EN ISO 22112:2006
(Main)Dentistry - Artificial teeth for dental prostheses (ISO 22112:2005)
Dentistry - Artificial teeth for dental prostheses (ISO 22112:2005)
ISO 22112:2005 specifies the classification, requirements, and test methods for synthetic polymer and ceramic teeth that are manufactured for use in prostheses used in dentistry.
Zahnheilkunde - Künstliche Zähne für Dentalprothesen (ISO 22112:2005)
Diese Internationale Norm legt eine Einteilung, Anforderungen und Prüfverfahren für synthetische Kunststoff- und Keramikzähne fest, die für Prothesen in der Zahnheilkunde hergestellt werden.
Art dentaire - Dents artificielles pour prothèses dentaires (ISO 22112:2005)
L'ISO 22112:2005 spécifie la classification, les exigences et les méthodes d'essai relatives aux dents en polymères synthétiques et aux dents en céramique fabriquées pour être utilisées dans l'art dentaire.
Zobozdravstvo - Umetni zobje za zobne proteze (ISO 22112:2005)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2006
1DGRPHãþD
SIST EN ISO 3336:2000
SIST EN ISO 4824:2000
SIST EN ISO 4824:2000/A1:2006
Zobozdravstvo - Umetni zobje za zobne proteze (ISO 22112:2005)
Dentistry - Artificial teeth for dental prostheses (ISO 22112:2005)
Zahnheilkunde - Künstliche Zähne für Dentalprothesen (ISO 22112:2005)
Art dentaire - Dents artificielles pour protheses dentaires (ISO 22112:2005)
Ta slovenski standard je istoveten z: EN ISO 22112:2006
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 22112
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2006
ICS 11.060.10 Supersedes EN ISO 3336:1996, EN ISO 4824:1996
English Version
Dentistry - Artificial teeth for dental prostheses (ISO
22112:2005)
Art dentaire - Dents artificielles pour prothèses dentaires Zahnheilkunde - Künstliche Zähne für Dentalprothesen
(ISO 22112:2005) (ISO 22112:2005)
This European Standard was approved by CEN on 6 February 2006.
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, Romania,
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
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 22112:2006: E
worldwide for CEN national Members.
Foreword
The text of ISO 22112:2005 has been prepared by Technical Committee ISO/TC 106
"Dentistry” of the International Organization for Standardization (ISO) and has been taken
over as EN ISO 22112:2006 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 September 2006, and conflicting
national standards shall be withdrawn at the latest by September 2006.
This document replaces EN 3336:1996 and EN 4824:1996.
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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Endorsement notice
The text of ISO 22112:2005 has been approved by CEN as EN ISO 22112:2006 without any
modifications.
INTERNATIONAL ISO
STANDARD 22112
First edition
2005-11-01
Dentistry — Artificial teeth for dental
prostheses
Art dentaire — Dents artificielles pour prothèses dentaires
Reference number
ISO 22112:2005(E)
©
ISO 2005
ISO 22112:2005(E)
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ii © ISO 2005 – All rights reserved
ISO 22112:2005(E)
Contents Page
Foreword. iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 1
4 Classification. 2
5 Requirements . 2
5.1 General. 2
5.2 Ceramic teeth . 3
5.3 Synthetic polymer teeth . 3
6 Sampling. 3
7 Inspection and test methods . 4
7.1 Visual inspection . 4
7.2 Dimensions of teeth. 4
7.3 Comparison with shade guide. 4
7.4 Surface finish of ceramic teeth . 5
7.5 Surface finish of synthetic polymer teeth . 5
7.6 Porosity of ceramic teeth. 6
7.7 Porosity of synthetic polymer teeth and other defects . 7
7.8 Radioactivity of ceramic teeth. 9
7.9 Anchorage of ceramic teeth to denture base polymers . 9
7.10 Resistance of ceramic teeth to thermal shock . 9
7.11 Quality of bonding of synthetic polymer teeth to denture-base polymers. 10
7.12 Resistance to blanching, distortion and crazing of synthetic polymer teeth. 12
7.13 Colour stability of synthetic polymer teeth. 13
7.14 Dimensional stability of synthetic polymer teeth. 13
8 Marking, labelling, packaging, and information to be supplied by the manufacturer. 14
8.1 Marking, labelling and packaging . 14
8.2 Information to be supplied by manufacturer . 14
8.3 Manufacturer’s instructions . 15
Bibliography . 16
ISO 22112:2005(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 22112 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 2, Prosthodontic
materials.
This first edition cancels and replaces ISO 3336:1993, ISO 4824:1993 and ISO 4824:1993/Amd. 1:1997 which
have been technically revised.
iv © ISO 2005 – All rights reserved
INTERNATIONAL STANDARD ISO 22112:2005(E)
Dentistry — Artificial teeth for dental prostheses
1 Scope
This International Standard specifies the classification, requirements, and test methods for synthetic polymer
and ceramic teeth that are manufactured for use in prostheses used in dentistry.
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.
1)
ISO 483 , Plastics — Small enclosures for conditioning and testing using aqueous solutions to maintain the
humidity at a constant value
ISO 1567:1999, Dentistry — Denture base polymers
2)
ISO 1942 , Dentistry — Vocabulary
ISO 3950:1984, Dentistry — Designation system for teeth and areas of the oral cavity
ISO 6873:1998, Dental gypsum products
ISO 7491:2000, Dental materials — Determination of colour stability
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.
3.1
diatoric teeth
teeth designed to be retained by anchorage slots and/or holes
3.2
pin teeth
teeth designed to be retained by headed pins
3.3
set
set of six anterior teeth or eight posterior teeth, as received from the manufacturer
1) To be published. (Revision of ISO 483:1988)
2) To be published. [Revision of ISO 1942 (all parts):1989]
ISO 22112:2005(E)
3.4
half-set
three teeth on one side of a set of anterior teeth or four teeth on one side of a set of posterior teeth
3.5
mould chart
chart representing the form, shape and dimensions of all individual teeth of a set
4 Classification
Artificial teeth are grouped in accordance with the following classification:
a) Type 1: anterior teeth;
b) Type 2: posterior teeth.
5 Requirements
5.1 General
5.1.1 Biocompatibility
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 be made to ISO 10993-1 and ISO 7405.
5.1.2 Dimensions of teeth
The dimensions of the teeth when examined in accordance with 7.2 shall not differ by more than 5 % for
synthetic polymer teeth and 7 % for ceramic teeth from the values shown in the manufacturer’s mould chart.
5.1.3 Colour and blending of shades
When tested in accordance with 7.3, sets of anterior and posterior teeth shall exhibit no perceptible colour
difference compared with the manufacturer’s shade guide (8.2.2) or nominated shade guide. Blended teeth
shall show no line of demarcation between incisal and cervical portions on the facial aspects of the teeth.
NOTE This requirement is not intended to disallow especially designed demarcations placed to simulate borders of
restorations or enamel imperfections found in natural teeth.
5.1.4 Surface finish
When inspected visually in accordance with 7.1, the teeth as received (excluding retention areas) shall have a
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