标准编号：ISO 27186:2020
中文名称：主动植入式医疗设备 植入式心律管理设备用四极连接器系统 尺寸和试验要求
英文名称：Active implantable medical devices — Four-pole connector system for implantable cardiac rhythm management devices — Dimensional and test requirements
发布日期：2020-11
标准范围
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.
标准预览图
立即下载标准文件