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1、 NEMA XR 23 NEMA XR 23 “QUALITY CONTROL MANUAL” TEMPLATE FOR MANUFACTURERS OF HARDCOPY OUTPUT DEVICES LABELED FOR FINAL INTERPRETATION IN FULL-FIELD DIGITAL MAMMOGRAPHY Copyright National Electrical Manufacturers Association Provided by IHS under license with NEMALicensee=NASA Technical Standards 1/
2、9972545001 Not for Resale, 04/19/2007 09:17:41 MDTNo reproduction or networking permitted without license from IHS -,-,- Copyright National Electrical Manufacturers Association Provided by IHS under license with NEMALicensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 09:17:41 M
3、DTNo reproduction or networking permitted without license from IHS -,-,- NEMA Standards Publication XR 23-2006 “Quality Control Manual” Template for Manufacturers of Hardcopy Output Devices Labeled for Final Interpretation in Full-field Digital Mammography Published by: National Electrical Manufactu
4、rers Association 1300 North 17th Street, Suite 1752 Rosslyn, Virginia 22209 www.nema.org Copyright 2006 by the National Electrical Manufacturers Association. All rights including translation into other languages, reserved under the Universal Copyright Convention, the Berne Convention for the Protect
5、ion of Literary and Artistic Works, and the International and Pan American Copyright Conventions. Copyright National Electrical Manufacturers Association Provided by IHS under license with NEMALicensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 09:17:41 MDTNo reproduction or ne
6、tworking permitted without license from IHS -,-,- NOTICE AND DISCLAIMER The information in this 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 ther
7、e is unanimous agreement among every person participating in the development of this document. The National Electrical Manufacturers Association (NEMA) standards and guideline publications, of which the document contained herein is one, are developed through a voluntary consensus standards developme
8、nt process. This process brings together volunteers and/or seeks out the views of persons who have 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
9、 does not independently test, evaluate, or verify the accuracy or completeness of any information or 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 sp
10、ecial, indirect, consequential, or compensatory, directly or indirectly resulting from the publication, use of, application, or reliance on this document. NEMA disclaims and makes no guaranty or warranty, express or implied, as to the accuracy or completeness of any information published herein, and
11、 disclaims and makes no warranty that the information in this document will fulfill any of your particular 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 mak
12、ing this document available, NEMA is not undertaking to render professional or other services for 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 judgm
13、ent or, as appropriate, seek the advice of a competent professional in determining the exercise of 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 addition
14、al views or information not covered by this publication. NEMA has no power, nor does it undertake 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
15、statement of compliance with any health or safety related information in this document shall not be attributable to NEMA and is solely the responsibility of the certifier or maker of the statement. Copyright National Electrical Manufacturers Association Provided by IHS under license with NEMALicense
16、e=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 09:17:41 MDTNo reproduction or networking permitted without license from IHS -,-,- Copyright 2006 by the National Electrical Manufacturers Association. Foreword to the Device Manufacturer When full-field digital mammography (FFDM) sy
17、stems were first introduced, all components (e.g., image receptor, acquisition workstation, diagnostic workstation/monitor, hardcopy output device) were provided or qualified for use by the image receptor manufacturer (IRM). The IRM also provided a comprehensive quality control (QC) plan to enable m
18、ammography facilities to meet their responsibilities under the MQSA1 final regulations. Subsequently, FDA approved manufacturers other than the IRMs to market hardcopy and softcopy displays for FFDM images. This has made system QC more difficult since, under MQSA regulations, the facility is require
