BS EN ISO 13116-2014

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BSENISO13116 2014
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BSI Standards Publication BS EN ISO 13116:2014 Dentistry — Test Method for Determining Radio-Opacity of MaterialsBS EN ISO 13116:2014 BRITISH STANDARD National foreword This British Standard is the UK implementation of EN ISO 13116:2014. The UK participation in its preparation was entrusted to Technical Committee CH/106/1, Dental restorative and orthodontic materials. 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 contract. Users are responsible for its correct application. © The British Standards Institution 2014. Published by BSI Standards Limited 2014 ISBN 978 0 580 82429 6 ICS 11.060.10 Compliance 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 November 2014. Amendments issued since publication Date Text affected EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM EN ISO 13116 November 2014 ICS 11.060.10 English Version Dentistry - Test Method for Determining Radio-Opacity of Materials (ISO 13116:2014) Médecine bucco-dentaire - Méthodes de détermination de la radio opacité des matériaux (ISO 13116:2014) Zahnheilkunde - Prüfverfahren zur Bestimmung der Röntgensichtbarkeit von Materialien (ISO 13116:2014) This European Standard was approved by CEN on 6 September 2014. 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 standards 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 notified 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, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, 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 EBS EN ISO 13116:2014 EN ISO 13116:2014 (E) 3 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” 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 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 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, 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. Endorsement notice The text of ISO 13116:2014 has been approved by CEN as EN ISO 13116:2014 without any modification. BS EN ISO 13116:2014ISO 13116:2014(E)Contents Page Foreword iv 1 Scope . 1 2 Normative references 1 3 T erms and definitions . 1 4 Requirements 1 5 Sampling 1 6 Apparatus . 2 6.1 Suitable moulds for constructing samples of the test-material 2 6.2 Screw micrometer gauge, or equivalent device 2 6.3 Aluminium step wedge 2 6.4 Dental X-ray unit 2 6.5 Dental X-ray sensor . 2 7 Test conditions and procedures . 3 7.1 Test conditions 3 7.2 Preparation of test specimens . 3 7.3 Test procedure for analogue equipment . 3 7.4 Test procedure for digital equipment 3 8 Treatment of results . 4 © ISO 2014 – All rights reserved iiiBS EN ISO 13116:2014ISO 13116:2014(E) Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives). Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents). Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement. For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword — Supplementary information The committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC 1, Filling and restorative materials.iv © ISO 2014 – All rights reservedBS EN ISO 13116:2014Dentistry — Test Method for Determining Radio-Opacity of Materials 1 Scope This International 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, 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. This test may be performed with conventional or digital sensoring techniques of dental X-ray apparatus. 2 Normative references The 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 cited 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 specifications ISO 1942, Dentistry — Vocabulary ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates and times 3 T erms a nd definiti ons For the purposes of this document, the terms and definitions given in ISO 1942 apply. 4 Requirements This International Standard does not set pass/fail limits for radio-opacity. If a manufacturer claims that a material is radio-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- opacity equivalent to 1 mm of aluminium has a radio-opacity equivalent to that of dentine. 5 Sampling The 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. The test sample normally consists of packages prepared for retail sale. INTERNATIONAL ST ANDARD ISO 13116:2014(E) © ISO 2014 – All rights reserved 1BS EN ISO 13116:2014ISO 13116:2014(E) 6 Apparatus 6.1 Suitable moulds for constructing samples of the test-material Details of suitable moulds are specified in the appropriate product standard. Typically, moulds for specimens 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 specimens 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 of low radio-opacity, thicker specimens may be required. 6.2 Screw micrometer gauge, or equivalent device Reading and accurate to 0,01 mm. 6.3 Aluminium step wedge With purity at least 98 % (mass fraction) of aluminium with less than 0,1 % (mass fraction) copper and less than 1,0 % (mass fraction) iron 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 overall 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 unit With a total filtration of 1,5 to 2 mm aluminium, and capable of operation at (60 ± 10) kV, with suitable accessories. The unit shall be used in conjunction with conventional and/or d ig it a l X-r ay sen sor i ng e qu ipment . 6.5 Dental X-ray sensor NOTE One of three sensoring techniques may be used to determine the radio-opacity of the test material. 6.5.1 Analogue sensoring 6.5.1.1 Dental X -r a y oc clusal film of speed group D, E or F (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 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 sensoring 6.5.2.1 Intra-oral X-ray sensor calibrated for use with appropriate software.2 © ISO 2014 – All rights reservedBS EN ISO 13116:2014ISO 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 sensor 1) . 6.5.3 Imaging plates 6.5.3.1 Phosphor imaging 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 scanner 1) 7 Test conditions and procedures 7.1 Test conditions Use test conditions as outlined in the appropriate product standard. 7.2 Preparation of test specimens Prepare the test specimens according to the procedure outlined in the appropriate product standard. Measure the thickness of all samples using the measuring 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 equipment Position the X-ray source (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, 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 (T s ) and the steps of the aluminium step wedge (6.3) with the micrometer (6.2) to an 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 of 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 equipment Measure the thickness of the specimen (T s ) 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 does not constitute an endorsement by ISO of this product.© ISO 2014 – All rights reserved 3BS EN ISO 13116:2014ISO 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 with X-rays (6.4) at a target-film distance of 300 - 400 mm. Repea
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