Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (ISO 15883-6:2011)
洗衣机消毒器 - 第6部分:对非侵入性 非关键医疗设备和保健设备采用热消毒的洗衣消毒器的要求和测试(ISO 15883-6:2011)
发布日期:
2015-08-19
实施日期:
2015-08-19
ISO 15883-6:2011规定了消毒消毒器(WD)的特殊要求,当通过清洁和热消毒(A0不低于60)可以达到必要的消毒保证水平时,打算使用,并且不需要独立的关键流程的自动化记录保存。它旨在与ISO 15883-1结合使用,该标准给出了WD的一般要求。
可以使用这种特定类型的WD的产品的范围仅限于非侵入性和非关键性的装置和设备(即不渗透皮肤或接触粘膜表面)
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).