EN ISO 5139:2023
(Main)Dentistry - Polymer-based composite machinable blanks (ISO 5139:2023)
Dentistry - Polymer-based composite machinable blanks (ISO 5139:2023)
This document specifies the characteristics of polymer-based composite machinable blanks with respect to the milling process and provides the test methods that address the clinical issues specific to those materials. In addition, this document specifies the items to be described on the packaging and materials, as well as descriptions to be included in the instructions for use.
The polymer-based composite machinable blanks covered in this document are blanks that are used for fabricating permanent dental restorative appliances (e.g. single crowns or inlays) by milling processes. They do not include large-sized blanks (e.g. discs) that allow for the fabrication of two or more units of crowns or bridges from one blank or materials for temporary use.
Zahnheilkunde - Maschinell bearbeitbare Rohlinge aus Verbundwerkstoffen auf Polymerbasis (ISO 5139:2023)
Dieses Dokument legt die Eigenschaften von maschinell bearbeitbaren Rohlingen aus Verbundwerkstoffen auf Polymerbasis im Hinblick auf den Fräsprozess fest und stellt die Prüfverfahren bereit, die sich mit den klinischen Fragen befassen, die für diese Materialien spezifisch sind. Darüber hinaus wird in diesem Dokument festgelegt, welche Angaben auf der Verpackung und den Werkstoffen aufzubringen sind und welche Beschreibungen in der Gebrauchsanweisung enthalten sein müssen.
Bei den in diesem Dokument behandelten maschinell bearbeitbaren Rohlingen aus Verbundwerkstoffen auf Polymerbasis handelt es sich um Rohlinge, die für die Herstellung von dauerhaftem Zahnersatz (z. B. Einzelkronen oder Inlays) durch Fräsverfahren verwendet werden. Sie umfassen keine großformatigen Rohlinge (z. B. Scheiben), die die Herstellung von zwei oder mehr Kronen- oder Brückeneinheiten aus einem Rohling ermöglichen, oder Materialien zur vorübergehenden Verwendung.
Médecine bucco-dentaire - Ébauches usinables en composite à base de polymères (ISO 5139:2023)
Le présent document spécifie les caractéristiques des ébauches usinables en composite à base de polymères à déterminer pour le fraisage. Il fournit également les méthodes d’essai permettant de répondre aux enjeux cliniques propres à ces matériaux. En outre, le présent document spécifie les éléments devant figurer sur l’emballage et sur les matériaux ainsi que les informations à fournir dans les instructions d’utilisation.
Les ébauches usinables en composite à base de polymères dont traite le présent document sont des ébauches utilisées pour la fabrication de dispositifs de restauration dentaire permanents (par exemple, couronnes ou inlays uniques) par fraisage. Ne sont pas concernées les ébauches de grande taille (par exemple, disques) permettant la fabrication d’au moins deux couronnes ou bridges à partir d’une seule ébauche ou de matériaux de temporisation.
Zobozdravstvo - Polimerni kompozitni polizdelki, ki jih je mogoče obdelovati (ISO 5139:2023)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 5139:2023
01-september-2023
Zobozdravstvo - Polimerni kompozitni polizdelki, ki jih je mogoče obdelovati (ISO
5139:2023)
Dentistry - Polymer-based composite machinable blanks (ISO 5139:2023)
Zahnheilkunde - Maschinell bearbeitbare Rohlinge aus Verbundwerkstoffen auf
Polymerbasis (ISO 5139:2023)
Médecine bucco-dentaire - Ébauches usinables en composite à base de polymères (ISO
5139:2023)
Ta slovenski standard je istoveten z: EN ISO 5139:2023
ICS:
11.060.10 Zobotehnični materiali Dental materials
SIST EN ISO 5139:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 5139:2023
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SIST EN ISO 5139:2023
EN ISO 5139
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2023
EUROPÄISCHE NORM
ICS 11.060.10
English Version
Dentistry - Polymer-based composite machinable blanks
(ISO 5139:2023)
Médecine bucco-dentaire - Ébauches usinables en Zahnheilkunde - Maschinell bearbeitbare Rohlinge aus
composite à base de polymères (ISO 5139:2023) Kompositen auf Polymerbasis (ISO 5139:2023)
This European Standard was approved by CEN on 18 April 2023.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 5139:2023 E
worldwide for CEN national Members.
