Test or certification item 测试或认证名称:  心电电缆和导线 ECG cables and leadwires 

 

Test or certification info 测试和认证相关内容:

本标准涵盖用于采集心脏监护仪/遥测发射器（ANSI/AAMI/IEC 60601-2-27）、诊断心电图仪（ANSI/AAAMI/IEC60601-1-2-25）和动态心电图记录器/事件记录器（ANSI/AAMI/IEC 6001-2.47）的表面心电图（ECG）监测信号的主干电缆和患者导线。从最广泛的意义上讲，本标准适用于任何使用患者导线和可能的ECG主干电缆采集表面心电图信号的ECG设备

This standard covers TRUNK CABLES and PATIENT LEADWIRES used to acquire surface electrocardiographic (ECG) monitoring signals for cardiac monitors/telemetry transmitters (ANSI/AAMI/IEC 60601-2-27), diagnostic electrocardiographs (ANSI/AAMI/IEC 60601-2-25) and ambulatory ECG recorders/event recorders (ANSI/AAMI/IEC 60601-2-47). In the broadest sense, this standard applies to any ECG DEVICE that uses PATIENT LEADWIRES and possibly ECG TRUNK CABLES to acquire surface electrocardiographic signals

本标准的目的是通过在主干电缆和患者导线连接器之间建立公共接口，允许在具有隔离患者连接的ECG设备之间交换ECG主干电缆和病人导线。还规定了用于隔离患者连接器的主干电缆和患者引线的性能和安全标准。本标准的原始范围涉及与心脏监护仪一起使用的主干电缆和患者导线。范围扩大到包括与其他心电图设备一起使用的患者导线，包括诊断心电图仪、动态心电图（Holter）记录仪/事件记录仪和心电图遥测。

The objective of this standard is to allow ECG TRUNK CABLES and PATIENT LEADWIRES to be interchanged between ECG DEVICES with isolated PATIENT connections by establishing a common interface between the TRUNK CABLE and the PATIENT LEADWIRE connectors. Performance and safety criteria for TRUNK CABLES and PATIENT LEADWIRES used with isolated PATIENT connectors are also specified. This standard's original scope related to TRUNK CABLES and PATIENT LEADWIRES used with cardiac monitors. The scope was extended to include PATIENT LEADWIRES used with other ECG DEVICES including diagnostic electrocardiographs, ambulatory ECG (Holter) recorders/event recorders and ECG telemetry.

Norm refer 涉及法规: AAMI

 

Refer products 涉及产品:  医疗器械

 

Lead time 周期:  常规服务 regular service 25 工作日 working days （ URGENT service, to be confirm, 加急服务待定 ）

 

Sample size 送样规格:  每个型号线束3根 + 控制设备主机1台

Others 其他信息:  

Photo for reference 涉及图片:

 

Sample report 样本报告：