ONORM EN ISO 15883-2 : 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 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.