oSIST prEN ISO 6872:2023
(Main)Dentistry - Ceramic materials (ISO/DIS 6872:2023)
Dentistry - Ceramic materials (ISO/DIS 6872:2023)
Zahnheilkunde - Keramische Werkstoffe (ISO/DIS 6872:2023)
Médecine bucco-dentaire - Matériaux céramiques (ISO/DIS 6872:2023)
Zobozdravstvo - Keramični materiali (ISO/DIS 6872:2023)
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Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO 6872:2023
01-julij-2023
Zobozdravstvo - Keramični materiali (ISO/DIS 6872:2023)
Dentistry - Ceramic materials (ISO/DIS 6872:2023)
Zahnheilkunde - Keramische Werkstoffe (ISO/DIS 6872:2023)
Médecine bucco-dentaire - Matériaux céramiques (ISO/DIS 6872:2023)
Ta slovenski standard je istoveten z: prEN ISO 6872
ICS:
11.060.10 Zobotehnični materiali Dental materials
oSIST prEN ISO 6872:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 6872:2023
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oSIST prEN ISO 6872:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 6872
ISO/TC 106/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
2023-05-16 2023-08-08
Dentistry — Ceramic materials
Médecine bucco-dentaire — Matériaux céramiques
ICS: 11.060.10
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
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THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
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STANDARDS MAY ON OCCASION HAVE TO
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POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 6872:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
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PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023
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oSIST prEN ISO 6872:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 6872
ISO/TC 106/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
Dentistry — Ceramic materials
Médecine bucco-dentaire — Matériaux céramiques
ICS: 11.060.10
This document is circulated as received from the committee secretariat.
COPYRIGHT PROTECTED DOCUMENT
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
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WHICH REFERENCE MAY BE MADE IN
Reference number
Email: copyright@iso.org
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 6872:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
© ISO 2023 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023
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oSIST prEN ISO 6872:2023
ISO/DIS 6872:2023(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
3.1 Material . 1
3.2 Processing . 3
3.3 Properties . 4
4 Types, classes, and their identification. 4
5 Requirements . 5
5.1 Uniformity . 5
5.2 Freedom from extraneous materials . 6
5.3 Mixing and condensation properties of type I ceramics . 6
5.4 Physical and chemical properties . 6
5.5 Biocompatibility . 6
5.6 Shrinkage factor . 6
6 Sampling . 6
6.1 Type I ceramics . 6
6.2 Type II ceramics. 6
7 Test methods . 7
7.1 Preparation of test specimens . 7
7.1.1 Components of test specimens (type I ceramics) . 7
7.1.2 Apparatus for mixing . 7
7.1.3 Method of mixing . 7
7.1.4 Procedure for specimen fabrication . 7
7.1.5 Firing . 7
7.2 Radioactivity of dental ceramic . 8
7.2.1 Preparation of samples . 8
7.2.2 Counting procedure . 8
7.2.3 Assessment of results . 8
7.3 Flexural strength. 8
7.3.1 Three-point and four-point bending tests . 8
7.3.2 Biaxial flexure test (piston-on-three-ball test) .12
7.4 Linear thermal expansion coefficient . 14
7.4.1 Apparatus . 14
7.4.2 Preparing of test specimens (type I and type II ceramics) . 14
7.4.3 Dilatometric measurement . 14
7.4.4 Assessment of results . 14
7.5 Glass transition temperature . 14
7.5.1 Operating procedure . 14
7.5.2 Assessment of results .15
7.6 Chemical solubility . 15
7.6.1 Reagent .15
7.6.2 Apparatus . 15
7.6.3 Preparation of test specimens . 16
7.6.4 Procedure . 16
7.6.5 Calculation and assessment of results . 16
8 Information and instructions .16
8.1 Information . . 16
8.1.1 General . 16
8.1.2 Type I Ceramics . 16
iii
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oSIST prEN ISO 6872:2023
ISO/DIS 6872:2023(E)
8.1.3 Type II ceramics . 16
8.2 Instructions for use . 17
9 Packaging, marking, and labelling .17
9.1 Packaging . 17
9.2 Marking and labelling . 17
Annex A (informative) Fracture toughness .19
Annex B (informative) Weibull statistics .26
Annex C (informative) Protocol to assess the hydrothermal stability of yttria-stabilized
tetragonal zirconia (Y-TZP) .28
Bibliography .32
iv
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oSIST prEN ISO 6872:2023
ISO/DIS 6872:2023(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 meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO's adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC 2, Prosthodontic
materials.
This fifth edition cancels and replaces the fourth edition (ISO 6872:2015), which has been technically
revised with the following changes:
— incorporation of ISO 6872:2015/Amd 1:2018
— addition of informative annex on protocol to assess the hydrothermal stability of yttria-stabilized
tetragonal zirconia (Y-TZP)
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oSIST prEN ISO 6872:2023
ISO/DIS 6872:2023(E)
Introduction
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.
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oSIST prEN ISO 6872:2023
DRAFT INTERNATIONAL STANDARD ISO/DIS 6872:2023(E)
Dentistry — Ceramic materials
1 Scope
This International Standard specifies the requirements and the corresponding test methods for dental
ceramic materials for fixed all-ceramic and metal-ceramic restorations and prostheses.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 3696, Water for analytical laboratory use — Specification and test methods
ISO 1942, Dentistry — Vocabulary
ISO 13078, Dentistry — Dental furnace — Test method for temperature measurement with separate
thermocouple
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.
3.1 Material
3.1.1
addition ceramic
add-on ceramic
correction ceramic
dental ceramic material which is fired at a reduced temperature and is normally applied to restore
contact areas on a dental restoration or prosthesis
3.1.2
aesthetic ceramic
dental porcelain (3.1.5) or glass ceramic (3.1.10) having appropriate translucency and colour used to
mimic the optical properties of natural teeth
3.1.3
chromatic dentin ceramic
dentine ceramic having a high strength or saturation of the hue (color)
3.1.4
dental ceramic
inorganic, non-metallic material which is specifically formulated for use when processed according to
the manufacturers’ instructions to form the whole or part of a dental restoration or prosthesis
3.1.5
dental porcelain
predominantly, glassy dental ceramic (3.1.4) material used mainly for aesthetics in a dental restoration
or prosthesis
1
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3.1.6
dentine ceramic
dental ceramic (3.1.4) material used to form the overall shape and basic colour of a dental restoration or
prosthesis simulating the natural tooth dentine
3.1.7
enamel ceramic
dental ceramic (3.1.4) material used to overlay, either partially or wholly, the dentine ceramic (3.1.6)
and also, to form the more translucent incisal third of a dental restoration or prosthesis simulating the
natural tooth enamel
3.1.8
flame-sprayed dental ceramic
dental ceramic core or substructure layer formed via the technique of flame-spraying
3.1.9
fluorescent ceramic
dental ceramic (3.1.4) material that absorbs radiant energy and emits it in the form of radiant energy of
a different wavelength band all or most of whose wavelengths exceed that of the absorbed energy
EXAMPLE Absorption of ultraviolet light with emission of blue light.
3.1.10
glass ceramic (dental)
dental ceramic (3.1.4) material formed by the action of heat treatment on a glass in order to cause
initiation and growth of a wholly or predominantly crystalline microstructure
3.1.11
glass-infiltrated dental ceramic
dental ceramic core or substructure layer which is porous and is subsequently densified by the
infiltration of specialised glass at elevated temperature
3.1.12
glaze ceramic
dental ceramic (3.1.4) material which is overlayed and fired at a lower temperature compared to dentine
ceramic (3.1.6) or enamel ceramic (3.1.7) to produce a thin coherent sealed surface, the level of gloss
being determined by the firing conditions
3.1.13
liner
dental ceramic (3.1.4) material used on all ceramic substructure forming a layer that provides a
background colour upon which dentine or opaceous dentine can be applied to achieve overall aesthetics
3.1.14
modelling fluid
liquid with which a dental ceramic powder is mixed in order to shape or model it into its required form
prior to firing
3.1.15
modifying enamel ceramic
enamel ceramic (3.1.7) used to modify the surface contour of a restoration, for example, add a contact,
often fired at a lower temperature than the enamel ceramic or dentine ceramic
3.1.16
monolithic ceramic
dental ceramic (3.1.4) that is substantially made of a single uniform material
Note 1 to entry: A thin layer of glaze (3.3.4) (staining technique) can be applied.
2
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oSIST prEN ISO 6872:2023
ISO/DIS 6872:2023(E)
3.1.17
opaceous dentine ceramic
dental ceramic (3.1.4) material having a higher opacity than a dentine ceramic (3.1.6) material, but which
can still be used to contribute to the overall shape and basic colour of a dental restoration or prosthesis
simulating the natural tooth dentine
3.1.18
opalescent enamel ceramic
enamel ceramic (3.1.7) material that scatters shorter wavelengths of light (e.g. blue) and transmits
longer wavelengths of light (e.g. red)
3.1.19
opaque dental ceramic
dental ceramic (3.1.4) material which when applied to a metallic substructure, according to the
manufacturer’s instructions, acts to bond to the metal surface forming a layer that provides a
background colour and interface upon which other dental ceramic materials can be applied to achieve
overall aesthetics
3.1.20
shoulder ceramic
margin ceramic
dental ceramic (3.1.4) material used to form shape and colour at the marginal area of the dental
restoration or prosthesis simulating natural tooth dentine in this area
3.1.21
stain ceramic
dental ceramic powder or paste which is normally intensely coloured and which is formulated to be
used either internally or externally during the build-up of a dental restoration or prosthesis to simulate
details within or on the surface as are found in natural teeth
3.1.22
substructure (core) dental ceramic
predominantly, polycrystalline dental ceramic material that forms a supporting substructure upon
which one or more layers of dental ceramic (3.1.4) or dental polymer material are applied, either
partially or totally, to form a dental restoration or prosthesis
3.2 Processing
3.2.1
air firing dental ceramic
firing of dental ceramics (3.1.4) under ambient atmospheric pressure
3.2.2
dental CAD/CAM
computer-aided design/computer-aided manufacture (CAD/CAM) procedures to manufacture a dental
restoration or prosthesis normally including the following stages: a) a digital scanning procedure of the
model, wax-up, or intra-orally to produce a 3D data set; b) software manipulation of the 3D data set to
design the prosthesis; c) a computer-directed machine tool that performs the manufacturing process
3.2.3
condensation of dental ceramic
powder process whereby a slurry of dental ceramic powder is vibrated to compact the powder prior to
sintering
3.2.4
injectable, castable, or pressable dental ceramic
dental ceramic (3.1.4) material, normally in the form of a pellet or ingot (often pre-sintered), designed
for use in a specialised furnace which enables the ingot to be injected/cast/pressed into a mould
prepared through the lost wax technique
3
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oSIST prEN ISO 6872:2023
ISO/DIS 6872:2023(E)
3.2.5
sintering of a dental ceramic
process whereby heat and potentially other process parameters, for example, mechanical or gas
pressure, are applied to a ceramic powder or powder compact in order to densify the ceramic into its
required form
Note 1 to entry: “Firing” and “sintering” are used interchangeably in this International Standard (“firing”
connoting the application of heat to drive sintering).
3.2.6
vacuum firing dental ceramic
firing of dental ceramics (3.1.4) at reduced pressure (i.e. under vacuum) to yield the required density
and associated aesthetics especially the degree of translucency
Note 1 to entry: Dental ceramics for vacuum firing have a specific particle size distribution to reduce the
entrapment of porosity.
3.3 Properties
3.3.1
class of dental ceramic
classification of a dental ceramic (3.1.4) material according to its intended function
3.3.2
fracture toughness
conventional fracture mechanics parameter indicating the resistance of a material to crack extension
(propagation)
3.3.3
glass transition temperature
approximate midpoint of the temperature range over which a glass transforms between elastic
and viscoelastic behaviour characterized by the onset of a rapid change in its coefficient of thermal
expansion
3.3.4
glaze
surface appearance obtained when the gloss is clinically and aesthetically acceptable
4 Types, classes, and their identification
For the purposes of this International Standard, dental ceramics are designated into two types.
— Type I: Ceramic products that are provided as powders, pastes, or aerosols.
— Type II: All other forms of ceramic products.
Ceramics are divided into five classes according to their intended clinical use and according to the
descriptions in Table 1. If colour is added to a ceramic powder for identification purposes, the colour
coding given in Table 2 is recommended.
Table 1 — Classification of ceramics for fixed prostheses by intended clinical use with required
mechanical and chemical properties
Class Recommended clinical indications Mechanical and chemical properties
Flexural strength
[MPa] Chemical solubility
2
minimum value for [μg/cm ]
mean (see 7.3.1.4)
4
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oSIST prEN ISO 6872:2023
ISO/DIS 6872:2023(E)
TTabablele 1 1 ((ccoonnttiinnueuedd))
Class Recommended clinical indications Mechanical and chemical properties
a) Monolithic ceramic for single-unit anterior 50 <100
1 prostheses, veneers, inlays, or onlays
adhesively cemented.
b) Ceramic for coverage of a metal framework 50 <100
or a ceramic substructure.
a) Monolithic ceramic for single-unit anterior 100 <100
2
or posterior prostheses adhesively cemented.
b) Partially or fully covered substructure ceramic 100 <2 000
for
single-unit anterior or posterior prostheses
adhesively cemented.
a) Monolithic ceramic for single-unit anterior 300 <100
or posterior prostheses and for three-unit
3
prostheses not involving molar restoration
adhesively or non-adhesively cemented.
b) Partially or fully covered substructure for sin- 300 <2 000
gle-unit
anterior or posterior prostheses and for
three-unit prostheses not involving molar
restoration adhesively or non-adhesively
cemented.
a) Monolithic ceramic for three-unit 500 <100
4
prostheses involving molar restoration.
b) Partially or fully covered substructure for 500 <2 000
three-unit prostheses involving molar
restoration.
Monolithic ceramic for prostheses involving 800 <100
partially or fully covered substructure for four or
5 more units or fully covered
substructure for prostheses involving
four or more units.
Table 2 — Recommended colour coding for the identification of type I dental ceramic powders
Material Colour coding
Dentine ceramic Pink
Enamel ceramic Blue
Fluorescent ceramic Yellow
Highly chromatic dentine ceramic Orange
Opalescent enamel ceramic Blue-green
Modifying enamel ceramic Purple
(e.g. translucent, clear)
5 Requirements
5.1 Uniformity
The inorganic pigment(s) used to produce the colour of a fired dental ceramic and any organic
colorants (for colour coding) shall be uniformly dispersed throughout the dental ceramic material and
in powdered ceramic products, no segregation of the pigment(s) shall take place when the powder is
mixed as in 7.1.3. Check by visual inspection.
5
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oSIST prEN ISO 6872:2023
ISO/DIS 6872:2023(E)
5.2 Freedom from extraneous materials
5.2.1 Dental ceramic materials shall be free from extraneous materials
...
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