ISO 15883-6-2011 垫圈-消毒器具.第6部分:非侵入式,非关键医疗设备和保健设备用的利用热消毒的垫圈-消毒器具的试验和要求

标准号：ISO 15883-6-2011
中文标准名称：垫圈-消毒器具.第6部分:非侵入式,非关键医疗设备和保健设备用的利用热消毒的垫圈-消毒器具的试验和要求
英文标准名称：Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment
标准类型：C47
发布日期：2011/4/15 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C47
国际标准分类号：11.080.10
引用标准：ISO 15883-1-2006;ISO/TS 15883-5
适用范围：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.