DIN EN ISO 15883-7:2025-08
Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-critical thermolabile medical devices and health care equipment (ISO 15883-7:2025); German version EN ISO 15883-7:2025
| Fecha edición: |
2025-08-01
En Vigor
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|---|---|
| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This document specifies the requirements for washer-disinfectors (WD) intended to be used for the cleaning and chemical disinfection, in a single operating cycle, of reusable items such as the following: a) bed frames; b) bedside tables; c) transport carts; d) containers; e) surgical tables; f) sterilization containers; g) surgical clogs; h) wheelchairs; i) aids for persons with disabilities. This document also specifies the performance requirements for the cleaning and disinfection of the WD and its components and accessories. Devices identified within the scopes of ISO 15883 2, ISO 15883 3, ISO I5883-4, and ISO 15883 6 do not fall within the scope of this document. In addition, the methods are specified, as well as instrumentation and instructions required, for type testing, works testing, validation (installation, operation, and performance qualification on first installation), routine control, and monitoring, as well as requalifications required to be carried out periodically and after essential repairs. |
| Keywords: | Bedsteads|Chemical|Cleaning|Cleaning equipment|Cleaning machines|Definitions|Disinfection|Disinfection apparatus|Disinfectors|Haulage cars|Laboratory apparatus|Laboratory ware|Medical devices|Medical equipment|Operating tables|Performance requirements|Re-usable|Reuse|Specification (approval)|Testing|Wheelchairs |
| ICS: | 11.080.10 - Material de esterilización |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 15883-7:2025 Idéntica ISO 15883-7:2025 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 15883-7:2016-10 Reemplaza a DIN EN ISO 15883-7:2024-03 |
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