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UNE-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. (ISO 15883-2:2006)

Available format(s)

Hardcopy , PDF

Language(s)

Spanish, Castilian, English

Published date

10-14-2009

US$90.94
Excluding Tax where applicable

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 on medical
                        devices
Bibliography

Specifies 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
CTN 111
DocumentType
Standard
Pages
20
PublisherName
Asociacion Espanola de Normalizacion
Status
Current
SupersededBy
Supersedes

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