1、March 2015 Translation by DIN-Sprachendienst.English price group 7No 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 1
2、1.060.10!%AJZ“2303955www.din.deDDIN EN ISO 13116Dentistry Test Method for Determining Radio-Opacity of Materials(ISO 13116:2014);English version EN ISO 13116:2014,English translation of DIN EN ISO 13116:2015-03Zahnheilkunde Prfverfahren zur Bestimmung der Rntgensichtbarkeit von Materialien (ISO 1311
3、6:2014);Englische Fassung EN ISO 13116:2014,Englische bersetzung von DIN EN ISO 13116:2015-03Mdecine bucco-dentaire Mthodes de dtermination de la radio opacit des matriaux (ISO 13116:2014);Version anglaise EN ISO 13116:2014,Traduction anglaise de DIN EN ISO 13116:2015-03www.beuth.deDocument comprise
4、s 10 pagesIn case of doubt, the German-language original shall be considered authoritative.03.15 DIN EN ISO 13116:2015-03 2 A comma is used as the decimal marker. National foreword This document (EN ISO 13116:2014) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaboration with
5、 Technical Committee CEN/TC 55 “Dentistry” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the DIN-Normenausschuss Dental (DIN Standards Committee Dentistry), Working Committee NA 014-00-01 AA Fllungswerkstoffe. The DIN Standards corresponding to the Internat
6、ional Standards referred to in this document are as follows: ISO 1942 DIN EN ISO 1942 ISO 3665 DIN EN ISO 3665 ISO 8601 DIN ISO 8601 National Annex NA (informative) Bibliography DIN EN ISO 1942, Dentistry Vocabulary DIN EN ISO 3665, Photography Intra-oral dental radiographic film and film packets Ma
7、nufacturer specifications DIN ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 13116 November 2014 ICS 11.060.10 English Version Dentistry - Test Method for Determining Radio-Opacity of
8、Materials (ISO 13116:2014) Mdecine bucco-dentaire - Mthodes de dtermination de la radio opacit des matriaux (ISO 13116:2014) Zahnheilkunde - Prfverfahren zur Bestimmung der Rntgensichtbarkeit von Materialien (ISO 13116:2014) This European Standard was approved by CEN on 6 September 2014. CEN members
9、 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 standards may be obtained on application
10、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 notified to the CEN-CENELEC Management
11、 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, Iceland, Ireland, Italy, Latvia, Lit
12、huania, 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 CEN-CENELEC Management Centre: Avenue Marnix 17,
13、B-1000 Brussels 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 13116:2014 EContents PageForeword 31 Scope . 42 Normative references 43 Terms and definitions . 44 Requirements 45 Sampling 46 Apparatus . 56.1 Suitable mould
14、s for constructing samples of the test-material 56.2 Screw micrometer gauge, or equivalent device 56.3 Aluminium step wedge 56.4 Dental X-ray unit 56.5 Dental X-ray sensor . 57 Test conditions and procedures . 67.1 Test conditions 67.2 Preparation of test specimens . 67.3 Test procedure for analogue
15、 equipment . 67.4 Test procedure for digital equipment 68 Treatment of results . 72DIN EN ISO 13116:2015-03 EN ISO 13116:2014 (E) Foreword This document (EN ISO 13116:2014) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaboration with Technical Committee CEN/TC 55 “Dentistry”
16、 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 May 2015, and conflicting national standards shall be withdrawn at the latest by May 2015. Attention is dr
17、awn 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 organizations of the follow
18、ing 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, Malta, Netherlands, No
19、rway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 13116:2014 has been approved by CEN as EN ISO 13116:2014 without any modification. 3DIN EN ISO 13116:2015-03 EN ISO 13116:2014 (E) 1 ScopeThis Internatio
20、nal Standard specifies test methods for determination of radio-opacity of a test material by reference to a specimen of an aluminium standard. The method is designed to discriminate radio-opacity at a clinically meaningful level and is not designed to take account of factors which may affect precise
