SIST EN 26876:2000
(Main)Dentistry - Dental root canal sealing materials (ISO 6876:1986)
Dentistry - Dental root canal sealing materials (ISO 6876:1986)
Zahnheilkunde - Zahnärztlicher Wurzelkanal - Versiegelungswerkstoffe (ISO 6876:1986)
Art dentaire - Produits dentaires pour le scellement des canaux radiculaires (ISO 6876:1986)
Dentistry - Dental root canal sealing materials (ISO 6876:1986)
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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Dentistry - Dental root canal sealing materials (ISO 6876:1986)Zahnheilkunde - Zahnärztlicher Wurzelkanal - Versiegelungswerkstoffe (ISO 6876:1986)Art dentaire - Produits dentaires pour le scellement des canaux radiculaires (ISO 6876:1986)Dentistry - Dental root canal sealing materials (ISO 6876:1986)11.060.10Dental materialsICS:Ta slovenski standard je istoveten z:EN 26876:1990SIST EN 26876:2000en01-januar-2000SIST EN 26876:2000SLOVENSKI
STANDARD
SIST EN 26876:2000
SIST EN 26876:2000
SIST EN 26876:2000
International Standard INTERNATIONAL ORGANlZATlON FOR STANDARDlZATlONoME~b’HAPOfiHAR OPt-AHM3AL&lR fl0 CTAH~APTbl3A~VlWORGANISATION INTERNATIONALE DE NORMALISATION Dental root canal sealing materials Produits dentaires pour Ie sceikment des canaux radiculaires First edition - 1986-12-01 w - UDC 615.463 : 616.314 Ref. No. ISO 6876-1986 (EI Descriptors : dental materials, sealing materials, material specifications. Price based on 4 pages SIST EN 26876:2000
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. Esch 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, govern- mental and non-governmental, in liaison with ISO, also take part in the work. Draft International Standards adopted by the technical committees are circulated to the member bodies for approval before their acceptance as International Standards by the ISO Council. They are approved in accordance with ISO procedures requiring at least 75 % approval by the member bodies voting. International Standard ISO 6876 was prepared by Technical Committee ISO/TC 106, Dentistry. Users should note that all International Standards undergo revision from time to time and that any reference made herein to any other International Standard implies its latest edition, unless otherwise stated. International Organkation for Standardization, 1986 Printed in Switzerland SIST EN 26876:2000
INTERNATIONAL STANDARD ISO 6876-1986 (E) Dental root canal sealing materials 1 Scope and field of application This International Standard specifies requirements for materials used for permanent obturation of the root canal with or without the aid of obturating Points. This International Standard only covers materials intended for orthograde (root filling inserted from coronal aspect) use. 2 References ISO 3665, Photography - Intra-oral dental radiographic ftlm - Specifica tion. ISO 3696, Water for laboratory use - Specifications and test methods. 1) ISO/TR 7405, Biological evaluation of dental materials. 3 Classif ication The root canal sealing materials covered by this International Standard are classified into the following types : Type 1 : Setting materials. These are materials which set within 72 h of commence- ment of mixing. Type 2 : Non-setting materials. 4 Requirements 4.1 Component The component of the sealing material shall be free from extraneous matter. The purity and sterility of the ingredients shall comply with the relevant pharmacopoeia applicable in the country in which the material is marketed, or with such national regulations as are applicable to purity and sterility of pharmaceutical products. The ingredients shall, when used in accordance with the manufacturer’s instructions, form a material which camplies with the requirements of this International Standard. 1) At present at the Stage of draft. 4.2 Freedom from toxicity The material shall not Cause any irreversible darnage when in contact with the oral tissues. Reference shall be made to ISO/TR 7405 which gives guidance on the biological evaluation of dental materials. 4.3 Flow The flow of the material, when determined in accordance with 7.3, shall produce a disc with a diameter of not less than 20 mm. 4.4 Working time The working time for type 1 materials having a working time of less than 30 min, when determined by the method given in 7.4, shall be within + 10 % of the working time stated by the manufacturer [sec 5e)l. 4.5 Setting time The setting time of type 1 materials, determined by the method given in 7.5, shall be within + 10 % of the setting time stated by the manufacturer [sec 5e)l. For materials having a setting time greater than 30 min for which the manufacturer quotes a range of times, the setting time measured shall be within the specified range. 4.6 Film thickness The film thickness, for materials intended for use with obtu- rating Points, shall not be more than 50 Fm, when tested in ac- cordante with 7.6. 4.7 Radio-Opacity The material, when tested in accordance with 7.7, shall have a radio-opacity equivalent of not less than 3 mm of aluminium. 4.8 Solubility and disintegration The solubility of the material, when determined in accordance with 7.8, shall not exceed 3 % by mass, nor shall the specimen show evidente of disintegration. 1 SIST EN 26876:2000
ISO 68764986 (El 5 Manufacturer’s instructions 7.3.2 Procedure Instructions shall the following : accompany each package and shall include Using the glass delivery tube (7.3.1.31, deposit 0,075 ml of the material, mixed in accordance with the manufacturer’s instruc- tions, onto one of the glass plates (7.3.1 .l). After 180 + 5 s from the Start of mixing, place the other glass plate centrally on the material and carefully apply, by means of the loading device (7.3.1.2), the 2,5 kg load. After 10 min from the Start of mixing, remove the load and measure the major and minor diameters of the disc. Record the mean of the major and minor diameters. If the diameters differ from each other by more than 1 mm, repeat the test. a) instructions for use of the material, including, where applicable, the method of mixing and component mixing ratio ; b) the recommended or necessary ; method for sterilization, if possi ble c) principal material(s) ; components and active ingredients of 7.3.3 Calculation and expression of results d) recommended conditions of storage ; Carry out three determinations, calculate the mean result and record it, to the nearest millimetre, as the flow value. e) the working time (if less than 30 min) and the setting time of the material - if the material is of the non-setting variety this should be stated ; if a precise setting time cannot be determined but it exceeds 30 min, a range may be quoted ; 7.4 Working time NOTE - This test applies only to type 1 time of less than 30 min (sec 4. 4). materials having a working f) indications for clinical use, including whether the material is manufactured for use with obturating Points - if the material tan Cause staining of the tooth, this should be stated together with any precautions necessary to minimize this effect. 7.4.1 Apparatus The apparatus specified in 7.3.1 shall be used. 6 Sampling 7.4.2 Procedure The Sample shall consist of one or more retail packages from the same batch, containing sufficient material to carry out the specified tests, plus an allowance for repeats, if necessary. Using the glass delivery tube (7.3.1.31, deposit 0,075 ml of the material, mixed in accordance with the manufacturer’s instruc- tions, onto one of the glass plates (7.3.1 .l). After 210 zt: 5 s from the Start of mixing, place the other glass plate centrally on the material and carefully apply, by means of the loading device (7.3.1.2), the 2,5 kg load. Apply the load for 7 min, then remove it and measure the major and minor diameters of the disc. Record the mean of the major and minor diameters. 7 Test methods 7.1 Test conditions Repeat the test with newly mixed material applying the load at increasing intervals of time after the Start of mixing until the diameter has decreased by 10 % from the flow value (sec 7.3.3). Unless otherwise stated by the manufacturer, all tests shall be carried out at 23 ZL 2 OC and at a relative humidity of (50 If: 5) %. 7.2 Preparation of material for testing 7.4.3 Calculation
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