标准编号：ISO 14708-1:2014
中文名称：外科移植 现行的医疗移植设备 第1部分：安全,商标和生产者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：2014-08
标准范围
This part of ISO 14708 specifies requirements that are generally applicable to active implantablemedical devices.NOTE 1 For particular types of active implantable medical devices, these general requirements aresupplemented or modified by the requirements of particular parts of ISO 14708.The tests that are specified in ISO 14708 are type tests and are to be carried out on samples of an activeimplantable medical device to show compliance.This part of ISO 14708 is applicable not only to active implantable medical devices that are electricallypowered but also to those powered by other energy sources (for example by gas pressure or by springs).This part of ISO 14708 is also applicable to some non-implantable parts and accessories of the activeimplantable medical devices.NOTE 2 The device that is commonly referred to as an active implantable medical device can be a singledevice, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of theseparts are required to be either partially or totally implantable, but there is a need to specify some requirementsof non-implantable parts and accessories if they could affect the safety or performance of the implantable device.NOTE 3 In this part of ISO 14708, terms printed in small capital letters are used as defined in Clause 3. Where adefined term is used as a qualifier in another term, it is not printed in small capital letters unless the concept thusqualified is also defined.NOTE 4 The terminology used in this part of ISO 14708 is intended to be consistent with the terminology ofISO/TR 14283:2004.
立即下载标准文件