21、, inherent values of radio-opacity such as background noise, X-ray beam power, grey scale correction and image enhancement. It is recognized that such factors can change the value of radio-opacity but not the relative ranking compared to standard thicknesses of an internal standard such as aluminium
22、. This test may be performed with conventional or digital sensoring techniques of dental X-ray apparatus.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition c
23、ited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 3665, Photography Intra-oral dental radiographic film and film packets Manufacturer specificationsISO 1942, Dentistry VocabularyISO 8601, Data elements and interchange formats I
24、nformation interchange Representation of dates and times3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 1942 apply.4 RequirementsThis International Standard does not set pass/fail limits for radio-opacity. If a manufacturer claims that a material is r
25、adio-opaque, the radio-opacity, determined in accordance with Clause 7, shall have a value at least equivalent to the minimum level specified in the appropriate product standard requirements.NOTE Aluminium has a radio-opacity equivalent to that of dentine. Thus 1 mm of material having a radio-opacit
26、y equivalent to 1 mm of aluminium has a radio-opacity equivalent to that of dentine.5 SamplingThe relevant product standard defines the details of the sampling procedure.NOTE Normal procedures are for a sample to be drawn from one batch to provide sufficient material to complete the prescribed test.
27、 The test sample normally consists of packages prepared for retail sale.4DIN EN ISO 13116:2015-03 EN ISO 13116:2014 (E) 6 Apparatus6.1 Suitable moulds for constructing samples of the test-materialDetails of suitable moulds are specified in the appropriate product standard. Typically, moulds for spec
28、imens suitable for use in this test have a thickness ranging from 0,5 mm to 2,5 mm with straight right-angled edges. The specimens shall be homogenous and have a uniform thickness but the shape and size are not critical providing there is sufficient area for a determination to be made and that the s
29、pecimens can be located near the centre of the film or sensor.NOTE 1 10 mm diameter has been found to be suitable for disc shaped specimens.NOTE 2 For highly radio-opaque materials (e.g. containing zirconia), thinner specimens up to a maximum of 1,5 mm thickness may be required; while for materials
30、of low radio-opacity, thicker specimens may be required.6.2 Screw micrometer gauge, or equivalent deviceReading and accurate to 0,01 mm.6.3 Aluminium step wedgeWith purity at least 98 % (mass fraction) of aluminium with less than 0,1 % (mass fraction) copper and less than 1,0 % (mass fraction) iron
31、present, having a thickness range from 0,5 mm to 5,0 mm in equally spaced steps. Measure the thickness of each step with the micrometer (6.2) to an accuracy of 0,01 mm. There must be less than a 0,05 mm variation in thickness over the area of each step. The wedge must be free standing.NOTE The overa
32、ll dimensions may be adjusted for the convenience of the user.A thickness difference of each step in the step-wedge of approximately 0,5 mm is recommended.6.4 Dental X-ray unitWith a total filtration of 1,5 to 2 mm aluminium, and capable of operation at (60 10) kV, with suitable accessories. The uni
33、t shall be used in conjunction with conventional and/or digital X-ray sensoring equipment.6.5 Dental X-ray sensorNOTE One of three sensoring techniques may be used to determine the radio-opacity of the test material.6.5.1 Analogue sensoring6.5.1.1 Dental X-ray occlusal film of speed group D, E or F
34、(as specified in ISO 3665) and freshly-prepared developing solution and fixer prepared and used in accordance with manufacturers instructions.6.5.1.2 Densitometer using white light and capable of measuring in the optical density range 0 to 3,0 to a resolution of 0,01, calibrated at zero and against
35、a reference with optical density of (2,5 0,5) known to an accuracy of 0,01, and using an aperture of (2,0 0,1) mm. The densitometer must be prepared to be stable to 0,01 at an optical density of (2,5 0,5) over 30 min or a recalibration shall be performed before each set of readings.6.5.2 Digital sen
