1、NEMA Standards PublicationNational Electrical Manufacturers AssociationNEMA XR 27-2013X-ray Equipment for Interventional ProceduresUser Quality Control Mode 2013 National Electrical Manufacturers Association NEMA XR 27-2013 X-ray Equipment for Interventional Procedures User Quality Control Mode with
2、 AMENDMENT 1 Published by: National Electrical Manufacturers Association 1300 North 17th Street, Suite 900 Rosslyn, Virginia 22209 www.nema.org www.medicalimaging.org Copyright 2013 by the 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. XR 27-2013 with Amendment 1 Page 2 NOTICE AND DISCLAIMER The information in this publication was considered technically sou
4、nd 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. National Electrical Manufacturers Associati
5、on (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 an interest in the topic covered by this pu
6、blication. 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 or the soundness of any judgments contained
7、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 publication, use of, application, or reliance on th
8、is 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 particular purposes or needs. NEMA does not
9、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 or on behalf of any person or entity, nor
10、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 of reasonable care in any given circumstance
11、s. 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 to police or enforce compliance with the c
12、ontents 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 be attributable to NEMA and is solely the re
13、sponsibility of the certifier or maker of the statement. XR 27-2013 with Amendment 1 Page 3 2013 National Electrical Manufacturers Association CONTENTS _Toc328793768 Foreword 4 Conventions 4 Member Company List 5 History 6 Section 1 - OVERVIEW . 7 1.1 SCOPE 7 1.2 RATIONALE . 7 1.3 REFERENCES . 8 1.4
14、 DEFINITIONS. 8 1.5 ABBREVIATIONS 10 Section 2 - REQUIREMENTS 12 2.1. GENERAL REQUIREMENTS 12 2.2 CONTROL OF ACCESS 12 2.3 QUALITY CONTROL TESTING OF THE XRAY CONTROL PARTS OF THE EQUIPMENT . 13 2.4 ACCESS TO AND EXPORT OF BOTH FOR PROCESSING AND FOR PRESENTATION IMAGES 13 2.5 CALIBRATION INPUTS FOR
15、 MANDATORY FIELDS IN THE RADIATION DOSE STRUCTURED REPORT (RDSR) 14 2.6 ELECTRONIC DOCUMENTATION OF SYSTEM CONFIGURATION . 15 2.7 ACCESS TO RADIATION DOSE STRUCTURED REPORTS (RDSR) 15 ANNEX A - Rationales . 17 ANNEX B - De-identification of RDSR 23 XR 27-2013 with Amendment 1 Page 4 2013 National El
16、ectrical Manufacturers Association Foreword This standard is intended to be used by medical imaging device manufacturers in the design and manufacture of x-ray equipment intended to perform interventional procedures. This standard was developed by the Interventional Group of the x-ray Imaging Sectio
17、n of the Medical Imaging thus K=dEtr/dm, in units of J/kg, where the special name for the unit of kerma is gray (Gy). When the material is air, the quantity is referred to as air kerma (21 CFR 1020.30). DOSE RELATED PARAMETER: parameter that has an influence on the system AIR KERMA rate as defined a
18、t 20 cm PMMA (as per clause 203.6.101 - Range of AIR KERMA rates in RADIOSCOPY from IEC 60601-2-43:2010), and also has an influence on the maximum AIR KERMA rate in RADIOSCOPY. EQUIPMENT: fixed x-ray equipment intended to perform prolonged interventional procedures. EXAM PROTOCOL SELECTION BUTTON: a
19、 single hardware or software setting which is associated with a full set of programmed technical factors and control algorithms designed to optimize the image acquisition and display. FOR PROCESSING IMAGES: image detector data that has been processed to account for detector and x-ray system limitati
20、ons as allowed in IEC 62220-1 Ed.1. FOR PRESENTATION IMAGES: images acquired and processed as identical to the images acquired during INTENDED USE and without resizing or reduction in bit depth. DOSE AREA PRODUCT: product of the area of the cross-section of an x-ray beam and the averaged AIR KERMA o
21、ver that cross-section. The unit is the gray square meter (Gy.m2) (adapted from IEC 60601-2-54:2009). INTENDED USE: use of a product, process or service in accordance with the specifications, instructions and information provided by the manufacturer (ISO 14971:2000). Note: INTENDED USE should not be
22、 confused with normal use. While both include the concept of use as intended by the manufacturer, INTENDED USE focuses on the medical purpose while normal use incorporates not only the medical purpose, but maintenance, service, transport, etc. as well. MANUAL CONTROL MODE: a mode of EQUIPMENT operat
