| 标准号 | 名称 | 采信 |
|---|
| IEC 60086-4 | Primary batteries - Part 4: Safety of lithium batteries [Including: Corrigendum 1 (2019) and Cor | FDA |
| IEC 60086-5 | Primary batteries - Part 5: Safety of batteries with aqueous electrolyte | FDA |
| IEC 60336 | Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Focal spot dimensio | FDA |
| IEC 60417 | Graphical symbols for use on equipment | FDA |
| IEC 60601-1 | Medical electrical equipment - Part 1: General requirements for basic safety and essential perfo | FDA |
| IEC 60601-1-2 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential per | FDA |
| IEC 60601-1-3 | Medical electrical equipment - Part 1-3: General requirements for basic safety and essential per | FDA |
| IEC 60601-1-6 | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential per | FDA |
| IEC 60601-1-8 | Medical electrical equipment - Part 1-8: General requirements for basic safety and essential per | FDA |
| IEC 60601-2-1 | Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essent | FDA |
| IEC 60601-2-2 | Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essent | FDA |
| IEC 60601-2-4 | Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essent | FDA |
| IEC 60601-2-5 | Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essent | FDA |
| IEC 60601-2-6 | CONSOLIDATED VERSION Medical electrical equipment - Part 2-6: Particular requirements for the ba | FDA |
| IEC 60601-2-8 | Medical electrical equipment - Part 2-8: Particular requirements for the safety of therapeutic X | FDA |
| IEC TR 60601-4-2 | Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: | FDA |
| IEC TS 60601-4-2 | Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: | FDA |
| IEC TS 60601-4-6 | Medical electrical equipment - Part 4-6: Guidance and interpretation - Voluntary guidance to hel | FDA |
| IEC 60601-1-10 | Medical electrical equipment - Part 1-10: General requirements for basic safety and essential pe | FDA |
| IEC 60601-1-11 | Medical electrical equipment - Part 1-11: General requirements for basic safety and essential pe | FDA |
| IEC 60601-1-12 | Medical electrical equipment - Part 1-12: General requirements for basic safety and essential pe | FDA |
| IEC 60601-2-10 | Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essen | FDA |
| IEC 60601-2-11 | Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essen | FDA |
| IEC 60601-2-16 | Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essen | FDA |
| IEC 60601-2-17 | Medical electrical equipment - Part 2-17: Particular requirements for the safety of automaticall | FDA |
| IEC 60601-2-18 | Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essen | FDA |
| IEC 60601-2-19 | Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essen | FDA |
| IEC 60601-2-20 | Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essen | FDA |
| IEC 60601-2-21 | Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essen | FDA |
| IEC 60601-2-22 | Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential | FDA |
| IEC 60601-2-23 | Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essen | FDA |
| IEC 60601-2-25 | Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essen | FDA |
| IEC 60601-2-27 | Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essen | FDA |
| IEC 60601-2-28 | Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essen | FDA |
| IEC 60601-2-29 | Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essen | FDA |
| IEC 60601-2-31 | Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essen | FDA |
| IEC 60601-2-33 | Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essen | FDA |
| IEC 60601-2-34 | Medical electrical equipment - Part 2-34: Particular requirements for the basic safety, includin | FDA |
| IEC 60601-2-35 | Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essen | FDA |
| IEC 60601-2-36 | Medical electrical equipment - Part 2-36: Particular requirements for the safety of equipment fo | FDA |
| IEC 60601-2-37 | Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essen | FDA |
| IEC 60601-2-39 | Medical electrical equipment Part 2-39: Particular requirements for basic safety and essential p | FDA |
| IEC 60601-2-40 | Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essen | FDA |
| IEC 60601-2-43 | Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential p | FDA |
| IEC 60601-2-44 | Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essen | FDA |
| IEC 60601-2-45 | Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essen | FDA |
| IEC 60601-2-47 | Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essen | FDA |
| IEC 60601-2-50 | Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essen | FDA |
| IEC 60601-2-52 | Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essen | FDA |
