EN ISO 10477:2004
(Main)Dentistry - Polymer-based crown and bridge materials (ISO 10477:2004)
Dentistry - Polymer-based crown and bridge materials (ISO 10477:2004)
ISO 10477:2004 classifies polymer-based dental crown and bridge materials and specifies their requirements. It also specifies the test methods to be used to determine compliance with these requirements.
ISO 10477:2004 is applicable to polymer-based dental crown and bridge materials for laboratory-fabricated permanent facings or anterior crowns that may or may not be attached to a metal substructure. It also applies to polymer-based dental crown and bridge materials for which the manufacturer claims adhesion to the metal substructure without macromechanical retention such as beads or wires.
ISO 10477:2004 is not applicable to polymer-based materials that are used to make crowns, veneers or repairs in the operatory, nor does it cover the application of those materials to stress-bearing areas of posterior teeth.
Zahnheilkunde - Kronen- und Brückenkunststoffe (ISO 10477:2004)
In dieser Internationalen Norm werden zahnärztliche Kronen und Brückenkunststoffe in Typen eingeteilt und die Anforderungen festgelegt. Außerdem beschreibt sie die Prüfverfahren, die verwendet werden, um die Übereinstimmung mit diesen Anforderungen zu ermitteln.
Diese Internationale Norm gilt für zahnärztliche Kronen und Brückenkunststoffe, die im zahntechnischen Labor für definitive Verblendungen oder Frontzahnkronen hergestellt werden, und die wahlweise mit oder ohne Metallgerüst verwendet werden. Sie gilt auch für zahnärztliche Kronen und Brückenkunststoffe, für die der Hersteller eine Haftung an dem Metallgerüst ohne makromechanische Retention wie Perlen oder Drähte beansprucht.
Diese Internationale Norm gilt nicht für Kunststoffe, die während der Behandlung in der Zahnarztpraxis für die Herstellung von Kronen oder Verblendungen oder die für Reparaturen verwendet werden. Ebenso gilt sie nicht für Kunststoffe, die Kaukräften im Seitenzahnbereich ausgesetzt sind.
Art dentaire - Produits à base de polymères pour couronnes et ponts (ISO 10477:2004)
L'ISO 10477:2004 établit une classification des produits à base de polymères pour couronnes et ponts, et spécifie les exigences qui leur sont applicables. Elle spécifie également les méthodes d'essai à utiliser en vue de la détermination de leur conformité à ces exigences.
L'ISO 10477:2004 est applicable aux produits à base de polymères pour couronnes et ponts pour facettes permanentes ou couronnes antérieures fabriquées en laboratoire, susceptibles ou non d'être fixées à une infrastructure métallique. Elle s'applique également aux produits à base de polymères pour couronnes et ponts pour lesquels le fabricant revendique une adhérence à l'infrastructure métallique sans rétention macromécanique, telle que les billes ou les fils.
L'ISO 10477:2004 n'est pas applicable aux produits à base de polymères utilisés pour fabriquer des couronnes, des facettes ou en vue des réparations au cabinet. Elle ne traite pas non plus des produits destinés à être appliqués aux zones des dents postérieures soumises à des contraintes de compression.
Zobozdravstvo – Polimerni materiali za prevleke in mostičke (ISO 10477:2004)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-marec-2005
1DGRPHãþD
SIST EN ISO 10477:2000
SIST EN ISO 10477:2000/A1:2000
=RER]GUDYVWYR±3ROLPHUQLPDWHULDOL]DSUHYOHNHLQPRVWLþNH ,62
Dentistry - Polymer-based crown and bridge materials (ISO 10477:2004)
Zahnheilkunde - Kronen- und Brückenkunststoffe (ISO 10477:2004)
Art dentaire - Produits a base de polymeres pour couronnes et ponts (ISO 10477:2004)
Ta slovenski standard je istoveten z: EN ISO 10477:2004
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 10477
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2004
ICS 11.060.10 Supersedes EN ISO 10477:1996
English version
Dentistry - Polymer-based crown and bridge materials (ISO
10477:2004)
Art dentaire - Produits à base de polymères pour Zahnheilkunde - Kronen- und Brückenkunststoffe (ISO
couronnes et ponts (ISO 10477:2004) 10477:2004)
This European Standard was approved by CEN on 10 September 2004.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2004 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10477:2004: E
worldwide for CEN national Members.