19、d to follow a quality assurance program substantially the same as the one recommended by the IRM. However, the QC plan of the IRM may not adequately address the needs of components developed by other manufacturers. This increasing heterogeneity of FFDM systems has created a desire to delegate the re
20、sponsibility for developing QC procedures for the individual system components to the manufacturers of those components. However, it is also desirable, especially for the end-user, to retain some consistency in the QC documentation that accompanies new FFDM components. NEMAs Mammography Subcommittee
21、 has developed a template that provides both a consistent presentation format, and a minimum set of QC tests that should be included as part of the quality assurance plan of a hardcopy output device intended for use in an FFDM system. Hardcopy-device manufacturers who follow this template when devel
22、oping their quality assurance programs, including at least the tests listed, will have incorporated the essential aspects of quality assurance that the image receptor manufacturers have included in their recommended quality assurance programs, thus easing the burden of the mammography facility to es
23、tablish and maintain a quality assurance program for the hardcopy device substantially the same as the one recommended by the IRM. The following sections of this document constitute the content of that template. Each QC test includes an objective, a testing frequency, an equipment list, a test proce
24、dure, action limits that define acceptable outcomes, and instructions on the use of the test results. In some cases, real- world test conditions and action limits that have been found to be appropriate and reasonable have been included in the QC tests. This content may be incorporated in whole, or i
25、n part, as deemed appropriate by the manufacturer of the output device. However, it is recognized that it may not be practical, or possible, on all output devices to implement verbatim the tests as set forth in these examples. Therefore, it is recommended that the manufacturer include in its final Q
26、C plan a test for each concept presented in this template. The manufacturer may alter the details of the tests to accommodate the characteristics of a specific device, or particular regulatory requirements. If the manufacturer chooses to modify the actions specified in this template, or deviate from
27、 current MQSA regulations for tests added to the template, the manufacturer must apply to the FDA for an Alternative Standard (see 21 CFR 900.18). The device manufacturer may also include additional tests beyond those specified in the template. Each such test must include the same elements as and fo
28、llow the form of tests in the template. Procedure contents must be written in regulatory language using auxiliary verbs such as “shall” or “must,” or in the imperative mood. They may not include references to other documents or commercial products. Recommendations regarding test procedures, and refe
29、rences to documents and commercial products may be included in the Guidance section of the QC plan, an example of which is included as the final section of the template. The manufacturer should review the content of this Guidance section, and provide material of a similar nature appropriate to the m
30、anufacturers product. 1 The United States Mammography Quality Standards Act of 1992, as amended by the Mammography Quality Standards Reauthorization Acts of 1998 and 2004 (MQSRA). (This page is to be removed from manufacturers final QC manual.) Copyright National Electrical Manufacturers Association
31、 Provided by IHS under license with NEMALicensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 09:17:41 MDTNo reproduction or networking permitted without license from IHS -,-,- Copyright 2006 by the National Electrical Manufacturers Association. All instructions and comments to t
32、he manufacturer using the template are italicized, red, and enclosed in square brackets, e.g., Manufacturer to . Wherever such notations occur, the manufacturer of the hardcopy output device must insert the necessary information. The “Equipment Required” section of each test may list one or more dig
33、ital test images appropriate for the test. While the manufacturer is free to create specific images that fulfill the equipment requirements of each test, or even handle multiple tests, there are also publicly available images produced by various organizations that can be used. Examples of such organ
