标准摘要
[中文适用范围]： 该文件规定了用于具有起搏、电描记图传感和/或除颤功能的植入式心律管理（CRM）设备的四极连接器系统。 该文件包括对可植入导线的连接器部分以及对连接到可植入脉冲发生器的配合连接器腔的要求。 基本尺寸和性能要求与适当的测试方法一起指定。 注：任何特定部件的安全性、可靠性、生物相容性、生物稳定性和功能均由制造商负责。 本文档无意取代现有的单极或双极连接器标准（例如 ISO 11318 和 ISO 5841-3）或提供替代标准。 本文件不适用于预期输出大于 1000 V 和/或 50 A 的高压系统。 本文件不适用于包含不具备传统起搏、电描记图传感和/或除颤功能的传感器或独特电极的系统功能。 本文档并未指定所有连接器功能。 本文件并未涉及组装到系统中的引线和脉冲发生器的功能兼容性、安全性或可靠性的所有方面。 注：不符合本文件的引线和脉冲发生器连接器系统可能是安全可靠的，并且具有临床优势。 [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