prEN ISO 15883-7由欧洲标准化委员会 IX-CEN 发布于 。
prEN ISO 15883-7在国际标准分类中归属于: 11.080.10 消毒设备。
prEN ISO 15883-7 清洗消毒机 第7部分:对非关键耐热医疗器械和医疗保健设备采用化学消毒的清洗消毒机的要求和测试 (ISO/DIS 15883-7:2024)的最新版本是哪一版?
prEN ISO 15883-7已经是当前最新版本。
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.
分析测试百科网讯 正逢德国美诺实验室清洗消毒机第10万台庆功之际,2015年11月20日上海美诺之家举办了德国美诺文化之旅——客户交流活动,让客户近距离体验百年品牌的品质保障。 德国美诺 Miele 始创于 1899年,专注于制造适用于厨房、洗衣房及用于地板护理的家用电器,以及用于商业运营和医疗设施中的电器。...
7.软件研究 参见《医疗器械软件注册技术审查指导原则》(国家食品药品监督管理总局通告2015年第50号)的相关要求,根据产品清洗消毒不彻底可能对患者造成的风险,软件安全性级别建议为B级。 ...
德国美诺Miele公司展台 德国美诺Miele公司是生产专业清洗消毒设备和高端商用电器专业清洗消毒设备的德国制造商,本次在BCEIA 2017展会上带来了新一代实验室专用清洗消毒系统——PG8583CD实验室器皿清洗消毒机。...
Miele 清洗消毒机采用密闭式的全自动运行程序,使实验室潜在的危险大大降低。换言之,Miele清洗消毒机为工作人员提供了良好的保护作用。 实验室里用于测试、分析、发生反应、隔离或清洗、取样的大部分器材,都由玻璃、陶瓷和塑料制成。因此,清洗和干燥是必备的功能。其中,清洗过程必须保证器材在再使用时不被之前的使用所影响。每个实验室的要求都不尽相同。...
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