Name: UNI EN ISO 15883-2 : 2009
Brand: UNI

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

Published date

09-03-2009

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

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	UNI EN ISO 15883-2 : 2006

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