This document specifies particular requirements for washer-disinfectors (WD) intended for use when the level of assurance of disinfection that is necessary can be achieved by cleaning and thermal disinfection (A0 not less than 60) and does not require an independent automated record of critical processes to be kept. It is intended to be used in conjunction with ISO 15883-1, which specifies general requirements for WD.

The range of products on which WD of this particular type can be used is restricted to non-invasive and non-critical devices and equipment (i.e. not penetrating skin or contacting mucosal surfaces).

NOTE            Thermal disinfection can be achieved by rinsing the load with hot water, exposure to steam, or combination of the two.

This document does not cover powered devices, lumened devices, and other semi-critical and critical medical devices.

Devices identified within the scopes of ISO 15883-2, ISO 15883-3, ISO 15883-4, and ISO 15883-7 do not fall within the scope of this document.