JIS-Z-4752-2-1-2005-ENG.pdf

JIS JAPANESE I N DUSTRIAL STANDARD Translated and Published by Japanese Standards Association JIS Z 4752-2-1:2005 Evaluation and routine testing in medical imaging departments - Part 24 : Constancy tests - Film processors ICs 11.040.50; 37.040.10 Reference number : JIS Z 4752-2-1 : 2005 (E) PROTECTED BY COPYRIGHT 17 S Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/13/2007 23:09:27 MDTNo reproduction or networking permitted without license from IHS -,-,- Z 4752-2-1 : 2005 Foreword This translation has been made based on the original Japanese Industrial Standard established by the Minister of Health, Labour and Welfare and the Minister of Economy, Trade and Industry through deliberations at the Japanese Industrial Standards Committee according to the proposal of establishing a Japanese Industrial Standard from Japanese Society of Radiological Technology (JSRT)/Japanese Standards Association (JSA), with a draft being attached, based on the provision of Article 12 Clause 1 of the Industrial Standardization Law. Date of Establishment: 2005-03-25 Date of Public Notice in Official Gazette: 2005-03-25 Investigated by: Japanese Industrial Standards Committee Standards Board Technical Committee on Medical Equipment JIS Z 4752-2-1 : 2005, First English edition published in 2005-08 Translated and published by: Japanese Standards Association 4-1-24, Akasaka, Minato-ku, Tokyo, 107-8440 JAPAN In the event of any doubts arising as to the contents, the original JIS is to be the final authority. O JSA 2005 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or meclianical, including photocopying and microfilm, without permission in writing from tlie publisher. Printed in Japan M non-screen film; photographic film for indirect radiography, as used for recording . output images of X-ray image intensifiers, other transferred radiological images; - photographic material for copying radiograms; photographic material for making permanent images as used in diagnostic equipment such as for general reconstructive tomography (CT scanning), digital imaging, ultrasound, magnetic resonance, nuclear medicine. The method described in this Standard is intended primarily for automatic film processors, but may be adapted for testing equipment for manual processing. This Standard is a part of a series of standards which will describe test methods for the constancy of properties of various subsystems of diagnostic X-ray equipment, as described in IEC 61223-1. PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/13/2007 23:09:27 MDTNo reproduction or networking permitted without license from IHS -,-,- 2 Z 4752-2-1 2005 Remarks The International Standard corresponding to this Standard is as follow s. In addition, symbols which denote the degree of correspondence in the contents between the relevant International Standard and JIS are IDT (identical), MOD (modified), and NEQ (not equivalent) according to ISO/IEC Guide 21. IEC 61223-2-1 Evaluation and routine testing in medical imaging departments- part 2-1:Constancy tests- Film processors (MOD) “1.2 Object This Standard describes constancy parameters in film processors, and a method to check these parameters, in order to ensure that the conditions for producing consistent radiograms of adequate quality on radiographic and photographic materials are maintained. 2 Normative references The following standards contain provisions which, through reference in this text, constitute provisions of this Standard. If the indication of the year of coming into effect or the year of publication is given to these referred standards, only the edition of the indicated year constitutes the provision of this Standard but the revision and amendment made thereafter do not apply. The normative references without the indication of the year of coming into effect apply only to the most recent edition (including amendments). JIS T 0601-1 Remarks : JIS Z 4005 Remarks : JIS Z 4752-1 Remarks Medical electrical equipment -Part 1:General requirements for safety IEC 60601-111988 Medical electrical equipment - Part 1: General requirements for safety, Amendment 1 : 1993 and Amendment 2 : 1995 are equivalent to the said standard. Medical radioloQ -Terminology IEC 60788: 1984 Medical radiolo,qi; -Terminology is equivalent to the said standard. Evaluation and routine testing in medical imaging departments -Part 1: General aspect IEC 61223-1: 1993 Evaluation and routine testing in medical imaging departments -Part 1: General aspects is identical with the said standard. JIS Z 4752-2-3 Evaluation and routine testing in medical imaging departments -Part 2-3: Constancy tests -Darkroom safelight conditions Remarks 1 IEC 61223-2-3: 1993 Evaluation and routine testing in medical imaging departments -Part 2-3: Constancy tests -Darkroom safelight conditions is identical with the said standard. JIS Z 4905 Photography - Medical radiographic cassettes/screens/JiInls and hard-copy imaging fi Ims -Dimensions and speciJications JIS Z 4918 IS0 4090 : 199 1 Film illuminators for medical X-rq films Photography -Film dimensions -Medical radiography PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/13/2007 23:09:27 MDTNo reproduction or networking permitted without license from IHS -,-,- 3 Z 4752-2-1 2005 IS0 8374 : 1986 IS0 8402 : 1986 QualiQ-VocabularL. Photogizphy -Determination o f IS0 safelight conditions 3 Terminology 3.1 Use of terms For the boldfaced terms that appear in this Standard, the definitions in the following standards apply: JIS Z 4005 JIS Z 4752-1 - JISZ 4905 - JISZ 4918 - 3.2 of this Standard 3.2 Definitions 3.2.1 film processor for use in medical diagnostic radiology, a combination of equipment and devices to process the latent radiological information, recorded on, or transferred to, radiographic or photographic material, into a permanent, visible image 3.2.2 film base plus fog density for constancy tests in X-ray equipment, the optical density in an area of the radiogram on the processed control film, that has not been exposed to light from a sensitometer 3.2.3 for constancy tests in X-ray equipment, the specific value of optical density in an area of the radiogram produced by a constant exposure to a light source speed index NOTE The value of speed index normally is established at an optical density in the range from 0.8 to 1.2 above that of film base plus fog density. 3.2.4 for constancy tests in X-ray equipment, difference between the speed index and the value of optical density produced by a constant exposure from a light source, greater than that used for producing the speed index contrast index NOTES 1 This exposure is normally aimed at an optical density in the range from 1-.8-to-2-.-2 above that of film base plus frog density. Speed index and contrast index are used as constancy parameters and are intended to facilitate the routine checks described in this Standard. They must not be confused with the sensitometric definitions of sensitivity in terms of speed and average gradient. 