SIST EN ISO 9693:2001
(Main)Metal-ceramic dental restorative systems (ISO 9693:1999)
Metal-ceramic dental restorative systems (ISO 9693:1999)
Migrated from Progress Sheet (TC Comment) (2000-07-10): Parallel ISO/CEN vote in 1999: positive result in ISO, negative result in CEN. ++ E-mail from D. Lennan to Mr Keller (CEN/TC 55 Secr.) on 1999-12-13, asking ++ what is the CEN/TC 55 decision/advice for the next step (MAL/2000-01-04). ++ E-mail from TC Sec : UNI change of vote from Negative to abstention (sj 000413). ++ --> Res.BT 86/1995 'voting behaviour'applies which means a kind of launch of PQ+ ++ FV. Therefore ISO 9693 reference is maintained at the publication even if it is ++ CEN only since ISO 9693 was already published in ISO in december 1999 (TA/000619
Dentale restaurative Metallkeramiksysteme (ISO 9693:1999)
Diese Internationale Norm beschreibt die Anforderungen und Prüfverfahren für zahnärztliche metallische Werkstoffe die durch Gießen oder mit Maschinen verarbeitet werden und für Keramiken, die bei der Herstellung von metall- keramischen zahnärtzlichen Restaurationen verwendet werden, zusammen mit den Anforderungen und Prüfverfahren für die Verbundstruktur. Die Anforderungen dieser Internationalen Norm beziehen sich auf metallische Werkstoffe und Keramiken, die im Verbund zur Anwendung kommen und gelten nicht für metallische Werksstoffe oder Keramiken allein.
Systemes pour restaurations dentaires métallo-céramiques (ISO 9693:1999)
La présente Norme internationale spécifie des exigences et des méthodes d'essai pour les matériaux céramiques dentaires traités par coulage ou usinage, et pour les céramiques convenant pour être utilisées dans la fabrication des restaurations dentaires métalIo-céramiques, ainsi que des exigences et des méthodes d'essai pour la structure composite. Les exigences de la présente Norme internationale s'appliquent aux matériaux métalliques et aux céramiques lorsqu'ils sont utilisés ensemble et que la conformité ne peut être revendiquée pour les matériaux métalliques seuls ou pour les céramiques seules.
Metal-ceramic dental restorative systems (ISO 9693:1999)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 9693:2001
01-november-2001
1DGRPHãþD
SIST EN ISO 9693:2000
Metal-ceramic dental restorative systems (ISO 9693:1999)
Metal-ceramic dental restorative systems (ISO 9693:1999)
Dentale restaurative Metallkeramiksysteme (ISO 9693:1999)
Systemes pour restaurations dentaires métallo-céramiques (ISO 9693:1999)
Ta slovenski standard je istoveten z: EN ISO 9693:2000
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
SIST EN ISO 9693:2001 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 9693:2001
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SIST EN ISO 9693:2001
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SIST EN ISO 9693:2001
INTERNATIONAL ISO
STANDARD 9693
Second edition
1999-12-15
Metal-ceramic dental restorative systems
Systèmes pour restaurations dentaires métallo-céramiques
Reference number
ISO 9693:1999(E)
©
ISO 1999
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SIST EN ISO 9693:2001
ISO 9693:1999(E)
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ii © ISO 1999 – All rights reserved
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SIST EN ISO 9693:2001
ISO 9693:1999(E)
Contents Page
Foreword.iv
Introduction.v
1 Scope .1
2 Normative references .1
3 Terms and definitions .1
4 Requirements.2
5 Sampling.4
6 Test methods.4
7 Information and instructions .10
8 Packaging, marking and labelling.11
Bibliography .14
© ISO 1999 – All rights reserved iii
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SIST EN ISO 9693:2001
ISO 9693:1999(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 3.
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.
International Standard ISO 9693 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee
SC 2, Prosthodontic materials.
Attention is drawn to the possibility that some of the elements of this International Standard may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
This second edition cancels and replaces the first edition (ISO 9693:1991), which has been technically revised.
