ISO 15883-6:2011 PDF

Scope: WARNING — Devices identified within the scope of ISO 15883-2, ISO 15883-3 and ISO 15883-4 shall not be processed in washer-disinfectors specified in this part of ISO 15883. Examples of medical devices that are not to be processed in these devices include powered devices, lumened devices and other invasive devices. This part of ISO 15883 specifies particular requirements for washer-disinfectors (WDs) 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 gives general requirements for WDs. The range of products on which WDs of this particular type can be used is restricted to devices and equipment which are non-invasive and non-critical (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.

ISO 15883-6:2011 Referenced Document

ISO 15883-1:2006 Washer-disinfectors - Part 1: General requirements, terms and definitions and tests
ISO/TS 15883-5 Washer-disinfectors - Part 5: Test soils and methods for demonstrating cleaning efficacy

2011 ISO 15883-6:2011 Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment