标准号：ISO 14708-1-2000
实施状态：作废
中文名称：外科植入物.有源可植入医疗装置.第1部分:安全、标记及制造商提供信息的一般要求
英文名称：Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
发布日期：2000-11
被替代标准：ISO 14708-1-2014
代替标准：ISO/FDIS 14708-1-2000
采用标准：GOST R ISO 14708-1-2012,IDT
起草单位：ISO/TC 150
标准简介：This part of ISO 14708 specifies requirements that are generally applicable to active implantable medical devices.
NOTE For particular types of active implantable medical devices, these general requirements are supplemented or modified by the requirements of particular standards which form additional parts of ISO 14708. Special care is required in applying this part of ISO 14708 to active implantable medical devices where no particular standard exists.
The tests that are specified in this part of ISO 14708 are type tests intended to be carried out on samples of a device to show compliance, and are not intended to be used for the routine testing of manufactured products.
This part of ISO 14708 is applicable not only to active implantable medical devices that are electrically powered, but also to those powered by other energy sources (for example gas pressure or springs).
This part of ISO 14708 is also applicable to some non-implantable parts and accessories of the devices (see 3.3).
文件格式：PDF
文件大小：259.91KB
文件页数：48
（以上信息更新时间为：2019-11-23）
ISO 14708-1-2000 外科植入物.有源可植入医疗装置.第1部分_安全、标记及制造商提供信息的一般要求.pdf
(259.91 KB)
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