Dentistry - Artificial teeth for dental prostheses (ISO 22112:2017)

ISO 22112:2017 specifies the classification, requirements, and test methods for artificial teeth such as ceramic teeth and polymer teeth that are industrially manufactured for use in dental prostheses.

Zahnheilkunde - Künstliche Zähne für Dentalprothesen (ISO 22112:2017)

Médecine bucco-dentaire - Dents artificielles pour prothèses dentaires (ISO 22112:2017)

L'ISO 22112:2017 spécifie la classification, les exigences et les méthodes d'essai relatives aux dents artificielles, telles que les dents en céramique ou en polymère, fabriquées industriellement en vue d'être utilisées dans des prothèses dentaires.

Zobozdravstvo - Umetni zobje za zobne proteze (ISO 22112:2017)

Ta dokument določa razvrstitev, zahteve in preskusne metode za umetne zobe, na primer keramične in polimerne zobe, ki so industrijsko izdelani za uporabo v zobnih protezah.

General Information

Status
Withdrawn
Publication Date
29-Nov-2017
Withdrawal Date
27-Feb-2018
Technical Committee
Drafting Committee
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
30-Aug-2017
Completion Date
30-Aug-2017

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SLOVENSKI STANDARD
SIST EN ISO 22112:2017
01-november-2017
1DGRPHãþD
SIST EN ISO 22112:2006
Zobozdravstvo - Umetni zobje za zobne proteze (ISO 22112:2017)
Dentistry - Artificial teeth for dental prostheses (ISO 22112:2017)
Zahnheilkunde - Künstliche Zähne für Dentalprothesen (ISO 22112:2017)

Médecine bucco-dentaire - Dents artificielles pour prothèses dentaires (ISO 22112:2017)

Ta slovenski standard je istoveten z: EN ISO 22112:2017
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
11.060.15 Zobni implantati Dental implants
SIST EN ISO 22112:2017 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 22112:2017
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SIST EN ISO 22112:2017
EN ISO 22112
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2017
EUROPÄISCHE NORM
ICS 11.060.10 Supersedes EN ISO 22112:2006
English Version
Dentistry - Artificial teeth for dental prostheses (ISO
22112:2017)

Médecine bucco-dentaire - Dents artificielles pour Zahnheilkunde - Künstliche Zähne für Dentalprothesen

prothèses dentaires (ISO 22112:2017) (ISO 22112:2017)
This European Standard was approved by CEN on 6 May 2017.

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 CEN-CENELEC 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

translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management

Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,

Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels

© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 22112:2017 E

worldwide for CEN national Members.
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SIST EN ISO 22112:2017
EN ISO 22112:2017 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 22112:2017
EN ISO 22112:2017 (E)
European foreword

This document (EN ISO 22112:2017) 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 February 2018, and conflicting national standards

shall be withdrawn at the latest by February 2018.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN ISO 22112:2006.

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,

Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,

France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,

Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
Endorsement notice

The text of ISO 22112:2017 has been approved by CEN as EN ISO 22112:2017 without any modification.

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SIST EN ISO 22112:2017
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SIST EN ISO 22112:2017
INTERNATIONAL ISO
STANDARD 22112
Second edition
2017-08
Dentistry — Artificial teeth for dental
prostheses
Médecine bucco-dentaire — Dents artificielles pour prothèses
dentaires
Reference number
ISO 22112:2017(E)
ISO 2017
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SIST EN ISO 22112:2017
ISO 22112:2017(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, Published in Switzerland

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form

or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior

written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of

the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved
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SIST EN ISO 22112:2017
ISO 22112:2017(E)
Contents  Page

Foreword ..........................................................................................................................................................................................................................................v

1  Scope ................................................................................................................................................................................................................................. 1

2  Normative references ...................................................................................................................................................................................... 1

3  Terms and definitions ..................................................................................................................................................................................... 1

4  Classification ............................................................................................................................................................................................................ 2

5  Requirements .......................................................................................................................................................................................................... 2

5.1 General ........................................................................................................................................................................................................... 2

5.1.1 Biocompatibility ............................................................................................................................................................... 2

5.1.2 Dimensions of teeth ...................................................................................................................................................... 2

5.1.3 Colour and blending of shades............................................................................................................................. 2

5.1.4 Surface finish ....................................................................................................................................................................... 2

