EN 21563:1991

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Alginate dental impression material (ISO 1563:1990)Zahnärztliche Alginat-Abformmasse (ISO 1563:1990)Produits pour empreintes dentaires a base d'alginate (ISO 1563:1990)Alginate dental impression material (ISO 1563:1990)11.060.10Dental materialsICS:Ta slovenski standard je istoveten z:EN 21563:1991SIST EN 21563:2000en01-januar-2000SIST EN 21563:2000SLOVENSKI
STANDARD
INTERNATIONAL STANDARD 1563 Second edition 1990-09-01 Dental alginate impression material Produifs pour empreintes dentaires 3 base d’alginafe Reference number ISO 1563:1990(E) SIST EN 21563:2000

ISO 1563:1990(E) Contents Page Scope . 1 Normative reference . 1 Definitions . 1 Requirements . . 1 Sampling . 2 . . Test methods . 2 Manufacturer’s instructions . 5 Packaging and marking . 5 0 ISO 1990 All rights reserved. No part of this publication may be reproduced or utilized in any form or by any means, electronie or mechanical, including photocopying and microfilm, without Permission in writing from the publisher. International Organization for Standardization Case Postale 56 l CH-121 1 Geneve 20 l Switzerland Printed in Switzerland SIST EN 21563:2000

ISO 1563:1990(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. 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. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an Interna- tional Standard requires approval by at least 75 % of the member bodies casting a vote. International Standard ISO 1563 was prepared by Technical Committee ISO/TC 106, Denfisfry. This second edition cancels and replaces the first edition (ISO 1563:1978), of which it constitutes a technical revision. This revision of ISO 1563 differs from the first edition in the following respects: a) The System of classification into classes A, B and C based on clinical application has been deleted because it has been recognized that class A alginate materials should not be used to obtain models for making fixed restorations and that all class C alginates tan be used for normal impression procedures. As a consequence the “viscosity” requirement has also been deleted. The System of classification into types I and II, based on the Speed of settinq, has also been deleted because it has been recognized that the best‘indication of the Speed of setting is given by the setting time itself. b) The test for setting time given in the first edition of ISO 1563 has been omitted because it proved to be too laborious and because no other test has been introduced due to lack of knowledge about the clinical significance. As a result this revision does not contain a requirement for the setting time as such but requires the manufacturer’s stated setting time to be checked by the requirement on recovery after de- formation. c) The water-bath testing temperature is now defined as 35 “C + 1 “C, the temperature which offers a heating rate of the test specimen comparable to the heating rate of impression material under oral conditions. . . . Ill SIST EN 21563:2000

ISO 1563:1990(E) d) The requirement as to the proportioning devices has been deleted because of the opinion that a moderate deviation in the powder-to- water ratio will not affect clinical results. iv SIST EN 21563:2000

ISO 1563:1990(E) Introduction While it was recognized by the committee that prepared this lnterna- tional Standard that the mixed Paste, when used in accordance with the manufacturer’s instructions, should have no unpleasant odour or fla- vour, the committee was unable to specify any requirements in this re- spect. The material should neither Cause irritation of the normal oral mucosa nor contain poisonous ingredients of sufficient quantity to harm human beings. Specific qualitative and quantitative requirements for freedom from bi- ological hazard are not included in this International Standard, but it is recommended that reference should be made ISO/TR 7405, Biological evaluation of dental maferials, when assessing possible biological or toxicological hazards. SIST EN 21563:2000

