IEC 61676 AMD 1-2008 Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of x-ray tube voltage in diagnostic radiology Amend.pdf

1、 IEC 61676Edition 1.0 2008-11INTERNATIONAL STANDARD Medical electrical equipment Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology IEC61676:2002/A1:2008(E) AMENDMENT 1 THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2008 IEC, Geneva, Switzerland

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9、TIONAL STANDARD Medical electrical equipment Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology INTERNATIONAL ELECTROTECHNICAL COMMISSION DICS 11.040.50; 11.040.55 PRICE CODEISBN 2-8318-1019-6AMENDMENT 1 Registered trademark of the International El

10、ectrotechnical Commission 2 61676 Amend. 1 IEC:2008 FOREWORD This amendment has been prepared by subcommittee 62C, Equipment for radiotherapy, nuclear medicine and radiation dosimetry, of IEC technical committee 62, Electrical equipment in medical practice. The text of this amendment is based on the

11、 following documents: Enquiry draft Report on voting 62C/445/CDV 62C/452/RVC Full information on the voting for the approval of this amendment can be found in the report on voting indicated in the above table. NOTE In this amendment, a new influence quantity “Additional tungsten filtration (tube agi

12、ng)” has been introduced. The committee has decided that the contents of this publication will remain unchanged until the maintenance result date indicated on the IEC web site under “http:/webstore.iec.ch“ in the data related to the specific publication. At this date, the publication will be reconfi

13、rmed, withdrawn, replaced by a revised edition, or amended. _ 4.3.5 Limits of variation Replace the existing Table 2 by the following: 61676 Amend. 1 IEC:2008 3 Table 2 Minimum RATED RANGE OF USE, REFERENCE CONDITIONS, STANDARD TEST CONDITIONS, LIMITS OF VARIATION ( L) and INTRINSIC ERROR (E) over t

14、he EFFECTIVE RANGE of use, for the pertaining INFLUENCE QUANTITY INFLUENCE QUANTITY Minimum RATED RANGE of use REFERENCE CONDITIONS STANDARD TEST CONDITIONS E kV L % Sub-clause Voltage waveform and frequency: Diagnostic Mammography Constant potential, 2-, 6-, 12-pulse and medium frequency generators

15、 aConstant potential Constant potential Constant potential, ripple less than 4 % 0,5 2,0 4.4.2 Anode angle: Diagnostic Mammography 6 to 18 15 to 24 12 20 REFERENCE VALUE 2 REFERENCE VALUE 2 0,5 0,5 4.4.3 Filtration: Diagnostic Mammography CT Dental 2,5 mm Al to 3,5 mm Al b25 mm Al to 35 m Mo c4 mm A

16、l to 8 mm Al 1 mm Al to 2 mm Al 3,0 mm Al 30 m Mo 6 mm Al 1,5 mm Al REFERENCE VALUE 5 % REFERENCE VALUE 5 % REFERENCE VALUE 5 % REFERENCE VALUE 5 % 0,5 1,5 1,5 1,5 4.4.4 Dose rate: Diagnostic MammographyCT Dental Fluoroscopic 20 mGy/s to 200 mGy/s 25 mGy/s to 150 mGy/s 20 mGy/s to 200 mGy/s 5 mGy/s

17、to 50 mGy/s 1 mGy/s to 10 mGy/s As stated by manufacturer REFERENCE VALUE 20 % 0,5 0,5 0,5 0,5 0,5 4.4.5 Irradiation time: Diagnostic Other 10 ms to 1 000 ms 200 ms to 1 000 ms 100 ms 500 ms REFERENCE VALUE 20 % REFERENCE VALUE 20 % 0,5 0,5 4.4.6 Field size: Rated Range Large Field Length and width

