标准号：ISO 14708-2-2005
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2部分:心脏起搏器
英文名称：Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers
发布日期：2005-10
被替代标准：ISO 14708-2-2012
代替标准：ISO 5841-1-1989;ISO/FDIS 14708-2-2005
起草单位：ISO/TC 150
标准简介：This Part 2 specifies requirements that are applicable to those ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat
bradyarrhythmias.
The tests that are specified in ISO 14708 are type tests, and are to be carried out on samples of a device to show
compliance.
This Part 2 is also applicable to some non-implantable parts and accessories of the devices (see Note 1).
The characteristics of the IMPLANTABLE PULSE GENERATOR or LEAD shall be determined by either the appropriate
method detailed in this Part 2 or by any other method demonstrated to have an accuracy equal to, or better than, the
method specified. In the case of dispute, the method detailed in this Part 2 shall apply.
Any features of an ACTIVE IMPLANTABLE MEDICAL DEVICE intended to treat tachyarrhythmias are covered by another ISO
document under development.
文件格式：PDF
文件大小：1.74MB
文件页数：104
（以上信息更新时间为：2019-11-22）
ISO 14708-2-2005 外科植入物.有源可植入医疗装置.第2部分_心脏起搏器.pdf
(1.74 MB)
|
|
