NEMA XR 31-2016 Standard Attributes on X-ray Equipment for Interventional Procedures.pdf

1、NEMA Standards Publication National Electrical Manufacturers Association NEMA XR 31-2016 Standard Attributes on X-ray Equipment for Interventional ProceduresNEMA XR 31-2016 Page 1 2016 National Electrical Manufacturers Association NEMA Standards Publication XR 31-2016 Standard Attributes on X-ray Eq

2、uipment for Interventional Procedures Published by: National Electrical Manufacturers Association 1300 North 17 thStreet, Suite 900 Rosslyn, Virginia 22209 www.nema.org 2016 National Electrical Manufacturers Association. All rights including translation into other languages, reserved under the Unive

3、rsal Copyright Convention, the Berne Convention for the Protection of Literary and Artistic Works, and the International and Pan American Copyright Conventions. NEMA XR 31-2016 Page 2 2016 National Electrical Manufacturers Association NOTICE AND DISCLAIMER The information in this publication was con

4、sidered 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. The National Electri

5、cal 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 an interest in t

6、he 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 or the soundness

7、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 publication, use of, app

8、lication, 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 disclaims and makes no warranty that the information in this document will fulfill any of your particular purposes

9、 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 or on behalf of a

10、ny 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 of reasonable care

11、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 to police or enfo

12、rce 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 be attributable to

13、NEMA and is solely the responsibility of the certifier or maker of the statement. NEMA XR 31-2016 Page i 2016 National Electrical Manufacturers Association Foreword This standard was developed by the Interventional Group of the X-Ray Imaging Section of the Medical Imaging & Technology Alliance (MITA

14、), a division of NEMA. This first edition standard is intended to identify key features of stationary interventional x-ray equipment which contribute: a) to enhance patient care. b) to help manage patient doses of ionizing radiation while still enabling the system to deliver sufficient image quality

15、 needed by the physician. NOTEExamples of interventional x-ray equipment for which this standard is intended include prolonged neurovascular and cardiovascular interventional procedures as indicated in the annex AA of IEC 60601-2-43:2010. This standard can enable the designated individuals of the he

16、alth facilities responsible to maintain the risk management of the interventional x-ray rooms, to evaluate how their equipment manufactured at a given date is positioned regarding the key dose management features specified in this standard. They should take these factors into consideration when perf

17、orming risk management evaluations on existing equipment. The Interventional Group, MITA, and NEMA as a whole convey their determination and commitment to help ensure that clinicians have the tools needed to manage the amount of radiation that is used during extended interventional x-ray procedures.

18、 Inquiries, comments, and proposed or recommended revisions should be submitted to the X-Ray Imaging Section by contacting: Executive Director Medical Imaging & Technology Alliance (MITA) 1300 North 17 thStreet, Suite 900 Rosslyn, Virginia 22209 At the time of the approval of the standard, the Inter

19、ventional Group was composed of the following members: Agfa HealthCare GE Healthcare Medtronic Inc. Philips Healthcare Shimadzu Medical Systems Siemens Healthineers Toshiba America Medical Systems Ziehm Imaging, Inc. At the time of the approval of the standard, the X-Ray Imaging Section was composed

20、 of the following members: Agfa HealthCare Canon Healthcare Systems Capintec, Inc. CIRS NEMA XR 31-2016 Page ii 2016 National Electrical Manufacturers Association EIZO Corporation EOS imaging FUJIFILM Medical Systems U.S.A., Inc. GE Healthcare Hitachi Medical Systems America, Inc. Hologic Inc. Konic

21、a Minolta Medical Imaging USA, Inc. MEDIAN Technologies, Inc. Medtronic, Inc. Modus Medical NeuroLogica Corporation Neusoft Medical Systems, USA, Inc. Philips Healthcare Samsung Medison Shimadzu Medical Systems USA Siemens Healthineers Swissray International, Inc. Toshiba America Medical Systems Zie

22、hm Imaging, Inc. NEMA XR 31-2016 Page iii 2016 National Electrical Manufacturers Association CONTENTS Foreword . i Section 1 Overview . 1 1.1 Scope . 1 1.2 Normative References 1 1.3 Conventions. 2 1.4 Definitions . 2 Section 2 Requirements On Attributes . 4 2.1 Dosimetric Indications . 4 2.2 Added

