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
„Accepted guidelines of technology“ EN ISO 15883-1 to -4 (2009) Addition: Guideline of DGKH, DGSV and AKI for Germany (2008) Requirements and test procedures of washer/disinfectors with • Thermal disinfection for surgical instruments, anesthesia devices, bins, utensils, glass devices etc. • Thermal disinfection for bedpans • Chemical disinfection for thermolabile endoscopes German recommendation for the validation and routine monitoring of cleaning and disinfection processes for medical devices (MDs) and recommendation for the selection of machines 5.21-27 540 Dr. U. Kaiser 01/2011
Test procedures for WDs according EN ISO 15883-1 (1) 1. Type test/test during production 2. Validation during installation with 1. Installation qualification (IQ) 2. Operational Qualification (OQ) 3. Perfomance Qualification (PQ) 3. Routine monitoring (ROUT) and annually requalification (RQ) 5.22-27 541 Dr. U. Kaiser 01/2011
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„Accepted guidelines of technology“<br />
<strong>EN</strong> <strong>ISO</strong> <strong>15883</strong>-1 to -4<br />
(2009)<br />
Addition:<br />
Guideline of DGKH,<br />
DGSV and AKI <strong>for</strong><br />
Germany (2008)<br />
Requirements and test <strong>procedures</strong> of washer/disinfectors with<br />
• Thermal disinfection <strong>for</strong> surgical instruments, anesthesia<br />
devices, bins, utensils, glass devices etc.<br />
• Thermal disinfection <strong>for</strong> bedpans<br />
• Chemical disinfection <strong>for</strong> thermolabile endoscopes<br />
German recommendation <strong>for</strong> the validation and routine<br />
monitoring of cleaning and disinfection processes <strong>for</strong> medical<br />
devices (MDs) and recommendation <strong>for</strong> the selection of<br />
machines<br />
5.21-27 540 Dr. U. Kaiser 01/2011