DIN EN ISO 3665-2013 Photography - Intra-oral dental radiographic film and film packets - Manufacturer specifications (ISO 3665 2011) German version EN ISO 3665 2013《摄影 口内牙科放射线照片和胶.pdf

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1、July 2013 Translation by DIN-Sprachendienst.English price group 9No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 37

2、.040.25!%English version EN ISO 3665:2013,English translation of DIN EN ISO 3665:2013-07Fotografie Intraorale dentale Rntgenfilme und Filmpackungen Herstellerangaben (ISO 3665:2011);Englische Fassung EN ISO 3665:2013,Englische bersetzung von DIN EN ISO 3665:2013-07Photographie Film et paquets de fil

3、ms pour la radiographie dentaire intrabuccale Spcifications (ISO 3665:2011);Version anglaise EN ISO 3665:2013,Traduction anglaise de DIN EN ISO 3665:2013-07www.beuth.deDocument comprises pagesIn case of doubt, the German-language original shall be considered authoritative.1407.13 DIN EN ISO 3665:201

4、3-07 2 A comma is used as the decimal marker. National foreword This document (EN ISO 3665:2013) has been prepared by Technical Committee CEN/TC 55 “Dentistry” (Secretariat: DIN, Germany) in collaboration with ISO/TC 42 “Photography”. The responsible German body involved in its preparation was the N

5、ormenausschuss Dental (Dentistry Standards Committee), Working Committee NA 014-00-08 AA Rntgendiagnostik. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 1 DIN EN ISO 1 ISO 8374 DIN ISO 8374 ISO 15223-1 DIN EN ISO 15223-1 ISO 18906 DIN

6、 ISO 18906 National Annex NA (informative) Bibliography DIN EN ISO 1, Geometrical product specification (GPS) Standard reference temperature for geometrical product specifications and verification DIN EN ISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and inform

7、ation to be supplied Part 1: General requirements DIN ISO 8374, Photography Determination of ISO safelight conditions DIN ISO 18906, Imaging materials Photographic films Specifications for safety film EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 3665 March 2013 ICS 37.040.25 English Vers

8、ion Photography - Intra-oral dental radiographic film and film packets - Manufacturer specifications (ISO 3665:2011) Photographie - Film et paquets de films pour la Fotografie - Intraorale dentale Rntgenfilme und Filmpackungen - Herstellerangaben (ISO 3665:2011) This European Standard was approved b

9、y CEN on 1 March 2013. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standar

10、ds may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and noti

11、fied to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Ic

12、eland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Cent

13、re: Avenue Marnix 17, B-1000 Brussels 2013 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 3665:2013: Eradiographie dentaire intrabuccale - Spcifications (ISO 3665:2011) Contents Page DIN EN ISO 3665:2013-07 EN ISO 3665:2013 (E

14、) Foreword 3 1 Scope 4 2 Normative references 4 3 Terms and definitions .4 4 Film and packet classifications 5 4.1 Film speed groups .5 4.2 Film size numbers5 4.3 Packet dimensions 5 5 Requirements .6 5.1 Symbols 6 5.2 Film requirements 6 5.2.1 Film type .6 5.2.2 Film corner dimensions 6 5.2.3 Film

15、thickness 7 5.2.4 Film safelight sensitivity .7 5.2.5 Film identification of the radiation side of the processed film .8 5.2.6 Sensitometric properties of the film 8 5.2.7 Base plus fog density at the point of manufacture 8 5.2.8 Film expiry date 8 5.3 Packet requirements .8 5.3.1 General 8 5.3.2 Pa

16、cket width and length 9 5.3.3 Packet thickness 9 5.3.4 Moisture protection .9 6 Sampling, inspection and testing 9 6.1 Sampling .9 6.2 Inspection .9 6.3 Testing 9 6.3.1 Base plus fog density, film speed and average gradient 9 6.3.2 Size numbers 9 6.3.3 Squareness and edge straightness .10 6.3.4 Unif