| IEC 60601-2-54 | Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essen | FDA |
| IEC 60601-2-57 | Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essen | FDA |
| IEC 60601-2-62 | Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essen | FDA |
| IEC 60601-2-63 | Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essen | FDA |
| IEC 60601-2-64 | Medical electrical equipment - Part 2-64: Particular requirements for the basic safety and essen | FDA |
| IEC 60601-2-65 | Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essen | FDA |
| IEC 60601-2-68 | Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essen | FDA |
| IEC 60627 | Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-sc | FDA |
| IEC 60731 | Consolidated Version Medical electrical equipment - Dosimeters with ionization chambers as used | FDA |
| IEC 60806 | Determination of the maximum symmetrical radiation field of X-ray tube assemblies and X-ray sour | FDA |
| IEC 60812 | Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FM | FDA |
| IEC 60825-1 | Safety of laser products - Part 1: Equipment classification, and requirements [Including: Techni | FDA |
| IEC TR 60878 | Graphical symbols for electrical equipment in medical practice [Including: Corrigendum 1 (2023)] | FDA |
| IEC 60976 | Medical electrical equipment - Medical electron accelerators - Functional performance characteri | FDA |
| 引用IEC 61010-1 | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part | FDA |
| IEC 61145 | Calibration and usage of ionization chamber systems for assay of radionuclides | FDA |
| IEC 61161 | Ultrasonics -- Power measurement -- Radiation force balances and performance requirements | FDA |
| IEC 61168 | Radiotherapy simulators - Functional performance characteristics | FDA |
| IEC 61217 | Radiotherapy equipment - Coordinates, movements, and scales | FDA |
| IEC 61223-2-6 | Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy tests - Imag | FDA |
| IEC 61223-3-2 | Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Ima | FDA |
| IEC 61223-3-4 | Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Ima | FDA |
| IEC 61223-3-5 | Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Ima | FDA |
| IEC 61223-3-6 | Evaluation and routine testing in medical imaging departments - Part 3-6: Acceptance and constan | FDA |
| IEC 61223-3-7 | Evaluation and routine testing in medical imaging departments - Part 3-7: Acceptance and constan | FDA |
| IEC 61223-3-8 | Evaluation and routine testing in medical imaging departments - Part 3-8: Acceptance and constan | FDA |
| IEC 61303 | Medical electrical equipment - Radionuclide calibrators - Particular methods for describing perf | FDA |
| IEC 61326-1 | Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: Ge | FDA |
| IEC 61326-2-6 | Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: | FDA |
| IEC 61391-1 | Ultrasonics - Pulse-echo scanners - Part 1: Techniques for calibrating spatial measurement syste | FDA |
| IEC 61391-2 | Ultrasonics - Pulse-echo scanners - Part 2: Measurement of maximum depth of penetration and loca | FDA |
| IEC 61674 | Medical electrical equipment -- Dosimeters with ionization chambers and/or semiconductor detecto | FDA |
| IEC 61689 | Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the fre | FDA |
| IEC 61846 | Ultrasonics - Pressure pulse lithotripters - Characteristics of fields | FDA |
| IEC 61847 | Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics | FDA |
| IEC 61910-1 | Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured | FDA |
| IEC 62083 | Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning sy | FDA |
| IEC 62127-1 | Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic field | FDA |
| IEC 62127-2 | Ultrasonics -- Hydrophones -- Part 2: Calibration for ultrasonic fields up to 40 MHz | FDA |
| IEC 62127-03 | Ultrasonics -- Hydrophones -- Part 3: Properties of hydrophones for ultrasonic fields up to 40 M | FDA |
| 引用IEC 62133 | Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requir | FDA |
| 引用IEC 62133-1 | Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requir | FDA |
| 引用IEC 62133-2 | Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requir | FDA |
| IEC 62220-1-1 | Medical electrical equipment-Characteristics of digital X-ray imaging devices Part 1-1: Determin | FDA |
| IEC 62220-1-2 | Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-2: Dete | FDA |
| IEC 62220-1-3 | Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3: Dete | FDA |
| IEC 62274 | Medical electrical equipment - Safety of radiotherapy record and verify systems | FDA |
| IEC 62304 | Medical device software - Software life cycle processes | FDA |