2 4 4.1 In an initial series of constancy tests, the baseline values of the three constancy parameters of the film processor (film base plus fog density, speed index and contrast index) are determined. This is achieved by exposing control films under specific conditions prior to processing them in the film processor under test. General aspects of constancy tests Principle of the test procedures PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/13/2007 23:09:27 MDTNo reproduction or networking permitted without license from IHS -,-,- 4 Z 4752-2-1 2005 NOTE Whilst it is possible to use pre-exposed films available from the manufacturers of photosensitive materials, this method is not recommended in preference to the use of freshly exposed control films because of the differences in the characteristic response of the pre-exposed films from those currently in use in the X-ray department. The subsequent performance of the film processor is monitored routinely by processing further control films, and the measured values of the constancy parameters are compared with the baseline values in order to detect deviations from constancy. In X-ray departments where more than one film processor is in use, the performance of several film processors can be approximately harmonized by adjusting their individual developer temperatures (see annex E). 4.2 Test equipment 4.2.1 Control films Control film of photographic or radiographic film are produced by exposure under a stepwedge to light emitted from a calibrated and stable light source. The control films should be of the same type as the radiographic materialk) normally used in the X-ray department and should be stored under the same conditions. As far as is practicable, control films used for successive constancy tests should be of the same type and batchíemulsion number, and should be taken from the same package. One package should not be in use for a period exceeding six months, nor beyond its expiry date. Prior to changing the batch or type of radiographic material used for the control films, it is necessary to adjust the baseline values of the constancy parameters. This is achieved by simultaneously processing control films from both the current and replacement batches. The appropriate degree of adjustment is then determined from a comparison of the measured constancy parameters. If more than one type of radiographic material is processed in the same film processor, it may be necessary to use several series of control films, one representative of each type of radiographic material, in order to allow for differences in characteristic response of the different types of material. 4.2.2 Control films should be exposed by means of a sensitometer equipped with a suitable stepwedge. The light output should be reproducible to within t 2 %. The sensitometer should provide at least two levels of exposure which result in optical densities on the processed control films: a) within the range 0.8 to 1.2 above film base plus fog density, and b) within the range 1,8to-2,2-.above film base plus fog density. Sensitometer No part of the control film should be exposed to light from the sensitometer in order to permit measurement of the film base plus fog density on the processed control film. A stepwedge containing a series of steps will enable differences in the sensitivity of different types of control film to be taken into account. PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/13/2007 23:09:27 MDTNo reproduction or networking permitted without license from IHS -,-,- 5 Z 4752-2-1 2005 4.2.3 Densitometer consistently within IO.02. 4.2.4 Thermometer The temperatures of the processing solutions are measured by a metal stem or digital thermometer to within I O . 1°C. Optical densities are measured with a densitometer which reads A mercury in glass thermometer should not be used. 4.3 Film processor : Cleaning, maintenance and log book Prior to any constancy test, it shall be ensured that the film processor is set up in accordance with the instructions given in the accompanying documents for the radiographic materials, the film processor and the chemicals; the optimum developer temperature is known either as determined, see annex E, or as given in the accompanying documents for the radiographic materials; the film processor is maintained in accordance with the instructions given in the accompanying documents for the radiographic materials, the film processor and the chemicals. A maintenance log-book attached to each film processor is essential in order to record: when maintenance is carried out; - when the processing solutions are changed, - when new replenishment solution is added, and - when any other changes relevant to the performance of the film processor were made. 4.4 Darkroom safelight conditions Where, during a constancy test according to this technical report, radiographic or photographic materials are openly handled prior to the test, it must be insured that the darkroom conditions as well as the film storage conditions are satisfactory, and, if necessary, that constancy tests according to JIS Z 4752-2-3 have been carried out. 5 Test procedure 5.1 5.1.1 Method a) It should be assured that: Determination of constancy of film processor performance the fïlm processor has undergone routine maintenance; and its performance is satisfactoiy (see annex E). b) The film processor is set at the selected optimum temperature for the development solution. c) The “start-up” procedure recommended in the accompanying documents is followed, and a period of 30 min allowed for the solution temperatures to stabilize. PROTECTED BY COPYRIGHT Copyright Japanese Standards Association Provided by IHS under license with JSALicensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/13/2007 23:09:27 MDTNo reproduction or networking permitted without license from IHS -,-,- 6 Z 4752-2-1 2005 d) The solution and wash water temperatures are checked. If feasible, the replenishment rates, wash water flow rate, and dryer temperatures are measured. Temperatures and flow rates are adjusted if necessauy and allowed to stabilize. Using the sensitometer, a series of two to six control films are exposed. It is sufficient to expose only one side of a double emulsion film. After at least 30 min but no longer than 4 h, the control films are processed. e) f) However;ifj,t.ls.-det-em.j,ned-t-hat-the-co-ntol. . oms. .are constantly. .Processed. .in a glven-tim-e-Period-afte-exosui.e,-the-above. .may. b.e. .disregarded: The control films are processed so that the leading edge is the least exposed end of the stepwedge pattern. The sheets of control film are passed into the film processor always at the same side of the feeding slit. g) In the three areas of each control film the optical densities are measured (see 4.2.2). h) For each constancy parameter, the average value is determined of the optical densities measured in the six radiograms. In an initial constancy test, these three average values are the baseline values for fil