UNE EN ISO 15883-7:2025
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)
Lavadoras desinfectadoras. Parte 7: Requisitos y ensayos para las lavadoras desinfectadoras que utilizan desinfección química para los productos sanitarios termolábiles no críticos y para los equipos de asistencia sanitaria. (ISO 15883-7:2025).
| Standard number: | UNE EN ISO 15883-7:2025 |
| Pages: | 45 |
| Released: | 2025-12-10 |
| Status: | Standard |
| Pages (Spanish): | 51 |
UNE EN ISO 15883-7:2025
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 which are necessary in order to achieve the required performance. 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. NOTE 1 WD corresponding to this document can also be used for cleaning and chemical disinfection of other thermolabile and reusable devices as recommended in the IFU for those devices. NOTE 2 The specified performance requirements of this document cannot ensure the inactivation or removal of the causative agent(s) (prion proteins) of transmissible spongiform encephalopathies.
