1、NEMA Standards PublicationNational Electrical Manufacturers AssociationNEMA/MITA XR 30-2016Quality Control Tools for Digital Projection RadiographyNEMA/MITA XR 30-2016Page 1 2016 National Electrical Manufacturers Association NEMA Standards Publication NEMA/MITA XR 30-2016 Quality Control Tools for D
2、igital Projection Radiography Published by: National Electrical Manufacturers Association 1300 North 17th Street, Suite 900 Rosslyn, Virginia 22209 www.nema.org www.medicalimaging.org 2016 National Electrical Manufacturers Association. All rights including translation into other languages, reserved
3、under the Universal Copyright Convention, the Berne Convention for the Protection of Literary and Artistic Works, and the International and Pan American Copyright Conventions. NEMA/MITA XR 30-2016 Page 2 2016 National Electrical Manufacturers Association NOTICE AND DISCLAIMER The information in this
4、 publication was considered technically sound by the consensus of persons engaged in the development and approval of the document at the time it was developed. Consensus does not necessarily mean that there is unanimous agreement among every person participating in the development of this document.
5、National Electrical Manufacturers Association (NEMA) standards and guideline publications, of which the document contained herein is one, are developed through a voluntary consensus standards development process. This process brings together volunteers and/or seeks out the views of persons who have
6、an interest in the topic covered by this publication. While NEMA administers the process and establishes rules to promote fairness in the development of consensus, it does not write the document and it does not independently test, evaluate, or verify the accuracy or completeness of any information o
7、r the soundness of any judgments contained in its standards and guideline publications. NEMA disclaims liability for any personal injury, property, or other damages of any nature whatsoever, whether special, indirect, consequential, or compensatory, directly or indirectly resulting from the publicat
8、ion, use of, application, or reliance on this document. NEMA disclaims and makes no guaranty or warranty, expressed or implied, as to the accuracy or completeness of any information published herein, and disclaims and makes no warranty that the information in this document will fulfill any of your p
9、articular purposes or needs. NEMA does not undertake to guarantee the performance of any individual manufacturer or sellers products or services by virtue of this standard or guide. In publishing and making this document available, NEMA is not undertaking to render professional or other services for
10、 or on behalf of any person or entity, nor is NEMA undertaking to perform any duty owed by any person or entity to someone else. Anyone using this document should rely on his or her own independent judgment or, as appropriate, seek the advice of a competent professional in determining the exercise o
11、f reasonable care in any given circumstances. Information and other standards on the topic covered by this publication may be available from other sources, which the user may wish to consult for additional views or information not covered by this publication. NEMA has no power, nor does it undertake
12、 to police or enforce compliance with the contents of this document. NEMA does not certify, test, or inspect products, designs, or installations for safety or health purposes. Any certification or other statement of compliance with any health or safetyrelated information in this document shall not b
13、e attributable to NEMA and is solely the responsibility of the certifier or maker of the statement. NEMA/MITA XR 30-2016Page i 2016 National Electrical Manufacturers Association CONTENTS Foreword . ii Conventions ii Member Company List iii Section 1 Overview iv 1.1 Scope 1 1.2 Rationale . 1 1.3 Refe
14、rences 2 1.4 Definitions . 2 Section 2 Requirements 5 2.1 Access to and Export of Original Data . 5 2.2 Electronic Documentation of Image Processing Parameters . 5 Annex A Rationales . 5 NEMA/MITA XR 30-2016 Page ii 2016 National Electrical Manufacturers Association Foreword This standard is intende
15、d to be used by medical imaging device manufacturers in the design and manufacture of x-ray equipment intended to be used for projection radiography. This standard was developed by the Computed Radiography-Digital Radiography Group of the X-ray Imaging Section of the Medical Imaging the pixel values
16、 alone will suffice. NOTE 2original data images and presentation data images are not required to be simultaneously generated and transmitted from the same acquisition. NOTE 3Additional equipment may be required (e.g. PC, CD/DVD drive, approved USB device, laptop wired by Ethernet connection, etc.) t
17、o enable export. The access to the original data should be restricted to a dedicated user (e.g. a quality control user) in order to prevent use during clinical operation. 2.2 Electronic Documentation of Image Processing Parameters The equipment shall provide means to electronically document image pr
18、ocessing parameters. The equipment shall provide means to export the image processing parameters sets in a compatible format file to an output device. The accompanying documents shall specify the methodology for export and format of the exported data. NOTE 1Due to the proprietary nature of image pro
19、cessing algorithms, image processing parameter information can be provided in a manner that protects proprietary content, but sufficiently enables validation of constancy (e.g. referencing generically as “Image Processing Parameters Set A: parameter 1 value, parameter 2 value, etc.”). NOTE 2Addition
20、al equipment may be required (e.g. PC, CD/DVD drive, approved USB device, laptop wired by Ethernet connection, etc.) to enable export. Data elements incorporated in the electronic documentation may also include the date of configuration of the image processing parameters set. Data elements incorpora
21、ted in the electronic documentation may also include the ability to identify the user configuring the image processing parameters set. A documentation of the factory default image processing parameters sets shall be available. NEMA/MITA XR 30-2016 Page 6 2016 National Electrical Manufacturers Associ
22、ation Annex ARationales (Informative) General Guidance This annex provides a concise rationale for the important requirements of this standard. Its purpose is to promote effective application of the standard by explaining the reasons for the requirements and provide additional guidance where appropr
23、iate. A.1 Access To and Export of Original Data Digital images exported from imaging equipment in DICOM or other formats are often compressed in bit-depth and/or matrix size, and are commonly processed for presentation. Such processing often degrades the utility of the images for an evaluation of sy
24、stem aspects of detector performance, image spatial resolution, contrast sensitivity, noise content, artifacts, and uniformity. Original data are intended to perform: a) Relative quantitative QC tests for evaluation of detector performance and focal spot. b) Some tests on objects using automatic sof
25、tware analysis tools that require original data. The availability of original data should not interfere with the intended use of the equipment. consequently, access to original data should be controlled by restriction to a quality control user that is logged on and authorized to use that system or b
26、y locating specific functionality under a dedicated quality control mode, if the equipment provides such a mode. A.2 Electronic Documentation of Image Processing Parameters The objective is to create an output file in a compatible format (e.g. EXCEL compatible) documenting the image processing param
27、eters sets. This electronic documentation is to include all parameters that may directly influence image quality, such as: contrast (gradation), brightness (density), sharpness (frequency), etc. Manufacturers provide a suggested or starting set of image processing parameters. Radiology departments o
28、ptimize their image processing parameters when a new digital system is installed, and regularly thereafter to maintain quality assurance (ICRP 93, 2004). It is the responsibility of the responsible organization to assure that these modifications are clinically justified. Flagging the differences bet
29、ween e.g., the factory default and the local Image processing parameters simplifies the review and clinical audit processes for which the user is responsible. This will be adequately supported by an electronic documentation of the image processing parameters. There is no prior assumption regarding t
30、he safety and effectiveness of any local requirements or preferences relative to the corresponding factory default image processing parameter values. NATIONAL ELECTRICAL MANUFACTURERS ASSOCIATION 1300 NORTH 17TH STREET, SUITE 900 ROSSLYN. VA 22209www.NEMA.orgTO ORDER ADDITIONAL NEMA STANDARDS VISITWWW.GLOBAL.IHS.COM OR CALL 1-800-854-7179/1-303-397-79565612_0514TB
