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
| Autor: | V. Schmidt, Ulrike Beilenhoff, J. F. Rey, R. Blum, C. S. Neumann, H. Biering |
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| Rok vydání: | 2007 |
| Předmět: |
Endoscopes
Quality Control medicine.medical_specialty Quality management Scope (project management) Routine testing business.industry Gastroenterology MEDLINE Reproducibility of Results Guideline Process validation Checklist Disinfection Europe Equipment Reuse Equipment Contamination Humans European standard Medicine Medical physics business Nuclear medicine Disinfectants |
| Zdroj: | Endoscopy. 39:85-94 |
| ISSN: | 1438-8812 0013-726X |
| Popis: | 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 |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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