DIN EN IEC 63077:2024-01
Good refurbishment practices for medical imaging equipment (IEC 63077:2019); German version EN IEC 63077:2019
| Fecha edición: |
2024-01-01
En Vigor
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| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This document describes and defines the process of refurbishment of used medical imaging equipment and applies to the restoring of used medical imaging equipment to a condition of safety and effectiveness comparable to that of new equipment. This restoration includes actions such as repair, rework, software/hardware updates, and the replacement of worn parts with original parts. This document enumerates the actions, that must be performed, and the manner consistent, with relevant specifications and service procedures required to ensure that the refurbishment of medical imaging equipment is done without changing the finished medical imaging equipment's performance, safety specifications, or intended use according to its original or applicable valid registration. |
| Keywords: | Commissioning|Definitions|Electric contact protection|Electrical engineering|Electrical protection equipment|Electrical safety|Electrically-operated devices|Equipment safety|Examination (quality assurance)|Image processing|Image quality|Imaging|Inspection|Instruments|Maintenance|Measurement|Measuring techniques|Mechanical safety|Medical equipment|Medical sciences|Medical technology|Protection against electric shocks|Refurbishment|Remanufacturing|Repair|Repairs|Reprocessing|Safety|Safety of products|Safety requirements|Secondhand|Specification (approval)|Testing|Testing conditions|Use state |
| ICS: | 11.040.55 - Equipo de diagnóstico |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN IEC 63077:2019 Idéntica IEC 63077:2019 |
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Reemplazo Normas |
Reemplaza a DIN EN IEC 63077:2022-10 |
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