ISO 13402
(Main)Surgical and dental hand instruments — Determination of resistance against autoclaving, corrosion and thermal exposure
Surgical and dental hand instruments — Determination of resistance against autoclaving, corrosion and thermal exposure
Describes test methods to determine the resistance of stainless steel surgical and dental hand instruments 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
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FINAL DRAFT
International
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ISO/FDIS 13402
ISO/TC 170
Surgical and dental hand
Secretariat: DIN
instruments — Determination of
Voting begins on:
resistance against autoclaving,
2024-12-05
corrosion and thermal exposure
Voting terminates on:
2025-01-30
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
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WITH THEIR COMMENTS, NOTIFICATION OF ANY
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MADE IN NATIONAL REGULATIONS.
Reference number
ISO/FDIS 13402:2024(en) © ISO 2024
FINAL DRAFT
ISO/FDIS 13402:2024(en)
International
Standard
ISO/FDIS 13402
ISO/TC 170
Surgical and dental hand
Secretariat: DIN
instruments — Determination of
Voting begins on:
resistance against autoclaving,
corrosion and thermal exposure
Voting terminates on:
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
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 SUPPOR TING DOCUMENTATION.
© ISO 2024
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
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 Reference number
ISO/FDIS 13402:2024(en) © ISO 2024
ii
ISO/FDIS 13402:2024(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/FDIS 13402:2024(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 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/FDIS 13402:2024(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
FINAL DRAFT International Standard ISO/FDIS 13402:2024(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
hand instruments against autoclaving, corrosion and thermal exposure.
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 3696, Water for analytical laboratory use — Specification and test methods
ISO 7554-3, Surgical instruments — Terms, measuring methods and tests — Part 3: Test methods
EN 13018, Non-destructive testing — Visual testing — General principles
3 Terms and definitions
No terms and definitions are listed in this document.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
4 Test methods
4.1 General
All tests are type tests.
4.2 Sampling plan
a) Each instrument manufacturer shall define an appropriate sampling plan for ensuring instrument
1)
safety and quality. The sampling shall be done according to ISO/DIS 7554-3 .
b) Rejected lots are often re-passivated and re-tested, typically using an increased sample size of
instruments. If the lot is rejected a second time, the cause of the repeat failure should be evaluated
before proceeding.
1) Under preparation.
ISO/FDIS 13402:2024(en)
4.3 Overview of test methods and applicability
Table 1 enlists several methods for testing. The tests applicable should be chosen according to the materials
of the instrument and be performed using the procedure described in respective annex.
When placing an order, the purchaser states whether both tests are to be carried out or which of the two
tests. If the purchaser does not so indicate, the choice is left to the discretion of the manufacturer.
Table 1 — Overview of test methods and applicability
Test method Applicability Annex
Boiling test in deion- Martensitic, austenitic, ferritic material with less than 16 % chromium, and Annex A
ized water precipitation hardening materials and austenitic materials, precipitation
(normative)
hardening materials shall use the boiling test.
Instruments containing stainless steel materials that are exclusively to the
following shall use the boil test and copper sulfate test: austenitic materials,
precipitation hardening materials, and ferritic materials containing equal or
greater than 16 % chromium.
The boiling test allows to detect surface imperfections, free iron, or other
anodic surface contaminations on stainless steel.
Boiling test in 0,9 % Instruments made from stainless steel materials such as austenitic ma- Annex B
NaCl solution terials, precipitation hardening materials and ferritic materials with a
(informative)
chromium content of 16 % or more should be tested with the boiling test in
0,9 % NaCl.
Copper sulfate test Instruments containing stainless steel materials that are exclusively to the Annex C
for steels with equal following shall use the copper sulfate test and boiling test: austenitic mate-
(normative)
or greater than 16 % rials, precipitation hardening materials, and ferritic materials containing
chromium. equal or greater than 16 % chromium.
Copper sulfate test Instruments made from martensitic with less than 16 % chromium, and Annex D
for steels with less precipitation hardening materials to improper heat treatment shall be
(normative)
than 16 % chromi- tested with copper sulfate test.
um
Test in 0,3 % NaCl Instruments made from Austenitic steel should be tested with 0,3 % NaCl Annex E
solution solution. (informative)
Corrosion test exclusively for austenitic steels.
Test with Citric acid Instruments made from austenitic steel should be tested with citric acid Annex F
solution solution. (informative)
Corrosion test exclusively for austenitic steels
...
ISO/DISFDIS 13402:2023(E)
ISO/TC 170
Secretariat: DIN
Date: 2024-10-2511-21
Surgical and dental hand 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
FDIS stage
DRAFT INTERNATIONAL STANDARD ISO/DIS 13402:2023(E)
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
EmailE-mail: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ISO/DISFDIS 13402:2023(E2024(en)
Contents
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/DISFDIS 13402:2023(E2024(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 2Clause 2;;
— — addition of Clause 3Clause 3;;
— — addition of Clause 4cClause 4 including a table with an overview of test methods;
— — addition of Clause 5Clause 5;;
— — addition of Annexes AAnnex A to H Annex 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.
4 © ISO 2023 – All rights reserved
iv
ISO/DISFDIS 13402:2023(E2024(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 Standardsstandards. The requirements for such tests
are defined and stated within the body of the product Standardstandard 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 compliedhave been compiled in this
document.
v
ISO/FDIS 13402:2024(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 hand
instruments against autoclaving, corrosion and thermal exposure.
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.
EN 285:2021-12; Sterilization — Steam sterilizers — Large sterilizers
EN 13018, Non-destructive testing — Visual testing — General principles
EN 13060:2019-02, Small steam sterilizers
ISO 3696:1987, Water for analytical laboratory use — Specification and test methods
ISO 7554-3, Surgical instruments — Terms, measuring methods and tests — Part 3: Test methods
EN 13018, Non-destructive testing — Visual testing — General principles
3 Terms and definitions
No terms and definitions are listed in this document.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— — ISO Online browsing platform: available at https://www.iso.org/obp
— — IEC Electropedia: available at https://www.electropedia.org/
4 Test methods
4.1 General
All tests are type tests.
4.2 Sampling plan
a) 1. Each instrument manufacturer shall define an appropriate sampling plan for ensuring instrument
1)
safety and quality. The sampling shall be done according to ISO/DIS 74457554-3. .
b) 2. Rejected lots are often re-passivated and re-tested, typically using an increased sample size of
instruments. If the lot is rejected a second time, it is recommended that the cause of the repeat failure
should be evaluated before proceeding.
1)
Under preparation.
ISO/FDIS 13402:2024(en)
4.3 Overview of test methods and applicability
Table 1Table 1 enlists several methods for testing. The tests applicable should be chosen according to the
materials of the instrument and be performed using the procedure described in respective annex.
When placing an order, the purchaser states whether both tests are to be carried out or which of the two tests.
If the purchaser does not so indicate, the choice is left to the discretion of the manufacturer.
Table 1 — Overview of test methods and applicability
Test method Applicability Annex
Boiling test in Martensitic, austenitic, ferritic material with less than 16 % chromium, Annex A
deionized water and precipitation hardening materials and austenitic materials,
Annex A
precipitation hardening materials shall use the boiling test.
(normative)
Instruments containing stainless steel materials that are exclusively to the
following shall use the boil test and copper sulfate test: austenitic
materials, precipitation hardening materials, and ferritic materials
containing equal or greater than 16 % chromium.
The boiling test allows to detect surface imperfections, free iron, or other
anodic surface contaminations on stainless steel.
Boiling test in Instruments made from stainless steel materials such as austenitic Annex B
0,9 % NaCl solution materials, precipitation hardening materials and ferritic materials with a
Annex B
chromium content of 16 % or more should be tested with the boiling test
(informative)
in 0,9 % NaCl.
Copper sulfate test Instruments containing stainless steel materials that are exclusively to the Annex C
for steels with following shall use the copper sulfate test and boiling test: austenitic
Annex C
equal or greater materials, precipitation hardening materials, and ferritic materials
(normative)
than 16 % containing equal or greater than 16 % chromium.
chromium.
Copper sulfate test Instruments made from martensitic with less than 16 % chromium, and Annex D
for steels with less precipitation hardening materials to improper heat treatment shall be
Annex D
than 16 % tested with copper sulfate test.
(normative)
chromium
Test in 0,3 % NaCl Instruments made from Austenitic steel should be tested with 0,3 % NaCl Annex EAnnex E
solution solution. (informative)
Corrosion test exclusively for austenitic steels.
Test with Citric Instruments made from austenitic steel should be tested with Citriccitric Annex FAnnex F
acid acid solution. (informative)
solution
Corrosion test exclusively for austenitic steels.
