EN 866-1 : 1997

Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 General requirements
5 Test organisms and their preparation for the
    manufacture of inoculated carriers
6 Carriers and their inoculation
7 Packaging and labelling of inoculated carriers for
    distribution
8 Preparation of biological indicators from inoculated
    carriers
9 Packaging and labelling of biological indicators
10 Determination of test organism resistance
Annexes
A (normative) Determination of growth inhibition by
    carriers exposed to the sterilization process
B (normative) Determination of test organism resistance
C (informative) Relationship between the components of
    biological test systems
D (informative) Bibliography

Defines general requirements for manufacturing biological systems for use in testing sterilizers and sterilizing processes.