诊断成像
本类别共 13 条标准。
| 标准编号 | 标题 | 适用范围 | GSPR |
|---|---|---|---|
| IEC 60601-2-7:1998 | Medical electrical equipment - Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators | High-voltage generators of diagnostic X-ray generators. | 14, 16 |
| IEC 60601-2-28:2017 | Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis | X-ray tube assemblies for medical diagnosis. | 14, 16 |
| IEC 60601-2-33:2022 | Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis | MRI equipment for medical diagnosis. | 14, 16 |
| IEC 60601-2-43:2022 | Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures | X-ray equipment for interventional procedures. | 14, 16 |
| IEC 60601-2-44:2009+AMD1:2012+AMD2:2016 | Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography | X-ray equipment for computed tomography. | 14, 16 |
| IEC 60601-2-45:2023 | Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices | Mammographic X-ray equipment and stereotactic devices. | 14, 16 |
| IEC 60601-2-54:2022 | Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy | X-ray equipment for radiography and radioscopy. | 14, 16 |
| IEC 62563-1:2022 | Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods | Medical image display systems - Evaluation methods. | 14, 14.1 |
| IEC 62220-1-1:2015 | Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-1: Determination of the detective quantum efficiency - Detectors used in radiographic imaging | DQE measurement for digital radiographic detectors. | 14, 16 |
| IEC 62220-1-2:2007 | Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-2: Determination of the detective quantum efficiency - Detectors used in mammography | DQE measurement for mammographic detectors. | 14, 16 |
| IEC 62220-1-3:2008 | Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3: Determination of the detective quantum efficiency - Detectors used in dynamic imaging | DQE measurement for dynamic imaging detectors. | 14, 16 |
| IEC 61223-3-5:2019 | Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance and constancy tests - Imaging performance of computed tomography X-ray equipment | CT imaging performance testing. | 14, 16 |
| IEC 62464-1:2018 | Magnetic resonance equipment for medical imaging - Part 1: Determination of essential image quality parameters | MRI image quality parameters. | 14, 16 |