ISO 14708-4:2008 外科植入物 有源植入性医疗器械 第4部分：植入式输液泵

标准编号：ISO 14708-4:2008

中文名称：外科植入物 有源植入性医疗器械 第4部分：植入式输液泵

英文名称：Implants for surgery — Active implantable medical devices — Part 4: Implantable infusion pumps

发布日期：2008-11

标准范围

ISO 14708-4:2008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。ISO 14708-4:2008也适用于设备的一些非植入零件和附件。ISO 14708-4:2008中规定的试验是在装置样品上进行的型式试验，以证明符合性，不用于制造产品的常规试验。

ISO 14708-4:2008 is applicable to active implantable medical devices intended to deliver medicinal substances to site-specific locations within the human body.ISO 14708-4:2008 is also applicable to some non-implantable parts and accessories of the devices.The tests that are specified in ISO 14708-4:2008 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.

标准预览图