Washer-disinfectors — Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment
洗衣机消毒器第6部分:非侵入性非关键医疗器械和医疗设备用热消毒洗衣机消毒器的要求和试验
发布日期:
2011-04-12
ISO 15883-6:20 11规定了洗涤消毒器(WD)的特殊要求,这些消毒器旨在通过清洁和热消毒(A0不低于60)达到必要的消毒保证水平,并且不要求保留关键过程的独立自动化记录。它旨在与ISO 15883-1结合使用,ISO 15883-1给出了WDs的一般要求。
可使用该特定类型WDs的产品范围仅限于非侵入性和非关键(即不穿透皮肤或不接触粘膜表面)的器械和设备。
ISO 15883-6:2011 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).