Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Performance requirements
5 Mechanical requirements and protocol requirements
6 Testing for conformity
7 Documentation
8 Information to be provided by the manufacturer
9 Marking, labelling and packaging
10 Information to be requested from the purchaser by
the manufacturer
Annex A (normative) - Summary of test programmes
Annex B (normative) - Methods for microbiological
evaluation of disinfection of liquid transport
system
Annex C (normative) - Tests for microbiological
contamination of post-disinfection rinse water
Annex D (normative) - Preparation and evaluation of indicators
for microbiological testing of the efficacy
of chemical disinfection of the load
Annex E (informative) - Examples of test locations for the
tests with biological indicators
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of
EU Directive 93/42/EEC on medical devices
Bibliography