EN ISO 3665-2013 en Photography - Intra-oral dental radiographic film and film packets - Manufacturer specifications《摄影 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 3665:2013BS EN ISO 3665:2013 BRITISH STANDARDNational forewordT

2、his British Standard is the UK implementation of EN ISO 3665:2013. It is identical to ISO 3665:2011. It supersedes BS ISO 3665:2011 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/106, Dentistry.A list of organizations represented on this committee

3、can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2013. Published by BSI Standards Limited 2013ISBN 978 0 580 80204 1ICS 37.040.25Co

4、mpliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 September 2011.Amendments/corrigenda issued since publicationDate Text affected30 June 2013 This corrigendum ren

5、umbers BS ISO 3665:2011 as BS EN ISO 3665:2013EUROPEAN 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) Photographie - Film et paquets de film

6、s 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 comply with the CEN/CENELEC Internal Reg

7、ulations 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-CENELEC Management Centre or to any CEN mem

8、ber. 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 the same status as the official versions.

9、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, Luxembourg, Malta, Netherlands, Norway, Poland

10、, 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 All rights of exploitation in any form an

11、d by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 3665:2013: EBS 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 Standardizat

12、ion (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 publication of an identical text or by endorsement, at the latest by Septembe

13、r 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 CENELEC shall not be held responsible for identifying any or all such patent

14、 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 Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, Fr

15、ance, 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. Endorsement notice The text of ISO 3665:2011 has been approved by CEN as EN IS

16、O 3665:2013 without any modification. BS ISO 3665:2011INTERNATIONAL STANDARD ISO 3665:2011(E)Photography Intra-oral dental radiographic film and film packets Manufacturer specifications1 ScopeThis International Standard establishes a system for the classification of intra-oral radiographic film by t

17、he 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 packaging and labelling requirements.This International Standard is applicable to intra-

18、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 Normative referencesThe following referenced documents are indispensable for the ap

19、plication 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 Specifications (GPS) Standard reference temperature for geometrical product specificatio

20、n 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 conditionsISO 554, Standard atmospheres for conditioning and/or testing Specifica

21、tionsISO 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 15223-1, Medical devices Symbols to be used with medical device labels, labelling and

22、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 definitions apply.3.1expiry datedate, set by the manufacturer, beyond which the manuf

23、acturer 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 energy to those charged particles that it producesNOTE Gy = 1 J/kg of air (equiv

24、alent to 114,5 R or to 0,029 5 C/kg). ISO 2011 All rights reserved 1BS EN ISO 3665:2013BS 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 sp

25、eed of the film/process system shall be designated 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 te

26、rms of size numbers as given in Table 2.Table 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

27、 do exist in some markets.4.3 Packet dimensionsThe 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)BS ISO 3665:20113.3packetreceptacle containing one or more radiographic films intended for intra-oral use3.4pa

28、ckagereceptacle 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 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 5

29、5,956,0 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 millimetresSize number Dimensions of film(tol. 0,5)Approximate radius of corners(tol. 2)011Aa2344Aa5a22,0 35,024,0 40,024,0 3

30、0,030,5 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 are designated in Tables 3 and 4.ISO 3665:2011(E)2 ISO 2011 All rights reservedBS ISO 3665:2011Table 3 Packet maximum wid

31、thDimensions 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 not common worldwide sizes but do exist in some markets.Table 4 Packet maximum lengthDimensions in millimetresSize number

32、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 in some markets.5 Requirements5.1 SymbolsThe symbols used shall be in accordance with ISO 15223-1.5.2 Film requirements

33、5.2.1 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 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

34、(see Figure 1).ISO 3665:2011(E) ISO 2011 All rights reserved 3BS EN ISO 3665:2013ISO 3665:2011(E)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.

35、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 measurable difference in density when compared to that portion not exposed to the safelight.

36、ISO 3665:2011(E)4 ISO 2011 All rights reservedBS EN ISO 3665:2013ISO 3665:2011(E)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 safel

37、ight 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 3665:2011(E)

38、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 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 indicati

39、ng 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 properties of the film5.2.6.1 The film shall exhibit a uniform response to radiation.5.2.6

40、.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 plus fog density of the film shall be no greater than 0,25.NOTE This requirement applies on

41、ly 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 maximum base plus fog density of 0,40 to set the expiry date of the film.NOTE A manufacturers

42、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 limit film bending and provide a light-tight enclosure.When X-ray attenuation is provided

43、 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 be clearly stated on the package and the recommended method shall be included in the in

44、structions 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.I

45、f 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.NOTE 1 The lead foil of 0,038 mm or equivalent material provides protection from back s

46、catter 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 be used to indicate exposure technique error on a processed film.ISO 3665:2011(E) ISO 2

47、011 All rights reserved 5BS EN ISO 3665:2013ISO 3665:2011(E)BS ISO 3665:20115.3.2 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 the holding tab attached to the packet.

48、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

49、 procedure and shall be able to be disinfected with a liquid disinfectant.NOTE Concern regarding the possible transmission of communicable diseases has introduced the need to disinfect film packets prior to processing in dental practice. Protection from damage by the disinfection solution can be achieved by using a protective barrier or plastic foil overwrap on each packet. The process of disinfection and the necessary precautions to be taken in the handling of pac