DIN EN ISO 15883-2:2009-09
Current
The latest, up-to-date edition.
WASHER-DISINFECTORS - PART 2: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR SURGICAL INSTRUMENTS, ANAESTHETIC EQUIPMENT, BOWLS, DISHES, RECEIVERS, UTENSILS, GLASSWARE, ETC.
Hardcopy , PDF
English
01-01-2009
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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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