1,0 for a single production batch
   7.4 Procedure for Method 1 for product with an average
        bioburden in the range 0,1 to 0,9 for multiple or
        single production batches
8 Method 2: Dose setting using fraction positive information
   from incremental dosing to determine an extrapolation factor
   8.1 Rationale
   8.2 Procedure for Method 2A
   8.3 Procedure for Method 2B
9 Method VD[max] - Substantiation of 25 kGy or 15 kGy as the
   sterilization dose
   9.1 Rationale
   9.2 Procedure for Method VD[max[25]] for multiple production
        batches
   9.3 Procedure for Method VD[max[25]] for a single production
        batch
   9.4 Procedure for Method VD[max[15]] for multiple production
        batches
   9.5 Procedure for Method VD[max[15]] for a single production
        batch
10 Auditing sterilization dose
   10.1 Purpose and frequency
   10.2 Procedure for auditing a sterilization dose
        established using Method 1 or Method 2
   10.3 Procedure for auditing a sterilization dose
        substantiated using VD[max]
11 Worked examples
   11.1 Worked examples for Method 1
   11.2 Worked examples for Method 2
   11.3 Worked examples for Method VD[max]
   11.4 Worked example of a sterilization dose audit for a
        dose established using Method 1, the findings from
        which necessitated augmentation of the sterilization
        dose
   11.5 Worked example of a sterilization dose audit for a
        dose established using Method 2A, the findings from
        which necessitated augmentation of the sterilization
        dose
   11.6 Worked example of a sterilization dose audit for a
        sterilization dose substantiated using Method VD[max[25]]
Annex ZA (informative) Relationship between this International
         Standard and the Essential Requirements of EU Directives
         90/385/EEC of 20 June 1990 concerning active implantable
         medical devices, 93/42/EEC of 14 June 1993 concerning
         medical devices and 98/79/EC of 7 December 1988
         concerning in vitro diagnostic medical devices
Bibliography

Describes 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].