17、ormity .10 6.3.5 Safelight sensitivity .10 6.3.6 Film packets and lead foil dimensions 10 7 Marking and instructions for use .10 7.1 Data on packet .10 7.2 Data on package 11 7.3 Instructions for use .12 7.4 Compliance .12 2 Foreword The text of ISO 3665:2011 has been prepared by Technical Committee

18、 ISO/TC 42 “Photography” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 3665:2013 by Technical Committee CEN/TC 55 “Dentistry” the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by pu

19、blication of an identical text or by endorsement, at the latest by September 2013, and conflicting national standards shall be withdrawn at the latest by September 2013. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or C

20、ENELEC shall not be held responsible for identifying any or all such patent rights. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Rep

21、ublic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. End

22、orsement notice The text of ISO 3665:2011 has been approved by CEN as EN ISO 3665:2013 without any modification. DIN EN ISO 3665:2013-07 EN ISO 3665:2013 (E) 3 1 ScopeThis International Standard establishes a system for the classification of intra-oral radiographic film by the speed of the film/proc

23、ess system and by the size of the film. It specifies the sensitometric characteristics of the film/process systems, the physical characteristics of the film and packets, and it describes packaging and labelling requirements.This International Standard is applicable to intra-oral dental radiographic

24、film for manual or automatic processing. It does not apply to films intended to be exposed with fluorescent intensifying screens, or films intended to be viewed primarily by reflected light.2 Normative referencesThe following referenced documents are indispensable for the application of this documen

25、t. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 1, Geometric Product Specifications (GPS) Standard reference temperature for geometrical product specification and verificationISO 5-2

26、, Photography and graphic technology Density measurements Part 2: Geometric conditions for transmittance densityISO 5-3, Photography and graphic technology Density measurements Part 3: Spectral conditionsISO 554, Standard atmospheres for conditioning and/or testing SpecificationsISO 5799, Photograph

27、y Direct-exposing medical and dental radiographic film/process systems Determination of ISO speed and ISO average gradientISO 8374, Photography Determination of ISO safelight conditionsISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplie

28、d Part 1: General requirementsISO 18906, Imaging materials Photographic films Specifications for safety film3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.3.1expiry datedate, set by the manufacturer, beyond which the manufacturer does not guarante

29、e the quality of the product when handled, shipped and stored according to his instructions3.2grayGydose of X and/or gamma radiation absorbed by 1 kg of air, which imparts 1 J of initial kinetic energy to those charged particles that it producesNOTE Gy = 1 J/kg of air (equivalent to 114,5 R or to 0,

30、029 5 C/kg).DIN EN ISO 3665:2013-07 EN ISO 3665:2013 (E) 4 3.3packetreceptacle containing one or more radiographic films intended for intra-oral use3.4packagereceptacle containing multiple packets4 Film and packet classifications4.1 Film speed groupsThe speed of the film/process system shall be desi

31、gnated in terms of speed groups as specified in ISO 5799 and given in Table 1.Table 1 Speed groupsSpeed group Speed range(Gy 102)DEF14,0 to 27,928,0 to 55,956,0 to 111,94.2 Film size numbersThe size of intra-oral radiographic film shall be designated in terms of size numbers as given in Table 2.Tabl

32、e 2 Film sizesDimensions in millimetresSize number Dimensions of film(tol. 0,5)Approximate radius of corners(tol. 2)011Aa2344Aa5a22,0 35,024,0 40,024,0 30,030,5 40,527,0 54,057,0 76,054,0 70,040,0 50,066666888aThese sizes are not common worldwide sizes but do exist in some markets.4.3 Packet dimensi

33、onsThe maximum width and length are designated in Tables 3 and 4.DIN EN ISO 3665:2013-07 EN ISO 3665:2013 (E) 5 Table 3 Packet maximum widthDimensions in millimetresSize number Maximum width of film Maximum width of packet011Aa2344Aa5a22,524,524,531,027,557,554,540,526,528,528,535,031,561,558,544,5a

34、These sizes are not common worldwide sizes but do exist in some markets.Table 4 Packet maximum lengthDimensions in millimetresSize number Maximum length of film Maximum length of packet011Aa2344Aa5a35,540,530,541,054,576,570,550,539,544,534,545,058,580,574,554,5aThese sizes are not common worldwide

