本文件规定了主动植入式医疗设备的特殊要求，旨在将药物输送至人体内特定位置，为患者和使用者提供基本的安全保证。它对ISO？14708-1:2014进行了修订和补充。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至人体内特定位置的主动植入式医疗设备。 本文件也适用于第3条中定义的设备的一些非植入零件和附件。 本文件中规定的试验为型式试验，拟在装置样品上进行，以证明符合性，不拟用于制造产品的常规试验。 注:本文件不适用于非植入式输液系统。

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.