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SIST EN ISO 5139:2023
EN ISO 5139:2023 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 5139:2023
EN ISO 5139:2023 (E)
European foreword
This document (EN ISO 5139:2023) 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 November 2023, and conflicting national standards
shall be withdrawn at the latest by November 2023.
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.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 5139:2023 has been approved by CEN as EN ISO 5139:2023 without any modification.
3
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SIST EN ISO 5139:2023
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SIST EN ISO 5139:2023
INTERNATIONAL ISO
STANDARD 5139
First edition
2023-05
Dentistry — Polymer-based composite
machinable blanks
Médecine bucco-dentaire — Ébauches usinables en composite à base
de polymères
Reference number
ISO 5139:2023(E)
© ISO 2023
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SIST EN ISO 5139:2023
ISO 5139:2023(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
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SIST EN ISO 5139:2023
ISO 5139:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Characteristics . 2
4.1 Requirement . 2
4.2 Recommendations . 2
4.2.1 Machining damage . 2
4.2.2 Machinability . 2
4.2.3 Bonding properties between blank and holding jig . 2
5 Sampling . 2
6 Test methods . 2
6.1 General . 2
6.2 Size of blanks . 2
6.2.1 Apparatus . 2
6.2.2 Procedure . 2
6.3 Machining damage . 3
6.3.1 General . 3
6.3.2 Apparatus . 3
6.3.3 Water . 3
6.3.4 Preparation of test specimens . 3
6.3.5 Procedure . 4
6.3.6 Expression of results . 4
7 Packaging and labelling . 5
7.1 Packaging . 5
7.2 Labelling . 5
7.2.1 General . 5
7.2.2 Labelling of outer pack . 6
7.2.3 Labelling of polymer-based composite machinable blank . 6
8 Instructions for use . .6
Annex A (informative) Preparation method of control specimen for flexural strength .8
Annex B (informative) Milling design of test specimen for machining damage .13
Annex C (informative) Test method to determine the bonding properties between blank
and holding jig .14
Bibliography .18
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SIST EN ISO 5139:2023
ISO 5139:2023(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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use
of (a) patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed
patent rights in respect thereof. As of the date of publication of this document, ISO had not received
notice of (a) patent(s) which may be required to implement this document. However, implementers are
cautioned that this may not represent the latest information, which may be obtained from the patent
database available at www.iso.org/patents. ISO shall not be held responsible for identifying any or all
such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of 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
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 9, Dental
CAD/CAM systems, in collaboration with the European Committee for Standardization (CEN) Technical
Committee CEN/TC 55, Dentistry, in accordance with the Agreement on technical cooperation between
ISO and CEN (Vienna Agreement).
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
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SIST EN ISO 5139:2023
ISO 5139:2023(E)
Introduction
Specific qualitative and quantitative test methods for demonstrating freedom from unacceptable
biological hazards are not included in this document, but it is recommended that, for the assessment of
possible biological hazards, reference should be made to ISO 10993-1 and ISO 7405.
Requirements for the materials properties of polymer-based composite machinable blanks are not
included in this document, but these requirements will be included in a future edition of ISO 10477.
The test method to determine the bonding properties between blank and holding jig is not included in
this document, but it is recommended to adopt the test procedure given in Annex C when measuring the
bonding properties between blank and holding jig.
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SIST EN ISO 5139:2023
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SIST EN ISO 5139:2023
INTERNATIONAL STANDARD ISO 5139:2023(E)
Dentistry — Polymer-based composite machinable blanks
1 Scope
This document specifies the characteristics of polymer-based composite machinable blanks with
respect to the milling process and provides the test methods that address the clinical issues specific
to those materials. In addition, this document specifies the items to be described on the packaging and
materials, as well as descriptions to be included in the instructions for use.