35、sizes but do exist in some markets.5 Requirements5.1 SymbolsThe symbols used shall be in accordance with ISO 15223-1.5.2 Film requirements5.2.1 Film typeThe film shall be of the safety type defined in ISO 18906 and shall be housed within the light-tight enclosure.5.2.2 Film corner dimensionsDue to t

36、he manufacturing process for the packet, there may be a slight ledge or step on the film itself. The step shall be no greater than 0,2 mm (see Figure 1).DIN EN ISO 3665:2013-07 EN ISO 3665:2013 (E) 6 21XKeyX enlarged view of the film chip1 size 2 film2 stepNOTE Maximum step 0,2 mm.Figure 1 Film corn

37、er characteristics5.2.3 Film thicknessFilm thickness shall not be greater than 0,25 mm.5.2.4 Film safelight sensitivityWhen testing a film by means of the procedures described in ISO 8374, no portion of the film exposed to the safelight recommended by the manufacturer shall have any visible or measu

38、rable difference in density when compared to that portion not exposed to the safelight.DIN EN ISO 3665:2013-07 EN ISO 3665:2013 (E) 7 5.2.5 Film identification of the radiation side of the processed filmThe film shall have an indicator at or near one edge denoting the side intended to be towards the

39、 radiation source. A preferred means is an embossed dot with the raised portion indicating the irradiated side.NOTE An alternative means used by some manufacturers is to place radiopaque numbers on the packet. The number can be read correctly on the irradiated side of the film.5.2.6 Sensitometric pr

40、operties of the film5.2.6.1 The film shall exhibit a uniform response to radiation.5.2.6.2 The speed classification shall be in accordance with ISO 5799.5.2.6.3 The average gradient in accordance with ISO 5799 shall be greater than 1,50.5.2.7 Base plus fog density at the point of manufactureBase plu

41、s fog density of the film shall be no greater than 0,25.NOTE This requirement applies only to the manufacturer of the film. The manufacturer shall retain testing data and results, should national bodies require verification for audit purposes.5.2.8 Film expiry dateThe manufacturer shall use a maximu

42、m base plus fog density of 0,40 to set the expiry date of the film.NOTE A manufacturers recommended monobath process may produce an increase in fog value of 0,05.5.3 Packet requirements5.3.1 GeneralEach packet shall contain one or more sheets of radiographic film, together with the components that l

43、imit film bending and provide a light-tight enclosure.When X-ray attenuation is provided by an internal mechanism, a sheet of lead foil or other material with equivalent X-ray attenuation characteristics shall be included in each packet.If attenuation is provided by an external mechanism, this shall

44、 be clearly stated on the package and the recommended method shall be included in the instructions for use.The covering of the packets shall have high visibility under the recommended safelight illumination.The edges of the packets should be smoothly rounded and sufficiently blunt to avoid discomfor

45、t to the patient.Each packet shall be provided with a means for easily unwrapping film.If present, the lead foil or equivalent material shall be positioned on that side of the film intended to face away from the radiation source. A material other than lead shall provide the same level of attenuation

46、.NOTE 1 The lead foil of 0,038 mm or equivalent material provides protection from back scatter radiation to allow 19 lp/mm. Thicker foils can be used but do not provide any significant improvement in image quality or shielding.NOTE 2 Alternatively, a radiopaque number on the front of each packet can

47、 be used to indicate exposure technique error on a processed film.DIN EN ISO 3665:2013-07 EN ISO 3665:2013 (E) 8 5.3.2 Packet width and lengthThe maximum width or length of the packets shall not be more than 4,0 mm greater than the corresponding width or length of the film. This does not apply to th

48、e holding tab attached to the packet.5.3.3 Packet thicknessThe maximum thickness of the packet not counting any tab used for positioning shall be 2,0 mm. For interproximal film, the tab shall have a minimum length and width of 20 mm.5.3.4 Moisture protectionThe packets should be able to withstand the moisture in a mouth during an X-ray procedure and shall be able to be disinfected with a liquid disinfectant.NOTE Concern regarding the possible transmission of communicable diseases has