BS EN ISO 3665-2013 Photography Intra-oral dental radiographic film and film packets Manufacturer specifications《摄影术 口内牙科放射线照片和胶片包 制造商规范》.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS ISO 3665:2011Photography Intra-oraldental radiographic film andfilm packets ManufacturerspecificationsBS EN ISO 3665:2013Copyright European Committee for Standardization Provi

2、ded by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 3665:2013 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 3665:2013. It is identical to ISO 3665:2011. It supersedes BS ISO 3665:201

3、1 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/106, Dentistry.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contrac

4、t. Users are responsible for its correct application. The British Standards Institution 2013. Published by BSI Standards Limited 2013ISBN 978 0 580 80204 1ICS 37.040.25Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the autho

5、rity of the Standards Policy and Strategy Committee on 30 September 2011.Amendments/corrigenda issued since publicationDate Text affected30 June 2013 This corrigendum renumbers BS ISO 3665:2011 as BS EN ISO 3665:2013Copyright European Committee for Standardization Provided by IHS under license with

6、CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 3665 March 2013 ICS 37.040.25 English Version Photography - Intra-oral dental radiographic film and film packets - Manufacturer specifications (ISO 3665:2011

7、) Photographie - Film et paquets de films pour la radiographie dentaire intrabuccale - Spcifications (ISO 3665:2011) Fotografie - Intraorale dentale Rntgenfilme und Filmpackungen - Herstellerangaben (ISO 3665:2011) This European Standard was approved by CEN on 1 March 2013. CEN members are bound to

8、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 standards may be obtained on application to the CEN-CEN

9、ELEC 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 notified to the CEN-CENELEC Management Centre has th

10、e 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, Iceland, Ireland, Italy, Latvia, Lithuania, Luxemb

11、ourg, 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 Centre: Avenue Marnix 17, B-1000 Brussels 2013 CEN A

12、ll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 3665:2013: ECopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS

13、 EN ISO 3665:2013EN ISO 3665:2013 (E)EN ISO 3665:2013 (E) 3 Foreword The text of ISO 3665:2011 has been prepared by Technical Committee 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 “De

14、ntistry” the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication 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 2

15、013. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. According to the CEN-CENELEC Internal Regulations, the national standards organiz

16、ations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Ma

17、lta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 3665:2011 has been approved by CEN as EN ISO 3665:2013 without any modification. Copyright European Committee for Standardization Pro

18、vided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS ISO 3665:2011INTERNATIONAL STANDARD ISO 3665:2011(E)Photography Intra-oral dental radiographic film and film packets Manufacturer specifications1 ScopeThis International Standard

19、establishes a system for the classification of intra-oral radiographic film by the speed of the film/process 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 packagin

20、g 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 intended to be viewed primarily by reflected light.2 Nor

21、mative referencesThe following referenced documents are indispensable for the application of this document. 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 Specific

22、ations (GPS) Standard reference temperature for geometrical product specification and verificationISO 5-2, Photography and graphic technology Density measurements Part 2: Geometric conditions for transmittance densityISO 5-3, Photography and graphic technology Density measurements Part 3: Spectral c

23、onditionsISO 554, Standard atmospheres for conditioning and/or testing SpecificationsISO 5799, Photography 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-

24、1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied 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 defin

25、itions apply.3.1expiry datedate, set by the manufacturer, beyond which the manufacturer does not guarantee 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

26、energy to those charged particles that it producesNOTE Gy = 1 J/kg of air (equivalent to 114,5 R or to 0,029 5 C/kg). ISO 2011 All rights reserved 1BS EN ISO 3665:2013Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking pe

27、rmitted without license from IHS-,-,-BS ISO 3665:20113.3packetreceptacle 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 designated

28、 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.Table 2 Fi

29、lm 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 dimensionsThe

30、 maximum width and length are designated in Tables 3 and 4.ISO 3665:2011(E)2 ISO 2011 All rights reservedBS EN ISO 3665:2013ISO 3665:2011(E)Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license fro

31、m IHS-,-,-BS ISO 3665:20113.3packetreceptacle 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 designated in terms of speed groups a

32、s 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.Table 2 Film sizesDimensions in milli

33、metresSize 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 dimensionsThe maximum width and length a

34、re designated in Tables 3 and 4.ISO 3665:2011(E)2 ISO 2011 All rights reservedBS ISO 3665:2011Table 3 Packet maximum widthDimensions in millimetresSize number Maximum width of film Maximum width of packet011Aa2344Aa5a22,524,524,531,027,557,554,540,526,528,528,535,031,561,558,544,5aThese sizes are no

35、t 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 sizes but do exist

36、 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 the manufacturing p

37、rocess 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).ISO 3665:2011(E) ISO 2011 All rights reserved 3BS EN ISO 3665:2013ISO 3665:2011(E)Copyright European Committee for Standardization Provided by IHS under license with

38、 CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS ISO 3665:201121XKeyX enlarged view of the film chip1 size 2 film2 stepNOTE Maximum step 0,2 mm.Figure 1 Film corner characteristics5.2.3 Film thicknessFilm thickness shall not be greater than 0,25 mm.5.2.4 Film

39、 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 measurable difference in density when compared to that portion not exposed to the safelight.ISO 3665:2

40、011(E)4 ISO 2011 All rights reservedBS EN ISO 3665:2013ISO 3665:2011(E)Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS ISO 3665:201121XKeyX enlarged view of the film chip1 siz

41、e 2 film2 stepNOTE Maximum step 0,2 mm.Figure 1 Film corner 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 recomm

42、ended by the manufacturer shall have any visible or measurable difference in density when compared to that portion not exposed to the safelight.ISO 3665:2011(E)4 ISO 2011 All rights reservedBS ISO 3665:20115.2.5 Film identification of the radiation side of the processed filmThe film shall have an in

43、dicator 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 the irradiated side.NOTE An alternative means used by some manufacturers is to place radiopaque numbers on the packet. The number can be

44、read correctly on the irradiated side of the film.5.2.6 Sensitometric properties 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 t

45、han 1,50.5.2.7 Base plus fog density at the point of manufactureBase plus 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

46、audit purposes.5.2.8 Film expiry dateThe manufacturer shall use a maximum 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

47、or more sheets of radiographic film, together with the components that limit 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 eac

48、h packet.If attenuation is provided by an external mechanism, this shall 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 discomfort 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