UNI EN ISO 15883-4 : 2009

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Performance requirements
   4.1 General
   4.2 Systems for leak testing
   4.3 Cleaning
   4.4 Disinfecting
   4.5 Final (post-disinfection) rinsing
   4.6 Purging to remove rinse water
   4.7 Drying
   4.8 Self-disinfection
   4.9 Water treatment equipment
5 Mechanical and process requirements
   5.1 Materials Design, manufacture and construction
   5.2 Device channel irrigation system
   5.3 Venting and drainage systems
   5.4 Temperature control
   5.5 Process chemicals
   5.6 Process verification
   5.7 Dosing systems
6 Testing for conformity
   6.1 General
   6.2 Test equipment
   6.3 Water used for final (post-disinfection) rinsing
   6.4 Hardness of water used during type testing
   6.5 Leak test
   6.6 Channels non-obstruction test
   6.7 Channels non-connection test
   6.8 Load dryness
   6.9 Thermometric tests
   6.10 Chemical dosing tests
   6.11 Tests of cleaning efficacy
   6.12 Test of disinfection efficacy
7 Documentation and inspection
8 Information to be supplied by the manufacturer
9 Marking, 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 (informative) - 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) - Typical specifications of trumpet
        valves and connection ports
Annex G (informative) - Additional notes on microbiological
        testing of chemical disinfection processes
Annex ZA (informative) Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 93/42/EEC
Bibliography

Describes the particular requirements, including performance, for washer-disinfectors (WDs) that are intended to be used for cleaning and chemical disinfection of thermolabile endoscopes.