Thermal test The resistance to thermal stress of instruments made from martensitic or Annex GAnnex G
austenitic steel should be tested with the thermal test (informative)
Autoclave test Instruments made from martensitic or austenitic steel should be tested Annex HAnnex H
with the autoclave test. (normative)
(informative)
The sterilization test should simulate normal operating conditions.
5 Test report
The test report for each determination shall include at least the following information:
a) identification of the sample including description;
b) a reference to this document, i.e. ISO/FDIS 13402:——;:—;
ISO/FDIS 13402:2024(en)
c) identification of used method;
d) any unusual features observed during the determination;
e) any deviations from the procedure;
f) starting and completion dates of test;
g) identification of laboratory carrying out the analysis;
h) signature and name of (an) authorized person(s).
ISO/FDIS 13402:2024(en)
Annex A
(normative)
Boiling test in deionized water
A.1 General
The boiling test is suitable for martensitic, austenitic, ferritic materials with less than 16 % chromium and
precipitation hardening materials to detect surface defects, free iron or other anodic surface impurities on
stainless steel.
Instruments containing stainless steel materials that are exclusively to the following shall use both the boiling
test and copper sulfate test: austenitic materials, precipitation hardening materials, and ferritic materials
containing equal or greater than 16 % chromium.
A.2 Reagents
A.2.1 A.2.1 Deionized water according to EN ISO 3696, quality 3.
A.3 Apparatus
A.3.1 A.3.1 Chemically non-reacting vessel, e.g. made of glass or ceramic.
A.3
...
PROJET FINAL
Norme
internationale
ISO/FDIS 13402
ISO/TC 170
Instruments chirurgicaux et
Secrétariat: DIN
dentaires à main — Détermination
Début de vote:
de la résistance au passage à
2024-12-05
l'autoclave, à la corrosion et à
Vote clos le:
l'exposition à la chaleur
2025-01-30
Surgical and dental hand instruments — Determination of
resistance against autoclaving, corrosion and thermal exposure
LES DESTINATAIRES DU PRÉSENT PROJET SONT
INVITÉS À PRÉSENTER, AVEC LEURS OBSERVATIONS,
NOTIFICATION DES DROITS DE PROPRIÉTÉ DONT ILS
AURAIENT ÉVENTUELLEMENT CONNAISSANCE ET À
FOURNIR UNE DOCUMENTATION EXPLICATIVE.
OUTRE LE FAIT D’ÊTRE EXAMINÉS POUR
ÉTABLIR S’ILS SONT ACCEPTABLES À DES FINS
INDUSTRIELLES, TECHNOLOGIQUES ET COM-MERCIALES,
AINSI QUE DU POINT DE VUE DES UTILISATEURS, LES
PROJETS DE NORMES
TRAITEMENT PARALLÈLE ISO/CEN
INTERNATIONALES DOIVENT PARFOIS ÊTRE CONSIDÉRÉS
DU POINT DE VUE DE LEUR POSSI BILITÉ DE DEVENIR DES
NORMES POUVANT
SERVIR DE RÉFÉRENCE DANS LA RÉGLEMENTATION
NATIONALE.
Numéro de référence
ISO/FDIS 13402:2024(fr) © ISO 2024
PROJET FINAL
ISO/FDIS 13402:2024(fr)
Norme
internationale
ISO/FDIS 13402
ISO/TC 170
Instruments chirurgicaux et
Secrétariat: DIN
dentaires à main — Détermination
Début de vote:
de la résistance au passage à
2024-12-05
l'autoclave, à la corrosion et à
Vote clos le:
l'exposition à la chaleur
2025-01-30
Surgical and dental hand instruments — Determination of
resistance against autoclaving, corrosion and thermal exposure
LES DESTINATAIRES DU PRÉSENT PROJET SONT
INVITÉS À PRÉSENTER, AVEC LEURS OBSERVATIONS,
NOTIFICATION DES DROITS DE PROPRIÉTÉ DONT ILS
AURAIENT ÉVENTUELLEMENT CONNAISSANCE ET À
FOURNIR UNE DOCUMENTATION EXPLICATIVE.
