I.S. 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
Bibliography
Annex ZA (informative) - Relationship between this European
                         Standard and the Essential Requirements
                         of EU Directive 93/42/EEC

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