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DIN EN ISO 15883-4:2016-07 (Draft)

DIN EN ISO 15883-4:2016-07 (Draft)

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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Superseded date

07-03-2021

Language(s)

German

Published date

01-01-2016

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

Vorwort
Einleitung
1 Anwendungsbereich
2 Normative Verweisungen
3 Begriffe
4 Leistungsanforderungen
   4.1 Allgemeines
   4.2 Systeme für die Dichtheitsprüfung
   4.3 Reinigung
   4.4 Desinfektion
   4.5 Nachspülen (nach der Desinfektion)
   4.6 Beseitigung von Spülwasser
   4.7 Trocknen
   4.8 Selbstdesinfektion
   4.9 Wasseraufbereitungsanlage
5 Anforderungen an die Mechanik und den Prozess
   5.1 Werkstoffe - Gestaltung, Herstellung und Konstruktion
   5.2 Kanaldurchspülungssystem des Geräts
   5.3 Belüftungs- und Abflusssysteme
   5.4 Temperaturregelung
   5.5 Prozesschemikalien
   5.6 Prozessüberprüfung
   5.7 Dosiersysteme
6 Prüfung auf Konfomität
   6.1 Allgemeines
   6.2 Prüfgeräte
   6.3 Für das abschliessende Spülen (nach der Desinfektion)
        verwendetes Wasser
   6.4 Härte des bei der Typprüfung verwendeten Wassers
   6.5 Dichtheitsprüfung
   6.6 Prüfung auf Durchgängigkeit der Kanäle
   6.7 Prüfung auf nicht angeschlossene Kanäle
   6.8 Trockenheit der Beladung
   6.9 Thermometrische Prüfungen
   6.10 Prüfungen auf Chemikaliendosierung
   6.11 Prüfungen für die Wirksamkeit der Reinigung
   6.12 Prüfungen der Wirksamkeit der Desinfektion
7 Dokumentation und Inspektion
8 Vom Hersteller zu erbringende Angaben
9 Kennzeichnung, Beschilderung und Verpackung
10 Angaben, die der Hersteller vom Käufer fordern muss
Anhang A (informativ) Zusammenfassung der in diesem
          Teil der ISO 15883 behandelten Tätigkeiten
Anhang B (normativ) Mikrobiologische Prüfung der
          Wirksamkeit der chemischen Desinfektion
          der Beladung
Anhang C (informativ) Zusammenfassung der Prüfprogramme
Anhang D (normativ) Verfahren zur mikrobiologischen
          Bewertung der Desinfektion von
          Flüssigkeitstransportsystemen
Anhang E (normativ) Prüfungen auf mikrobielle
          Kontamination des Spülwassers nach der
          Desinfektion
Anhang F (informativ) Typische Spezifikationen von
          Trompetenventilen und Anschlüssen
Anhang G (informativ) Zusätzliche Anmerkungen zur
          mikrobiologischen Prüfung chemischer
          Desinfektionsprozesse
Literaturhinweise
Anhang ZA (informativ) Zusammenhang zwischen dieser
          Internationalen Norm und den grundlegenden
          Anforderungen der EG-Richtlinie 93/42/EWG
          über Medizinprodukte

Diese Europäische Norm legt Leistungsanforderungen und Prüfverfahren für Reinigungs-Desinfektionsgeräte fest, die für die Reinigung und Desinfektion von thermolabilen wiederverwendbaren Instrumenten einschliesslich Endoskopen verwendet werden.

DevelopmentNote
DRAFT 2016 issued in July 2016. (07/2016)
DocumentType
Draft
Pages
182
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Superseded

Standards Relationship
EN ISO 15883-4:2009 Identical
ISO 15883-4:2008 Identical

DIN EN ISO 11135:2014-10 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11135:2014)
DIN EN ISO 15883-6:2016-04 Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (ISO 15883-6:2011)
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)

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 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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Hardcopy - German
PDF - German
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