Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General technical requirements
5 Performance requirements
6 Safety
7 Categories of tests
8 Test equipment
9 Test programme
10 Test methods
Annex A (informative) Clarification of the definition of
                       hollow space A and hollow space B
Annex B (informative) Process evaluation system
Annex C (informative) Suggested maximum limits of contaminants
                       in and specification for water for
                       steam sterilization
Annex D (informative) Example of a table to be supplied with
                       pre-purchase documentation and with the
                       instructions for use
Annex E (informative) Load support systems
Annex F (informative) Rationale for the tests
Annex ZA (informative) Relationship between this European
                       Standard and the Essential Requirements
                       of EU Directive 93/42 EEC on medical
                       devices
Bibliography