YY/T 0722-2016 English PDFUS$564.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0722-2016: Medical electrical equipment--Dosimetric instrument used for non-invasive measurement of X-ray tube voltage in diagnostic radiology Status: Valid YY/T 0722: Historical versions
Basic dataStandard ID: YY/T 0722-2016 (YY/T0722-2016)Description (Translated English): Medical electrical equipment--Dosimetric instrument used for non-invasive measurement of X-ray tube voltage in diagnostic radiology Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C43 Classification of International Standard: 11.040.50 Word Count Estimation: 30,381 Date of Issue: 2016-07-29 Date of Implementation: 2017-06-01 Older Standard (superseded by this standard): YY/T 0722-2009 Regulation (derived from): State Food and Drug Administration Notice 2016 (No.129) Issuing agency(ies): State Food and Drug Administration YY/T 0722-2016: Medical electrical equipment--Dosimetric instrument used for non-invasive measurement of X-ray tube voltage in diagnostic radiology---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order. Medical electrical equipment - Dosimetric instrument used for non-invasive measurement of X-ray tube voltage in diagnostic radiology ICS 11.040.50 C43 People's Republic of China Pharmaceutical Industry Standard Replacing YY/T 0722-2009 Medical electrical equipment is used in diagnostic radiology X - ray tube voltage non - access measurement of dosimeter instruments (IEC 61676..2009, IDT) 2016-07-29 released 2017-06-01 implementation State Food and Drug Administration issued Directory Preface Ⅴ Introduction Ⅵ 1 Scope 1 2 normative reference document 1 3 Terms and definitions 1 General performance requirements for practical peak voltage measurement 4.1 Amount to be measured 4 4.2 Limits of performance characteristics 4 4.2.1 Limits 4 4.2.2 Maximum error 4 4.2.2.1 Maximum relative error at voltages above 50 kV 4 4.2.2.2 Maximum inherent error at voltages below 50 kV 5 4.2.3 Super range and below range indication 5 4.2.4 Repeatability 5 4.2.5 Long-term stability 6 4.3 Variance limits due to influence quantity effect 6 4.3.1 Impact 6 4.3.2 Minimum rated rating for use 6 4.3.3 Reference conditions 6 4.3.4 Standard test conditions 6 4.3.5 Variability limits 6 4.4 Performance test procedures 8 4.4.1 Overview 8 4.4.2 Dependence of instrument response on voltage waveform and frequency 4.4.3 Dependence of instrument response on anode angle 4.4.4 Dependence of Instrument Response on Filtration 4.4.5 Dependence of instrument response on dose rate 10 4.4.6 Dependence of instrument response on irradiation time 10 4.4.7 Dependence of instrument response on radiation field size 10 4.4.7.1 Dependence of instrument response on changes in the size of the radiation field within the rated range 4.4.7.2 Dependence of instrument response on large radiation field size 10 4.4.8 Dependency of instrument response on focus point - detector distance 10 4.4.9 Dependence of instrument response on radiation incidence angle 11 4.4.10 The dependence of the instrument on the rotation angle of the detector and the X-ray tube axis 4.4.10.1 Describes the dependency of the instrument on the preferred alignment direction to the manufacturer 4.4.10.2 The manufacturer does not specify the dependency of the instrument on the preferred alignment direction 4.4.11 Dependence of Instrument Response on Temperature and Humidity 11 4.4.12 The dependence of the instrument on the operating voltage 4.4.13 Dependence of Instrument Response on Electromagnetic Compatibility 4.4.13.1 Electrostatic discharge 12 4.4.13.2 RF electromagnetic field 12 4.4.13.3 Conducted interference caused by bursts and radio frequencies 13 4.4.13.4 Voltage sags, short interruptions and voltage changes 4.4.13.5 Surge (impact) 13 4.4.14 Additional tungsten filtration (X-ray tube aging) 13 Special instrument requirements and marking 5.1 Requirements for the entire instrument 14 5.2 Overview 14 5.3 Display 14 5.4 Measuring range 14 5.5 connectors and cables 6 random file 15 6.1 Overview 15 6.2 Information provided 6.3 Instrument Description 15 6.4 Detector 15 6.5 Delay 15 6.6 Measuring window 15 6.7 Data Interface 6.8 Transport and storage 15 Appendix A (informative) Recommended Performance Standard for Access Dividers Appendix B (informative) Additional instructions for practical peak voltages 17 Appendix C (informative) Glossary 23 Figure B.1 Example of a double pulse generator waveform Figure B.2 Example of constant voltage generator waveform Figure B.3 Example of descending load waveform Table 1 Minimum effective range 4 Table 2 The minimum range of reference, reference conditions, standard test conditions, variation limits (± L), the effective use The inherent error in the range (E) 7 Table 3 Minimum test points and test values for the practical peak voltage used to influence the mass test Table 4 Maximum half-value layer (HVL) that relies on the anode angle Table B.1 20 sample values of 20 download waveforms in Figure B.3 Table B.2 Voltage bandwidth, probability and weight factor 20 for the 20 sample values for the falling load waveform in Figure B.3 Table B.3 20 equally spaced samples of the falling load waveform in Figure B.3 ForewordThis standard is drafted in accordance with the rules given in GB/T 1.1-2009. This standard replaces YY/T 0722-2009 "Medical electrical equipment for diagnostic radiology for X-ray tube voltage Non-access measurement Of the dose instrument. " Compared with YY/T 0722-2009, the main technical changes are as follows. --- 3.16 "actual peak voltage" to "practical peak voltage"; - Table 2 adds a line to the minimum rated rating, reference conditions, and criteria for additional tungsten filtration (X-ray tube aging) Test conditions, variation limits (± L), the use of the effective range of the inherent error (E) and other values; --- Added Article 4.4.14 Additional tungsten filtration (X-ray tube aging); - Added Table 4, depending on the maximum half-value layer (HVL) of the anode angle. This standard uses the translation method equivalent to IEC 61676..2009 "Medical electrical equipment used in diagnostic radiology for X-ray tube voltage Non-access measurement of dosimetry instruments ". For ease of use, this standard has been modified as follows. In Chapter 2, "normative reference documents", the cited IEC and ISO and other standards, which have been converted into national standards, to Reference to national standards. Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents. This standard is proposed by the State Food and Drug Administration. This standard by the National Medical Electrical Appliances Standardization Technical Committee of Radiation Therapy, Nuclear Medicine and Radiation Dosing Equipment Subcommittee (SAC/TC10/SC3). The drafting of this standard. Beijing Medical Device Testing Institute, China Testing Technology Research Institute, China Institute of Metrology. The main drafters of this standard. Wang Peichen, Huang Yang, Guo Bin, Xie Shibing, Li Yue Ling, Song Lianyou, Zheng Lifu. This standard replaced the previous version of the standard release. YY/T 0722-2009.IntroductionThe X-ray tube voltage measured by an access or non-access instrument, the result is usually a single number representing the tube voltage Value, and whether the tube voltage is a constant voltage, whether it is dependent on the waveform changes with time. The market is used to measure the X-ray tube voltage The non-access instrument often refers to the tube voltage with "average peak voltage", but the "average peak voltage" is not clearly defined and And may be any of the mean values of all voltage peaks. In the case where the amount considered is not clearly defined, it is not possible to establish a measuring X-ray Tube voltage non-access instrument performance requirements of the test procedures, for this purpose, according to the recent literature 1) proposed, known as "practical peak power Pressure "as the basis for the establishment of this standard. Practical peak voltage has a clear definition, and applies to any waveform, the amount of emission X-ray Line spectrum distribution and image attributes, even when the tube voltage waveform is very different, work in the same practical peak voltage X-ray hair The device also produces the same low contrast in X-ray photographs. Details of this concept are given in Appendix B, Appendix B Example of practical peak voltage calculation in the case of "falling load" waveforms. The introduction of a new amount, the result will lead to the problem. the standard has been prepared to complete, its purpose is to measure the practical peak voltage Of the instruments, but these instruments in the past design is clearly not the case. However, from the current market