心脏封堵器装载器检测

YY/T 1553-2017 心血管植入物 心脏封堵器

本标准的适用范围包括经导管植入的用于治疗心脏缺损等病变的心脏封堵器，主要包括房间隔缺损封堵器、室间隔缺损封堵器、动脉导管未闭封堵器及卵圆孔未闭封堵器。 本标准在基于当前医学知识水平的前提下规定了对心脏封堵器的要求。关于安全性，本标准在预期性能、设计属性、材料、设计评价、制造、灭菌包装及制造商提供

Cardiovascular implants.Cardiac occluder

T/CSBM 0014-2021 心脏封堵器体外脉动耐久性测试方法

1 通用要求: 1.1 仪器设备 1.1.1 测试系统需要实现设定压力（压差）、频率、测试温度和循环计数功能，若需要监控其他参数，阐述使用该方法的依据。 1.1.2 压力控制系统∶应选择在测试频率下能精准测量器械附近压力的压力传感系统，并且压力测量系统

Test methods for in vitro pulsatile durability testing of cardiac occluder

ISO 22679:2021 心血管植入物.经导管心脏封堵器

Cardiovascular implants — Transcatheter cardiac occluders

T/CSBM 0017-2021 镍钛形状记忆合金心脏封堵器形状恢复性能评价方法

技术要求： 1 总则 1.1 心脏封堵器形状恢复性能评价宜依据本文件开展测试，并对其结果进行评价。 1.2 心脏封堵器形状恢复性能评价测试应至少考虑以下方面∶ a） 测试人员应有一定的专业背景，经过测试方法和设备使用的培训; b） 测试用

Evaluation method for evaluating shape recoverability of Nickel-Titanium shape memory alloy cardiac occluder

T/GDMES 0017-2020 左心耳封堵器系统

本标准在基于当前知识水平的前提下规定了对左心耳封堵器的要求。关于安全方面，本标准在预期性能、设计属性、材料、设计评价、上市后监督、制造、灭菌、包装及制造商提供信息方面提出了要求

Left atrial appendage closure system

GB 16174.1-1996 心脏起博器 第1部分;植入式心脏起博器

本标准制定了基本术语和定义，并规定了植入式心脏起搏器的标志及包装要求。还对起搏器脉冲发生器的抗环境应力能力规定了最低要求与相应的试验方法。 附录A解释了区分脉冲发生器工作模式的代码。附录B提出了确证基本电参数符合要求的试验方法。附录C描述了脉冲发生器的标称使用寿命的估计和表达。附录D

Cardiac pacemakers--Part 1: Implantable pacemakers

JUS N.S5.606-1985 心脏去纤颤器和心脏去纤颤监测仪的测试

Testing ofcardiac defibrillators — monitors

CSN 24 3334-1966 心脏驱动器

Heart driver

IEC TR3 61288-2:1993 心脏除颤器 心脏除颤监护器 第2部分:维护

Contains guidelines regarding maintenance to be performed by clinical engineering personnel. Does not apply to automatic implantable defibrillators

Cardiac defibrillators; cardiac defibrillators-monitors; part 2: maintenance

IEC TR3 61288-1:1993 心脏除颤器 心脏除颤监护器 第1部分:操作

Contains guidelines regarding the safe and effective operation and maintenance to be performed by medical and nursing personnel. Does not apply

Cardiac defibrillators; cardiac defibrillators-monitors; part 1: operation

SIS SS IEC 601-2-5:1986 医疗电气设备．心脏去纤颤器及心脏去纤颤器监测器安全细则

This clause of the General Standard applies except as follows: 1.1 Scope Addition: This Particular Standard specifies requirements

Medical electrical equipment - Particular requirements for the safety of cardiac defibrillators and cardiac defibrillator-monitors

SIS SS IEC 601-2-4:1986 医疗电气设备．心脏去纤颤器及心脏去纤颤器监测器安全细则

Medical electrical equipment -Particular requirements for the safety of cardiac defibrillators and cardiac defibrillator-monitors

CSA IEC-1288-1-98-CAN/CSA:1998 心脏除颤器-心脏除颤器-监测器-第1部分:操作.第1版.CEI/IEC 1288-1:1993

Cardiac Defibrillators - Cardiac Defibrillators-Monitors - Part 1: Operation First Edition; CEI/IEC 1288-1: 1993

Cardiac Defibrillators - Cardiac Defibrillators-Monitors - Part 1: Operation First Edition; CEI/IEC 1288-1: 1993

CSA IEC-1288-2-98-CAN/CSA:1998 心脏除颤器-心脏除颤器-监测器-第2部分:维护.第1版.CEI/IEC 1288-2:1993

This International Standard specifies requirements for classification of wire electrodes in the as-welded condition and in the post weld heat-treated

Cardiac Defibrillators - Cardiac Defibrillators-Monitors - Part 2: Maintenance First Edition; CEI/IEC 1288-2: 1993

