UNE-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. (ISO 15883-2:2006)
Hardcopy , PDF
Spanish, Castilian, English
10-14-2009
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.
Committee |
CTN 111
|
DocumentType |
Standard
|
Pages |
20
|
PublisherName |
Asociacion Espanola de Normalizacion
|
Status |
Current
|
SupersededBy | |
Supersedes |
Standards | Relationship |
ISO 15883-2:2006 | Identical |
NBN EN ISO 15883-2 : 2009 | Identical |
NEN EN ISO 15883-2 : 2009 | Identical |
NS EN ISO 15883-2 : 2009 | Identical |
I.S. EN ISO 15883-2:2009 | Identical |
SN EN ISO 15883-2 : 2009 | Identical |
UNI EN ISO 15883-2 : 2009 | Identical |
BS EN ISO 15883-2:2009 | Identical |
EN ISO 15883-2:2009 | Identical |
NF EN ISO 15883-2 : 2009 | Identical |
DIN EN ISO 15883-2:2009-09 | Identical |
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