BS EN 45502-2-1-2004 活性可植入医疗设备.用于治疗缓慢性心率失常的活性可植入医疗器件的详细要求(心脏起搏器)

标准号：BS EN 45502-2-1-2004
中文标准名称：活性可植入医疗设备.用于治疗缓慢性心率失常的活性可植入医疗器件的详细要求(心脏起搏器)
英文标准名称：Active implantable medical devices - Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
标准类型：C35
发布日期：2004/1/20 12:00:00
实施日期：2004/1/20 12:00:00
中国标准分类号：C35
国际标准分类号：11.040.40
适用范围：This Part 2-1 specifies requirements that are applicable to those ACTIVE IMPLANTABLE MEDICAL DEVICESintended to treat bradyarrhythmias.The tests that are specified in EN 45502 are type tests, and are to be carried out on samples of a deviceto show compliance.This Part 2-1 is also applicable to some non-implantable parts and accessories of the devices (seeNote 1).The characteristics of the IMPLANTABLE PULSE GENERATOR or LEAD shall be determined by either theappropriate method detailed in this Part 2-1 or by any other method demonstrated to have an accuracyequal to, or better than, the method specified. In the case of dispute, the method detailed in this Part 2-1shall apply.Any features of an ACTIVE IMPLANTABLE MEDICAL DEVICE intended to treat tachyarrhythmias are covered byEN 45502–2-2.