UNE-EN ISO 15883-7:2025
Current
The latest, up-to-date edition.
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)
Hardcopy , PDF
English, Spanish, Castilian
10-12-2025
This document specifies the requirements for washer-disinfectors (WD) intended to be used for thecleaning 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 WDand 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 notfall within the scope of this document.In addition, the methods are specified, as well as instrumentation and instructions required, for typetesting, works testing, validation (installation, operation, and performance qualification on firstinstallation), routine control, and monitoring, as well as requalifications required to be carried outperiodically and after essential repairs.NOTE 1 WD corresponding to this document can also be used for cleaning and chemical disinfection of otherthermolabile 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 removalof the causative agent(s) (prion proteins) of transmissible spongiform encephalopathies.
| Committee |
CTN 111
|
| DocumentType |
Standard
|
| Pages |
45
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 15883-7:2025 | Identical |
| EN ISO 15883-7:2025 | Identical |
| BS EN ISO 15883-7:2025 | Equivalent |
| I.S. EN ISO 15883-7:2025 | Equivalent |
| DIN EN ISO 15883-7:2025-08 | Equivalent |
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