SIST EN ISO 10139-2:2009
(Main)Dentistry - Soft lining materials for removable dentures - Part 2: Materials for long-term use (ISO 10139-2:2009)
Dentistry - Soft lining materials for removable dentures - Part 2: Materials for long-term use (ISO 10139-2:2009)
This part of ISO 10139 specifies requirements for softness, adhesion, water sorption, and water solubility as well as for packaging, marking and manufacturer's instructions for soft denture lining materials suitable for long-term use. These materials may also be used for maxilliofacial prostheses.
Zahnheilkunde - Weiche Unterfütterungswerkstoffe für Prothesen - Teil 2: Werkstoffe für Langzeitanwendungen (ISO 10139-2:2009)
Dieser Teil von ISO 10139 enthält Anforderungen an die Weichheit, Haftfestigkeit, Wasseraufnahme und Wasserlöslichkeit ebenso wie an die Verpackung, Kennzeichnung und Gebrauchsanweisung für weiche Unterfütterungswerkstoffe, die für Langzeitanwendungen vorgesehen sind. Diese Werkstoffen können auch für maxillofaziale Prothesen verwendet werden.
Art dentaire - Produits souples pour intrados de prothèses dentaires amovibles - Partie 2: Produits pour utilisation de longue durée (ISO 10139-2:2009)
L'ISO 10139-2:2009 spécifie les exigences afférentes à la souplesse, à l'adhésion, à la sorption d'eau et à la solubilité dans l'eau des produits souples pour intrados de prothèses dentaires adaptés à un usage à long terme. Elle traite également des exigences relatives à leur conditionnement, à leur marquage et à leur mode d'emploi. Ces produits peuvent également être utilisés pour les prothèses maxillo-faciales.
Zobozdravstvo - Mehki materiali za prevleko snemnih zobnih protez - 2. del: Materiali za dolgoročno uporabo (ISO 10139-2:2009)
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Zahnheilkunde - Weiche Unterfütterungswerkstoffe für Prothesen - Teil 2: Werkstoffe für Langzeitanwendungen (ISO 10139-2:2009)Art dentaire - Produits souples pour intrados de prothèses dentaires amovibles - Partie 2: Produits pour utilisation de longue durée (ISO 10139-2:2009)Dentistry - Soft lining materials for removable dentures - Part 2: Materials for long-term use (ISO 10139-2:2009)11.060.10Dental materialsICS:Ta slovenski standard je istoveten z:EN ISO 10139-2:2009SIST EN ISO 10139-2:2009en01-oktober-2009SIST EN ISO 10139-2:2009SLOVENSKI
STANDARDSIST EN ISO 10139-2:20021DGRPHãþD
SIST EN ISO 10139-2:2009
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 10139-2August 2009ICS 11.060.10Supersedes EN ISO 10139-2:2001
English VersionDentistry - Soft lining materials for removable dentures - Part 2:Materials for long-term use (ISO 10139-2:2009)Art dentaire - Produits souples pour intrados de prothèsesdentaires amovibles - Partie 2: Produits pour usage à longterme (ISO 10139-2:2009)Zahnheilkunde - Weichbleibende Unterfütterungswerkstoffefür Prothesen - Teil 2: Werkstoffe für dieLangzeitanwendung (ISO 10139-2:2009)This European Standard was approved by CEN on 31 July 2009.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN 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 translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre:
Avenue Marnix 17,
B-1000 Brussels© 2009 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 10139-2:2009: ESIST EN ISO 10139-2:2009
EN ISO 10139-2:2009 (E) 2 Contents Page Foreword .3 SIST EN ISO 10139-2:2009
EN ISO 10139-2:2009 (E) 3 Foreword This document (EN ISO 10139-2:2009) has been prepared by Technical Committee ISO/TC 106 "Dentistry" in collaboration with by 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 February 2010, and conflicting national standards shall be withdrawn at the latest by February 2010. 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. This document supersedes EN ISO 10139-2:2001. 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, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 10139-2:2009 has been approved by CEN as a EN ISO 10139-2:2009 without any modification.