| IEC 62359 | Ultrasonics - Field characterization - Test methods for the determination of thermal and mechani | FDA |
| IEC 62366-1 | Medical devices - Part 1: Application of usability engineering to medical devices | FDA |
| IEC TS 62443-1-1 | Industrial communication networks - Network and system security - Part 1-1: Terminology, concept | FDA |
| IEC 62443-2-1 | Industrial communication networks - Network and system security - Part 2-1: Establishing an indu | FDA |
| IEC TR 62443-3-1 | Industrial communication networks - Network and system security - Part 3-1: Security technologie | FDA |
| IEC TS 62462 | Ultrasonics - Output test - Guide for the maintenance of ultrasound physiotherapy systems | FDA |
| IEC 62464-1 | Magnetic resonance equipment for medical imaging Part 1: Determination of essential image qualit | FDA |
| IEC 62471 | Photobiological safety of lamps and lamp systems | FDA |
| IEC 62485-1 | Safety requirements for secondary batteries and battery installations - Part 1: General safety i | FDA |
| IEC 62485-2 | Safety requirements for secondary batteries and battery installations - Part 2: Stationary batte | FDA |
| IEC 62485-3 | Safety requirements for secondary batteries and battery installations - Part 3: Traction batteri | FDA |
| IEC 62485-4 | Safety requirements for secondary batteries and battery installations - Part 4: Valve-regulated | FDA |
| IEC 62494-1 | Medical electrical equipment - Exposure index of digital X-ray imaging systems - Part 1: Definit | FDA |
| IEC 62555 | Ultrasonics -- Power measurement -- High intensity therapeutic ultrasound (HITU) transducers and | FDA |
| IEC 62563-1 | Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods | FDA |
| IEC 62563-2 | Medical electrical equipment - Medical image display systems - Part 2: Acceptance and constancy | FDA |
| IEC 62667 | Medical electrical equipment - Medical light ion beam equipment - Performance characteristics | FDA |
| IEC 63045 | Ultrasonics - Non-focusing short pressure pulse sources including ballistic pressure pulse sourc | FDA |
| IEC 63145-10 | Eyewear display - Part 10: Specifications | FDA |
| IEC 63145-20-10 | Eyewear display - Part 20-10: Fundamental measurement methods - Optical properties | FDA |
| IEC 63145-20-20 | Eyewear display - Part 20-20: Fundamental measurement methods - Image quality | FDA |
| IEC 63145-22-10 | Eyewear display - Part 22-10: Specific measurement methods for AR type - Optical properties | FDA |
| IEC TR 63183 | Guidance on error and warning messages for software used in radiotherapy | FDA |
| IEC 63465 | Calibration and quality control in the use of radionuclide calibrators | FDA |
| IEC 80001-1 | Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, re | FDA |
| IEC TR 80001-2-1 | Application of risk management for IT- networks incorporating medical devices - Part 2-1: Step-b | FDA |
| IEC TR 80001-2-2 | Application of risk management for IT Networks incorporating medical devices - Part 2-2: Guidanc | FDA |
| IEC TR 80001-2-3 | Application of risk management for IT Networks incorporating medical devices - Part 2-3: Guidanc | FDA |
| IEC TR 80001-2-4 | Application of risk management for IT-networks incorporating medical devices -- Part 2-4: Applic | FDA |
| IEC TR 80001-2-5 | Application of risk management for IT-networks incorporating medical devices - Part 2-5: Applica | FDA |
| IEC TR 80001-2-8 | Application of risk management for IT-networks incorporating medical devices - Part 2-8: Applica | FDA |
| IEC TR 80001-2-9 | Application of risk management for it-networks incorporating medical devices - Part 2-9: Applica | FDA |
| IEC TR 80002-1 | Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device sof | FDA |
| IEC 80369-5 | Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for | FDA |
| IEC 80601-2-26 | Medical electrical equipment -- Part 2-26: Particular requirements for the basic safety and esse | FDA |
| IEC 80601-2-30 | Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essen | FDA |
| IEC 80601-2-49 | Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essen | FDA |
| IEC 80601-2-58 | Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential | FDA |
| IEC 80601-2-59 | Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essen | FDA |
| IEC 80601-2-60 | Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essen | FDA |
| IEC 80601-2-77 | Medical electrical equipment - Part 2-77: Particular requirements for the BASIC SAFETY and essen | FDA |
| IEC 80601-2-78 | Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential | FDA |
| IEC 81001-5-1 | Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - | FDA |
| IEC 82304-1 | Health software - Part 1: General requirements for product safety | FDA |