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1. Scope of this guideline 2. Quality management: the roles of validation and routine testing3. Responsibilities and qualifications4. Validation4.1. Prerequisites4.2. Installation qualification (IQ)4.3. Operational qualification (OQ)4.4. Performance qualification (PQ)5. Routine testing6. Frequency6.1. Frequency of validation and revalidation6.2. Frequency of routine testing7. References8. AppendicesAppendix 1: GlossaryAppendix 2.: Example of a checklist of prerequisites for installation of a washer-disinfectorAppendix 3.: Example of a checklist for installation qualificationAppendix 4.: Example of a checklist for operational qualificationAppendix 5.: Example of a checklist for performance qualificationAppendix 6.: Routine testing: checklist

endoscopy

ESGE/ESGENA guideline for process validation and routine testing for reprocessing endoscopes in washer-disinfectors, according to the European Standard prEN ISO 15883 parts 1, 4 and 5