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.- -~ - - _.--- --_- INTERNATIONAL STANDARD ISO 1563:1990(E) Dental alginate impression material 1 Scope This International Standard applies to dental alginate impression materials used in dentistry to take impressions of teeth and tissues of the oral cavity. lt specifies requirements for dental materials containing an alginate as essential gel-forming in- gredient, which, after mixing with water in accord- ante with the manufacturer’s instructions, is capable of reacting to form a material suitable for taking impressions. 2 Normative reference The following Standard contains provisions which, through reference in this text, constitute provisions of this International Standard. At the time of publi- cation, the edition indicated was valid. All Standards are subject to revision, and Parties to agreements based on this International Standard are encour- aged to investigate the possibility of applying the most recent edition of the Standard indicated below. Members of IEC and ISO maintain registers of cur- rently valid International Standards. ISO 6873: ‘i 983, Derotal gypsunj products. 4 Requirements 4.1 Powder The powder shall be uniform and free from foreign materials (matter). Compliance with this requirement shall be deter- mined in accordance with 6.2. 4.2 Biocompatibility See the introduction (ps v) for guidance on biocompatibility. 4.3 Mixed material The material, mixed in accordance with the manu- facturer’s instructions, shall be homogeneous and free from lumps and granules and shall have a smooth surface; it shall form a smooth plastic mass. Compliance with this requirement shall be deter- mined in accordance with 6.2. 4.4 Mlixing time The mixing time, stated by the manufacturer, shall not be more than 60 s (1 min). 3 Definitions 4.5 Total working time For the purposes of this International Standard, the following deflnitions apply. 3.1 mixing time: That part of the total working time specified or required in Order to obtain a satisfactory mix. 3.2 total working time: That period of time between the Start of mixing and the commencement of set- ting. 3,3 setting time: That period of time between the Start of mixing and the achievement of the neces- sary elasticity to remove the impression. When determined in accordance with 6.3, the aver- age Penetration value achieved shall not exceed 0,25 mm at the end of the total working time stated by the manufacturer. 4.6 Compatibility with gypsum and reproduction of detail The impression material shall impart a smooth sur- face to, and separate cleanly from, a gypsum cast made from a recommended brand of gypsum prod- uct; this cast poured against the impression shall reproduce the 50 Pm-line [see figure 3a)] without 1 SIST EN 21563:2000

ISO 1563:1990(E) interruption when the test specified in 6.4 is carried out. 4.7 Recovery from deformation When determined in accordance with 6.5, the recov- er-y from deformation shall be at least 95 %. 4.8 Strain in compression When determined in accordance with 6.6, the strain in compression shall be neither less than 5 % nor more than 20 %. 49 . Compressive strength When determined in accordance with 6.7, the compressive strength shall be at least 0,35 MPa. 5 Sampling Representative samples from a Single manufactur- ing batch, including all necessary manufacturer’s instructions and devices, shall be obtained. The amount of material and deionized or distilled water to be obtained shall be sufficient to produce approximately 750 g of impression material to com- plete all the tests. 6 Test methods 6.1 General The alginate powder in the closed original Container and the test equipment (except for the smaller items used for mixing and specimen formation) shall be conditioned for not less than IO h at 23 ‘C + 2 OC and (50 k 10) % relative humidity. The sialler items may be used after 30 min storage in the pre- scribed environment. Unless otherwise stated, all tests shall be carried out under these conditions. Distilled or deionized mixing water shall be used at the temperature as stated by the manufacturer or otherwise at 23 “C + 1 “C. - The proportions of powder and water shall be in ac- cordante with the manufacturer’s instructions and shall be achieved by weighing the components. The specimen shall be prepared by mixing the alginate powder with water using the ratio and the method of mixing specified in the manufacturer’s instructions. 6.2 Visual inspection Compliance with the requirements laid down in 4.1, 4.3, clause 7 and, as far as applicable, clause 8 shall be determined by visual inspection. 6.3 Total working time 6.3.1 Apparatus 6.3.1.1 Penetrometer, equipped with a cylindrical penetrator @ and a dial indicator Q, graduated in 0,Ol mm intervals, with a spindle @ having a travel of at least 25 mm (see figure 1). The penetrator shall have a total mass of 50 g + 1 g and shall be positioned with its longi- tudinal axis perpendicular to the base of the instru- ment. The penetrometer shall have a mechanical or magnetic locking device @ so that the penetrator tan be fixed in any vertical Position. 6.3.1.2 Rigid ring mould, made of brass or stainless steel, at the discretion of the manufacturer (see fig- ure 2). NOTE 1 If brass is used, the internal surface of the ring should be covered with a thin film of a non-reactive grease. 6.3.1.3 Smooth flat glass plate, large enough to support the ring mould (6.3.1.2). 6.3.2 Procedure Place the glass plate (6.3.1.3) on the base of the penetrometer (6.3.1.1). Allow the penetrator to come into contact with the plate, take a fiducial reading (reading a) and then raise and fix the penetrator so that the tip is well above the upper end of the ring mould (6.3.1.2). Place the ring mould on the plate centrally under the penetrator and fill it with mixed material. Level the upper surface. Place the penetrator in contact with the upper surface of the material and fix it in that Position. Five seconds (5 s) before the end of the total working time stated by the manufacturer, release the penetrator, with the spindle @ held in the “up” Position. Ten sec- onds (IO s) after release, fix the penetrator in the released (lowered) Position. The lower the spindle until contact is made and take a second reading (reading h). 6.3.3 Expression of results Calcu late the differente between readings a and h in mil limetres. Record the average of three tests as the result. 2 SIST EN 21563:2000

