kSIST FprEN ISO 21850-2:2025

Dentistry - Materials for dental instruments - Part 2: Polymers (ISO/FDIS 21850-2:2025)

This document specifies polymers commonly used in manufacturing dental instruments.
It is applicaple to polymers materials used to manufacture either an entire instrument or a part of the instrument.
It is applicable to single-use and reusable dental instruments, connected to a power-driven system or not.
This document is not applicable to devices and instruments used long-term in the mouth of the patient (e.g. crown, bridges, implants) or to devices and instruments not made of polymers.
It contains a current selection of polymers suitable for use in the manufacture of dental instruments.

Zahnheilkunde - Werkstoffe für Dentalinstrumente - Teil 2: Kunststoffe (ISO/FDIS 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/FDIS 21850-2:2025)

Zobozdravstvo - Materiali za dentalne instrumente - 2. del: Polimeri (ISO/FDIS 21850-2:2025)

General Information

• Status: Not Published
• Public Enquiry End Date: 30-Jul-2024
• ICS: 11.060.20 - Dental equipment
• ICS: 11.060.25 - Dental instruments
• Technical Committee: VAZ - Healthcare
• Current Stage: 5020 - Formal vote (FV) (Adopted Project)
• Start Date: 27-Mar-2025
• Due Date: 15-May-2025
• Completion Date: 31-Mar-2025
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Ref Project: FprEN ISO 21850-2 - Dentistry - Materials for dental instruments - Part 2: Polymers (ISO/FDIS 21850-2:2025)

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN ISO 21850-2:2024
01-julij-2024
Zobozdravstvo - Materiali za dentalne instrumente - 2. del: Polimeri (ISO/DIS 21850
-2:2024)
Dentistry - Materials for dental instruments - Part 2: Polymers (ISO/DIS 21850-2:2024)
Zahnheilkunde - Werkstoffe für Dentalinstrumente - Teil 2: Kunststoffe (ISO/DIS 21850-
2:2024)
Titre manque - Partie 2: Titre manque (ISO/DIS 21850-2:2024)
Ta slovenski standard je istoveten z: prEN ISO 21850-2
ICS:
11.060.25 Zobotehnični instrumenti Dental instruments
oSIST prEN ISO 21850-2:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN ISO 21850-2:2024
oSIST prEN ISO 21850-2:2024
DRAFT
International
Standard
ISO/DIS 21850-2
ISO/TC 106/SC 4
Dentistry — Materials for dental
Secretariat: DIN
instruments —
Voting begins on:
Part 2: 2024-05-20
Polymers
Voting terminates on:
2024-08-12
ICS: 11.060.20
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
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.
Reference number
ISO/DIS 21850-2:2024(en)
oSIST prEN ISO 21850-2:2024
DRAFT
ISO/DIS 21850-2:2024(en)
International
Standard
ISO/DIS 21850-2
ISO/TC 106/SC 4
Dentistry — Materials for dental
Secretariat: DIN
instruments —
Voting begins on:
Part 2:
Polymers
Voting terminates on:
ICS: 11.060.20
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2024
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: [phone]
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 21850-2:2024(en)
ii
oSIST prEN ISO 21850-2:2024
ISO/DIS 21850-2:2024(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
oSIST prEN ISO 21850-2:2024
ISO/DIS 21850-2:2024(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 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, Dentsitry, Subcommittee SC 4, Dental
instruments.
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.

iv
oSIST prEN ISO 21850-2:2024
ISO/DIS 21850-2:2024(en)
Introduction
There is increasing number of newly developed dental surgical techniques with increasing number of
procedures such as dental implant placements. Market for the dental instrument is also rapidly growing
with demands for new and better instruments.
This document is intended to harmonize the approval procedures and to reduce the costs caused by repeated
approval and test procedures in different coun
...