The polymer-based composite machinable blanks covered in this document are blanks that are used for
fabricating permanent dental restorative appliances (e.g. single crowns or inlays) by milling processes.
They do not include large-sized blanks (e.g. discs) that allow for the fabrication of two or more units of
crowns or bridges from one blank or materials for temporary use.
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 1942, Dentistry — Vocabulary
ISO 3696:1987, Water for analytical laboratory use — Specification and test methods
ISO 4049:2019, Dentistry — Polymer-based restorative materials
ISO 6344-3, Coated abrasives — Determination and designation of grain size distribution — Part 3:
Microgrit sizes P240 to P5000
ISO 6872:2015, Dentistry — Ceramic materials
ISO 8601-1, Date and time — Representations for information interchange — Part 1: Basic rules
ISO 18675:2022, Dentistry — Machinable ceramic blanks
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
polymer-based composite machinable blank
piece of solid polymer-based composite (3.2) that is subjected to subtractive methods to remove material
from the piece leaving the final desired part
3.2
polymer-based composite
polymer-based dental material including either organic filler or inorganic filler, or both fillers that have
been treated by a coupling agent to ensure chemical bonding with the polymeric matrix
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SIST EN ISO 5139:2023
ISO 5139:2023(E)
3.3
holding jig
mandrel
jig that attaches a composite resin block to be mounted for milling machine
4 Characteristics
4.1 Requirement
Measure five product blanks in accordance with the method described in 6.2. The dimensions of all
blanks shall not be smaller than 0,25 mm nor larger than 1,00 mm than the size specified in Clause 8 d).
4.2 Recommendations
4.2.1 Machining damage
The machining damage of blanks should be evaluated in accordance with the methods described in 6.3.
4.2.2 Machinability
The machinability of blanks should be evaluated using the test method for merlon fracture test given in
ISO 18675:2022, Clause 8.
4.2.3 Bonding properties between blank and holding jig
The bonding properties between blank and holding jig should be evaluated. An example of the test
method for bonding properties is described in Annex C.
5 Sampling
The test sample shall consist of one or more packages for retail of one selected shade, corresponding
to the purpose of the test, from a single batch and contain sufficient material to carry out the specified
tests, plus an allowance for any necessary repetition of tests.
6 Test methods
6.1 General
Test specimens shall be prepared and tested at (23 ± 2) °C. The relative humidity shall be not less than
30 %.
6.2 Size of blanks
6.2.1 Apparatus
Micrometer, with an accuracy of 0,01 mm.
6.2.2 Procedure
Measure five blanks using a micrometer at the points where the size is specified by the manufacturer in
the instructions for use in Clause 8 d).
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SIST EN ISO 5139:2023
ISO 5139:2023(E)
6.3 Machining damage
6.3.1 General
Perform machining damage test in accordance with the method described in ISO 18675:2022, Clause 7.
Specifically, measure the three-point flexural strength for the control specimen fabricated by cutting
and grinding and for the machined specimen fabricated using a milling machine, and compare the
results between these specimens.
6.3.2 Apparatus
6.3.2.1 Oven, set at (37 ± 1) °C.
6.3.2.2 Universal mechanical testing machine, capable of a crosshead speed of (1,0 ± 0,5) mm/min;
for example, see ISO 7500-1.
6.3.2.3 Fixture for three-point bending, consisting of support rollers (1,5 mm to 2 mm in diameter,
tolerances are ±0,2 mm) positioned with their centres (12,0 ± 0,1) mm apart. The load shall be applied at
the midpoint between the supports by means of a third roller (1,5 mm to 2 mm in diameter, tolerances
are ±0,2 mm). Rollers shall be made from hardened steel or other hard material having a hardness
greater than 40 HRC (Rockwell C-scale) and have a smooth surface with a roughness less than 0,5 μm
Ra. It is recommended to measure the actual spacing between the centres of the support rollers, l, to
ensure it is (12,0 ± 0,1) mm.
6.3.2.4 Micrometer, with an accuracy of 0,01 mm.
6.3.2.5 CAD/CAM milling machine
6.3.3 Water
Water shall conform to ISO 3696:1987, Grade 2.
6.3.4 Preparation of test specimens
6.3.4.1 Test specimen dimensions
The width is: w = (4,0 ± 0,2) mm (dimension of the side at right angles to the direction of the applied
load).
The thickness is: b = (1,2 ± 0,2) mm (dimension of the side parallel to the direction of the applied load).
Lengths shall be at least 2 mm longer than the test span (12,0 ± 0,1) mm.
When the edge chamfer is necessary, it shall be prepared in accordance with the method described in
ISO 6872:2015, 7.3.1.2.1.
NOTE The dimensions of test specimen specified in this document are not verified for the measurement of
flexural strength absolute values for composite resin materials. There are some published scientific papers in
which flexural strength test of composite machinable blanks were performed at this size.
6.3.4.2 Test parameters
The test span is: l = (12,0 ± 0,5) mm (centre-to-centre distance between support rollers).
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SIST EN ISO 5139:2023
ISO 5139:2023(E)
6.3.4.3 Control specimen
Prepare test specimens from blanks. Polish the surface of specimen until the required thickness is
reached. Perform the final polishing using P1000 or finer silicon carbide waterproof abrasive paper.
Confirm the absence of chipping in the centre portion.
Specimens shall be plane-parallel for bending test. Prepare five specimens. Store the specimen in water
at (37 ± 1) °C for 7 d ± 4 h until the start of testing.
NOTE An example of detailed method is shown in Annex A.
6.3.4.4 Machined specimen
Fabricate test specimens of the abovementioned dimensions by the milling machine.
It is desirable to adopt a milling design and processing path that avoids bending test specimens during
milling. It is also desirable to arrange appropriate supports in the milling design for this purpose. When
setting the supports, ensure that the supports are located on the outer area of the test specimen for the
three-point bending test.
After the machining process, cut off the support portion using an appropriate method (e.g. diamond
disks).
Prepare five specimens having plane-parallel surfaces. Report the number of specimens that cannot be
tested due to machining failure.
Store the specimen in water at (37 ± 1) °C for 7 d ± 4 h until the start of testing. The test specimens are
subjected to the bending test without further surface polishing as is used for the control specimens.
NOTE Annex B gives an example of a specific milling design for test specimens from blanks.
6.3.5 Procedure
Measure the cross-sectional dimensions of each test specimen to ±0,01 mm. Then, place a test specimen
centrally on the supports of the test machine so that the load is applied to a 4 mm wide face along a
line perpendicular to the long axis of the test specimen and determine the maximum load required to
break the test specimen. Use a crosshead speed of (1,0 ± 0,5) mm/min. Repeat the procedure with the
remaining test specimens.
6.3.6 Expression of results
6.3.6.1 Calculation
Calculate the flexural strength, σ, in megapascals:
3Fl
σ =
2
2wb
where
F is the maximum applied load, in newtons;
l is the distance, in millimetres, between the supports, i.e. 12 mm;
w is the width of the test specimen, in millimetres;
b is the thickness of the test specimen, in millimetres.
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SIST EN ISO 5139:2023
ISO 5139:2023(E)
Calculate the mean and standard deviation of the flexural strength values for control and machined
specimens, followed by the percentage of change in flexural strength of the machined group as
compared with that of the control group.
6.3.6.2 Test report
Test report for machining damage should be in accordance with ISO 18675:2022, 7.3. The documentation
of the test shall include at least the following information:
a) name of manufacturer, brand name, shade – if applicable;
b) size of the blank(s);
c) lot-number of the blank(s);
d) fabrication conditions of the control specimens including sectioning methodology and finishing of
the surface;
e) length, width and height of the bar test specimens;
f) characterization (manufacturer, brand name, accuracy, etc.) of the micrometer gauge or another
appropriate device used to perform all necessary dimension measurements;
g) characterization (manufacturer, brand name, accuracy, etc.) of the milling machine used to
fabricate the specimens as a well as machining conditions (bur size, bur grit, feed rate if known)
and software (manufacturer and version) used for machining;
h) instruments (manufacturer, brand-name, accuracy, etc.) used for mechanical testing and conditions
of the test (such as crosshead speed, load cell);
i) flexural strength values of each specimen as well as mean and standard deviation of each group –
control and machined;
j) percentage of change in flexural strength of the machined group as compared to the control group;
k) number of specimens that cannot be tested due to machining failure;
l) appropriate statistical analysis to determine significant differences;
m) International Standard used (including its year of publication);
n) any deviation from recommended test procedure and unusual features observed;
o) date of test.
7 Packaging and labelling
7.1 Packaging
The components of the polymer-based composite machinable blank shall be supplied in such containers
that the contents are adequately protected and the quality of the polymer-based composite machinable
blank is not adversely altered before the expiry date marked on the package and the container [see
7.2.2 f)].
7.2 Labelling
7.2.1 General
The relevant information shall be provided on the outer pack, polymer-based composite machinable
blank or included in the instructions for use.
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SIST EN ISO 5139:2023
ISO 5139:2023(E)
7.2.2 Labelling of outer pack
Each outer pack shall be labelled with at least the following information:
a) name and address of the manufacturer;
b) trade name of the polymer-based composite machinable blank;
c) shade(s) or description which can be related to the manufacturer's shade guide or that
recommended by the manufacturer;
d) size dimensions and packaging quantity;
e) any special storage conditions;
f) expiry date when stored in accordance with the recommended conditions, expressed as year and
month according to ISO 8601-1;
g) lot number (batch code);
h) the word “radio-opaque” if the material is claimed to be in accordance with the requirements of
ISO 4049:2019, 5.5.
Additional information can be included at the discretion of the manufacturer.
7.2.3 Labelling of polymer-based composite machinable blank
Machinable blank (the resin part or holding jig) shall be labelled with at least the following information:
a) statements allowing identification of the product name or product;
b) shade(s) or description which can be related to the manufacturer's shade guide or that
recommended by the manufacturer;
c) lot number (batch code).
8 Instructions for use
Instructions for use, together with the description of the product, shall be provided by the manufacturer
for the user and accompany each set or package of polymer-based composite machinable blank with at
least the following information:
a) name and address of either the manufacturer or the distributor, or both;
b) trade name of the polymer-based composite machinable blank;
c) range of application;
d) dimensions of blanks;
e) range of dimensions of inorganic filler particles and the percentage by volume of total inorganic
...
SLOVENSKI STANDARD
oSIST prEN ISO 5139:2022
01-april-2022
Zobozdravstvo - Polimerni kompozitni polizdelki, ki jih je mogoče obdelovati
(ISO/DIS 5139:2022)
Dentistry - Polymer-based composite machinable blanks (ISO/DIS 5139:2022)
Zahnheilkunde - Maschinell bearbeitbare Rohlinge aus Kompositen auf Polymerbasis
(ISO/DIS 5139:2022)
Médecine bucco-dentaire - Ébauches usinables en composite à base de polymères
(ISO/DIS 5139:2022)
Ta slovenski standard je istoveten z: prEN ISO 5139
ICS:
11.060.10 Zobotehnični materiali Dental materials
oSIST prEN ISO 5139:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 5139:2022
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oSIST prEN ISO 5139:2022
DRAFT INTERNATIONAL STANDARD
ISO/DIS 5139
ISO/TC 106/SC 9 Secretariat: JISC
Voting begins on: Voting terminates on:
2022-01-27 2022-04-21
Dentistry — Polymer-based composite machinable blanks
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
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 5139:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022
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oSIST prEN ISO 5139:2022
ISO/DIS 5139:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
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oSIST prEN ISO 5139:2022
ISO/DIS 5139:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Characteristics . 2
4.1 Requirement . 2
4.2 Recommendations . 2
4.2.1 Machining damage . 2
4.2.2 Machinability . 2
4.2.3 Bonding properties between blank and holding jig . 2
5 Sampling . 2
6 Test methods . 2
6.1 General . 2
6.2 Size of blanks . 2
6.2.1 Apparatus . 2
6.2.2 Procedure . 2
6.3 Machining damage . 3
6.3.1 General . 3
6.3.2 Apparatus . 3
6.3.3 Water . 3
6.3.4 Preparation of test specimens . 3
6.3.5 Procedure . 4
6.3.6 Expression of results . 4
7 Packaging and labelling . 5
7.1 Packaging . 5
7.2 Labelling . 5
7.2.1 General . 5
7.2.2 Labelling of outer pack . 5
7.2.3 Labelling of polymer-based composite machinable blank . 6
8 Instructions for use . .6
Annex A (Informative) Preparation method of control test specimen for flexural strength .8
Annex B (Informative) Milling design of test specimen for machining damage .12
Annex C (Informative) Test method to determine the bonding properties between blank
and holding jig .13
Bibliography .17
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oSIST prEN ISO 5139:2022
ISO/DIS 5139:2022(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 of 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
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 9, Dental
CAD/CAM system.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
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oSIST prEN ISO 5139:2022
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Introduction
Specific qualitative and quantitative test methods for demonstrating freedom from unacceptable
biological hazards are not included in this document, but it is recommended that, for the assessment of
possible biological hazards, reference should be made to ISO 10993-1 and ISO 7405.
Requirements for the materials properties of polymer-based composite machinable blanks are not
included in this document, but these requirements will be included in a revision of ISO 10477, Dentistry–
Polymer-based crown and veneering materials.
The test method to determine the bonding properties between blank and holding jig and the test method
to determine shear bond strength to milled blank surface are not included in this document, but it is
recommended to adopt the test procedure given in Annex C and D when measuring these properties.
They will be included in a revision of this document when information becomes available to Technical
Committee ISO/TC 106/SC 9.
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oSIST prEN ISO 5139:2022
DRAFT INTERNATIONAL STANDARD ISO/DIS 5139:2022(E)
Dentistry — Polymer-based composite machinable blanks
1 Scope
This document specifies the characteristics of polymer-based composite machinable blanks with
respect to the milling process, and provides the test methods that address the clinical issues specific
to those materials. In addition, it specifies the items to be described on the packaging and materials, as
well as descriptions to be included in the instructions for use.
The polymer-based composite machinable blanks that this document covered are blanks that are used
for fabricating dental restorative appliances (e.g. single crowns or inlays) by milling processes. They do
not include large-sized blanks (e.g. discs) that allow for fabrication of two or more units of crowns or
bridges from one blank.
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 1942, Dentistry — Vocabulary
ISO 3696:1987, Water for analytical laboratory use — Specification and test methods
ISO 4049, Dentistry — Polymer-based restorative materials
ISO 6344-1, Coated abrasives — Grain size analysis — Part 1: Grain size distribution test
ISO 7500-1, Metallic materials — Calibration and verification of static uniaxial testing machines — Part 1:
Tension/compression testing machines — Calibration and verification of the force-measuring system
ISO 8601-1, Date and time — Representations for information interchange — Part 1: Basic rules
ISO/FDIS 18675:2021, Dentistry — Machinable ceramic blanks
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
polymer-based composite machinable blanks
piece of solid polymer-based composite (3.2) that is subjected to subtractive methods to remove material
from the piece leaving the final desired part
3.2
polymer-based composite
polymer-based dental material including either organic filler or inorganic filler, or both fillers that have
been treated by a coupling agent to ensure chemical bonding with the polymeric matrix
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oSIST prEN ISO 5139:2022
ISO/DIS 5139:2022(E)
3.3
holding jig
mandrel
jig attaching a composite resin block to be mounted for milling machine
4 Characteristics
4.1 Requirement
Measure five product blanks in accordance with the method described in 6.2. The dimensions of all
blanks shall not be smaller than 0,25 mm nor larger than 1,00 mm than the size specified in 8 d).
4.2 Recommendations
4.2.1 Machining damage
The machining damage of blanks should be evaluated in accordance with the methods described in 6.3.
4.2.2 Machinability
The machinability of blanks can be evaluated using the test method for merlon fracture test given in
ISO/FDIS 18675, 8.
4.2.3 Bonding properties between blank and holding jig
The bonding properties between blank and holding jig should be evaluated. An example of the test
method for bonding properties is described in Annex C.
5 Sampling
The test sample shall consist of one or more packages for retail of one selected shade, corresponding
to the purpose of the test, from a single batch and contain sufficient material to carry out the specified
tests, plus an allowance for any necessary repetition of tests.
6 Test methods
6.1 General
Test specimens shall be prepared and tested at (23 ± 2) °C. The relative humidity shall be not less than
30 %.
6.2 Size of blanks
6.2.1 Apparatus
Micrometre, with an accuracy of 0,01 mm.
6.2.2 Procedure
Measure five blanks using a micrometre at the points where the size is specified by the manufacturer
in the instructions for use 8 e).
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6.3 Machining damage
6.3.1 General
Perform machining damage test according to the method described in ISO/FDIS 18675:2021, 7.
Specifically, measure the three-point flexural strength for the control specimen fabricated by cutting
and grinding and for the machined specimen fabricated using a milling machine, and compare the
results between these specimens.
6.3.2 Apparatus
6.3.2.1 Oven, set at (37 ± 1) °C.
6.3.2.2 Universal mechanical testing machine, capable of a crosshead speed of (1 ± 0,5) mm/min
and an ability to measure applied loads between 10 N and [1 000 N or 2 500 N] ;e.g. see ISO 7500-1
6.3.2.3 Fixture for three-point bending, consisting of support rollers ((1,5 ± 0,2) mm to (2 ± 0,2)
mm, in diameter) positioned with their centres (12,0 ± 0,1) mm apart. The load shall be applied at the
midpoint between the supports by means of a third roller ((1,5 ± 0,2) mm to (2 ± 0,2) mm, in diameter).
Rollers shall be made from hardened steel or other hard material having a hardness greater than 40 HRC
(Rockwell C-scale) and have a smooth surface with a roughness less than 0,5 μm Ra. It is recommended
to measure the actual spacing between the centres of the support rollers (l) to ensure it is (12,0 ± 0,5)
mm.
6.3.2.4 Micrometre, with an accuracy of 0,01 mm.
6.3.2.5 CAD/CAM milling machine
6.3.3 Water
Water shall conform to ISO 3696:1987, Grade 2.
6.3.4 Preparation of test specimens
6.3.4.1 Test specimen dimensions
Width: w = (4 ± 0,2) mm (dimension of the side at right angles to the direction of the applied load)
Thickness: b = (1,2 ± 0,2) mm (dimension of the side parallel to the direction of the applied load)
Lengths shall be at least 2 mm longer than the test span (12,0 ± 0,1) mm.
When the edge chamfer is necessary, it shall be prepared in accordance with the method described in
ISO 6872:2015, 7.3.1.2.1.
NOTE The dimensions of test specimen specified in this document are not verified for the measurement of
flexural strength absolute values for composite resin materials. There are some published scientific papers that
flexural strength test of composite machinable blanks were performed at this size.
6.3.4.2 Test parameters
Test span: l = (12,0 ± 0,5) mm (centre-to-centre distance between support rollers).
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oSIST prEN ISO 5139:2022
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6.3.4.3 Control specimen
Prepare test specimens from blanks. Polish the surface of specimen until the required thickness is
reached. Perform the final polishing using P1000 or finer silicon carbide waterproof abrasive paper.
Confirm the absence of chipping in the centre portion.
Specimens shall be plane-parallel for bending test. Prepare five specimens. Store the specimen in water
at (37 ± 1) °C for 7 d ± 4 h until the start of testing.
NOTE An example of detailed method is shown in Annex A.
6.3.4.4 Machined specimen
Fabricate test specimens of the abovementioned dimensions by the milling machine.
NOTE 1 It is desirable to adopt a milling design and processing path that avoids bending test specimens during
milling. It is also desirable to arrange appropriate sup
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