Significant differences between this second edition and the first edition are:
� the scope includes metallic materials (not only alloys) processed by casting or machining;
� a requirement (4.3.3) and a test (6.3.3) on the debonding/crack-initiation strength for the metal-ceramic system
have been added, replacing the previous requirement and test related to metal-ceramic bond characterization.
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SIST EN ISO 9693:2001
ISO 9693:1999(E)
Introduction
Dental metallic materials and ceramics are suitable for use in fabrication of metal-ceramic dental restorations.
Specific qualitative and quantitative requirements for freedom from biological hazards are not included in this
International Standard, but it is recommended that, in assessing possible biological hazards, reference be made to
ISO 10993-1 and ISO 7405.
Requirements and test methods for tarnish and corrosion resistance for the components and for the metal-ceramic
system will be included in the future when they are available.
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SIST EN ISO 9693:2001
INTERNATIONAL STANDARD ISO 9693:1999(E)
Metal-ceramic dental restorative systems
1 Scope
This International Standard specifies requirements and test methods for dental metallic materials processed by
casting or machining, and for ceramics suitable for use in the fabrication of metal-ceramic dental restorations,
together with requirements and test methods for the composite structure.
The requirements of this International Standard apply to the metallic materials and ceramics when used in
combination, and compliance may not be claimed for either metallic materials or for ceramics alone.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of
this International Standard. For dated references, subsequent amendments to, or revisions of, any of these
publications do not apply. However, parties to agreements based on this International Standard are encouraged to
investigate the possibility of applying the most recent editions of the normative documents indicated below. For
undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC
maintain registers of currently valid International Standards.
ISO 3696:1987, Water for analytical laboratory use — Specification and test methods.
ISO 6872:1995, Dental ceramic.
ISO 6892:1998, Metallic materials — Tensile testing at ambient temperature.
ASTM B 265-95, Standard specification for titanium and titanium alloy strip, sheet and plate.
ASTM B 348-93, Standard specification for titanium and titanium alloy bars and billets.
3 Terms and definitions
For the purposes of this International Standard, the following terms and definitions apply.
3.1
alloy/metal conditioning
process of treating the metal substructure to enhance the bonding of ceramic to metal
3.2
coating agent
bonding agent
substance which, when applied to the metal substructure and fired under appropriate time-temperature conditions,
improves aesthetics and may enhance the adherence of ceramic to the coated metal surface
NOTE Examples of such substances are electroplated layers, or agents containing ceramic and/or alloy particles.
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SIST EN ISO 9693:2001
ISO 9693:1999(E)
3.3
dental dentine ceramic
slightly translucent, pigmented dental ceramic used to impart the overall shape and basic colour of the ceramic part
of a metal-ceramic restoration or prosthesis
3.4
dental enamel ceramic
translucent, lightly pigmented dental ceramic, used on a core or a base of dentine ceramic to simulate the natural
tooth enamel
3.5
firing schedule
temperature-time cycle stating the initial temperature, the time period (if any) at the initial temperature, the heating
rate, the final temperature, the time period (if any) at the final temperature and, in the case of vacuum firing, the
temperature of vacuum application and the point of release
3.6
heating rate
rate of temperature increase
NOTE It is expressed in degrees Celsius per minute.
3.7
metallic material
alloy or metal suitable for use as the substructure of a metal-ceramic restoration
3.8
opaque bonding dental ceramic
ceramic product that, when mixed with distilled water or other appropriate liquid, applied to a dental metallic material
and treated according to the firing schedule for the opaque ceramic, will bond to the metal surface to form a layer
that visibly masks the metallic colour
4 Requirements
4.1 Chemical composition
4.1.1 Metallic material
For noble metal alloys, the percentage of each alloy constituent shall not deviate from the value stated on the
package label or insert by more than 0,5 % (mass fraction) [see 8.2.2 c)].
For base metal alloys, the content of constituents present in excess of 20 % (mass fraction) shall not deviate from
the value stated on the package label or insert by more than 2 % (mass fraction). The content of constituents
present in excess of 2 % (mass fraction) but not in excess of 20 % (mass fraction) shall not deviate from the value
stated on the package label or insert by more than 1 % (mass fraction) [see 8.2.2 c)].
The percentage content of nickel, beryllium and cadmium shall not be greater than the amounts indicated on the
package label or insert [see 8.2.2 d)].
Testing shall be carried out in accordance with 6.1.1.
For unalloyed titanium, the grade according to ASTM Designation B 265-95 (strip, sheet and plate) or B 348-93
(bars and billets) shall be certified, i.e. standard specification data apply. A certificate from the supplier of the
titanium shall be required.
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4.1.2 Ceramic
The ceramic shall meet the requirements of ISO 6872:1995/Amd.1:1997, 5.1 and 5.2. Test in accordance with
ISO 6872:1995/Amd. 1:1997.
4.2 Biocompatibility
See the Introduction for guidance on biocompatibility.
4.3 Properties
4.3.1 Metallic material
The mechanical properties of the metallic materials as processed shall comply with the requirements of Table 1.
Table 1 — Mechanical properties of metallic materials
Proof stress of non- Percentage elongation
proportional elongation, after fracture
R
p0,2
MPa
%
min.
min.
250 3
The solidus and liquidus temperatures of the alloys shall not deviate by more than 25 °C from the values stated on
the package label or insert [see 8.2.2 g)].
�6 �1
The coefficient of linear thermal expansion of the alloys shall not deviate by more than 0,5� 10 K from the
value stated on the package label or insert [see 8.2.2 h)].
3
The density of the alloy as supplied by the manufacturer shall not deviate by more than 0,5 g/cm from the value
stated on the package label or insert [see 8.2.2 i)].
Testing shall be carried out in accordance with 6.1.2, 6.1.3, and 6.3.1, respectively. Standard testing procedures
shall be used for determining the density.
NOTE For titanium and other pure metals, controlled literature data for melting point, linear thermal expansion and density
canbeused; seee.g.[8].
4.3.2 Ceramic
The flexural strength and the chemical solubility of the fired ceramics shall meet the requirements of Table 2.
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ISO 9693:1999(E)
Table 2 — Properties of ceramics
Ceramic type Flexural strength Chemical solubility,
loss in mass
�2
MPa
�g�cm
min.
max.
Opaque 50 100
Dentine 50 100
Enamel 50 100
�6 �1
The coefficient of thermal expansion of the ceramics shall not deviate by more than 0,5 � 10 K from the value
stated by the manufacturer [see 8.2.3 e)].
The glass transition temperature of the ceramics shall not deviate by more than 20 °C from the value stated by the
manufacturer [see 8.2.3 f)].
Testing shall be carried out in accordance with 6.2.1, 6.3.1, and 6.3.2, respectively.
4.3.3 Metal-ceramic system
The debonding/crack-initiation strength of the metallic material and at least one specified (named) ceramic present
shall be greater than 25 MPa. The debonding/crack-initiation strength of the ceramic and at least one specified
(named) metallic material present shall be greater than 25 MPa.
Testing shall be carried out in accordance with 6.3.3.
The measured values for coefficients of linear thermal expansion are compared with the manufacturer´s values as a
means of quality control, but the values cannot provide an assurance that the alloy and ceramic are compatible.
5 Sampling
5.1 Metallic material
The sample shall be adequate to prepare the specimens for testing in accordance with this International Standard.
All of the metallic materials procured shall be unused and obtained from the same batch.
5.2 Ceramic
Take a sufficient amount of ceramic to carry out the necessary tests in accordance with this International Standard.
If there is more than one shade of opaque, dentine and enamel ceramics, respectively, take equal quantities of
each shade.
6 Test methods
6.1 Metallic material
6.1.1 Chemical composition
Use standard analytical procedures for determining the composition.
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For unalloyed titanium, specification data in accordance with 4.1.1 shall be provided by the manufacturer or
distributor of the metal.
6.1.2 Mechanical properties
6.1.2.1 Preparation of test specimens
Prepare six test specimens, as depicted in Figure 1 or 2, in accordance with the manufacturer´s procedure for
processing the substructures for metal-ceramic prostheses. Discard and replace specimens with visible defects.
Preheat the furnace. Place the metallic specimens in the furnace for 15 min with the atmosphere recommended for
the metallic material concerned. Use the highest temperature allowed with respect to the ceramic(s) recommended
for fusing to that metallic material. Remove the specimens from the
...
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