Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Performance requirements
5 Mechanical and process requirements
6 Testing for conformity
7 Documentation and inspection
8 Information to be supplied by the manufacturer
9 Marketing, labelling and packaging
10 Information to be requested from the purchaser
by the manufacturer
Annex A (informative) - Summary of activities covered
by this part of ISO 15883
Annex B (normative) - Microbiological testing of the efficacy
of chemical disinfection of the load
Annex C (normative) - Summary of test programmes
Annex D (normative) - Methods for microbiological
evaluation of disinfection of liquid transport system
Annex E (normative) - Tests for microbial contamination
of post-disinfection rinse water
Annex F (informative) - Additional notes on microbiological
testing of chemical disinfection processes
Annex G (informative) - Typical specifications of trumpet
valves and connection ports
Annex H (normative) - Establishing endoscope type test groups
Annex I (informative) - Establishing endoscope product families
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of EU Directive
93/42/EEC on medical devices
Bibliography