of non-access instrument exploratory test obtained The initial results can be expected that the future of the new instruments and most of the instruments on the market will be able to fully meet the requirements of this standard, no Overcome the difficulties. For the most important requirements for voltage waveforms and frequency dependence responses, these studies show that by applying the practical peaks The value voltage is used as the measurement amount and can more easily meet the requirements of the standard. X-ray generator X-ray tube voltage, its correction and adjustment is usually done by the manufacturer through direct access measurement, the use of non- The instrument of the access measurement method can of course also be used to check the calibrated X-ray tube voltage or adjust the X-ray tube voltage, but require that these instruments Uncertainty of voltage measurement with comparable measurements. One of the most important parameters for diagnosing X-ray devices is to apply to X-ray tubes , Because the quality of the image in the diagnostic radiology and the dose accepted by the patient under examination are both associated with the X-ray tube voltage related. The total uncertainty requirement is less than ± 5%, and this value is a guide to the variation limits of the effect of the effect. 1) See Appendix B. Medical electrical equipment is used in diagnostic radiology X - ray tube voltage non - access measurement of dosimeter instruments1 ScopeThis standard specifies the performance requirements and associated compliance tests for non-access measuring instruments for 150 kV X-ray tube voltages Test. This standard also describes the calibration method and gives a guide to estimating the uncertainty at different measurement conditions during calibration. Measurements in diagnostic radiology include mammography, computed tomography (CT), dental radiology, and X-ray examination. this The standards do not cover the safety of such instruments. Applicable electrical safety requirements are found in GB 4793.1-2007.2 normative reference documentsThe following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. GB 4793.1-2007 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1. General requirements (IEC 61010 - 1..2001, IDT) GB/T 17626.2 Electromagnetic compatibility test and measurement technology Electrostatic discharge immunity test (idtIEC 61000-4-2) GB/T 17626.3 Electromagnetic compatibility test and measurement technology Radio frequency electromagnetic radiation immunity test (idtIEC 61000-4-3) GB/T 17626.4 Electromagnetic compatibility test and measurement techniques Electrical fast transient burst immunity test (idtIEC 61000-4-4) GB/T 17626.5 Electromagnetic compatibility test and measurement technology Surge (impact) immunity test (idtIEC 61000-4-5) GB/T 17626.6 Electromagnetic compatibility test and measurement techniques Radio frequency field sensing conducted disturbance immunity test (idtIEC 61000- 4-6) GB/T 17626.11 Electromagnetic compatibility test and measurement techniques Immunity test for voltage sags, short interruptions and voltage variations (idt IEC 61000-4-11) IEC 60417 (all parts) Equipment graphic symbols (Graphicalsymbolsforuseonequipment) IEC 60788 Medical Radiology Terminology (Radiation Therapy, Nuclear Medicine and Radiation Dosage Equipment) (Medicalradiology-Termi- nology IEC 61187..1993 Electrical and Electronic Measurement Equipment (Electrical and Electronic Measurement Equipment) Documentation) ISO Guide 99..1993 Metrology Basic and General Terminology Glossary [Internationalvocabularyofbasicandgen- eraltermsinmetrology (ISBN92-67-01075-1)] ISO 7000. 1989 Equipment Graphic Symbols and Graphs (Graphicalsymbolsforuseonequipment-Index andsynopsis)3 terms and definitionsIEC 60788 and ISO Guide99 are defined and the following terms and definitions apply to this document. 3.1 Correction factor correctionfactor Will be operated under specified conditions to correct the indication value of the instrument to a non-dimensional multiplier of the indicated value of the instrument under a given reference condition. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0722-2016_English be delivered?Answer: Upon your order, we will start to translate YY/T 0722-2016_English as soon as possible, and keep you informed of the progress. 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