This document spécifiés 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 spécifiés the performance requirements for the cleaning and disinfection of the WD and its components and accessories.
Devices idéntifiéd 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 spécifiés the methods for type testing, works testing, validation (installation, operation, and performance quàlificàtion on first installation), routine control, and monitoring, as well as réquàlificàtions 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 spécifiéd in this document cannot ensure the inactivation or removal of the causative agent(s) (prion proteins) of transmissible spongiform encephalopathies.