Standards

Related Standards

1. Acoustic Noise Measurement Procedure for Diagnostic Magnetic Resonance maging (MRI) Devices
Provides methods for determining the acoustic noise level of an MRI system.

2. Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, Revision 3
Covers all active ultrasound apparatus designed for medical diagnostic use, including ultrasonic echo ranging devices (both manual and automatically scanned), through-transmission devices, Doppler echo equipment and combinations thereof.

3. Characteristics of and Test Procedures for a Phantom to Benchmark Cardiac Fluoroscopic and Photographic Performance
Describes procedures to test systems under conditions simulating a range of fluoroscopically guided invasive and interventional procedures.

4. Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images (MRI)
Defines test methods for measuring the signal-to-noise ratio, image uniformity and image non-uniformity of MRIs produced using phased array coils.

5. Characterization of the Specific Absorption Rate (SAR) for Magnetic Resonance Imaging Systems
Describes calorimetric and pulse energy methods of whole-body SAR measurements. Specifies tests for volume RF transmit coils that produce relatively homogeneous RF fields.

6. Determination of Gradient-Induced Electric Fields in Diagnostic Magnetic Resonance Imaging
Defines methods for determining the gradient-induced electric fields of diagnostic magnetic resonance imaging gradient coils (head and body) under a specific set of conditions.

7. Determination of Local Specific Absorption Rate (SAR) in Diagnostic Magnetic Resonance Imaging (MRI)
Defines methods for determining the local SAR of diagnostic MRI radio frequency coils under a specific set of conditions.

8. Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging
Describes test methods for measuring the performance of diagnostic magnetic resonance imaging systems under a specific set of conditions, using head and body coils and performing proton imaging. Does not address the use of surface coils, chemical shift imaging or spectroscopy.

9. Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel, Non-Volume Coils in Diagnostic Magnetic Resonance Imaging (MRI)
Defines methods for evaluating single-channel, non-volume special purpose radio-frequency coils for use with MRI. Both receive-only and transmit-receive coils are included. The system head and body coils, and single-channel volume specialty coils, are excluded, as are coils requiring multiple receiver channels for operation.

10. Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging
Describes a method for determining the slice thickness of proton images. Does not address spectroscopy, chemical shift imaging and warped slices.

11. Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images
Describes a method for determining the maximum percent difference between measured distances in an image and actual corresponding phantom dimensions. Evaluates geometric distortion in three orthogonal planes passing through the center of the specification volume.

12. Electrical, Thermal and Loading Characteristics of X-Ray Tubes Used for Medical Diagnosis
Provides test and presentation of data methods for assessing the electrical and thermal performance of x-ray tubes used in medical diagnosis.

13. High Voltage X-Ray Cable Assemblies and Receptacles
Defines electrical and structural test requirements of high voltage cable assemblies and receptacles used in diagnostic medical x-ray equipment from 10 kV to 200 kV.

14. Manufacturer Disclosure Statement for Medical Device Security
Consists of the MDS2 form and instructions for completing it. Assists professionals responsible for security-risk assessment in the management of medical device security issues. The information on the MDS2 form is not intended, and may be inappropriate, for other purposes.

15. Measurement of Dimensions and Properties of Focal Spots of Diagnostic X-Ray Tubes
Provides test methods for assessing the properties of focal spots for medical diagnostic x-ray tubes and is not intended for use with x-ray tubes used in computed tomography scanners.

16. Measurement of the Maximum Symmetrical Radiation Field from a Rotating Anode X-Ray Tube Used for Medical Diagnosis
Provides methods for measuring the maximum symmetrical radiation field from a rotating anode x-ray tube used for medical diagnosis. Not applicable for measuring the radiation field of a used tube with a roughened focal track or a tube designed to have a non-uniform air kerma rate for special applications.

17. Mechanical Safety Standard for Power Driven Motions of Electromedical Equipment
Covers all power-driven equipment motions accessible to patient or operator during intended use. Does not include transport drives for mobile equipment.