18、stated by manufacturer + 30 % 10 %30 cm by 30 cm As stated bymanufacturer.30 cm by 30 cm REFERENCE VALUE 2 % REFERENCE VALUE 2 % 0,5 2,0 4.4.7.1 4.4.7.2 Detector-Focal distance 32 cm to 60 cm or as stated by Mfg 40 cm or asstated by manufacturer REFERENCE VALUE 1 % 0,5 4.4.8 Angle of incidence Rotat

19、ion 5 180 0 0 REFERENCE VALUE 1 REFERENCE VALUE 1 0,5 0,5 4.4.9 4.4.10 Temperature Relative humidity 15 C to 35 C 80 % (max 20 g/m3) 20 C 50 % REFERENCE VALUE 2C 30 % TO 75 % 1,0 4.4.11 Power supply Line voltage and frequency Batteries Rechargeable batteries 115 V or 230 V + 10 % 15 %50 or 60 Hz As

20、stated by Mfg. Fresh to Low 115 V/230 V50 Hz/60 Hz as stated Fresh, mains disconnected REFERENCE VALUE 1 % REFERENCE VALUE 1 % REFERENCE VALUE 1 % 0,5 0,5 0,5 4.4.12.14.4.12.2 4.4.12.3Electromagnetic compatibility IEC 61000-4-2 IEC 61000-4-3 IEC 61000-4-4 IEC 61000-4-5 IEC 61000-4-6 IEC 61000-4-11 W

21、ithout anydisturbance Insignificant 1,0 4.4.13 Additional tungsten filtration (tube aging) 0 m to 10 m W 3 m W 0m W -3 m W 2,0 4.4.14 a Frequency range f = 50 Hz to 50 kHz, VOLTAGE RIPPLE (%) from 0 to (50-10log f), e.g. 0 % to 20 % at 1 000 Hz, 0 % to 3 % at 50 kHz. All frequencies above 50 kHz are

22、 treated as constant potential generators. b Filtration outside of MINIMUM RATED RANGE may be met by applying corrections. c X-RAY generator with a molybdenum anode, a beryllium window, and no ADDED FILTRATION other than the 30 m Mo. 4 61676 Amend. 1 IEC:2008 4.4 Performance test procedures Add a ne

23、w subclause as follows: 4.4.14 Additional tungsten filtration (tube aging) Over the RATED RANGE of additional tungsten filtration, the LIMITS OF VARIATION of RESPONSE shall not be greater than stated in Table 2. NOTE The higher the age of an X-ray tube, the anode roughens more and more depending on

24、the cumulative heat load during its total operation time. The roughening of the anode results in a hardening of the spectral photon distribution, which can be simulated by additional tungsten filtration, where zero filtration represents a new tube, and 10 m W an X-ray tube near the end of its lifeti

25、me, respectively. Before performing this test it should be proved that the X-ray tube used for this test is of moderate age, corresponding to an additional filtration of 0 m W 3 m W as required for the standard test conditions. This can be shown under the following conditions: 70 kV tube voltage and

26、 3,0 mm Al total filtration, by measuring the Al-HALF-VALUE LAYER (HVL) which should be less than the values in Table 4, depending on the anode angle of the tube: Table 4 Maximum HALF-VALUE LAYER (HVL) depending on anode angle Anode angle() 6 8 10 12 14 16 18 HVL (mm Al) 3,23 3,07 2,98 2,91 2,86 2,8

27、3 2,80 Compliance with the performance requirement shall now be checked by measuring the response of the instrument with the detector of the instrument exposed to the minimum and the maximum rated additional tungsten filtration and compared with a reference set of readings at reference filtration (w

28、ith 3 m additional tungsten filtration). Tests shall be made at the minimum test points indicated in Table 3 and in 4.4.1 to show compliance over the effective range of voltages. _ INTERNATIONAL ELECTROTECHNICAL COMMISSION 3, rue de Varemb PO Box 131 CH-1211 Geneva 20 Switzerland Tel: + 41 22 919 02 11 Fax: + 41 22 919 03 00 infoiec.ch www.iec.ch