5.1.5 Porosity and other defects ....................................................................................................................................... 3

5.2 Ceramic teeth............................................................................................................................................................................................ 3

5.2.1 Radioactivity ........................................................................................................................................................................ 3

5.2.2 Anchorage .............................................................................................................................................................................. 3

5.2.3 Resistance to thermal shock .................................................................................................................................. 3

5.3 Polymer teeth ........................................................................................................................................................................................... 3

5.3.1 Bonding to denture base polymer .................................................................................................................... 3

5.3.2 Resistance to blanching, distortion and crazing ................................................................................... 3

5.3.3 Colour stability .................................................................................................................................................................. 3

5.3.4 Dimensional stability ................................................................................................................................................... 3

6  Sampling ........................................................................................................................................................................................................................ 4

7  Measurement and test methods ........................................................................................................................................................... 4

7.1 Visual inspection ................................................................................................................................................................................... 4

7.2 Dimensions of teeth ............................................................................................................................................................................ 4

7.2.1 Reagents and/or materials ..................................................................................................................................... 4

7.2.2 Apparatus ............................................................................................................................................................................... 4

7.2.3 Procedure ............................................................................................................................................................................... 4

7.3 Comparison with shade guide ................................................................................................................................................... 5

7.3.1 Reagents and/or materials ..................................................................................................................................... 5

7.3.2 Apparatus ............................................................................................................................................................................... 5

7.4 Surface finish of ceramic teeth .................................................................................................................................................. 5

7.4.1 Reagents and/or materials ..................................................................................................................................... 5

7.4.2 Apparatus ............................................................................................................................................................................... 6

7.4.3 Processing .............................................................................................................................................................................. 6

7.4.4 Grinding ................................................................................................................................................................................... 6

7.5 Surface finish of polymer teeth ................................................................................................................................................. 6

7.5.1 Reagents and/or materials ..................................................................................................................................... 6

7.5.2 Apparatus ............................................................................................................................................................................... 7

7.5.3 Processing .............................................................................................................................................................................. 7

7.6 Porosity of ceramic teeth and other defects .................................................................................................................. 7

7.6.1 Reagents and/or materials ..................................................................................................................................... 7

7.6.2 Apparatus ............................................................................................................................................................................... 7

7.6.3 Preparation of specimens ........................................................................................................................................ 8

7.6.4 Procedure ............................................................................................................................................................................... 8

7.7 Porosity of polymer teeth and other defects ................................................................................................................. 8

7.7.1 Reagents and/or materials ..................................................................................................................................... 8

7.7.2 Apparatus ............................................................................................................................................................................... 8

7.7.3 Procedure ............................................................................................................................................................................... 8

7.8 Radioactivity of ceramic teeth ................................................................................................................................................... 9

7.8.1 Reagents and/or materials ..................................................................................................................................... 9

7.8.2 Apparatus ............................................................................................................................................................................... 9

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SIST EN ISO 22112:2017
ISO 22112:2017(E)

7.8.3 Sample preparation ....................................................................................................................................................10

7.8.4 Counting procedure....................................................................................................................................................10

7.8.5 Assessment of results ...............................................................................................................................................10

7.9 Anchorage of ceramic teeth to denture base polymers ....................................................................................10

7.9.1 Reagents and/or materials ..................................................................................................................................10

7.9.2 Apparatus ............................................................................................................................................................................10

7.9.3 Procedure ............................................................................................................................................................................10

7.10 Resistance of ceramic teeth to thermal shock ...........................................................................................................10

7.10.1 Reagents and/or materials ..................................................................................................................................10

7.10.2 Apparatus ............................................................................................................................................................................10

7.10.3 Preparation of specimens .....................................................................................................................................11

7.10.4 Procedure ............................................................................................................................................................................11

7.11 Bonding of polymer teeth to denture-base polymers ........................................................................................11

7.11.1 Reagents and/or materials ..................................................................................................................................11

7.11.2 Apparatus ............................................................................................................................................................................11

7.11.3 Procedure ............................................................................................................................................................................12

7.12 Resistance to blanching, distortion and crazing of polymer teeth ..........................................................14

7.12.1 Sampling...............................................................................................................................................................................14

7.12.2 Reagents and/or materials ..................................................................................................................................14

7.12.3 Apparatus ............................................................................................................................................................................14