DOCUMENT PROTÉGÉ PAR COPYRIGHT
OUTRE LE FAIT D’ÊTRE EXAMINÉS POUR
ÉTABLIR S’ILS SONT ACCEPTABLES À DES FINS
© ISO 2024 INDUSTRIELLES, TECHNOLOGIQUES ET COM-MERCIALES,
AINSI QUE DU POINT DE VUE DES UTILISATEURS, LES
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
PROJETS DE NORMES
TRAITEMENT PARALLÈLE ISO/CEN
INTERNATIONALES DOIVENT PARFOIS ÊTRE CONSIDÉRÉS
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
DU POINT DE VUE DE LEUR POSSI BILITÉ DE DEVENIR DES
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
NORMES POUVANT
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
SERVIR DE RÉFÉRENCE DANS LA RÉGLEMENTATION
NATIONALE.
ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
Tél.: +41 22 749 01 11
E-mail: copyright@iso.org
Web: www.iso.org
Publié en Suisse Numéro de référence
ISO/FDIS 13402:2024(fr) © ISO 2024
ii
ISO/FDIS 13402:2024(fr)
Sommaire Page
Avant-propos .iv
Introduction .v
1 Domaine d’application . 1
2 Références normatives . 1
3 Termes et définitions . 1
4 Méthodes d’essai . 1
4.1 Généralités .1
4.2 Plan d’échantillonnage .1
4.3 Vue d’ensemble des méthodes d’essai et de leur applicabilité .2
5 Rapport d’essai . 2
Annexe A (normative) Essai à l’eau bouillante dans de l’eau désionisée . 4
Annexe B (normative) Essai à l’eau bouillante dans une solution de NaCl à 0,9 % . 6
Annexe C (normative) Essai au sulfate de cuivre pour les aciers contenant au moins 16 % de
chrome . 8
Annexe D (normative) Essai au sulfate de cuivre pour les aciers martensitiques contenant
moins de 16 % de chrome . 10
Annexe E (informative) Essai dans une solution de chlorure de sodium à 0,3 % pour les aciers
austénitiques .12
Annexe F (informative) Essai avec une solution d’acide citrique pour les aciers austénitiques . 14
Annexe G (informative) Essai d’exposition à la chaleur.16
Annexe H (informative) Essai de passage à l’autoclave . 17
Bibliographie .18
iii
ISO/FDIS 13402:2024(fr)
Avant-propos
L’ISO (Organisation internationale de normalisation) est une fédération mondiale d’organismes nationaux
de normalisation (comités membres de l’ISO). L’élaboration des Normes internationales est en général
confiée aux comités techniques de l’ISO. Chaque comité membre intéressé par une étude a le droit de faire
partie du comité technique créé à cet effet. Les organisations internationales, gouvernementales et non
gouvernementales, en liaison avec l’ISO participent également aux travaux. L’ISO collabore étroitement avec
la Commission électrotechnique internationale (IEC) en ce qui concerne la normalisation électrotechnique.
Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont
décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier, de prendre note des différents
critères d’approbation requis pour les différents types de documents ISO. Le présent document
a été rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2
(voir www.iso.org/directives).
L’ISO attire l’attention sur le fait que la mise en application du présent document peut entraîner l’utilisation
d’un ou de plusieurs brevets. L’ISO ne prend pas position quant à la preuve, à la validité et à l’applicabilité
de tout droit de propriété revendiqué à cet égard. À la date de publication du présent document, l’ISO
n’avait pas reçu notification qu’un ou plusieurs brevets pouvaient être nécessaires à sa mise en application.
Toutefois, il y a lieu d’avertir les responsables de la mise en application du présent document que des
informations plus récentes sont susceptibles de figurer dans la base de données de brevets, disponible à
l’adresse www.iso.org/brevets. L’ISO ne saurait être tenue pour responsable de ne pas avoir identifié tout ou
partie de tels droits de brevet.
Les appellations commerciales éventuellement mentionnées dans le présent document sont données pour
information, par souci de commodité, à l’intention des utilisateurs et ne sauraient constituer un engagement.
Pour une explication de la nature volontaire des normes, la signification des termes et expressions
spécifiques de l’ISO liés à l’évaluation de la conformité, ou pour toute information au sujet de l’adhésion de
l’ISO aux principes de l’Organisation mondiale du commerce (OMC) concernant les obstacles techniques au
commerce (OTC), voir le lien suivant: www.iso.org/iso/fr/avant-propos.html.
Le présent document a été élaboré par le comité technique ISO/TC 170, Instruments chirurgicaux, en
collaboration avec le comité technique CEN/TC 55, Médecine bucco-dentaire, du Comité européen de
normalisation (CEN) conformément à l’Accord de coopération technique entre l’ISO et le CEN (Accord de
Vienne).