23、ion which does not automatically control one or more technique factors in order to obtain at a preselected location(s) a required quantity of radiation per unit time. MOBILE EQUIPMENT: TRANSPORTABLE EQUIPMENT intended to be moved from one location to another between periods of use while supported by
24、 its own wheels or equivalent means (IEC glossary 3). MODE OF OPERATION: a distinct method of RADIOSCOPY or RADIOGRAPHY provided by the manufacturer and selected with a set of several technique factors or other control settings uniquely associated with the mode. The set of distinct technique factors
25、 and control settings for the mode may be selected by the operation of a single control. Examples of distinct modes of operation include normal RADIOSCOPY (analog or digital), high-level control RADIOSCOPY, cineradiography (analog or digital), digital subtraction angiography, electronic RADIOGRAPHY
26、using the fluoroscopic image receptor, and photospot recording. In a specific mode of operation, certain system variables affecting AIR KERMA, AKR, or image quality, such as image magnification, x-ray field size, pulse rate, pulse duration, number of pulses, source-image receptor distance (SID), or
27、optical aperture, may be XR 27-2013 with Amendment 1 Page 10 2013 National Electrical Manufacturers Association adjustable or may vary; their variation per se does not comprise a mode of operation different from the one that has been selected (21 CFR 1020.30) PROTOCOL: set of parameters pre-defined
28、to perform an examination on live humans or animals. QUALITY CONTROL USER: person designated and qualified to perform the quality control on the EQUIPMENT. QUALITY CONTROL USER INTERFACE: a dedicated user interface on the EQUIPMENT for the USER QUALITY CONTROL MODE and different from the user interf
29、ace designed for the INTENDED USE (clinical mode). RADIOGRAPHY: technique for obtaining, recording and optionally processing directly or after transfer, information contained in an x-ray pattern at an image reception area intended to be analyzed during a time independent from the irradiation time (I
30、EC 60601-1-3). RADIOSCOPY: technique for obtaining continuously or periodically a sequence of x-ray patterns and presenting them directly or through a transfer and optional processing simultaneously and continuously as visible images. This mode is intended to provide real-time guidance to an ongoing
31、 action (IEC 60601-1-3). RESPONSIBLE ORGANIZATION: entity accountable for the use and maintenance of the EQUIPMENT. TRANSPORTABLE EQUIPMENT: EQUIPMENT which is intended to be moved from one place to another whether or not connected to a supply and without an appreciable restriction or range. EXAMPLE
32、: Mobile equipment and portable equipment (IEC glossary 3). USER QUALITY CONTROL MODE: mode intended to perform: - The quality controls ensuring the EQUIPMENT complies with its dose and image quality related specifications - The audit ensuring the EQUIPMENT settings are appropriate for the examinati
33、ons carried out. 1.5 ABBREVIATIONS AKR: AIR KERMA Rate CAK: Cumulative AIR KERMA (as defined in IEC 60601-2-54:2010) CF: Calibration Factor DSA: Digital Subtraction Angiography EPSB: Exam Protocol Selection Button DAP: Dose Area Product (as defined in IEC 60601-2-54:2010) HIPAA: Health Insurance Por
34、tability and Accountability Act IHE REM: Integrating the Healthcare Enterprise Radiation Exposure Monitoring XR 27-2013 with Amendment 1 Page 11 2013 National Electrical Manufacturers Association MTF: Modulation Transfer Function NPS: Noise Power Spectrum QA/QC: Quality Assurance/Quality Control RDS
35、R: X-ray Radiation Dose Structured Report (as defined in DICOM, PS 3.3, section A.35.8) XR 27-2013 with Amendment 1 Page 12 2013 National Electrical Manufacturers Association Section 2 - REQUIREMENTS 2.1. GENERAL REQUIREMENTS The equipment shall provide, as appropriate, one or several QUALITY CONTRO
36、L USER INTERFACE(S), that is/are different from the user interface designed for the INTENDED USE. Means shall be provided to prevent the operator from using the user quality control mode for the INTENDED USE of the EQUIPMENT. Note 1: it is ultimately the responsibility of the RESPONSIBLE ORGANIZATIO
37、N to ensure USER QUALITY CONTROL MODE is not used for the INTENDED USE of the EQUIPMENT. The fluoroscopic display monitor(s) in the control room and at the operators working position should indicate that the system is in USER QUALITY CONTROL MODE with a clearly legible display of the words Warning!
