EN ISO 15883-4:2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008)
01-25-2019
06-03-2009
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
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