SIST EN ISO 10139-2:2009
SIST EN ISO 10139-2:2009
Reference numberISO 10139-2:2009(E)© ISO 2009
INTERNATIONAL STANDARD ISO10139-2Second edition2009-08-01Dentistry — Soft lining materials for removable dentures — Part 2: Materials for long-term use Art dentaire — Produits souples pour intrados de prothèses dentaires amovibles —
Partie 2: Produits pour usage à long terme
SIST EN ISO 10139-2:2009
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SIST EN ISO 10139-2:2009
ISO 10139-2:2009(E) © ISO 2009 – All rights reserved iiiContents Page Foreword.iv Introduction.v 1 Scope.1 2 Normative references.1 3 Terms and definitions.1 4 Classification.2 5 Requirements.2 5.1 Shore A hardness, 24 h.2 5.2 Shore A hardness, 28 d.2 5.3 Bond strength.2 5.4 Sorption.2 5.5 Solubility.2 6 Sampling.3 7 Test methods.3 7.1 Test conditions.3 7.2 Shore A hardness.3 7.3 Bond strength.4 7.4 Water sorption and solubility.6 8 Requirements for packaging, marking and instructions supplied by manufacturer.9 8.1 Packaging.9 8.2 Marking.10 8.3 Manufacturer’s instructions for use.10 Bibliography.12
SIST EN ISO 10139-2:2009
ISO 10139-2:2009(E) iv © ISO 2009 – All rights reserved 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. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. 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. ISO 10139-2 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 2, Prosthodontic materials. This second edition cancels and replaces the first edition (ISO 10139-2:1999) which has been technically revised. ISO 10139 consists of the following parts, under the general title Dentistry — Soft lining materials for removable dentures: ⎯ Part 1: Materials for short-term use ⎯ Part 2: Materials for long-term use SIST EN ISO 10139-2:2009
ISO 10139-2:2009(E) © ISO 2009 – All rights reserved vIntroduction Denture lining materials for long-term use are classified in this part of ISO 10139 according to their softness. Although it is not claimed that any particular level of softness is superior to another, this classification is intended to assist clinicians because clinicians will have more information with which to make an informed choice. In this second edition of this part of ISO 10139, additional requirements for bond strength to denture base are added, as well as requirements for water sorption and solubility. A new test for the determination of the softness of the lining materials, the Shore A hardness test, has been introduced. This test cancels and replaces the penetration test of the first edition of this part of ISO 10139. Specific qualitative and quantitative requirements for freedom from biological hazard are not included in this part of ISO 10139. Information relevant to assessing possible biological or toxicological hazards is given in ISO 7405 and ISO 10993-1.
SIST EN ISO 10139-2:2009
SIST EN ISO 10139-2:2009
INTERNATIONAL STANDARD ISO 10139-2:2009(E) © ISO 2009 – All rights reserved 1Dentistry — Soft lining materials for removable dentures — Part 2: Materials for long-term use 1 Scope This part of ISO 10139 specifies requirements for softness, adhesion, water sorption and water solubility as well as for packaging, marking and manufacturer's instructions for soft denture lining materials suitable for long-term use. These materials may also be used for maxillofacial prostheses. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 1942, Dentistry — Vocabulary ISO 3696, Water for analytical laboratory use — Specification and test methods ISO 6344-1, Coated abrasives — Grain size analysis — Part 1: Grain size distribution test ISO 7619-1, Rubber, vulcanized or thermoplastic — Determination of indentation hardness — Part 1: Durometer method (Shore hardness) ISO 8601, Data elements and interchange formats — Information exchange — Representation of dates and times ISO 20795-1, Dentistry — Base polymers — Part 1: Denture base polymers 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply. 3.1 soft denture lining material soft resilient material bonded to the fitting surface of a denture to reduce trauma to the supporting tissues 3.2 long-term use use for a period of more than 28 d 3.3 immediate container container that is in direct contact with the material SIST EN ISO 10139-2:2009
ISO 10139-2:2009(E) 2 © ISO 2009 – All rights reserved 4 Classification Soft lining materials for long-term use are classified into the following types according to Shore A hardness of 24 h specimens (see 5.1) as determined in accordance with 7.2. ⎯ Type A: soft; ⎯ Type B: extra soft. 5 Requirements 5.1 Shore A hardness, 24 h When 24 h test specimens are subjected to a 5 s Shore A hardness test in accordance with 7.2.3.2, the material shall conform to the requirements for the relevant type as shown in Table 1. For a material to be classified as a particular type, the mean Shore A hardness for at least two of the three specimens shall conform to the requirements for that type, as specified in Table 1. If the results for two or more specimens are greater than 50, the material shall be deemed not to conform to this part of ISO 10139. Table 1 — Shore A hardness, 24 h – 5 s Type Shore A (24 h – 5 s) A (soft) 25 < Shore A u 50 B (extra soft) Shore A u 25 5.2 Shore A hardness, 28 d When 28 d test specimens are subjected to a 5 s Shore A hardness test in accordance with 7.2.3.3, the material shall conform to the requirements for the relevant type as shown in Table 2 for at least two of the three specimens. If the results for two or more specimens are greater than 55 for Type A materials, or greater than 35 for Type B materials, the material shall be deemed not to conform to this part of ISO 10139. Table 2 — Shore A hardness, 28 d – 5 s Type Shore A (28 d – 5 s) A (soft) u 55 B (extra soft) u 35 5.3 Bond strength The bond strength of the lining material to denture base shall be at least 1,0 MPa for eight out of ten tested specimens for Type A materials, and at least 0,5 MPa for eight out of ten tested specimens for Type B materials when tested in accordance with 7.3. 5.4 Sorption The increase in mass per volume (water sorption) shall not exceed 20 µg/mm3 for at least four out of five tested specimens when the processed lining material is tested in accordance with 7.4. 5.5 Solubility The loss in mass per volume (water solubility) shall not exceed 3 µg/mm3 for at least four out of five tested specimens when the processed lining material is tested in accordance with 7.4. SIST EN ISO 10139-2:2009
ISO 10139-2:2009(E) © ISO 2009 – All rights reserved 3If the loss in mass per volume (water solubility) does exceed 3 µg/mm3 for at least two out of five tested specimens when the processed lining material is tested in accordance with 7.4, the manufacturer of the material shall state the amount and the nature of the solubles from the materia
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