Customer Support: 131 242

  • There are no items in your cart
We noticed you’re not on the correct regional site. Switch to our AMERICAS site for the best experience.
Dismiss alert

I.S. EN ISO 15883-2:2009

Current
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.
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2009

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

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

Defines 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.

DocumentType
Standard
Pages
26
PublisherName
National Standards Authority of Ireland
Status
Current
Supersedes

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

View more information
$75.37
Including GST where applicable

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.

Need help?
Call us on 131 242, then click here to start a Screen Sharing session
so we can help right away! Learn more