標準號：BS EN 45502-2-2-2008
中文標準名稱：有源可植入醫療器件.用于治療緩慢性心率失常的活性可植入醫療器件的特殊要求(心臟起搏器)
英文標準名稱：Active implantable medical devices - Part 2-2:Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
標準類型：C45
發布日期：2008/10/31 12:00:00
實施日期：2008/10/31 12:00:00
中國標準分類號：C45
國際標準分類號：11.040.40
引用標準：EN 980;EN 28601;EN 45502-1;EN 45502-2-1;EN 60068-2-27;EN 60068-2-47;EN 60068-2-64;IEC 60878;ISO 5841-3 Technical Corrigendum 1-2003;ISO 11318;ANSI/AAMI PC69
適用范圍：This Part 2-2 of EN 45502 specifies requirements that are applicable to IMPLANTABLE CARDIOVERTERDEFIBRILLATORS and the functions of ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treattachyarrhythmia.The tests that are specified in EN 45502 are type tests and are to be carried out on samples of a device to show compliance.This part of EN 45502 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 theappropriate method detailed in this particular standard or by any other method demonstrated to haveaccuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in thisParticular Standard shall apply.Any aspect of an ACTIVE IMPLANTABLE MEDICAL DEVICE intended to treat bradyarrhythmias is covered byEN 45502–2-1 Particular requirements for active implantable medical devices intended to treatbradyarrhythmia (Pacemakers).NOTE 1 The device that is commonly referred to as an ACTIVE IMPLANTABLE MEDICAL DEVICE may in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required tobe either partially or totally implantable, but there is a need to specify some requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device.NOTE 2 The terminology used in this European Standard is intended to be consistent with the terminology of Directive 90/385/EEC.NOTE 3 In this European Standard, terms printed in small capital letters are used as defined in Clause 3. Where a defined term isused as a qualifier in another term, it is not printed in small capital letters unless the concept thus qualified is also defined.NOTE 4 Particular requirements for congestive heart failure devices are under consideration. These types of devices are not covered by this standard.