本文件规定了植入式心律管理（CRM）设备的四极连接器系统，该设备具有起搏、心电图传感和/或除颤功能。本文件包括对植入式导线连接器部分以及与植入式脉冲发生器相连的配套连接器腔的要求。基本尺寸和性能要求与适当的试验方法一起规定。 注:任何特定部件的安全性、可靠性、生物相容性、生物稳定性和功能由制造商负责。 本文件无意取代或提供现有单极或双极连接器标准（如ISO 11318和ISO 5841-3）的替代品。 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传感器或独特电极的系统，这些传感器或电极不能实现常规起搏、心电图传感和/或除颤功能。 本文档未指定所有连接器功能。 本文件并未涉及组装到系统中的导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:不符合本文件要求的导线和脉冲发生器连接器系统可能安全可靠，并具有临床优势。

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.