DOD A-A-54368-1991 (电击)去纤颤器和心脏检查器(便携式充电器)

The General Services Administration has authorized the use of this Commercial Item Description

DEFIBRILLATOR AND CARDIOSCOPE (THREE LEAD, PORTABLE, WITH CHARGER)

SIS SS IEC 601-2-4:1986 医疗电气设备．心脏去纤颤器及心脏去纤颤器监测器安全细则

Medical electrical equipment -Particular requirements for the safety of cardiac defibrillators and cardiac defibrillator-monitors

WS/T 603-2018 心脏除颤器安全管理

JJF 1149-2014 心脏除颤器校准规范

本规范适用于手动心脏除颤器和自动体外除颤器(AED)与除颤功能直接相关的计量特性的校准;不适用于植入式除颤器、遥控除颤器的校准

Calibration Specification for Cardiac Defibrillators

JUS N.S5.606-1985 心脏去纤颤器和心脏去纤颤监测仪的测试

Testing ofcardiac defibrillators — monitors

ISO 11318:2002 心脏除颤器.可植入心脏除颤器联结器系统DF-1.尺寸和试验要求

This International Standard specifies a unipolar connector assembly, DF-1, intended for use in connecting implantable defibrillator leads

Cardiac defibrillators - Connector assembly DF-1 for implantable defibrillators - Dimensional and test requirements

CSA CEI-1288-2-98-CAN/CSA-1998 心脏除颤器-心脏除颤器监视器-第2部分:维修.第1版.CEI/IEC 1288-2:1993

Defibrillateurs Cardiaques - Moniteurs-Defibrillateurs Cardiaques - Partie 2: Maintenance Premiere Edition; CEI/IEC 1288-2: 1993

Defibrillateurs Cardiaques - Moniteurs-Defibrillateurs Cardiaques - Partie 2: Maintenance Premiere Edition; CEI/IEC 1288-2: 1993

CSA IEC-1288-1-98-CAN/CSA:1998 心脏除颤器-心脏除颤器-监测器-第1部分:操作.第1版.CEI/IEC 1288-1:1993

Cardiac Defibrillators - Cardiac Defibrillators-Monitors - Part 1: Operation First Edition; CEI/IEC 1288-1: 1993

Cardiac Defibrillators - Cardiac Defibrillators-Monitors - Part 1: Operation First Edition; CEI/IEC 1288-1: 1993

CSA IEC-1288-2-98-CAN/CSA:1998 心脏除颤器-心脏除颤器-监测器-第2部分:维护.第1版.CEI/IEC 1288-2:1993

This International Standard specifies requirements for classification of wire electrodes in the as-welded condition and in the post weld heat-treated

Cardiac Defibrillators - Cardiac Defibrillators-Monitors - Part 2: Maintenance First Edition; CEI/IEC 1288-2: 1993

DB22/T 1962-2013 心脏除颤器和心脏除颤监护仪质量控制规范

DOD A-A-54347-1991 胎儿心脏监控器(有记录器的)

The General Services Administration has authorized the use of this Commercial Item Description

MONITOR, FETAL HEART (WITH RECORDER)

YY/T 0946-2014 心脏除颤器 植入式心脏除颤器用DF‐1连接器组件 尺寸和试验要求

本标准适用于将植入式心脏除颤电极导线与最大输出不超过1 kV/50 A的植入式心脏除颤脉冲发生器进行连接时使用的DF-1单极连接器组件。本标准规定了组件间配合的基本尺寸、性能要求和相应的试验方法。本标准未规定连接器的其他特性,如紧固方式和材料。本标准适用于连接器组件的外形和适配。本标准不适用于不同的

Cardiac defibrillators.Connector assembly DF-1 for implantable defibrillators.Dimensions and test requirements

ISO 11318:1993 心脏去纤颤器. 可植入体内的心脏去纤颤器联结器系统和试验要求

Cardiac defibrillators; connector assembly for implantable defibrillators; dimensional and test requirements

SJ/T 11046-1996 心脏起搏器用锂碘电池

Lithium-iodine batteries for cardiac pacemakers

BS ISO 11318:2002 心脏去纤颤器.可植入的心脏去纤颤器联结器组件DF-1.尺寸和试验要求

This International Standard specifies a unipolar connector assembly, DF-1, intended for use in connecting implantable defibrillator leads

Cardiac defibrillators - Connector assembly DF-1 for implantable defibrillators - Dimensions and test requirements

KS P ISO 11318:2012 心脏除颤器.可植入体内的心脏除颤器联结器系统DF.1.尺寸和试验要求

이 표준은 최대 출력 1 kV/50 A 이하의 이식용 제세동기 전원에 이식 가능한 제세동기

Cardiac defibrillators－Connector assembly DF-1 for implantable defibrillators－Dimensions and test requirements