Foreword
This document (EN ISO 10477:2004) 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 April 2005, and conflicting national
standards shall be withdrawn at the latest by April 2005.
This document supersedes EN ISO 10477:1996.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Endorsement notice
The text of ISO 10477:2004 has been approved by CEN as EN ISO 10477:2004 without any
modifications.
INTERNATIONAL ISO
STANDARD 10477
Second edition
2004-10-01
Dentistry — Polymer-based crown and
bridge materials
Art dentaire — Produits à base de polymères pour couronnes et ponts
Reference number
ISO 10477:2004(E)
©
ISO 2004
ISO 10477:2004(E)
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ii © ISO 2004 – All rights reserved
ISO 10477:2004(E)
Contents 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 Biocompatibility . 2
5.2 Sensitivity to ambient light, Type 2, Class 2 polymer-based crown and bridge materials . 2
5.3 Depth of cure, Type 2, Class 2 polymer-based crown and bridge materials . 3
5.4 Surface finish . 3
5.5 Flexural strength . 3
5.6 Bond strength. 4
5.7 Water sorption. 4
5.8 Solubility . 4
5.9 Shade consistency. 4
5.10 Colour stability . 4
6 Sampling . 4
6.1 For all tests . 4
6.2 For test of shade consistency . 4
6.3 For test of colour stability. 5
7 Test methods. 5
7.1 General. 5
7.2 Visual inspection. 5
7.3 Sensitivity to ambient light, Type 2, Class 2 polymer-based crown and bridge materials . 5
7.4 Depth of cure, Type 2, Class 2 polymer-based crown and bridge materials . 7
7.5 Surface finish . 7
7.6 Flexural strength . 8
7.7 Bond strength. 11
7.8 Water sorption and solubility . 13
7.9 Shade consistency and colour stability . 16
8 Packaging and labelling . 17
8.2 Labelling. 18
9 Manufacturer's instructions and information for the user. 19
9.1 Instructions for use. 19
9.2 Shade guide. 20
Bibliography . 21
ISO 10477:2004(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.
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 10477 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 2, Prosthodontic
materials.
This second edition cancels and replaces the first edition (ISO 10477:1992), which has been technically
revised. It also incorporates the amendment ISO 10477:1992/Amd.1:1998.
The following changes were made:
a) addition of a bonding test;
b) addition of a table for the test protocol and two tables of results.
iv © ISO 2004 – All rights reserved
ISO 10477:2004(E)
Introduction
Specific qualitative and quantitative requirements for freedom from biological hazards are not included in this
International Standard. Assessment of possible biological hazards is covered in ISO 10993-1 and ISO 7405.
INTERNATIONAL STANDARD ISO 10477:2004(E)
Dentistry — Polymer-based crown and bridge materials
1 Scope
This International Standard classifies polymer-based dental crown and bridge materials and specifies their
requirements. It also specifies the test methods to be used to determine compliance with these requirements.
This International Standard is applicable to polymer-based dental crown and bridge materials for laboratory-
fabricated permanent facings or anterior crowns that may or may not be attached to a metal substructure. It
also applies to polymer-based dental crown and bridge materials for which the manufacturer claims adhesion
to the metal substructure without macromechanical retention such as beads or wires.
This International Standard is not applicable to polymer-based materials that are used to make crowns,
veneers or repairs in the operatory, nor does it cover the application of those materials to stress-bearing areas
of posterior teeth.
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
...
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