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现行 EN ISO 15883-7:2016
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Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (ISO 15883-7:2016) 洗衣机消毒器 - 第7部分:使用化学消毒用于非侵入性 非关键不耐热的医疗设备和保健设备的洗衣消毒器的要求和测试(ISO 15883-7:2016)
发布日期: 2016-03-09
实施日期: 2016-03-09
ISO 15883-7:2016规定了用于清洁和化学消毒的洗涤消毒器(WD)在单个操作周期中对可重复使用的物品的以下特定要求: a)床架; b)床头柜; c)运输车; d)容器; e)手术台; f)灭菌容器; g)手术堵塞 h)轮椅,残疾人用品。 ISO 15883-7:2016还规定了清洁和消毒洗衣机消毒器及其组件和附件的性能要求,可能是为了达到所需性能所必需的。 在ISO 15883 - 2,ISO 15883 - 3,ISO I5883-4和ISO 15883 - 6范围内识别的设备不属于ISO 15883本部分的范围。 此外,还规定了方法,以及型式测试,工作测试,验证(第一次安装时的安装,操作和性能鉴定),日常控制和监控以及需要携带的重新认证所需的仪器和说明定期进行维修和维修。 注意对应于ISO 15883本部分的WD也可用于清洁和化学消毒其他耐热不易和可重复使用的设备,如设备制造商所推荐
ISO 15883-7:2016 specifies the particular requirements for washer-disinfectors (WD) intended to be used for the cleaning and chemical disinfection, in a single operating cycle, of reusable items such as the following: a) bedframes; b) bedside tables; c) transport carts; d) containers; e) surgical tables; f) sterilization containers; g) surgical clogs; h) wheelchairs, aids for the disabled. ISO 15883-7:2016 also specifies the performance requirements for the cleaning and disinfection of the washer-disinfector and its components and accessories which may be necessary in order to achieve the required performance. Devices identified within the scopes of ISO 15883‑2, ISO 15883‑3, ISO I5883-4, and ISO 15883‑6 do not fall within the scope of this part of ISO 15883. In addition, the methods are specified, as well as instrumentation and instructions required for type testing, works testing, validation (installation, operation, and performance qualification on first installation), routine control, and monitoring, as well as requalifications required to be carried out periodically and after essential repairs. NOTE WDs corresponding to this part of ISO 15883 can also be used for cleaning and chemical disinfection of other thermolabile and reusable devices as recommended by the device manufacturer. The performance requirements specified in this part of ISO 15883 may not ensure the inactivation or removal of the causative agent(s) (prion proteins) of Transmissible Spongiform Encephalopathies.
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归口单位: CEN/TC 102-
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现行
DIN EN ISO 15883-7
Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (ISO 15883-7:2016)
洗衣机消毒器第7部分:非侵入性非临界不耐热医疗器械和医疗设备用化学消毒洗衣机消毒器的要求和试验(ISO 15883-7-2016)
2016-10-01
现行
ISO 15883-7-2016
Washer-disinfectors — Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment
洗衣机消毒器 - 第7部分:采用化学消毒的非侵入性非关键耐热不可转换医疗设备和保健设备的洗衣机消毒器的要求和测试
2016-02-02
现行
EN ISO 15883-6-2015
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)
2015-08-19
现行
DIN EN ISO 15883-6
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: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(ISO 15883-6-2011)
2016-04-01