Cette seconde édition annule et remplace la première édition (ISO 13402:1995), qui a fait l’objet d’une
révision technique.
Les principales modifications sont les suivantes:
— restructuration du document;
— mise à jour de l’Article 2;
— ajout de l’Article 3;
— ajout de l’Article 4 incluant un tableau avec une vue d’ensemble des méthodes d’essai;
— ajout de l’Article 5;
— ajout des Annexes A à H incluant des méthodes d’essai.
Il convient que l’utilisateur adresse tout retour d’information ou toute question concernant le présent
document à l’organisme national de normalisation de son pays. Une liste exhaustive desdits organismes se
trouve à l’adresse www.iso.org/fr/members.html.
iv
ISO/FDIS 13402:2024(fr)
Introduction
Les méthodes décrites dans le présent document constituent une série harmonisée d’essais auxquels il est
possible de se référer, isolément ou non, dans les autres normes de produits. Les exigences relatives à ces
essais sont définies et indiquées dans le corps de la norme de produit, avec le nombre de cycles requis pour
chaque mode opératoire d’essai. Ces essais s’appliquent aux instruments dentaires et chirurgicaux et sont
déjà normalisés dans les normes de produits concernées (par exemple ISO 7151, ISO 9173-1). Cependant,
les modes opératoires d’essai indiqués dans les normes de produits étant quelque peu différents, il a été
procédé à un alignement et à une compilation.
Les méthodes d’essai applicables aux instruments dentaires et chirurgicaux, les plus importantes ont été
compilées dans le présent document.
v
PROJET FINAL Norme internationale ISO/FDIS 13402:2024(fr)
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
1 Domaine d’application
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.
2 Références normatives
Les documents suivants sont cités dans le texte de sorte qu’ils constituent, pour tout ou partie de leur
contenu, des exigences du présent document. Pour les références datées, seule l’édition citée s’applique. Pour
les références non datées, la dernière édition du document de référence s'applique (y compris les éventuels
amendements).
ISO 3696, Eau pour laboratoire à usage analytique — Spécification et méthodes d'essai
ISO 7554-3, Instruments chirurgicaux — Termes, méthodes de mesurage et essais — Partie 3: Méthodes d’essai
EN 13018, Essais non destructifs — Examen visuel — Principes généraux
3 Termes et définitions
Aucun terme n’est défini dans le présent document.
L’ISO et l’IEC tiennent à jour des bases de données terminologiques destinées à être utilisées en normalisation,
consultables aux adresses suivantes:
— ISO Online browsing platform: disponible à l’adresse https:// www .iso .org/ obp
— IEC Electropedia: disponible à l’adresse https:// www .electropedia .org/
4 Méthodes d’essai
4.1 Généralités
Tous les essais sont des essais de type.
4.2 Plan d’échantillonnage
a) Chaque fabricant d’instruments doit définir un plan d’échantillonnage approprié pour assurer la sécurité
1)
et la qualité des instruments. L’échantillonnage doit être réalisé conformément à l’ISO/DIS 7554-3 .
b) Les lots rejetés sont souvent soumis à une nouvelle passivation et à de nouveaux essais, en utilisant
généralement un effectif d’échantillon d’instruments plus important. Si le lot est rejeté une deuxième
fois, il convient d’évaluer la cause de l’échec répété avant de poursuivre.
1) En cours d’élaboration
ISO/FDIS 13402:2024(fr)
4.3 Vue d’ensemble des méthodes d’essai et de leur applicabilité
Le Tableau 1 énumère plusieurs méthodes d’essai. Il convient de choisir les essais applicables en fonction
des matériaux de l’instrument et de les effectuer en utilisant le mode opératoire décrit dans l’annexe
correspondante.
Lorsqu’un acheteur passe une commande, il indique s’il faut effectuer les deux essais ou un seul, et dans ce
cas lequel. Si l’acheteur ne donne aucune indication, le choix est laissé à la discrétion du fabricant.
Tableau 1 — Vue d’ensemble des méthodes d’essai et de leur applicabilité
Méthode d’essai Applicabilité Annexe
Essai à l’eau bouil- Les matériaux martensitiques, austénitiques, ferritiques contenant moins Annexe A
lante dans de l’eau de 16 % de chrome, ainsi que les matériaux durcis par précipitation et les
(normative)
désionisée matéria
...
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