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

ISO 15883-4:2008 specifies the particular requirements, including performance, for washer-disinfectors (WDs) that are intended to be used for cleaning and chemical disinfection of thermolabile endoscopes.ISO 15883-4:2008 also specifies the performance requirements for the cleaning and disinfection of the washer-disinfector and its components and accessories which may be required to achieve the necessary performance.The methods, instrumentation and instructions required for type testing, works testing, validation (installation, operational and performance qualification on first installation), routine control and monitoring and re-validation, periodically and after essential repairs, are also specified.ISO 15883-4:2008 can be used by prospective purchasers and manufacturers as the basis of agreement on the specification of WD manufacturers of endoscopes, cleaning products, disinfecting products, and also by users.