BS EN 45502-2-1:2003规定了适用于治疗缓慢性心律失常的主动植入式医疗设备的要求。BS EN 45502-2-1:2003中规定的试验为型式试验，应在装置样品上进行 以示服从。BS EN 45502-2-1:2003也适用于设备的一些非植入零件和附件（参见 注1）。植入式脉冲发生器或导线的特性应由 第2-1部分中详细说明的适当方法，或任何其他经证明具有准确性的方法 等于或优于指定的方法。如有争议，采用第2-1部分详述的方法 应适用。用于治疗快速性心律失常的主动植入式医疗设备的任何特征均包含在 EN 45502？2-2.注1:通常被称为主动植入式医疗设备的设备实际上可能是单个设备 设备组合，或一个或多个设备与一个或多个附件的组合。并非所有这些部件都需要安装 可部分或完全植入，但需要规定非植入零件和附件的一些要求 是否会影响植入设备的安全性或性能。注2:本欧洲标准中使用的术语旨在与指令中的术语一致 90/385/EEC。注3:在本欧洲标准中，使用小写字母印刷的术语，定义见第3条。其中定义了一个术语 在另一个术语中用作限定词，除非也定义了这样限定的概念，否则不以小写字母打印。 交叉引用:EN 28601:1992ISO 8601:1988EN 45502-1:1997EN 45502-2-2EN 60068.2.27:1993IEC 60068.2。27:1987EN 60068.2.47:1999IEC 60068-2-47:1999EN 60068.2.64:1994IEC 60068-2-64:1993ISO 5841-3:1992ISO 11318:1993ANSI/AAMI PC69-200090/385/EEC

BS EN 45502-2-1:2003 specifies requirements that are applicable to those ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat bradyarrhythmias.The tests that are specified in BS EN 45502-2-1:2003 are type tests, and are to be carried out on samples of a device to show compliance.BS EN 45502-2-1:2003 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 2-1 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 2-1 shall apply.Any features of an ACTIVE IMPLANTABLE MEDICAL DEVICE intended to treat tachyarrhythmias are covered by EN 45502?2-2.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 to be 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 is used as a qualifier in another term, it is not printed in small capital letters unless the concept thus qualified is also defined.Cross References:EN 28601:1992ISO 8601:1988EN 45502-1:1997EN 45502-2-2EN 60068.2.27:1993IEC 60068.2. 27:1987EN 60068.2.47:1999IEC 60068-2-47:1999EN 60068.2.64:1994IEC 60068-2-64:1993ISO 5841-3:1992ISO 11318:1993ANSI/AAMI PC69-200090/385/EEC