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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

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Kehtiv alates 06.03.2025
Tegevusala (ICS grupid)
11.080.10 Steriliseerimisvahendid
Direktiivid või määrused
puuduvad

Standardi ajalugu

Staatus
Kuupäev
Tüüp
Nimetus
06.03.2025
Põhitekst
02.02.2016
Põhitekst
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:
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 15883-4, and ISO 15883-6 do not fall within the scope of this document.
In addition, this document specifies the methods for type testing, works testing, validation (installation, operation, and performance qualification on first installation), routine control, and monitoring, as well as requalifications to be carried out periodically and after essential repairs.
NOTE 1        WD covered by this document can also be used for cleaning and chemical disinfection of other thermolabile and reusable devices as recommended in the instructions for use (IFU) for those devices.
NOTE 2        The performance requirements specified in this document cannot ensure the inactivation or removal of the causative agent(s) (prion proteins) of transmissible spongiform encephalopathies.

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