ISO 11318:2002 心脏去纤颤器,可植入体内的心脏去纤颤器联接器系统和试验要求

标准编号:ISO 11318:2002

中文名称:心脏去纤颤器,可植入体内的心脏去纤颤器联接器系统和试验要求

英文名称:Cardiac defibrillators — Connector assembly DF-1 for implantable defibrillators — Dimensions and test requirements

发布日期:2002-08

标准范围

本国际标准规定了单极连接器组件DF-1,用于将植入式除颤器引线连接至峰值输出不超过1 kV/50 a的植入式除颤器发生器。规定了与连接器配合有关的基本尺寸和性能要求,以及试验方法。本国际标准未规定其他连接器功能,如紧固方式和材料。本国际标准适用于连接器组件的形式和安装,并未涉及不同植入式除颤器导线和植入式除颤器发生器组件的功能兼容性、系统性能或可靠性的所有方面。

This International Standard specifies a unipolar connector assembly, DF-1, intended for use in connecting implantable defibrillator leads to implantable defibrillator generators that do not produce more than 1 kV/50 A peak output. Essential dimensions and performance requirements related to connector fit are specified, along with test methods.This International Standard does not specify other connector features such as fastening means and material. This International Standard is applicable to the form and fit of the connector assembly, and does not address all aspects of functional compatibility, system performance, or reliability of different implantable defibrillator leads and implantable defibrillator generator assemblies.

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