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BS EN ISO 15883-4:2009

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

Washer-disinfectors Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes

Available format(s)

Hardcopy , PDF

Superseded date

08-01-2019

Superseded by

BS EN ISO 15883-4:2018

Language(s)

English

Published date

30-09-2009

€303.84
Excluding VAT

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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