体外诊断(IVD)医用设备检测

YY 0648-2008 测量、控制和试验室用电气设备的安全要求.第2-101部分:体外诊断(IVD)医用设备的专用要求

除下述内容外，GB 4793.1中的该章适用。 替换： 本标准适用于预期用作体外诊断（IVD）医用目的，包括自测体外诊断医用目的的设备。 体外诊断医用设备，论单独或组合使用，是制造商预期用于体外样品检查，这些样品包括来自人体的血和组织样本，其单独或主要目的是为下面一个或几个方面提供信息

Safety requirments for electrical equipment for measurement,control and laboratory use.Part 2-101:Particular requirments for in vitro diagnostic(IVD）medical equipment

DIN EN 61326-2-6:2013 测量, 控制和实验室用电气设备. 电磁兼容性 (EMC) 要求. 第2-6部分:特殊要求. 体外诊断 (IVD) 医用设备 (IEC 61326-2-6-2012); 德文版本EN 61326-2-6-2013

Electrical equipment for measurement, control and laboratory use - EMC requirements.Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment (IEC 61326-2-6:2012); German version EN 61326-2-6:2013

MEDDEV 2.14/3-2007 医疗设备指导方针.有关体外诊断设备的指导方针:使用说明书(IFU)和其他体外诊断(IVD)医疗设备信息的提供.适用于制造商和公告机构的指导方针.修订件1

GUIDELINES ON MEDICAL DEVICES IVD GUIDANCES: Supply of Instructions For Use (IFU) and other information for In-vitro Diagnostic (IVD) Medical Devices A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES

BS EN IEC 61326-2-6:2021 测量、控制和实验室用电气设备 EMC要求 特殊要求 体外诊断（IVD）医疗设备

Electrical equipment for measurement, control and laboratory use. EMC requirements. Particular requirements. In vitro diagnostic (IVD) medical equipment

GB/T 18268.26-2010 测量、控制和实验室用的电设备 电磁兼容性要求 第26部分：特殊要求 体外诊断(IVD)医疗设备

GB/T 18268.1的范围适用于本部分。此外，GB/T 18268的本部分根据体外诊断(IVD)医疗设备的特性及其电磁环境，规定了其电磁兼容性的抗扰度和发射的基本要求

Electrical equipment for measurement,control and laboratory use.EMC requirements.Part 26:Particular requirements.In vitro diagnostic(IVD) medical equipment

IEC 61326-2-6:2020 电气设备用于测量 控制和实验室使用 - Emc要求 - 第2-6部分:特殊要求 - 体外诊断（ivd）医疗设备

Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment

BS EN 61326-2-6:2013 测量、控制和实验室用电气设备.电磁兼容性(EMC)的要求.详细要求.体外诊断(IVD)医疗设备

Electrical equipment for measurement, control and laboratory use. EMC requirements. Particular requirements. In vitro diagnostic (IVD) medical equipment

NF C46-050-2-6*NF EN 61326-2-6:2013 测量, 控制和实验室使用电气设备. EMC要求. 第2-6部分: 详细要求. 体外诊断(IVD)医疗设备

Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6 : particular requirements - In vitro diagnostic (IVD) medical equipment

DIN EN 61010-2-101:2003 测量、控制和实验室用电气设备的安全要求.第2-101部分:体外诊断(IVD)医疗设备的特殊要求

Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment (IEC 61010-2-101:2002, modified); German version EN 61010-2-101:2002

GOST IEC 61010-2-101:2013 测量, 控制和实验室用电气设备的安全要求. 第2-101部分. 体外诊断 (IVD) 医疗设备的特殊要求

Safety requirements for electrical equipment for measurement, control and laboratory use. Part 2-101. Particular requirements for in vitro diagnostic (IVD) medical equipment

ISO 23640:2011 体外诊断医疗装置.体外诊断剂的稳定性评估

In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents

JIS C1010-2-101-2017 测量、控制和试验室用电气设备的安全性要求.第2-101部分:体外诊断(IVD)医疗设备的详细要求

Safety requirements for electrical equipment for measurement, control and laboratory use -- Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment

JIS C1010-2-101-2013 测量、控制和试验室用电气设备的安全性要求.第2-101部分:体外诊断(IVD)医疗设备的详细要求

Safety requirements for electrical equipment for measurement, control and laboratory use -- Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment

KS P ISO 18113-4-2015(2020 体外诊断医疗设备 - 制造商提供的信息（标签） - 第4部分:体外诊断试剂用于自检

In vitro diagnostic medical devices — Information supplied by the manufacturer(labelling) — Part 4: In vitro diagnostic reagents for self-testing

