Test procedures for WDs according EN ISO 15883-1 - Sterivita.lv
Test procedures for WDs according EN ISO 15883-1 - Sterivita.lv
Test procedures for WDs according EN ISO 15883-1 - Sterivita.lv
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<strong>Test</strong> <strong>procedures</strong> <strong>for</strong> <strong>WDs</strong> <strong>according</strong> <strong>EN</strong> <strong>ISO</strong> <strong>15883</strong>-1 (6)<br />
Additions<br />
Source<br />
Requirement<br />
<strong>EN</strong> <strong>ISO</strong> <strong>15883</strong>-2 • Definition of dosing accuracy of chemicals of minimum 5 %<br />
Guideline DGKH,<br />
DGSV and AKI <strong>for</strong><br />
Germany<br />
<strong>EN</strong> <strong>ISO</strong> <strong>15883</strong>-4<br />
(<strong>WDs</strong> <strong>for</strong> thermolabile<br />
endoscopes)<br />
• Determination to test devices not complying the standards<br />
• Definition reference PCD (Crile-clamps with<br />
blood contamination in the joint)<br />
• Definition of the test load<br />
• Definition of proteine limit value and test of it<br />
• Restatement routine monitoring<br />
• Definition of dosing accuracy of chemicals of minimum 5 %<br />
• Extension and specialization of the scope covering the<br />
requirements <strong>for</strong> endoscope <strong>WDs</strong> (WD-E), e.g.:<br />
• Requirements on the leak tightness of endoscopes<br />
• Requirements on the failure indication of blockage or<br />
missing connection of canals<br />
• Cleaning and flushing of canals<br />
• Chemical disinfection at average temperature<br />
• Self-disinfection of WD-E without endoscopes<br />
using disinfectants or thermal disinfection<br />
5.27-27 546 Dr. U. Kaiser 01/2011
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