ANSI IT2.49-1997 Photography - Intra-Oral Dental Photographic Film - Specification《摄影.牙科用射线照相胶片.规范ISO 3665-1996》.pdf

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1、97 9 072Li150 0538488 O .aphy - 1 Dental Photograp ton hic Film - This material s re roduced fro 2,qC ! 2coPl (ri g ht 897, with permission of the American National Standards Institute, Inc. Not for resale. No part ofthis publication may be copied or reproduced in any form, electronic retrieval syst

2、em or otherwise, without the prior written permission of the American National Standards Institute, Inc., 11 West 42nd Street, New York, New York 10036. American National Standard - -a mmn American National Standards Institute Il West 42nd Street New York, New York 10036 ANSVIS0 3665-1 996, ANSVNAPM

3、 lT2.49-1997 American National Standard for Photography - Intra-oral Dental Photographic Film - Specif cat ion Secretariat National Association of Photographic Manufacturers, Inc. Approved February 13,1997 American National Standards Institute, Inc. STD*ANSI IT2.49-ENGL 1997 0729150 0538490 75b Ame

4、rica n National Stan da rd Approval of an American National Standard requires review by ANSI that the requirements for due process, consensus, and other criteria for approval have been met by the standards developer. Consensus is established when, in the judgment of the ANSI Board of Standards Revie

5、w, substantial agreement has been reached by directly and materially affected interests. Substantial agreement means much more than a simple majority, but not necessarily unanimity. Consensus requires that all views and objections be considered, and that a concerted effort be made toward their resol

6、ution. The use of American National Standards is completely voluntary; their existence does not in any respect preclude anyone, whether he has approved the standards or not, from manufacturing, marketing, purchasing, or using products, processes, or procedures not conforming to the standards. The Am

7、erican National Standards Institute does not develop standards and will in no circumstances give an interpretation of any American National Standard. Moreover, no person shall have the right or authority to issue an interpretation of an American National Standard in the name of the American National

8、 Standards Institute. Requests for interpretations should be addressed to the secretariat or sponsor whose name appears on the title page of this standard. CAUTION NOTICE: This American National Standard may be revised or withdrawn at any time. The procedures of the American National Standards Insti

9、tute require that action be taken periodically to reaffirm, revise, or withdraw this standard. Purchasers of American National Standards may receive current information on all standards by calling or writing the American National Standards Institute. Published by American National Standards Institut

10、e 11 West 42nd Street, New York, New York 10036 Copyright O 1997 by American National Standards institute Ali rights reserved. No pari of this publication may be reproduced in any form, in an electronic retrieval system or otherwise, without prior written permission of the publisher. Printed in the

11、United States of America Contents Page Foreword. . ii Introduction v 1 Scope . 1 2 Normative references 1 3 Definitions 1 4 Classification 2 5 Requirements . 2 6 Sampling, inspection and testing . 4 7 Package marking 6 Tables 1 IS0 speed groups . 2 2 Film sizes . 2 Annex A Storage abuse test 8 I - -

12、 STD-ANSI IT2.47-ENGL I797 W 0724350 0538472 527 Foreword (This foreword is not pari of American National Standard ANSI/ISO 3665- 1996, ANSVNAPM lT2.49-1997. The main text of this document is identi- cal to IS0 3665: 1996.) IS0 (the International Organization for Standardization) is a worldwide fed-

13、 eration of national standards bodies (IS0 member bodies). The work of preparing International Standards is normally carried out through IS0 tech- nical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that c

14、ommittee. International organizations, governmental and non-gov- ernmental, in liaison with ISO, also take part in the work. IS0 collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. Draft International Standards adopted by

15、the technical committees are cir- culated to the member bodies for voting. Publication as an International Standard requires approval by at least two-thirds of the member bodies casting a vote. International Standard IS0 3665 was prepared jointly by Technical Committee ISOTTC 42, Photography, ISOTTC

16、 106, Dentistry, and the FDI (World Dental Federation). This second edition cancels and replaces the first edition (IS0 3665: 1976), which has been technically revised to include new units for speed measurement, safelight sensitivity, and two additional film sizes. Some questions were raised regardi

17、ng base plus fog levels and storage conditions in this new edition. As a result, JWG 17 has been reactivated to investigate these issues for a future revision. Suggestions for improvement of this standard will be welcome. They should be sent to the National Association of Photographic Manufacturers,

18、 Inc., 550 Mamaroneck Avenue, Suite 307, Harrison, NY 10528-1 61 2. This standard was processed and approved for submittal to ANSI by NAPM Technical Committee IT2 on Image Evaluation. Committee approval of the standard does not necessarily imply that all committee members voted for its approval. At

