SIST 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 protheses 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
SIST EN ISO 22112:2006
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
SIST EN ISO 22112:2006 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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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.
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EN ISO 22112:2006 (E)
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.
2
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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
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ISO 22112:2005(E)
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ii © ISO 2005 – All rights reserved
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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 2005 – All rights reserved iii
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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
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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]
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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
smooth, lustrous, non-porous surface.
When ceramic teeth are tested in accordance with 7.4, the processing shall not have impaired the original
finish of the teeth, and the teeth shall be capable of being ground and polished.
When synthetic polymer teeth are tested in accordance with 7.5, the teeth shall be capable of being polished
to restore the original finish.
5.1.5 Freedom from porosity and other defects
Ceramic teeth shall not show more than a total of 16 pores of diameter greater than 30 µm on the four test
surfaces when tested in accordance with 7.6. No more than six of those pores shall have diameters ranging
from W 40 µm and u 150 µm. There shall be no pores of diameter greater than 150 µm.
2 © ISO 2005 – All rights reserved
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ISO 22112:2005(E)
Synthetic polymer teeth, when examined in accordance with 7.7, shall exhibit no porosity or defect, such as
rough trimming, rough finish or visible impurities, on the coronal surfaces.
5.2 Ceramic teeth
5.2.1 Radioactivity
When tested in accordance with 7.8, ceramic teeth shall have an activity concentration of no more than
–1
1,0 Bq⋅g of uranium–238.
5.2.2 Anchorage
All ceramic diatoric teeth, examined in accordance with 7.9, shall provide a means of positive retention and
have holes all of which shall be open and unsealed.
5.2.3 Resistance to thermal shock
Ceramic teeth shall, when tested in accordance with 7.10, show no signs of cracking.
5.3 Synthetic polymer teeth
5.3.1 Bonding to denture base polymers
All synthetic polymer teeth shall be capable of being bonded to heat-polymerized denture-base materials
(Type 1), which conform to ISO 1567:1999. For five out of the six test specimens, the bond formed between
the ridge lap portion of the teeth and the denture base polymer shall pass the test described in 7.11.
5.3.2 Resistance to blanching, distortion and crazing
When tested in accordance with 7.12, no teeth shall exhibit blanching or distortion. No teeth shall exhibit
crazing with the exception of the ridge lap surfaces and the cervical portion of the teeth up to the cervical line.
5.3.3 Colour stability
When tested in accordance with 7.13, there shall be no perceptible colour change between the exposed and
unexposed halves of the tooth and the unexposed tooth.
5.3.4 Dimensional stability
When tested in accordance with 7.14, the dimensional change of a tooth shall be within ± 2 % of its original
mesio-distal dimension.
6 Sampling
The sample shall consist of six groups, each comprising sets of mandibular and maxillary anterior and
posterior teeth (if available).
For comparisons with the manufacturer's shade guide, all available shades of anterior teeth and five shades of
available posterior teeth shades shall be included.
Five mould sizes shall be included covering the range of mould sizes shown by the manufacturer’s mould
chart. The teeth shall be representative of the physical dimensions of the brand and type.
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ISO 22112:2005(E)
7 Inspection and test methods
7.1 Visual inspection
Visually examine without magnification all the teeth in each set for compliance with the requirements given in
5.1.3 and 5.1.4.
7.2 Dimensions of teeth
7.2.1 Apparatus
7.2.1.1 Micrometer, accurate to ± 0,01 mm and fitted with parallel steel face pieces.
7.2.2 Procedure
Measure the maximum mesio-distal dimension of each upper (l , l ) and lower (l , l ) set of teeth (see
1 5 3 7
Clause 6) in the in-line plane for conformity to the mould chart dimensions (see 5.1.2). Measure the maximum
mesio-distal (l , l ) and cervico-incisal (h , h ) dimensions of the upper and lower left central incisors (21, 31),
2 4 1 2
and the overall facio-lingual (l , l ) dimensions of the crowns of the upper and lower left first molars (26, 36),
6 8
using a micrometer (7.2.1.1). See Figure 1 for these dimensions given in parentheses. The numerical tooth
designations given in parentheses are in accordance with ISO 3950:1984.
a) Dimensions of Type 1 teeth b) Dimensions of Type 2 teeth
Figure 1 — Dimensions of teeth to be measured
7.3 Comparison with shade guide
Select a maxillary central incisor of all available anterior shades and/or a maxillary premolar tooth (see
Clause 6) from each of the five different posterior tooth shades for evaluation. Evaluate in accordance with
ISO 7491:2000, 3.2.3. Compare the labial surfaces of each tooth to be tested to the shade guide by holding
the tooth alongside and in the same plane as the corresponding shade guide tooth, with the test tooth first on
one side of the shade guide tooth and then on the other. The tooth complies with 5.1.3 if there is no
perceptible colour difference.
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ISO 22112:2005(E)
7.4 Surface finish of ceramic teeth
7.4.1 Apparatus and materials
7.4.1.1 Denture base polymer, Type 1, complying with ISO 1567:1999.
7.4.1.2 Dental laboratory equipment, for denture flasking, processing, finishing and wet polishing.
7.4.1.3 Dental gypsum for investment, complying with ISO 6873:1998 (Type 2 or Type 3).
7.4.1.4 Dental modelling wax.
7.4.1.5 Wet 300 grit silicon carbide lathe wheel, of diameter (63 ± 3) mm and thickness (4,7 ± 0,3) mm,
capable of being rotated at (1 700 ± 300) r/min.
7.4.2 Processing
7.4.2.1 Preparation of specimens
Process a group of three teeth from different moulds of Type 1 teeth and likewise from Type 2 teeth to a
denture base polymer (7.4.1.1), using the dental laboratory equipment (7.4.1.2) and accepted denture
compression packing techniques, and following the manufacturer’s instructions. Use a gypsum product
(7.4.1.3) and a suitable modelling wax (7.4.1.4).
7.4.2.2 Procedure
After deflasking, using dental laboratory equipment and techniques, remove any surplus denture base
material from those surfaces of the
...
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