标准编号：ISO 15883-7:2016
中文名称：清洗消毒器 第7部分：无创伤、非关键医疗器械和保健设备采用化学消毒的清洗消毒器的要求和试验
英文名称：Washer-disinfectors — Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment
发布日期：2016-02
标准范围
This part of ISO 15883 specifies the particular requirements for washer-disinfectors (WD) intended tobe used for the cleaning and chemical disinfection, in a single operating cycle, of reusable items such asthe 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.This part of ISO 15883 also specifies the performance requirements for the cleaning and disinfection ofthe washer-disinfector and its components and accessories which may be necessary in order to achievethe required performance.Devices identified within the scopes of ISO 15883-2, ISO 15883-3, ISO I5883-4, and ISO 15883-6 do notfall within the scope of this part of ISO 15883.In addition, the methods are specified, as well as instrumentation and instructions required for typetesting, works testing, validation (installation, operation, and performance qualification on firstinstallation), routine control, and monitoring, as well as requalifications required to be carried outperiodically and after essential repairs.NOTE WDs corresponding to this part of ISO 15883 can also be used for cleaning and chemical disinfectionof 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 orremoval of the causative agent(s) (prion proteins) of Transmissible Spongiform Encephalopathies.
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