19、the time this standard was approved, the IT2 Committee had the following members: Michael R. Goodwin, Chairman Jack Holm, Vice-chairman James E. Harvey, Secretary Organization Represented American Roentgen Ray Society Joel Gray Association for Engineering Graphics and Imaging Systems Philip P. Nower

20、s Association for Information and Image Management (Liaison) Marilyn Wright Azon Corporation Bill Neithardt Canadian Standards Association (Liaison) . Trevor Smith CGATS . Richard S. Fisch Graphic Communication Association Norman W. Scharpf Graphic Microsystem . James R. Cox GTI Graphic Technology,

21、Inc. Charles G. Saleski Name of Represen ta tive James E. Harvey (Alt.) ii Organization Represented Name of Representative National Association of Photographic Manufacturers, Inc. Carolyn Franceschi Michael R. Goodwin Thomas McKeehan (Alt.) Brian E. Reed (Alt.) Alex Pendleton Thomas Lumenello (Alt.)

22、 Daniel E. Sinto Joseph Helm (Alt.) Robert L. Seyfert Robert A. Uzenoff Robert D. Whittall David W. Butcher (Alt.) Peter Krause (Alt.) Photographic Society of America . Jack Holm Professional Photographers of America . Robert M. Opfer PSI Associates William F. Voglesong Radiological Society of North

23、 America . Homer L. Twigg, Jr. Charles C. Rogers (Alt.) rhoMetric Associates . David L. Spooner Schawk, Inc . Paul R. Guy U.S. Department of Commerce - National Institute of Standards and Technology Daniel J. Dummer U.S. Department of the Army . Calvin F. Douglas Jack J. Hsia (Alt.) U.S. General Ser

24、vices Administration - Federal Supply and Services . Martin Robinson iii STD*ANSI IT2.49-ENGL Introduction The principal changes in this revision of IS0 3665 pertain to speed, safelight sensitivity and two added film sizes. Speed is determined by measurements expressed in grays rather than coulombs

25、per kilogram of air. This change in units was made to adopt the recommendation of the International Commission of Radiation Units and Measurements to use the gray as a measure of absorbed X and gamma radiation as opposed to coulombs per kilogram of air (a unit which simply measures ionization). The

26、constant in the equation for determining speed and the limits for the speed groups have been correspondingly changed so that the classification of products by speed in this International Standard essentially remains unchanged. Manufacturers are now required to specify a suitable safelight screen or

27、filter to be used with the product. This enables an “IS0 safelight condition“ as described in IS0 8374 to be realised; i.e. a safelight condition that will provide no measurable or visible effect upon a sensitized emulsion. The conditions of the storage test have been kept unchanged from the first e

28、dition of IS0 3665, and are in line with long established and proven testing conditions in the photographic industry. The storage test is primarily a test to determine the degree of sensitometric changes that might result from normal transient conditions which could be -encountered during shipment a

29、nd storage. Although the 70 % relative humidity conditions stated in this International Standard are beyond those suggested for storage by most manufacturers, experience has shown that such conditions, on a transient basis, would still allow for acceptable diagnostic radiographs. This test allows fo

30、r the measurement of the sensitometric effects of such transient conditions. A storage abuse test for abnormal conditions has been added as annex A. V AMERICAN NATIONAL STANDARD ANSI/ISO 3665-1996, ANSVNAPM lT2.49-1997 American National Standard for Photography - Intra-oral Dental Photographic Film

31、- Specification 1 Scope This International Standard establishes a system for the classification of intra-orai radiographic film by the speed of the filmprocess system and by the size of the film. It specifies the sensitometric characteristics of the filmprocess systems and the physical characteristi

32、cs of the film and packets; it also describes packaging and labelling requirements. This International Standard is applicable to intra-oral dental radiographic film for manual or automatic processing. It does not apply to films intended to be exposed with fluorescent intensifying screens, or films i

33、ntended to be viewed primarily by reflected light. 2 Normative references The following standards contain provisions which, through reference in this text, constitute provisions of this International Standard. At the time of publication, the editions indicated were valid. All standards are subject t

34、o revision, and parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. Members of IEC and IS0 maintain registers of currently valid International Standards. IS0 1 :1975, Standard

35、reference temperature for industrial length measurements. IS0 5-2:1991, Photography - Density measurements - Part 2: Geometric conditions for transmission density. IS0 543:1990, Photography - Photographic films - Specifications for safety film. IS0 554: 1 976, Standard atmospheres for conditioning a

