SIST EN ISO 21850-2:2025
(Main)Dentistry - Materials for dental instruments - Part 2: Polymers (ISO 21850-2:2025)
Dentistry - Materials for dental instruments - Part 2: Polymers (ISO 21850-2:2025)
This document specifies polymers commonly used in manufacturing dental instruments.
It is applicable to polymers used to manufacture either an entire instrument or part of an instrument.
It is applicable to single-use and reusable dental instruments, whether they are connected to a power-driven system or not.
This document does not apply to oral appliances and devices (e.g. splints, mouthpieces, crowns, bridges, implants), to instruments used long-term in the mouth of the patient or to devices and instruments not made of polymers.
This document contains a selection of polymers suitable for use in the manufacture of dental instruments.
Zahnheilkunde - Werkstoffe für Dentalinstrumente - Teil 2: Kunststoffe (ISO 21850-2:2025)
Dieses Dokument legt Polymere fest, die üblicherweise für die Herstellung von Dentalinstrumenten verwendet werden.
Es ist anwendbar für Polymere, die zur Herstellung von entweder einem ganzen Instrument oder einem Teil eines Instrumentes verwendet werden.
Es ist anwendbar für einmal verwendbare und wiederverwendbare Dentalinstrumente, unabhängig davon, ob diese an ein motorbetriebenes System angeschlossen sind oder nicht.
Dieses Dokument gilt nicht für orale Vorrichtungen und Produkte (z. B. Schiene, Mundstück, Krone, Brücken, Implantate) und Instrumente, die langzeitig im Mund des Patienten verwendet werden oder für Produkte und Instrumente, die nicht aus Polymeren bestehen.
Dieses Dokument enthält eine Auswahl an Polymeren, die für die Herstellung von Dentalinstrumenten geeignet sind.
Titre manque - Partie 2: Titre manque (ISO 21850-2:2025)
Ce document spécifie les polymères couramment utilisés dans la fabrication d’instruments dentaires.
Elle s’applique aux polymères utilisés pour fabriquer un instrument entier ou une partie d’instrument.
Il s’applique aux instruments dentaires à usage unique et réutilisables, qu’ils soient ou non reliés à un système motorisé.
Ce document ne s’applique pas aux appareils et dispositifs bucco-dentaires (par exemple, attelle, embout buccal, couronne, ponts, implants), aux instruments utilisés à long terme dans la bouche du patient ou aux dispositifs et instruments qui ne sont pas fabriqués en polymères.
Ce document contient une sélection de polymères pouvant être utilisés dans la fabrication d’instruments dentaires.
Zobozdravstvo - Materiali za dentalne instrumente - 2. del: Polimeri (ISO 21850-2:2025)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2025
Zobozdravstvo - Materiali za dentalne instrumente - 2. del: Polimeri (ISO 21850-
2:2025)
Dentistry - Materials for dental instruments - Part 2: Polymers (ISO 21850-2:2025)
Zahnheilkunde - Werkstoffe für Dentalinstrumente - Teil 2: Kunststoffe (ISO 21850-
2:2025)
Titre manque - Partie 2: Titre manque (ISO 21850-2:2025)
Ta slovenski standard je istoveten z: EN ISO 21850-2:2025
ICS:
11.060.25 Zobotehnični instrumenti Dental instruments
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 21850-2
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2025
EUROPÄISCHE NORM
ICS 11.060.20
English Version
Dentistry - Materials for dental instruments - Part 2:
Polymers (ISO 21850-2:2025)
Médecine bucco-dentaire - Matériaux pour instruments Zahnheilkunde - Werkstoffe für Dentalinstrumente -
dentaires - Partie 2: Polymères (ISO 21850-2:2025) Teil 2: Polymere (ISO 21850-2:2025)
This European Standard was approved by CEN on 16 June 2025.
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
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21850-2:2025 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 21850-2:2025) 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 December 2025, and conflicting national standards
shall be withdrawn at the latest by December 2025.
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 has been prepared under a standardization request addressed to CEN by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
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 21850-2:2025 has been approved by CEN as EN ISO 21850-2:2025 without any
modification.
International
Standard
ISO 21850-2
First edition
Dentistry — Materials for dental
2025-06
instruments —
Part 2:
Polymers
Médecine bucco-dentaire — Matériaux pour instruments
dentaires —
Partie 2: Polymères
Reference number
ISO 21850-2:2025(en) © ISO 2025
ISO 21850-2:2025(en)
© ISO 2025
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
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Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 21850-2:2025(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Materials . 2
4.1 Material designation .2
4.2 Polymer name .2
5 Selection of materials . 2
5.1 Selection of polymer for dental instruments.2
5.2 Certification of analysis . .3
5.3 Examples of polymer for dental instruments .3
6 Pre-clinical evaluation . 5
Bibliography . 6
iii
ISO 21850-2:2025(en)
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 responsibl
...
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