UNI EN ISO 15883-2 : 2009
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.
03-09-2009
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Performance requirements
4.1 General
4.2 Cleaning
4.3 Disinfecting
4.4 Temperature of internal surfaces of processed devices
5 Mechanical and control requirements
5.1 Load connectors
5.2 Control systems
5.3 Process verification
6 Testing for conformity
6.1 General
6.2 Tests for soil removal from chamber walls, load
carrier and load
6.3 Thermometric tests
7 Information to be supplied by the manufacturer
8 Information to be requested from the purchaser by
the supplier of the WD
Annex A (informative) - Summary of test programmes
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42/EEC
Bibliography
Describes particular requirements for washer-disinfectors (WD) that are intended for use for the cleaning and thermal disinfection, in a single operating cycle, of re-usable medical devices such as surgical instruments, anaesthetic equipment, bowls, dishes and receivers, utensils and glassware.
| Committee |
CT 44
|
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| SN EN ISO 15883-2 : 2009 | Identical |
| NF EN ISO 15883-2 : 2009 | Identical |
| UNE-EN ISO 15883-2:2009 | Identical |
| NEN EN ISO 15883-2 : 2009 | Identical |
| EN ISO 15883-2:2009 | Identical |
| NBN EN ISO 15883-2 : 2009 | Identical |
| ISO 15883-2:2006 | Identical |
| DIN EN ISO 15883-2:2009-09 | Identical |
| BS EN ISO 15883-2:2009 | Identical |
| I.S. EN ISO 15883-2:2009 | Identical |
| NS EN ISO 15883-2 : 2009 | Identical |
| 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 |
| 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 |
| 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 |
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