36、ndor testing - Specifications. IS0 5799:1991, Photography - Direct-exposing medical and dental radiographic fildprocess systems - Determination of IS0 speed and IS0 average gradient. IS0 8374: 1 986, Photography - Detemination of IS0 safelight conditions. 3 Definitions For the purposes of this Intem

37、ational Standard, the following definitions apply. 3.1 packet: Receptacle containing one or more radiographic films intended primarily for intra-oral use. 3.2 package: Receptacle containing multiple packets. 1 STD*ANSI IT2-99-ENGL 1997 0729150 0538q9b 17q IS0 speed group C D E F ANSVIS0 3665-1 996,

38、ANSI/NAPM lT2.49-1997 IS0 speed rangel) (Gy x 102)-1 7.0 to 13,9 14,O to 27,9 28,O to 55.9 56?0to111,9 3.3 gray (Gy): That dose of X and/or gamma radiation absorbed by 1 kg of air which imparts 1 J of initial kinetic energy to those charged particles which it produces. IS0 size number O 1A 1 21) 3 4

39、 4A 5 4 Classification 4.1 IS0 speed groups The IS0 speed of the fildprocess system shall be designated in terms of speed groups as specified in IS0 5799 and given in table 1. Dimensions of film Approximate radius of comers (tol. f 05) (toi. I2,O) 22,O X 35,O 6 24,O X 30,O 6 24,O X 40,O 6 30,5 X 40,

40、5 6 27.0 X 54.0 6 57,O X 76,O 8 54,O X 70,O 8 40.0 X 50,O 8 4.2 IS0 size numbers The size of intra-oral radiographic film shall be designated in terms of IS0 size numbers as given in table 2. 5 Requirements 5.1 General 5.1.1 Each packet shall contain one or more sheets of radiographic film, a sheet

41、of lead foil or other material with equivalent X-ray attenuation characteristics, together with components which limit film bending and provide a light- tight enclosure. i) 1 Gy = 1 Jkg of air (equivalent to 1143 R or to 0,029 5 Wg). 2 STD-ANSI IT2Oq7-ENGL 1777 0724350 0538477 O00 U ANSI/ISO 3665-1

42、996, ANSVNAPM lT2.49-1997 5.1.2 The covering of the packets shall have high visibility under the recommended safelight illumination, shall be resistant to the ingress of moisture, and shall be able to be disinfected with a liquid disinfectant. 5.1.3 Edges of the packets shall be smoothly rounded and

43、 sufficiently blunt to avoid the sensation by the patient that the film packet is cutting into hidher mucosa. 5.1.4 Each packet shall be provided with a means for easily unwrapping the film. 5.1.5 The lead foil or other equivalent material shall be positioned on that side of the film intended to fac

44、e away from the radiation source. 5.1.6 The film shall be of the safety type as defined in IS0 543 and shall be housed within the light-tight enclosure. 5.2 Identification of the irradiated side of the packet Each packet shall have an indicator that tells which side should face the radiation source.

45、 An embossed dot, located near the edge of the film, is the preferred method of identification. Its raised portion indicates the side facing the radiation source. This is usually combined with a second means of identification on the side not facing the radiation source, such as a coloured tab with o

46、r without the words “opposite side toward tube“. 5.3 Identification of the radiation side of the processed film The film shall have an indicator at or near one edge denoting the side intended to be towards the radiation source. A preferred means is an embossed dot with the raised portion indicating

47、the irradiated side. 5.4 Uniformity The film shall exhibit a uniform response to radiation. 5.5 Evaluation before elevated temperature storage test The base plus fog density of films of speed groups C and D shall be less than 0,25.2) The base plus fog density of films of speed groups E and F shall b

48、e less than 0,35. The IS0 speed shall be within the designated IS0 speed group of the film. The IS0 average gradient shall be greater than 1,50. 5.6 Evaluation after elevated temperature storage test The base plus fog density of films of speed groups C and D shall be less than 0,302) The base plus f

49、og density of films of speed groups E and F shall be less than 0,40. The speed and average gradient shall not differ by more than 20 Oh from the IS0 speed and IS0 average gradient values, as determined before the elevated temperature storage test. 2) A manufacturers recommended monobath process may produce an increase in fog value of 0,05. 3 _ _ STD-ANSI IT2-47-ENGL 1777 0724150 0538498 T47 ANSVISO 3665-1 996, ANSVNAPM lT2.49-1997 5.7 Safelight sensitivity When testing a film by means of the procedures described in IS0 8374, no portion