標準號：ISO 15883-6-2011
中文標準名稱：墊圈-消毒器具.第6部分:非侵入式,非關鍵醫療設備和保健設備用的利用熱消毒的墊圈-消毒器具的試驗和要求
英文標準名稱：Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment
標準類型：C47
發布日期：2011/4/15 12:00:00
實施日期：1999/12/31 12:00:00
中國標準分類號：C47
國際標準分類號：11.080.10
引用標準：ISO 15883-1-2006;ISO/TS 15883-5
適用范圍：WARNING — Devices identified within the scope of ISO 15883-2, ISO 15883-3 and ISO 15883-4 shallnot be processed in washer-disinfectors specified in this part of ISO 15883. Examples of medicaldevices that are not to be processed in these devices include powered devices, lumened devices andother invasive devices.This part of ISO 15883 specifies particular requirements for washer-disinfectors (WDs) intended for use whenthe 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. Itis 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 equipmentwhich 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 ofthe two.