ISO 1563:1990(E) 6.4 Compatibility with gypsum and reproduction of detail 6.4.1 Apparatus 6.4.1.1 Ruled test block, made of cast or wrought austenitic stainless steel [see figure 3a)]. 6.4.1.2 Ring mould [figure 3b)]. 6.4.1.3 Split mould, such that gypsum cast tan he removed without darnage [see figure 3c)]. 6.4.1.4 Smooth flat metal or glass plate, large enough to be a base for the ring mould (6.4.1.2). 6.4.1.5 Mass, 1 kg. 6.4.1.6 Water bath, capable of being maintained at 35 OC + 1 OC. -. 6.4.2 Procedure Place the ring mould (6.4.1.2) on the plate (6.4.1-4) and slightly overfili with mixed alginate material. Twenty seconds (20 s) before the end of the working time stated by the manufacturer, centre the clean test block (6.4.1.1) above the mould and press it down into the mass of alginate. Immediately place the assembly in the water bath (6.4.1.6), maintained at 35 OC + 1 YZ, and load with the 1 kg mass (6.4.1.5) conditioned at 35 OC + 1 OC. Three minutes (3 min) after the stated settinctime, remove the as- sembly from the water bath and separate the ring mould, toqether with the plate, from the test block. L Immediately prepare a gypsum mix, using a gypsum brand type 3 or 4 in accordance with ISO 6873, as recommended by the manufacturer [see (clause 7i)]. Rinse the alginate surface with water, or treat in any other way described in the manufac- turer’s instructions (e.g. with fixative Solution), and Shake off the excess fluid. Place the Split mould (6.4.1.3) on the ring mould and gently fill with the gypsum product mix, using mechanical Vibration in such a way that the gypsum product displaces any moisture adhering to the surface of the alginate. Al- low the gypsum product mix to harden for 30 min in excess of the setting time. Separate the Split mould containing the gypsum cast from the ring mould containing the alginate. 6.4.3 Test Observation Examine the gypsum cast under low-angle illumi- nation, at a magnification of x4 to ~12, and record whether the 50 Pm-line [line a in figure 3a)] is com- pletely reproduced over the full length of 25 mm be- tween the intersection lines. NOTES 2 lf the alginate impression material tends to stick to the surface of the ruled test block, it is recommended that this surface be painted immediately before the alginate is rnixed with a suitable separating agent- 3 To check that the gypsum product has not deteri- orated, it is recommended that the setting time be deter- mined in accordance with ISO 6873; the setting time should be within + 20 O/o of the time stated by the manu- facturer. 6.4.4 Expression of results Record whether the 50 Pm-line [line a in figure 3a)] is fully reproduced by at least two casts, resulting from three tests. 6.5 Recovery from deformation 6.5.1 Apparatus 6.5.1.1 Deformation apparatus, with sufficient forte to deform the specimen height by 20 % and capable of measuring the height with an accuracy of 0,Ol mm, without the specimen being displaced (see figure 4). The forte exerted by the spindle of the dial indicator shall be 0,6 N + 0,l N. - The material of the apparatus in figure4 shall be cast or wr
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