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