BS 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Washer-disinfectors Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
Hardcopy , PDF
08-01-2019
English
30-09-2009
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
Defines the particular requirements, including performance, for washer-disinfectors (WDs) that are intended to be used for cleaning and chemical disinfection of thermolabile endoscopes.
Committee |
CH/198
|
DocumentType |
Standard
|
Pages |
62
|
PublisherName |
British Standards Institution
|
Status |
Superseded
|
SupersededBy | |
Supersedes |
Standards | Relationship |
EN ISO 15883-4:2018 | Identical |
EN ISO 15883-4:2009 | Identical |
ISO 15883-4:2008 | Identical |
IEC 61010-2-040:2015 | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials |
EN 13624:2013 | Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area - Test method and requirements (phase 2, step 1) |
ISO 15883-1:2006 | Washer-disinfectors Part 1: General requirements, terms and definitions and tests |
EN 14348:2005 | Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants - Test methods and requirements (phase 2, step 1) |
ISO 11731-2:2004 | Water quality Detection and enumeration of Legionella Part 2: Direct membrane filtration method for waters with low bacterial counts |
EN 1717:2000 | Protection against pollution of potable water in water installations and general requirements of devices to prevent pollution by backflow |
ISO 384:2015 | Laboratory glass and plastics ware — Principles of design and construction of volumetric instruments |
EN 12353:2013 | Chemical disinfectants and antiseptics - Preservation of test organisms used for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity |
EN 13727:2012+A2:2015 | Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity in the medical area - Test method and requirements (phase 2, step 1) |
ISO/TS 15883-5:2005 | Washer-disinfectors Part 5: Test soils and methods for demonstrating cleaning efficacy |
EN 14562:2006 | Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2) |
ISO 11138-1:2017 | Sterilization of health care products — Biological indicators — Part 1: General requirements |
EN 14476:2013+A1:2015 | Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of virucidal activity in the medical area - Test method and requirements (Phase 2/Step 1) |
EN 14561:2006 | Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2) |
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