23、Filters 5 2.3 Range of Air-Kerma Rates in Fluoroscopy . 5 2.4 Last-Image-Hold (LIH) . 5 2.5 Virtual Collimation . 6 2.6 Stored Fluoroscopy . 6 2.7 Variable Pulsed Fluoroscopy Rate 6 2.8 Digital X-ray Imaging Device 6 Section 3 Implementation Of Standard Attributes . 7 3.1 Certification 7 3.2 Limitat

24、ions . 7 Section 4 Rationales 8 4.1 Dosimetric Indications . 8 4.2 Added Filters 9 4.3 Range Of Air-kerma Rates In Fluoroscopy . 9 4.4 Last-Image-Hold 10 4.5 Virtual Collimation 10 4.6 Stored Fluoroscopy 10 4.7 Variable Pulsed Fluoroscopy Rate .10 4.8 Digital X-ray Imaging Device .11 Section 5 Bibli

25、ography 12 NEMA XR 31-2016 Page iv 2016 National Electrical Manufacturers Association NEMA XR 31-2016 Page 1 2016 National Electrical Manufacturers Association Section 1 OVERVIEW 1.1 SCOPE This standard identifies key stationary x-ray interventional equipment attributes that contribute: a) to enhanc

26、e patient care. b) to help manage patient doses of ionizing radiation while still enabling the system to deliver sufficient image quality needed by the physician. NoteExamples of interventional x-ray equipment for which this standard is intended include prolonged neurovascular and cardiovascular int

27、erventional procedures as indicated in the annex AA of IEC 60601-2-43:2010. 1.2 NORMATIVE REFERENCES By reference herein the following normative documents are adopted, in whole, or in part as indicated in this standards publication. Code of Federal Regulations Title 21 Part 1020.30, Diagnostic X-ray

28、 Systems and Their Major Components ICRU 60, International Commission on Radiation Units & Measurements, Report 60, Fundamental Quantities and Units for Ionizing Radiation International Electrotechnical Commission 3, rue de Varemb Case postale 131 CH-1211 Geneva 20 Switzerland IEC 60601-1-3:1994 Med

29、ical Electrical EquipmentPart 1: General Requirements for Safety3. Collateral Standard: General Requirements for Radiation Protection in Diagnostic X-ray Equipment IEC 60601-1-3:2008 Medical Electrical EquipmentPart 1-3: General Requirements for Basic Safety and Essential PerformanceCollateral Stand

30、ard: Radiation Protection in Diagnostic X-ray Equipment IEC 60601-2-43:2000 Medical Electrical EquipmentPart 2-43: Particular Requirements for the Safety of X-ray Equipment for Interventional Procedures IEC 60601-2-43:2010 Medical Electrical EquipmentPart 2-43: Particular Requirements for the Basic

31、Safety and Essential Performance of X-ray Equipment for Interventional Procedures IEC 60601-2-54:2009 Medical Electrical EquipmentPart 2-54: Particular Requirements for the Basic Safety and Essential Performance of X-ray Equipment for Radiography and Radioscopy IEC 62220-1-3:2008 Medical Electrical

32、EquipmentCharacteristics of Digital x-Ray Imaging DevicesPart 1: Determination of the Detective Quantum Efficiency IEC TR 60788:2004 Medical Electrical EquipmentGlossary of Defined Terms NEMA XR 31-2016 Page 2 2016 National Electrical Manufacturers Association 1.3 CONVENTIONS The verbal forms used i

33、n this standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary verb: a) “Shall” means that compliance with a requirement or a test is mandatory for compliance with this standard. b) “Should” means that compliance with a requi

34、rement or a test is recommended but is not mandatory for compliance with this standard. c) “May” is used to describe a permissible way to achieve compliance with a requirement or test. Terms and abbreviations used throughout this standard that have been defined in clause 1.4 are in bold italics. Acc

35、eptance criteria used throughout this standard are in italics in the standard. 1.4 DEFINITIONS The terms defined in IEC have been extracted either from the glossary of defined terms (TR 60788:2004) or from the IEC standard from which a clause has been extracted for this document. added filter: Remov

