标准摘要
[中文适用范围]： 本标准规定了用于具有起搏、心电信号监测和/或除颤功能的植入式心脏节律管理装置的四极连接器系统。标准内容包括植入式导线连接部分的规格，以及连接于植入式脉冲发生器的配对连接器腔室的要求。标准规定了关键尺寸与性能要求，并提供了相应的测试方法。本标准无意替代或提供现行单极或双极连接器标准（如ISO 11318和ISO 5841-3）的替代方案。本标准不适用于预期输出电压大于1000伏特和/或电流大于50安培的高电压系统；亦不适用于包含传感器或特殊电极、无法实现常规起搏、心电信号监测和/或除颤功能的系统。本标准未规定连接器所有特征，亦未涉及 [外文原描述]： This document specifies a four-pole connector system for implantable cardiac rhythm management (CRM) devices which have pacing, electrogram sensing and/or defibrillation functions. This document includes requirements for the connector portion of an implantable lead as well as for the mating connector cavity attached to an implantable pulse generator. Essential dimensions and performance requirements are specified together with appropriate test methods. NOTE The safety, reliability, biocompatibility, biostability and function of any particular part are the responsibility of the manufacturer. This document is not intended to replace or provide alternatives for unipolar or bipolar connector standards that currently exist (such as ISO 11318 and ISO 5841-3). This document is not applicable to high-voltage systems with intended outputs greater than 1 000 V and/or 50 A. This document is not applicable to systems which include sensors or unique electrodes that are not capable of conventional pacing, electrogram sensing and/or defibrillation functions. This document does not specify all connector features. This document does not address all aspects of functional compatibility, safety or reliability of leads and pulse generators assembled into a system. NOTE Lead and pulse generator connector systems not conforming to this document can be safe and reliable and can have clinical advantages.
英文名称Active implantable medical devices — Four-pole connector system for implantable cardiac rhythm management devices — Dimensional and test requirements