EN ISO 21850-1:2020

SLOVENSKI STANDARD
01-julij-2020
Zobozdravstvo - Materiali za dentalne instrumente - 1. del: Nerjavno jeklo (ISO
21850-1:2020)
Dentistry - Materials for dental instruments - Part 1: Stainless steel (ISO 21850-1:2020)
Zahnheilkunde - Werkstoffe für Dentalinstrumente - Teil 1: Nichtrostende Stähle (ISO
21850-1:2020)
Médecine bucco-dentaire - Matériaux pour instruments dentaires - Partie 1: Partie 1:
Acier inoxydables (ISO 21850-1:2020)
Ta slovenski standard je istoveten z: EN ISO 21850-1:2020
ICS:
11.060.25 Zobotehnični instrumenti Dental instruments
77.140.20 Visokokakovostna jekla Stainless steels
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 21850-1
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2020
EUROPÄISCHE NORM
ICS 11.060.20
English Version
Dentistry - Materials for dental instruments - Part 1:
Stainless steel (ISO 21850-1:2020)
Médecine bucco-dentaire - Matériaux pour instruments Zahnheilkunde - Werkstoffe für Dentalinstrumente -
dentaires - Partie 1: Partie 1: Acier inoxydables (ISO Teil 1: Nichtrostende Stähle (ISO 21850-1:2020)
21850-1:2020)
This European Standard was approved by CEN on 26 April 2020.

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, Turkey 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
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21850-1:2020 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 21850-1:2020) 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 2020, and conflicting national standards
shall be withdrawn at the latest by November 2020.
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.
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, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 21850-1:2020 has been approved by CEN as EN ISO 21850-1:2020 without any
modification.
INTERNATIONAL ISO
STANDARD 21850-1
First edition
2020-04
Dentistry — Materials for dental
instruments —
Part 1:
Stainless steel
Médecine bucco-dentaire — Matériaux pour instruments dentaires —
Partie 1: Acier inoxydables
Reference number
ISO 21850-1:2020(E)
©
ISO 2020
ISO 21850-1:2020(E)
© ISO 2020
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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved

ISO 21850-1:2020(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Materials . 2
5 Selection of materials . 5
6 Performance evaluation — Pre-clinical evaluation .12
Annex A (informative) Equivalent stainless steels .13
Annex B (informative) Hardness, corrosion resistance, and mechanical strength .15
Bibliography .16
ISO 21850-1:2020(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 4,
Dental instruments, 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).
A list of all parts in the ISO 21850 series can be found on the ISO website.
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 © ISO 2020 – All rights reserved

ISO 21850-1:2020(E)
Introduction
There is an increasing number of newly developed dental surgical techniques with an increasing
number of procedures such as dental implant placements. The 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 countries with regard to the stainless steel materials
used in dental instruments.
INTERNATIONAL STANDARD ISO 21850-1:2020(E)
Dentistry — Materials for dental instruments —
Part 1:
Stainless steel
1 Scope
This document specifies stainless steel commonly used in manufacturing dental instruments.
It is applicable to stainless steel materials used to manufacture either an entire instrument or a part of
the instrument.
It is applicable to single-use and reusable dental instruments, whether it is or it is not connected to a
power-driven system.
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 stainless steel.
It contains a current selection of stainless steels suitable for use in the manufacture of dental
instruments.
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 7405, Dentistry — Evaluation of biocompatibility of medical devices used in dentistry
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 15510, Stainless steels — Chemical composition
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 http:// www .electropedia .org/
3.1
dental instrument
tool specially designed for use in dentistry
3.2
stainless steel
steel whose most characterizing element is chromium of at least 10,5 % (mass fraction) Cr and maximum
1,2 % (mass fraction) C, and the primary importance of which is its resistance to corrosion
ISO 21850-1:2020(E)
3.2.1
austenitic stainless steel
stainless steel (3.2) typically composed of less than 0,2 % (mass fraction) C, at least 16 % (mass fraction)
Cr, typically about 18 % (mass fraction) Cr and over 8 % (mass fraction) Ni, which cannot be hardened
by heat treatment
3.2.2
martensitic stainless steel
stainless steel (3.2) with low to medium carbon, at least 0,08 % (mass fraction) C and between 11,5 %
(mass fraction) and 19 % (mass fraction) Cr, which can be hardened by quenching and tempering
3.2.3
precipitation-hardening stainless steel
stainless steel (3.2) with a high strength resulting from the precipitation of intermetallic compounds
(the formation of very fine intermetallic phases, carbides and laves phases in the structure) by a final
heat treatment
3.2.4
ferritic stainless steel
stainless steel (3.2) with low carbon with less than 0,1 % (mass fraction) C and between 10,5 % (mass
fraction) and 30 % (mass fraction) Cr, but which cannot be hardened by heat treatment
4 Materials
4.1 Material designation
The specification of the chemical composition and the material designation of the stainle
...