34、izations include the American Association of Physicists in Medicine (TG-18, http:/www.aapm.org/pubs/reports/public/OR_03_Supplemental/), the Society of Motion Picture and Television Engineers (http:/www.smpte.org/smpte_store/standards/) and the European Reference Organization for Quality Assured Bre
35、ast Screening and Diagnostic Services (http:/www.euref.org/, which contains modified versions of the AAPM TG-18 images). The test images mentioned in the template text are listed in the Guidance (4.1), along with references. It is strongly recommended that any image data required for the QC tests in
36、 this template (except QC Test 3.3) be stored on the hardcopy device itself, so that they can be called up by the user at will, without having to send an image file from some other component in the FFDM system. (This page is to be removed from manufacturers final QC manual.) Copyright National Elect
37、rical Manufacturers Association Provided by IHS under license with NEMALicensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 09:17:41 MDTNo reproduction or networking permitted without license from IHS -,-,- XR 23-2006 Page i Copyright 2006 by the National Electrical Manufacturer
38、s Association. CONTENTS Page Foreword .iii Section 1 OVERVIEW OF THE QUALITY CONTROL MANUAL.1 1.1 Scope of the Document.1 1.2 Regulatory Considerations1 1.3 Structure of the Document 1 1.4 Elements of a QC/Constancy Test2 1.5 The Need for Calibration .2 1.6 Test Summary .2 Section 2 QC TESTS FOR THE
39、 RADIOLOGIC TECHNOLOGIST4 2.1 Density Constancy Test.4 2.1.1 Objective.4 2.1.2 Establishing Operating Levels4 2.1.3 Performing the QC/Constancy Test .5 2.2 Fixer Retention Test5 2.2.1 Objective.5 2.2.2 Test Relevance and Conditions .5 2.3 Low-contrast Visibility Test5 2.3.1 Objective.5 2.3.2 Establi
40、shing Operating Levels6 2.3.3 Performing the QC/Constancy Test .6 2.4 Spatial Resolution Test6 2.4.1 Objective.6 2.4.2 Establishing Operating Levels7 2.4.3 Performing the QC/Constancy Test .7 2.5 (Darkroom) Fog Test.7 2.5.1 Objective.7 2.5.2 Test Relevance and Conditions .7 2.6 Artifact Test8 2.6.1
41、Objective.8 2.6.2 Establishing Operating Levels8 2.6.3 Performing the QC/Constancy Test .8 Section 3 QC TESTS FOR THE MEDICAL PHYSICIST.10 3.1 Grayscale Response Function Test10 3.1.1 Objective.10 3.1.2 Establishing Operating Levels10 3.1.3 Performing the QC/Constancy Test .10 3.2 Geometry Test.11 3
42、.2.1 Objective.11 3.2.2 Establishing Operating Levels11 3.2.3 Performing the QC/Constancy Test .11 3.3 Phantom Image Quality Test.12 3.3.1 Objective.12 3.3.2 Establishing Operating Levels12 3.3.3 Performing the QC/Constancy Test .12 Copyright National Electrical Manufacturers Association Provided by
43、 IHS under license with NEMALicensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 09:17:41 MDTNo reproduction or networking permitted without license from IHS -,-,- XR 23-2006 Page ii Copyright 2006 by the National Electrical Manufacturers Association. Section 4 GUIDANCE13 4.1 QC
44、 Test Images 13 4.2 Density Constancy Test (2.1)14 4.3 Fixer Retention Test (2.2)14 4.4 Low-Contrast Visibility Test (2.3).14 4.5 Spatial Resolution Test (2.4).14 4.6 (Darkroom) Fog Test (2.5).14 4.7 Artifact Test (2.6).15 4.8 Grayscale Response Function Test (3.1)15 4.9 Geometry Test (3.2) 15 4.10
45、Phantom Image Quality Test (3.3) 15 4.11 Mammography Equipment Evaluation (MEE).15 Copyright National Electrical Manufacturers Association Provided by IHS under license with NEMALicensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 09:17:41 MDTNo reproduction or networking permit
46、ted without license from IHS -,-,- XR 23-2006 Page iii Copyright 2006 by the National Electrical Manufacturers Association. Foreword Quality Control (QC) is important in any imaging system, but it is especially important in mammography. When full-field digital mammography (FFDM) systems were first i
47、ntroduced, all components (e.g., image receptor, acquisition workstation, diagnostic workstation/monitor, hardcopy output device) were provided or qualified for use by the image receptor manufacturer (IRM). The IRM also provided a comprehensive QC plan to enable mammography facilities to meet their
48、responsibilities under the Mammography Quality Standards Act2 (MQSA). Subsequently, FDA approved manufacturers other than the IRMs to market hardcopy and softcopy displays for FFDM images. This has made system QC more difficult since, under MQSA regulations, the facility is required to follow a quality assurance program substantially the same as the one recommended by the IRM. However, the QC plan of the IRM may not adequately address the needs of components developed by other manufacturers. The increasing heterog