KS P ISO 23640:2019 体外诊断医疗器械 - 体外诊断试剂稳定性评估

In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents

YY 0648-2008 测量、控制和试验室用电气设备的安全要求.第2-101部分:体外诊断(IVD)医用设备的专用要求

除下述内容外，GB 4793.1中的该章适用。 替换： 本标准适用于预期用作体外诊断（IVD）医用目的，包括自测体外诊断医用目的的设备。 体外诊断医用设备，论单独或组合使用，是制造商预期用于体外样品检查，这些样品包括来自人体的血和组织样本，其单独或主要目的是为下面一个或几个方面提供信息

Safety requirments for electrical equipment for measurement,control and laboratory use.Part 2-101:Particular requirments for in vitro diagnostic(IVD）medical equipment

DIN EN 61326-2-6:2013 测量, 控制和实验室用电气设备. 电磁兼容性 (EMC) 要求. 第2-6部分:特殊要求. 体外诊断 (IVD) 医用设备 (IEC 61326-2-6-2012); 德文版本EN 61326-2-6-2013

Electrical equipment for measurement, control and laboratory use - EMC requirements.Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment (IEC 61326-2-6:2012); German version EN 61326-2-6:2013

MEDDEV 2.14/3-2007 医疗设备指导方针.有关体外诊断设备的指导方针:使用说明书(IFU)和其他体外诊断(IVD)医疗设备信息的提供.适用于制造商和公告机构的指导方针.修订件1

GUIDELINES ON MEDICAL DEVICES IVD GUIDANCES: Supply of Instructions For Use (IFU) and other information for In-vitro Diagnostic (IVD) Medical Devices A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES

BS EN IEC 61326-2-6:2021 测量、控制和实验室用电气设备 EMC要求 特殊要求 体外诊断（IVD）医疗设备

Electrical equipment for measurement, control and laboratory use. EMC requirements. Particular requirements. In vitro diagnostic (IVD) medical equipment

GB/T 18268.26-2010 测量、控制和实验室用的电设备 电磁兼容性要求 第26部分：特殊要求 体外诊断(IVD)医疗设备

GB/T 18268.1的范围适用于本部分。此外，GB/T 18268的本部分根据体外诊断(IVD)医疗设备的特性及其电磁环境，规定了其电磁兼容性的抗扰度和发射的基本要求

Electrical equipment for measurement,control and laboratory use.EMC requirements.Part 26:Particular requirements.In vitro diagnostic(IVD) medical equipment

IEC 61326-2-6:2020 电气设备用于测量 控制和实验室使用 - Emc要求 - 第2-6部分:特殊要求 - 体外诊断（ivd）医疗设备

Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment

BS EN 61326-2-6:2013 测量、控制和实验室用电气设备.电磁兼容性(EMC)的要求.详细要求.体外诊断(IVD)医疗设备

Electrical equipment for measurement, control and laboratory use. EMC requirements. Particular requirements. In vitro diagnostic (IVD) medical equipment

NF C46-050-2-6*NF EN 61326-2-6:2013 测量, 控制和实验室使用电气设备. EMC要求. 第2-6部分: 详细要求. 体外诊断(IVD)医疗设备

Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6 : particular requirements - In vitro diagnostic (IVD) medical equipment

DIN EN 61010-2-101:2003 测量、控制和实验室用电气设备的安全要求.第2-101部分:体外诊断(IVD)医疗设备的特殊要求

Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment (IEC 61010-2-101:2002, modified); German version EN 61010-2-101:2002

GOST IEC 61010-2-101:2013 测量, 控制和实验室用电气设备的安全要求. 第2-101部分. 体外诊断 (IVD) 医疗设备的特殊要求

Safety requirements for electrical equipment for measurement, control and laboratory use. Part 2-101. Particular requirements for in vitro diagnostic (IVD) medical equipment

ISO 23640:2011 体外诊断医疗装置.体外诊断剂的稳定性评估

In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents

JIS C1010-2-101-2017 测量、控制和试验室用电气设备的安全性要求.第2-101部分:体外诊断(IVD)医疗设备的详细要求

Safety requirements for electrical equipment for measurement, control and laboratory use -- Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment

JIS C1010-2-101-2013 测量、控制和试验室用电气设备的安全性要求.第2-101部分:体外诊断(IVD)医疗设备的详细要求

Safety requirements for electrical equipment for measurement, control and laboratory use -- Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment

KS P ISO 18113-4-2015(2020 体外诊断医疗设备 - 制造商提供的信息（标签） - 第4部分:体外诊断试剂用于自检

In vitro diagnostic medical devices — Information supplied by the manufacturer(labelling) — Part 4: In vitro diagnostic reagents for self-testing

KS P ISO 23640:2019 体外诊断医疗器械 - 体外诊断试剂稳定性评估

In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents