SIST EN ISO 13402:2025
(Main)Surgical and dental hand instruments - Determination of resistance against autoclaving, corrosion and thermal exposure (ISO 13402:2025)
Surgical and dental hand instruments - Determination of resistance against autoclaving, corrosion and thermal exposure (ISO 13402:2025)
This document describes test methods to determine the resistance of stainless steel surgical and dental hand instruments against autoclaving, corrosion and thermal exposure.
Chirurgische und zahnärztliche Handinstrumente - Bestimmung der Beständigkeit gegenüber Sterilisation, Korrosion und Wärmebehandlung (ISO 13402:2025)
Dieses Dokument beschreibt Prüfverfahren zur Bestimmung der Beständigkeit von chirurgischen und zahnärztlichen Handinstrumenten aus nichtrostendem Stahl gegen Autoklavieren, Korrosion und Wärmeeinwirkung.
Instruments chirurgicaux et dentaires à main - Détermination de la résistance au passage à l'autoclave, à la corrosion et à l'exposition à la chaleur (ISO 13402:2025)
Le présent document décrit des méthodes d’essai qui permettent de déterminer la résistance des instruments chirurgicaux et dentaires à main en acier inoxydable au passage à l’autoclave, à la corrosion et à l’exposition à la chaleur.
Kirurški in zobozdravstveni ročni instrumenti - Določanje odpornosti proti avtoklaviranju, koroziji in toplotni izpostavljenosti (ISO 13402:2025)
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Standards Content (Sample)
SLOVENSKI STANDARD
01-maj-2025
Nadomešča:
SIST EN ISO 13402:2001
Kirurški in zobozdravstveni ročni instrumenti - Določanje odpornosti proti
avtoklaviranju, koroziji in toplotni izpostavljenosti (ISO 13402:2025)
Surgical and dental hand instruments - Determination of resistance against autoclaving,
corrosion and thermal exposure (ISO 13402:2025)
Chirurgische und zahnärztliche Handinstrumente - Bestimmung der Beständigkeit
gegenüber Sterilisation, Korrosion und Wärmebehandlung (ISO 13402:2025)
Instruments chirurgicaux et dentaires à main - Détermination de la résistance au
passage à l'autoclave, à la corrosion et à l'exposition à la chaleur (ISO 13402:2025)
Ta slovenski standard je istoveten z: EN ISO 13402:2025
ICS:
11.040.30 Operacijski instrumenti in Surgical instruments and
materiali materials
11.060.25 Zobotehnični instrumenti Dental instruments
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 13402
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2025
EUROPÄISCHE NORM
ICS 11.040.30; 11.060.25 Supersedes EN ISO 13402:2000
English Version
Surgical and dental hand instruments - Determination of
resistance against autoclaving, corrosion and thermal
exposure (ISO 13402:2025)
Instruments chirurgicaux et dentaires à main - Chirurgische und zahnärztliche Handinstrumente -
Détermination de la résistance au passage à Bestimmung der Beständigkeit gegenüber Sterilisation,
l'autoclave, à la corrosion et à l'exposition à la chaleur Korrosion und Wärmebehandlung (ISO 13402:2025)
(ISO 13402:2025)
This European Standard was approved by CEN on 2 March 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 13402:2025 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 13402:2025) has been prepared by Technical Committee ISO/TC 170 "Surgical
instruments" 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 September 2025, and conflicting national standards
shall be withdrawn at the latest by September 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 supersedes EN ISO 13402:2000.
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 13402:2025 has been approved by CEN as EN ISO 13402:2025 without any modification.
International
Standard
ISO 13402
Second edition
Surgical and dental hand
2025-03
instruments — Determination of
resistance against autoclaving,
corrosion and thermal exposure
Instruments chirurgicaux et dentaires à main — Détermination
de la résistance au passage à l'autoclave, à la corrosion et à
l'exposition à la chaleur
Reference number
ISO 13402:2025(en) © ISO 2025
ISO 13402:2025(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
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
ii
ISO 13402:2025(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Test methods . 1
4.1 General .1
4.2 Sampling plan .1
4.3 Overview of test methods and applicability .2
5 Test report . 2
Annex A (normative) Boiling test in deionized water . 4
Annex B (normative) Boiling test in 0,9 % NaCl solution. 6
Annex C (normative) Copper sulfate test for steels with equal or greater than 16 % chromium . 8
Annex D (normative) Copper sulfate test for martensitic steels with less than 16 % chromium .10
Annex E (informative) Test in 0,3 % sodium chloride solution of austenitic steels .12
Annex F (informative) Test with citric acid solution for austenitic steels . 14
Annex G (informative) Thermal test . 16
Annex H (informative) Autoclave test . 17
Bibliography .18
iii
ISO 13402:2025(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 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 170, Surgical 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).
This second edition cancels and replaces the first edition (ISO 13402:1995), which has been technically
revised.
The main changes are as follows:
— restructuring of the document;
— update of Clause 2;
— addition of Clause 3;
— addition of Clause 4 including a table with an overview of test methods;
— addition of Clause 5;
— addition of Annexes A to H including test methods.
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 13402:2025(en)
Introduction
The procedures described in this document form a harmonized series of tests that can be referred to,
individually or in combination, in other separate product standards. The requirements for such tests are
defined and stated within the body of the product standard along with the number of cycles for each test
procedure. The tests apply to dental and surgical instruments and are already standardized in relevant
product standards (e.g. ISO 7151, ISO 9173-1). However, the test procedures as stated in the product
standards differ in minor details. An alignment and a compilation were established.
The most important test methods for dental and surgical instruments have been compiled in this document.
v
International Standard ISO 13402:2025(en)
Surgical and dental hand instruments — Determination
of resistance against autoclaving, corrosion and thermal
exposure
1 Scope
This document describes test methods to determine the resistance of stainless steel surgical and dental
ha
...
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