Washer-disinfectors - Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devices

Washer-disinfectors - Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devices

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1   Scope

This document specifies requirements for washer-disinfectors (WD) that are intended for use for the cleaning and thermal disinfection, in a single operating cycle, of reusable critical and semi-critical medical devices, such as surgical instruments, anaesthetic equipment, and any non-critical devices used in conjunction with critical and semi-critical medical devices, such as bowls, dishes and receivers, utensils and glassware.
This document is intended to be used in conjunction with the general requirements specified in ISO 15883-1:2024, except those specified in 4.1.1.

NOTE The specified performance requirements of this document cannot ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies.