WASHER-DISINFECTORS - PART 2: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR SURGICAL INSTRUMENTS, ANAESTHETIC EQUIPMENT, BOWLS, DISHES, RECEIVERS, UTENSILS, GLASSWARE, ETC.

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2009

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 Reinigung
  4.3 Desinfektion
  4.4 Temperatur innerer Oberflächen behandelter Produkte
5 Mechanische und steuerungstechnische Anforderungen
  5.1 Konnektoren für die Beladung
  5.2 Regel- und Steuersysteme
  5.3 Prozessverifizierung
6 Prüfung auf Konformität mit der Norm
  6.1 Allgemeines
  6.2 Prüfungen der Schmutzentfernung von den
      Kammerwänden, vom Beladungsträger und
      der Beladung
  6.3 Thermometrische Prüfungen
7 Vom Hersteller anzugebende Informationen
8 Durch den Lieferanten des RDG vom Käufer zu
  fordernde Informationen
Anhang A (informativ) Übersicht über die Prüfprogrammee

Literaturhinweise
Anhang ZA (informativ) Zusammenhang zwischen dieser
          Europäischen Norm und den grundlegenden
          Anforderungen der EG-Richtlinie 93/42/EWG über
          Medizinprodukt

Diese Europäische Norm legt Anforderungen und Prüfverfahren für Reinigungs-Desinfektionsgeräte fest, die für die Reinigung und thermische Desinfektion wieder verwendbarer medizinischer Produkte wie chirurgische Instrumente, Anästhesiegeräte, Schüsseln, Schalen, Auffanggeräte, Utensilien und Glaswaren in einem einzigen Prozessablauf bestimmt sind.

DocumentType	Standard
Pages	22
PublisherName	German Institute for Standardisation (Deutsches Institut für Normung)
Status	Current

Standards	Relationship
ISO 15883-2:2006	Identical
NBN EN ISO 15883-2 : 2009	Identical
NEN EN ISO 15883-2 : 2009	Identical
NS EN ISO 15883-2 : 2009	Identical
I.S. EN ISO 15883-2:2009	Identical
SN EN ISO 15883-2 : 2009	Identical
UNI EN ISO 15883-2 : 2009	Identical
UNE-EN ISO 15883-2:2009	Identical
BS EN ISO 15883-2:2009	Identical
EN ISO 15883-2:2009	Identical
NF EN ISO 15883-2 : 2009	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)

BS 2745-3:1993	Washer-disinfectors for medical purposes Specification for washer-disinfectors except those used for processing human-waste containers and laundry
ISO 15883-1:2006	Washer-disinfectors Part 1: General requirements, terms and definitions and tests
DIN EN ISO 17664:2016-06 (Draft)	PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES (ISO 17664:2017)
ISO 4017:2014	Fasteners Hexagon head screws Product grades A and B
EN 10088-2:2014	STAINLESS STEELS - PART 2: TECHNICAL DELIVERY CONDITIONS FOR SHEET/PLATE AND STRIP OF CORROSION RESISTING STEELS FOR GENERAL PURPOSES
ISO 5356-2:2012	Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
ISO 5367:2014	Anaesthetic and respiratory equipment — Breathing sets and connectors
ISO 5362:2006	Anaesthetic reservoir bags
ISO/TS 15883-5:2005	Washer-disinfectors Part 5: Test soils and methods for demonstrating cleaning efficacy
IEC 61010-2-045:2000	Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-045: Particular requirements for washer disinfectors used in medical, pharmaceutical, veterinary and laboratory fields
DIN EN ISO 5356-2:2013-03	ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - PART 2: SCREW-THREADED WEIGHT-BEARING CONNECTORS (ISO 5356-2:2012)
ISO 5361:2016	Anaesthetic and respiratory equipment — Tracheal tubes and connectors
ISO 17664:2017	Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
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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DIN EN ISO 15883-2:2009-09

WASHER-DISINFECTORS - PART 2: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR SURGICAL INSTRUMENTS, ANAESTHETIC EQUIPMENT, BOWLS, DISHES, RECEIVERS, UTENSILS, GLASSWARE, ETC.

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referenced By This Book

Standards Referencing This Book

Category

Subcategory