NEMA-XR-23-2006.pdf
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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
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