I.S. EN ISO 15883-4:2009
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
WASHER-DISINFECTORS - PART 4: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR THERMOLABILE ENDOSCOPES
Hardcopy , PDF
06-30-2020
English
01-01-2009
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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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