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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Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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Superseded date

01-25-2019

Published date

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

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.

Committee
CEN/TC 102
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy

DIN EN ISO 15883-7 E : 2016 WASHER-DISINFECTORS - PART 7: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR NON-INVASIVE, NON-CRITICAL THERMOLABILE MEDICAL DEVICES AND HEALTHCARE EQUIPMENT (ISO 15883-7:2016)
12/30248648 DC : DRAFT AUG 2012 BS EN 16442 - CONTROLLED ENVIRONMENT STORAGE CABINET FOR DISINFECTED THERMOLABILE ENDOSCOPES
BS EN ISO 15883-7:2016 Washer-disinfectors Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment
I.S. EN 16442:2015 CONTROLLED ENVIRONMENT STORAGE CABINET FOR PROCESSED THERMOLABILE ENDOSCOPES
DIN EN 16442 E : 2015 CONTROLLED ENVIRONMENT STORAGE CABINET FOR PROCESSED THERMOLABILE ENDOSCOPES
I.S. EN ISO 15883-7:2016 WASHER-DISINFECTORS - PART 7: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR NON-INVASIVE, NON-CRITICAL THERMOLABILE MEDICAL DEVICES AND HEALTHCARE EQUIPMENT (ISO 15883-7:2016)
BS EN 16442:2015 Controlled environment storage cabinet for processed thermolabile endoscopes
ISO 15883-7:2016 Washer-disinfectors — Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment
DIN EN 16442:2015-05 CONTROLLED ENVIRONMENT STORAGE CABINET FOR PROCESSED THERMOLABILE ENDOSCOPES
UNE-EN 16442:2015 Controlled environment storage cabinet for processed thermolabile endoscopes
EN ISO 15883-7:2016 Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (ISO 15883-7:2016)
EN 16442:2015 Controlled environment storage cabinet for processed thermolabile endoscopes
DIN EN ISO 15883-7:2016-10 WASHER-DISINFECTORS - PART 7: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR NON-INVASIVE, NON-CRITICAL THERMOLABILE MEDICAL DEVICES AND HEALTHCARE EQUIPMENT (ISO 15883-7:2016)
UNE-EN ISO 15883-7:2016 Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (ISO 15883-7:2016)

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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