EN 30139-1:1994
(Main)Dentistry - Resilient lining materials removable dentures - Part 1: Short-term materials (ISO 10139-1:1991)
Dentistry - Resilient lining materials removable dentures - Part 1: Short-term materials (ISO 10139-1:1991)
Zahnheilkunde - Weichbleibende Unterfütterungswerkstoffe für Prothesen - Teil 1: Werkstoffe für kurzzeitige Anwendung (ISO 10139-1:1991)
Dieser Teil von ISO 10139 enthält die Anforderungen an die physikalischen Eigenschaften, die Prüfverfahren, Vorschriften über Verpackung und Kennzeichnung sowie die Gebrauchsanleitung des Herstellers über temporäre Unterfütterungswerkstoffe in der Zahnheilkunde.
Produits et matériel pour l'art dentaire - Produits souples pour intrados de prothèses dentaires amovibles - Partie 1: Produits à court terme (ISO 10139-1:1991)
Dentistry - Resilient lining materials removable dentures - Part 1: Short-term materials (ISO 10139-1:1991)
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Dentistry - Resilient lining materials removable dentures - Part 1: Short-term materials (ISO 10139-1:1991)Zahnheilkunde - Weichbleibende Unterfütterungswerkstoffe für Prothesen - Teil 1: Werkstoffe für kurzzeitige Anwendung (ISO 10139-1:1991)Produits et matériel pour l'art dentaire - Produits souples pour intrados de protheses dentaires amovibles - Partie 1: Produits a court terme (ISO 10139-1:1991)Dentistry - Resilient lining materials removable dentures - Part 1: Short-term materials (ISO 10139-1:1991)11.060.10Dental materialsICS:Ta slovenski standard je istoveten z:EN 30139-1:1994SIST EN 30139-1:2000en01-januar-2000SIST EN 30139-1:2000SLOVENSKI
STANDARD
SIST EN 30139-1:2000
SIST EN 30139-1:2000
SIST EN 30139-1:2000
SIST EN 30139-1:2000
SIST EN 30139-1:2000
INTERNATIONAL STANDARD First edition 1991-12-01 Dentistry - Resilient lining materials for removable dentures - Part 1: Short-term materials Produits et matWe/ pour /‘art dentaire - Produits soup/es pour intrados de prothbes dentaires amovibles - Partie I: Prod&s 3 court terme Reference number IS0 10139-1:1991(E) SIST EN 30139-1:2000
IS0 10139-1:1991(E) Foreword IS0 (the International Organization for Standardization) is a worldwide federation of national standards bodies (IS0 member bodies). The work of preparing International Standards is normally carried out through IS0 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, govern- mental and non-governmental, in liaison with ISO, also take part in the work. IS0 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 lnter- national Standard requires approval by at least 75 % of the member bodies casting a vote. International Standard IS0 10139-I was prepared by Technical Com- mittee ISO/TC 106, Dentistry, Sub-Committee SC 2, Prosthodontic ma- terials. IS0 10139 consists of the following parts, under the general title Dentistry - Resilient lining materials for removable dentures: - Part 1: Short-term materials - Part 2: Long-term materials 0 IS0 1991 All rights reserved. No part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from the publisher. International Organization for Standardization Case Postale 56 * CH-1211 Geneve 20 l Switzerland Printed in Switzerland ii SIST EN 30139-1:2000
IS0 10139-1:1991(E) Introduction 0.1 This part of IS0 10139 applies to denture lining materials com- monly referred to as “tissue conditioners” and temporary lining ma- terials. These materials are intended to be inserted into a denture at the chairside, to be used for a limited period or “short-term” of approxi- mately seven days with the aim of assisting the tissues in contact with the prosthesis to return to a healthy condition, or to improve the fit of a denture for several weeks. 0.2 Specific qualitative and quantitative requirements for freedom from biological hazard are not included in this International Standard, but it is recommended that, in assessing possible biological or toxicological hazards, reference should be made to lSO/TR 74051984, Biological evaluation of dental materials. 0.3 Although this International Standard does not specify requirements for the composition of the lining materials, some national and inter- national authorities do require details of composition to be provided by the manufacturer. . . . III SIST EN 30139-1:2000
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INTERNATIONAL STANDARD IS0 10139=1:1991(E) Dentistry - Resilient lining materials for removable dentures - Part 1: Short-term materials 1 Scope This part of IS0 10139 specifies requirements for the physical properties, test methods, packaging, mark- ing and manufacturer’s instructions for denture lin- ing materials suitable for short-term use. 3.1.2 The consistency measured shall be within + 15 % of the value stated by the manufacturer bee clause 89-J and shall not exceed limits stated in 3.1.1. 3.2 Penetration (behaviour in water) 2 Normative references The following standards contain provisions which, through reference in this text, constitute provisions of this part of IS0 10139. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this part of IS0 10139 are encouraged to investi- gate the possibility of applying the most recent edi- tions of the standards indicated below. Members of IEC and IS0 maintain registers of currently valid International Standards. IS0 1563: 1990, Dental alginate impression material. IS0 4823: 19911), Dental elastomeric impression ma- terials. 3.2.1 When tested according to 5.2, the material shall satisfy the following requirements: a) the 2 h penetration shall be not greater than I,8 mm; b) the seven-day penetration shall be not less than 0,18 mm; c) the ratio n/II shall be not greater than 5. 3.2.2 When tested according to 5.2, the value ob- tained for the penetration ratio (ratio A/II) shall not vary from the value stated by the manufacturer [see clause Sg)] by more than 0,5 and shall not ex- ceed the limit stated in 3.2.1. 3 Requirements 3.1 Consistency 4 Sampling 3.1.1 When determined according to 5.1, the con- sistency shall be between 25 mm and 75 mm. The higher the consistency the greater the initial flow. The test sample shall consist of a retail package, or packages, from the same batch. 1) To be published. SIST EN 30139-1:2000
IS0 10139=1:1991(E) 5 Test methods 5.1 Consistency test 5.1 .I Apparatus a) Delivery tube or syringe of a suitable material, for example, glass or polytetrafluoroethylene (PTFE), having an internal diameter between 10 mm and 15 mm and capable of dispensing a volume in excess of the sample size (i.e. in excess of 2 ml + 0,l ml). - b) Two glass plates, one of which (the “upper” plate) has a mass of 100 g + 1 g and a thickness - of not less than 2 mm. NOTE 1 This “upper” plate is referred to in the pro- cedure as the minor load. c) A weight of 1 000 g +.5 g. NOTE 2 This is referred to in the procedure as the major load. d) Equipment for applying loads vertically as shown in figure 1. e) Equipment capable of maintaining the test ap- paratus in an environment of (37 + 1) @C. - 5.1.2 Conditioning Allow all test apparatus to reach equilibrium in the environment of (37 + 1) OC for at least 30 min before testing. Loading device .------+, Figure 1 - Apparatus for determining consistency SIST EN 30139-1:2000
IS0 10139-1:1991(E) 5.1.3 Procedure Prepare a sample using the manufacturer’s rec- ommended technique. Where a range of mixing times is given, use the mean time. Use the syringe [5.1.la)] to dispense a sample of 2 ml + 0,l ml onto - one of the glass plates [5.l.lb)]. 30 s + 1 s after the end of mixing, compress the sample between the two glass plates by vertically ap
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