标准摘要
[中文适用范围]： 本文件规定了清洗消毒器（WD）的特定要求，适用于在消毒保证水平可通过清洗和热消毒（A0不低于60）实现，且无需独立自动记录关键过程的情况。本文件应与ISO 15883-1配合使用，后者规定了WD的一般要求。此类WD适用的产品范围仅限于非侵入性和非关键性设备和器械（即不穿透皮肤或接触黏膜表面的设备）。详见m [外文原描述]： 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.
英文名称Washer-disinfectors — Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-critical medical devices and health care equipment