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)
Ta dokument določa značilnosti polimernih kompozitnih polizdelkov, ki jih je mogoče obdelovati, glede na postopek rezkanja in podaja preskusne metode, ki obravnavajo za te materiale značilna klinična vprašanja. Poleg tega ta dokument določa elemente, ki jih je treba opisati na embalaži in
materialih, ter opise, ki jih je treba vključiti v navodila za uporabo.
Polimerni kompozitni polizdelki, ki jih je mogoče obdelovati in so zajeti v tem dokumentu, so polizdelki, ki se uporabljajo za izdelavo stalnih zobnih pripomočkov (npr. posameznih prevlek ali inlejev) s postopki rezkanja.
Ne vključujejo večjih polizdelkov (npr. plošč), s katerimi je mogoča izdelava dveh ali več prevlek ali mostičkov iz enega polizdelka, ali materialov za začasno uporabo.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
European foreword . 3
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.
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 5139:2023(E)
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Phone: +41 22 749 01 11
Email: copyright@iso.org
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Published in Switzerland
ii
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
iii
ISO 5139:2023(E)
Foreword
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