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DIN EN ISO 15883-4:2009-09

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Available format(s)

Hardcopy , PDF

Superseded date

04-06-2019

Language(s)

English

Published date

01-01-2009

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Performance requirements
5 Mechanical and process requirements
6 Testing for conformity
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
National Annex NA (informative) Bibliography

Defines the particular requirements, including performance, for washer-disinfectors (WDs) that are intended to be used for cleaning and chemical disinfection of thermolabile endoscopes.

DocumentType
Standard
Pages
61
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Superseded
SupersededBy

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
VDE 0411-2-040 : 2016 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 (IEC 61010-2-040:2015)
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)
DIN EN ISO 11731-2:2008-06 WATER QUALITY - DETECTION AND ENUMERATION OF LEGIONELLA - PART 2: DIRECT MEMBRANE FILTRATION METHOD FOR WATERS WITH LOW BACTERIAL COUNTS
DIN EN ISO 11138-1:2015-10 (Draft) STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11138-1:2017)
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)
DIN ISO 384:1978-12 LABORATORY GLASSWARE; PRINCIPLES OF DESIGN AND CONSTRUCTION OF VOLUMETRIC GLASSWARE
DIN EN 61010-2-040 : 2016 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 (IEC 61010-2-040:2015)

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