38、User Quality Control mode - Not Intended for Clinical Use or similar words in the appropriate language. The fluoroscopic display monitor(s) in the control room and at the operators working position shall indicate, in a clearly legible fashion, how to exit the USER QUALITY CONTROL MODE. Editing of a
39、PROTOCOL for permanent modification of system parameters shall be prohibited during the USER QUALITY CONTROL MODE. Safety functions for operator and/or EQUIPMENT protection (e.g. mechanical limits, x-ray tube loading) shall be fully functional while in the USER QUALITY CONTROL MODE. Note 2: safety f
40、unctions for patient protection (e.g., anti-collision, maximum AIR KERMA rates, fluoroscopic timing device, automatic termination after 10 minutes of continuous exposure, etc.) can be active but are not required during the USER QUALITY CONTROL MODE since no patient is present during the tests. The a
41、ccompanying documents shall indicate the instructions to protect, as appropriate, all the components of the image chain during the USER QUALITY CONTROL MODE. When the USER QUALITY CONTROL MODE is terminated, all safety functions shall be restored. 2.2 CONTROL OF ACCESS In order to operate the EQUIPM
42、ENT in the USER QUALITY CONTROL MODE, the EQUIPMENT should require that a QUALITY CONTROL USER is logged on and authorized to use that system. In order to permit rapid resumption of the INTENDED USE for emergencies, if the EQUIPMENT requires a password to enter in the USER QUALITY CONTROL MODE, a pa
43、ssword shall not be required to return to the INTENDED USE mode (i.e., normal clinical mode). Note: it is ultimately the responsibility of the RESPONSIBLE ORGANIZATION to manage authorized user access. EQUIPMENT should provide a free-form text field to enable entry of descriptive text during log-in
44、(e.g. name of QUALITY CONTROL USER). This text should be accessible in service logs by the manufacturer. XR 27-2013 with Amendment 1 Page 13 2013 National Electrical Manufacturers Association 2.3 QUALITY CONTROL TESTING OF THE XRAY CONTROL PARTS OF THE EQUIPMENT To enable x-ray dose related constanc
45、y testing, the EQUIPMENT shall provide means for the QUALITY CONTROL USER to perform x-ray dose related QA/QC tests. In addition to manufacturer recommended tests, the EQUIPMENT shall provide means to perform the following tests described in IEC 60601-2-43: - Half-value layer - Dose reproducibility
46、- mA linearity - kVp, mA, pulse width accuracy - CAK and DAP accuracy - X-ray tube output measurement - The EQUIPMENT shall provide x-ray acquisition conditions to perform the QA/QC tests. The EQUIPMENT shall enable selection of values, either by a MANUAL CONTROL MODE or by selecting preset combinat
47、ion values, for: - kV - mA - ms - spectral filtration - focal spot size The EQUIPMENT shall ensure that normal x-ray tube protection mechanisms remain active during USER QUALITY CONTROL MODE. In order to protect the x-ray detector from excessive radiation, the user is responsible to shield the detec
48、tor with sufficient lead material. Note 1: quality control testing of the x-ray control parts of the EQUIPMENT is not inclusive of the imaging detector, therefore there is no need to store images acquired while in this mode. Note 2: QA/QC of x-ray parameters may be incompatible with INTENDED USE; th
49、erefore patient entrance dose rate limits may not be active. 2.4 ACCESS TO AND EXPORT OF BOTH FOR PROCESSING AND FOR PRESENTATION IMAGES FOR PROCESSING IMAGES and FOR PRESENTATION IMAGES are not required to be generated during the same acquisition. 2.4.1 FOR PROCESSING IMAGES The EQUIPMENT shall provide access to the FOR PROCESSING IMAGES acquired during the QUALITY CONTROL MODE in both RADIOSCOPY and RADIOGRAPHY. EQUIPMENT shall enable the control of one or more of the following parameters: - kV XR 27-2013 with Amendment 1 Page 14 2013 National Electr
