DIN EN ISO 15883-4:2009-09
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - PART 4: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR THERMOLABILE ENDOSCOPES
Hardcopy , PDF
06-04-2019
English
01-01-2009
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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Superseded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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