7.12.4 Conditioning of test specimens ........................................................................................................................15

7.12.5 Procedure for exposure to monomer ..........................................................................................................15

7.12.6 Visual inspection ...........................................................................................................................................................15

7.13 Colour stability of polymer teeth .........................................................................................................................................15

7.13.1 General...................................................................................................................................................................................15

7.13.2 Reagents and/or materials ..................................................................................................................................15

7.13.3 Procedure ............................................................................................................................................................................15

7.14 Dimensional stability of polymer teeth ..........................................................................................................................15

7.14.1 Reagents and/or materials ..................................................................................................................................15

7.14.2 Apparatus ............................................................................................................................................................................16

7.14.3 Procedure ............................................................................................................................................................................16

8  Marking, labelling, and information to be supplied by the manufacturer ............................................16

8.1 Marking and labelling ....................................................................................................................................................................16

8.2 Information to be supplied by manufacturer ............................................................................................................16

8.2.1 Mould chart .......................................................................................................................................................................16

8.2.2 Shade guide .......................................................................................................................................................................17

8.3 Manufacturer’s instructions for use ..................................................................................................................................17

9  Packaging ..................................................................................................................................................................................................................17

Bibliography .............................................................................................................................................................................................................................18

iv © ISO 2017 – All rights reserved
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SIST EN ISO 22112:2017
ISO 22112:2017(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.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).

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. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/ patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO’s adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following

URL: w w w . i s o .org/ iso/ foreword .html.

This document was prepared by ISO/TC 106 Dentistry, Subcommittee SC 2 Prosthodontic materials.

This second edition cancels and replaces the first edition (ISO 22112:2005), which has been technically

revised.
The main changes compared to the previous edition are as follows:

— clarification of colour and blending requirement for multi-layered teeth (5.1.3);

— clarification of test procedure for surface finishing (7.5);

— for testing of radioactivity of ceramic teeth: gamma spectroscopy system is added (7.8).

© ISO 2017 – All rights reserved v
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SIST EN ISO 22112:2017
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SIST EN ISO 22112:2017
INTERNATIONAL STANDARD ISO 22112:2017(E)
Dentistry — Artificial teeth for dental prostheses
1  Scope

This document specifies the classification, requirements, and test methods for artificial teeth such as

ceramic teeth and polymer teeth that are industrially manufactured for use in dental prostheses.

2  Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements 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 483, Plastics — Small enclosures for conditioning and testing using aqueous solutions to maintain the

humidity at a constant value
ISO 1942, Dentistry — Vocabulary
ISO 3950, Dentistry — Designation system for teeth and areas of the oral cavity

ISO 6344-1, Coated abrasives — Grain size analysis — Part 1: Grain size distribution test

ISO 6873:2013, Dentistry — Gypsum products
ISO 7491:2000, Dental materials — Determination of colour stability
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 ISO 20795-1 and the

following apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— IEC Electropedia: available at http:// www .electropedia .org/
— ISO Online browsing platform: available at http:// www .iso .org/ obp
3.1
artificial teeth
manufactured product designed to simulate and replace natural teeth
3.2
diatoric teeth
teeth designed to be retained by anchorage slots and/or holes
3.3
pin teeth
teeth designed to be retained by headed pins
3.4
set

set of six anterior teeth or eight posterior teeth, as received from the manufacturer

© ISO 2017 – All rights reserved 1
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SIST EN ISO 22112:2017
ISO 22112:2017(E)
3.5
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

3.6
mould chart

chart representing the form, shape and dimensions of all individual teeth of a set

4  Classification

For the purposes of this document, artificial teeth are classified into the following types:

— Type 1: anterior teeth;
— 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 document, 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 designation of the teeth shall be as given in ISO 3950.

The dimensions of the teeth when examined in accordance with 7.2 shall not differ by more than 5 %

for 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.

Multi-layered 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 polymer teeth are tested in accordance with 7.5, the teeth shall be capable of being polished to

restore the original finish.
2 © ISO 2017 – All rights reserved
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SIST EN ISO 22112:2017
ISO 22112:2017(E)
5.1.5  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 ≥ 40 μm and ≤ 150 μm. There shall be no pores of diameter greater than 150 μm.

Examine the ceramic teeth in accordance with 7.6.
Polymer teeth shall exhibit no porosity or defect, such as rough
...

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