标准摘要
[中文适用范围]： 本文件规定了用于将药物输送到人体内特定位置的有源植入式医疗器械的特殊要求，为患者和用户提供基本的安全保证。 它修订和补充了 ISO 14708-1:2014。 本文件的要求优先于 ISO 14708-1 的要求。 本文件适用于旨在将药物输送到人体内特定位置的有源植入式医疗器械。 本文件也适用于第 3 条中定义的设备的一些非植入部件和附件。 本文件中指定的测试是旨在对设备样本进行的型式测试，以显示合规性，并不旨在用于制造产品的常规测试。 注：本文件不适用于非植入式输液系统。 [外文原描述]： This document specifies particular requirements for active implantable medical devices intended to deliver a medicinal substance to site-specific locations within the human body, to provide basic assurance of safety for both patients and users. It amends and supplements ISO 14708-1:2014. The requirements of this document take priority over those of ISO 14708-1. This document is applicable to active implantable medical devices intended to deliver medicinal substances to site-specific locations within the human body. This document is also applicable to some non-implantable parts and accessories of the devices defined in Clause 3. The tests that are specified in this document are type tests intended to be carried out on a sample of a device to show compliance and are not intended to be used for the routine testing of manufactured products. NOTE This document is not intended to apply to non-implantable infusion systems.
英文名称Implants for surgery — Active implantable medical devices — Part 4: Implantable infusion pump systems