18. Performance Measurements and Quality Control Guidelines for Non-Imaging Intraoperative Gamma Probes
Establishes definitions and describes quantitative measurements of performance characteristics and quality control tests for non-imaging intraoperative gamma probes.

19. Performance Measurements of Gamma Cameras
Provides a uniform criterion for the measurement and reporting of gamma camera performance parameters for single and multiple crystal cameras and tomographic devices that image a section or reconstruction image volume, or both.

20. Performance Measurements of Positron Emission Tomographs (PETs)
Provides a uniform and consistent method for measuring and reporting performance parameters of PETs. Included are time of flight and non–time of flight coincidence systems, discrete and continuous detector designs, single and multiple slice devices and multiplanar and volume reconstruction models.

21. Performance Measurements of Small Animal Positron Emission Tomographs (PETs)
Proposes a standardized methodology for evaluating the performance of PETs designed for animal imaging. Establishes a baseline of system performance in typical imaging conditions independent of camera design and applies to a wide range of camera models and geometries. Represents a subset of measurements that characterize the performance of PETs for specific imaging tasks typically encountered in small laboratory animal imaging facilities. This subset is deemed to be common across all tomographs existing at the time of publication.

22. Power Supply Guidelines for X-Ray Machines
Covers conventional medical and dental diagnostic x-ray equipment. Computed tomography, battery-powered therapy and industrial equipment are not included.

23. Quality Control Manual Template for Manufacturers of Displays and Workstations Labeled for Final Interpretation in Full-Field Digital Mammography (FFD…
Defines the minimum set of quality control tests to be applied to a manufacturer’s product labeled for final interpretation of images acquired using an FFDM image-acquisition system.

24. Quality Control Manual Template for Manufacturers of Hardcopy Output Devices Labeled for Final Interpretation in Full-Field Digital Mammography (FFDM)
Features templates that provide a consistent presentation format and a minimum set of quality control tests that should be included as part of the quality assurance plan of a hardcopy output device (e.g., printer) labeled for final interpretation in an FFDM system.

25. Quantification and Mapping of Geometric Distortion for Special Applications
Defines test methods for measuring the absolute spatial variation of geometric accuracy within magnetic resonance images. This standard presents the absolute geometric accuracy as a map, graph or table throughout the imaging region rather than as simple figures of merit, such as average or worst-case error.

26. Recommended Practices for Load-Bearing Mechanical Assemblies Used in Diagnostic Imaging
Outlines practices for the design, construction and use of load-bearing castings, weldments and threaded fasteners.

27. Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment, Revision 2
Applies to diagnostic ultrasound equipment intended for use on humans and capable of exceeding a thermal or mechanical index of 1.0.

28. Test Standard for the Determination of the Limiting Spatial Resolution of X-Ray Image Intensifier Systems
Includes optical viewing systems, video systems, photofluorographic film recording systems and cine film recording and projection systems.

29. Test Standard for the Determination of the Radial Image Distortion of an X-Ray Image Intensifier (XRII) System
Defines the NEMA standard method for determining radial image distortion of XRII systems under a given set of test conditions.

30. Test Standard for the Determination of the System Contrast Ratio (SCR) and the System Veiling Glare Index (SVGI) of an X-Ray Image Intensifier (XRII) …
Determines the SCR and the SVGI at the center of the image produced by an XRII system under a given set of test conditions. The measurement procedures described pertain to images formed by photofluorographic film, cine film, video and direct-viewing systems.

31. Test Standard for the Determination of the Visible Entrance Field Size of an X-Ray Image Intensifier (XRII) System
Defines the test standard method for the determination of the visible entrance field size of an XRII system. Includes direct-viewing, video, photofluorographic film recording, and cine film recording and projection systems.

32. Test Standard for the Measurement of the Image Signal Uniformity of an X-Ray Image Intensifier (XRII) System
Defines methods of measuring the image signal uniformity produced by an XRII system under a given set of test conditions.

 



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