36、soring6.5.2.1 Intra-oral X-ray sensor calibrated for use with appropriate software.5DIN EN ISO 13116:2015-03 EN ISO 13116:2014 (E) 6.5.2.2 Software capable of grey scale analysis with an accuracy of 1 grey value and compatible with the intra-oral sensor1).6.5.3 Imaging plates6.5.3.1 Phosphor imaging
37、 plates of a size suitable for the placement of specimens of the test material and the aluminium step wedge (6.3)6.5.3.2 Digital scanner compatible with the imaging plates.6.5.3.3 Software capable of grey scale analysis with an accuracy of 1 grey value and compatible with the digital scanner1)7 Test
38、 conditions and procedures7.1 Test conditionsUse test conditions as outlined in the appropriate product standard.7.2 Preparation of test specimensPrepare the test specimens according to the procedure outlined in the appropriate product standard. Measure the thickness of all samples using the measuri
39、ng device described in 6.2. There must be less than a 0,05 mm variation in thickness of specimens over the area in which the determination is to be made. Use a specimen thickness which complies with the appropriate product standard.7.3 Test procedure for analogue equipmentPosition the X-ray source (
40、6.4) perpendicular to the X-ray film (6.5.1.1). Place the specimen and the aluminium step wedge (6.3) in contact and upright, in the centre of the film.Irradiate the specimen, aluminium step wedge and film with X-rays at (60 10) kV at a target film distance of 300 mm to 400 mm for such a time that,
41、after processing, the region of film beside the specimen and aluminium has an optical density of between 1,5 and 2.NOTE Exposures of between 0,1 s and 0,4 s at 10 mA are typical.Measure the thickness of the specimen (Ts) and the steps of the aluminium step wedge (6.3) with the micrometer (6.2) to an
42、 accuracy of 0,01 mm. The optimal thickness of the specimen is stated in the appropriate product standard.If the thickness of the specimen is in the range specified by the product standard then, after developing and fixing the film, measure the optical density of the image of the specimen and that o
43、f each step of the aluminium using the densitometer (6.5.1.2).NOTE For many materials a specimen thickness of (1,0 0,1) mm is most appropriate.Carry out three separate exposures or the number specified in the product standard if that is greater.7.4 Test procedure for digital equipmentMeasure the thi
44、ckness of the specimen (Ts) and the steps of the aluminium step wedge (6.3) with the micrometer (6.2) to an accuracy of 0,01 mm.1) Adobe Photoshop is an example of a suitable product available commercially. This information is given for the convenience of users of this International Standard and doe
45、s not constitute an endorsement by ISO of this product.6DIN EN ISO 13116:2015-03 EN ISO 13116:2014 (E) Position the intra oral X-ray sensor (6.5.2.1) or the phosphor imaging plate (6.5.3.1). Place the specimen and the step wedge (6.3) in contact near the centre of the sensor. Irradiate the assembly
46、with X-rays (6.4) at a target-film distance of 300 - 400 mm. Repeat the procedure to find the appropriate exposure time to make a clear image without too great a contrast.Export the digital image file to the grey scale analysis software (6.5.2.2).NOTE The number of grey shades is assessed using the
47、measuring tool in the software. The number of grey shades in the digital image is given by the number of binary digits (bits) used to define a pixel.Using the grey scale analysis software, define a rectangular area to measure in the specimen image and measure the average grey value in that area.Repe
48、at this procedure with each of the steps of the step wedge.Carry out three separate exposures or the number specified in the product standard if that is greater.8 Treatment of resultsPlot the individual optical densities/grey values of each aluminium step against the thickness of each step, (see Figure 1). Take the optical density/grey value for the specimen of thickness Tsand determine from the plot the corresponding value of aluminium (Ta).The radio-opacity (aluminium equivalent) value of a s
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