发布时间:2024-05-27 17:49:26 - 更新时间:2024年06月29日 15:22
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이 규격은 심근에 접촉하는 전극을 사용하여 심장에 전기 자극을 줌으로써 부정맥을 보정하고
External cardiac pacemaker
External cardiac pacemaker
增补:本专用标准规定了适用于2.1.101所定义的带内部电源的体外心脏起搏器安全专用要求。本标准适用于2.1.104中定义的患者电缆。本标准不适用于直接或间接连到供电网的设备。本标准不适用于起搏电极或其他用于心电模拟的设备:1) 成为带其他功能的设备的内部部件;或2) 使刺激从外部通过胸腔或食道;或
Medical electrical equipment.Part 2:Particular requirements for the safety of external cardiac pacemakers with internal power source
Medical electrical equipment - Part 2-31 : particular requirements for the safety of external cardiac pacemakers with internal power source.
この規格は,2.1.101に定義する内部電源で駆動する体外式ペースメーカ(以下“機器”という。)の個別安全要求事項を規定する
Medical electrical equipment -- Part 2-31: Particular requirements for the safety of external cardiac pacemakers with internal power source
Specifies the particular safety requirements for external pacemakers powered by an internal electrical power source. Does not apply to equipment which
Medical electrical equipment - Part 2: Particular requirements for the safety of external cardiac pacemakers with internal power source
This is Amendment 1 to IEC 60601-2-31-1994 (Medical electrical equipment -Part 2-31:Particular requirements for the safety of external cardiac
Medical electrical equipment - Part 2-31: Particular requirements for the safety of external cardiac pacemakers with internal power source; Amendment 1
추가:이 개별 표준은 2.1.101에 정의된 내부 전원을 사용하는 체외용 인공 심장 박
Medical electrical equipment-Part 2-31:Particular requirements for the safety of external cardiac pacemakers with internal power source
Medical electrical equipment.Part 2-31: Particular requirements for basic safety and essential performance of external cardiac pacemakers with internal power source
Medical electrical equipment — Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of EXTERNAL PACEMAKERS powered by an INTERNAL
Medical electrical equipment - Part 2-31: Particular requirements for basic safety and essential performance of external cardiac pacemakers with internal power source
本文件规定了由内部电源供电的体外心脏起搏器的基本安全和基本性能。本文件适用于延伸非植入式脉冲发生器和起搏电极导线之间距离的电缆,但不适用于封闭有一根或多根被绝缘的导体,预期用于在体外心脏起搏器和患者心脏之间传输电能的软管。本文件不适用于GB 16174.1所涵盖的有源植入式医疗器械的植入部分、可以
Medical electrical equipment - Part 2-31: Particular requirements for basic safety and essential performance of external cardiac pacemakers with internal power source
Amendment 1 - Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
Amendment 1 Medical electrical equipment - Part 2-31 : Particular requirements for the safety of external cardiac pacemakers with internal power
Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of External Cardiac Pacemakers with Internal Power Source First Edition
이 규격은 심근에 접촉하는 전극을 사용하여 심장에 전기 자극을 줌으로써 부정맥을 보정하고
External cardiac pacemaker
External cardiac pacemaker
增补:本专用标准规定了适用于2.1.101所定义的带内部电源的体外心脏起搏器安全专用要求。本标准适用于2.1.104中定义的患者电缆。本标准不适用于直接或间接连到供电网的设备。本标准不适用于起搏电极或其他用于心电模拟的设备:1) 成为带其他功能的设备的内部部件;或2) 使刺激从外部通过胸腔或食道;或
Medical electrical equipment.Part 2:Particular requirements for the safety of external cardiac pacemakers with internal power source
Medical electrical equipment - Part 2-31 : particular requirements for the safety of external cardiac pacemakers with internal power source.
この規格は,2.1.101に定義する内部電源で駆動する体外式ペースメーカ(以下“機器”という。)の個別安全要求事項を規定する
Medical electrical equipment -- Part 2-31: Particular requirements for the safety of external cardiac pacemakers with internal power source
Specifies the particular safety requirements for external pacemakers powered by an internal electrical power source. Does not apply to equipment which
Medical electrical equipment - Part 2: Particular requirements for the safety of external cardiac pacemakers with internal power source
This is Amendment 1 to IEC 60601-2-31-1994 (Medical electrical equipment -Part 2-31:Particular requirements for the safety of external cardiac
Medical electrical equipment - Part 2-31: Particular requirements for the safety of external cardiac pacemakers with internal power source; Amendment 1
추가:이 개별 표준은 2.1.101에 정의된 내부 전원을 사용하는 체외용 인공 심장 박
Medical electrical equipment-Part 2-31:Particular requirements for the safety of external cardiac pacemakers with internal power source
Medical electrical equipment.Part 2-31: Particular requirements for basic safety and essential performance of external cardiac pacemakers with internal power source
Medical electrical equipment — Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of EXTERNAL PACEMAKERS powered by an INTERNAL
Medical electrical equipment - Part 2-31: Particular requirements for basic safety and essential performance of external cardiac pacemakers with internal power source
本文件规定了由内部电源供电的体外心脏起搏器的基本安全和基本性能。本文件适用于延伸非植入式脉冲发生器和起搏电极导线之间距离的电缆,但不适用于封闭有一根或多根被绝缘的导体,预期用于在体外心脏起搏器和患者心脏之间传输电能的软管。本文件不适用于GB 16174.1所涵盖的有源植入式医疗器械的植入部分、可以
Medical electrical equipment - Part 2-31: Particular requirements for basic safety and essential performance of external cardiac pacemakers with internal power source
Amendment 1 - Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
Amendment 1 Medical electrical equipment - Part 2-31 : Particular requirements for the safety of external cardiac pacemakers with internal power
Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of External Cardiac Pacemakers with Internal Power Source First Edition