36、able or irremovable filter positioned in the radiation beam to provide part or all of the additional filtration (IEC TR 60788:2004). air-kerma: Letter symbol: K quotient of dE trby dm, where dE tris the sum of the initial kinetic energies of all the charged particles in a mass dm of air, thus = Unit

37、: J kg -1(IEC TR 60788:2004) The special name for the unit of air-kerma is gray (Gy) (ICRU 60). cumulative air-kerma: The total air-kerma accrued from the beginning of an examination or procedure and includes all contributions from fluoroscopic and radiographic irradiation (21 CFR 1020.30). digital

38、x-ray imaging device: Device consisting of a digital x-ray detector including the protective layers installed for use in practice, the amplifying and digitizing electronics, and a computer providing the original data of the image (IEC 62220-1-3:2008). dose area product: Product of the area of the cr

39、oss-section of an x-ray beam and the averaged air- kerma over that cross-section. The unit is the gray square meter (Gyxm). (IEC 60601-2-54:2009). NOTEThe SI unit Gym may be expressed with a prefix e.g. as mGym to retain earlier used numeric dimensions of values displayed to the operator. NOTEThe “d

40、ose area product” is also known as the kerma-area-product (KAP). fluoroscopy: A technique for generating x-ray images and presenting them simultaneously and continuously as visible images. This term has the same meaning as the term “radioscopy“ in the standards of the International Electro-technical

41、 Commission (21 CFR 1020.30). half-value layers: Thickness of a specified material, which attenuates under narrow beam conditions X- radiation with a particular spectrum to an extent such that the air-kerma rate, exposure rate or absorbed NEMA XR 31-2016 Page 3 2016 National Electrical Manufacturers

42、 Association dose rate is reduced to one half of the value that is measured without the material. The half-value layer (HVL) is expressed in suitable submultiples of the meter together with the material (IEC 60601-1-3:2008). interventional procedure: See radioscopically guided interventional procedu

43、re. loading state: For an x-ray generator, state from the end of the ready state, when the intended function of the generator is initiated, until the end of the loading of the x-ray tube (IEC 60788:2004). loading time: Time, determined according to a specific method, during which the anode input pow

44、er is applied to the x-ray tube (IEC 60788:2004). operator: Person utilizing equipment individually with or without the aid of an assistant, who controls some or all functions of the equipment in his presence (IEC 60788:2004). patient: Living being (person or animal) undergoing medical or dental inv

45、estigation or treatment (IEC 60788:2004). radioscopically guided interventional procedure: Invasive procedure (involving the introduction of a device, such as a needle or a catheter into the patient) using radioscopy as the principal means of guidance, and intended to effect treatment or diagnosis o

46、f the medical condition of the patient (IEC 60601-2-43:2010). (Also known as interventional procedure.) reference air-kerma: Air-kerma free in air in the primary x-ray beam measured under specific conditions and expressed at the patient entrance reference point (IEC 60601-2-43:2010). NEMA XR 31-2016

47、 Page 4 2016 National Electrical Manufacturers Association Section 2 REQUIREMENTS ON ATTRIBUTES (Normative) 2.1 DOSIMETRIC INDICATIONS 2.1.1 Displayed at the working position of the operator during the interventional procedure The equipment shall comply either with IEC 60601-2-43:2000 clause 51.102.

48、4 or with IEC 60601-2- 43:2010 clause 203.6.4.5 in displaying reference air-kerma rate and cumulative air-kerma. For equipment manufactured prior to June 10, 2006, the units displayed may be R/min (Rontgen/min) and R (Rontgen) or mGy/min and mGy. The cumulative loading time of fluoroscopy for the wh

49、ole procedure shall be made available (IEC 60601-2-43:2000 clause 51.102.4 or IEC 60601-2-43:2010 clause 203.6.4.5). Compliance is determined by inspection and tests. The test shall be performed with a loading state of duration longer than 3s. 2.1.2 Dosimetric indication integrated into the equipment The following dosimetric indications shall be integrated into the equipment: a) Cumulative reference air-kerma b) Cumulative dose area product c) Cumulative loading time of fluoroscopy The cumulative dose