prEN ISO 13402
(Main)Surgical and dental hand instruments - Determination of resistance against autoclaving, corrosion and thermal exposure (ISO/DIS 13402:2023)
Surgical and dental hand instruments - Determination of resistance against autoclaving, corrosion and thermal exposure (ISO/DIS 13402:2023)
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/DIS 13402:2023)
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/DIS 13402:2023)
Kirurški in zobozdravstveni ročni instrumenti - Določanje odpornosti proti avtoklaviranju, koroziji in toplotni izpostavljenosti (ISO/DIS 13402:2023)
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Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2024
Nadomešča:
SIST EN ISO 13402:2001
Kirurški in zobozdravstveni ročni instrumenti - Določanje odpornosti proti
avtoklaviranju, koroziji in toplotni izpostavljenosti (ISO/DIS 13402:2023)
Surgical and dental hand instruments - Determination of resistance against autoclaving,
corrosion and thermal exposure (ISO/DIS 13402:2023)
Chirurgische und zahnärztliche Handinstrumente - Bestimmung der Beständigkeit
gegenüber Sterilisation, Korrosion und Wärmebehandlung (ISO/DIS 13402:2023)
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/DIS 13402:2023)
Ta slovenski standard je istoveten z: prEN ISO 13402
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.
DRAFT INTERNATIONAL STANDARD
ISO/DIS 13402
ISO/TC 170 Secretariat: DIN
Voting begins on: Voting terminates on:
2023-11-16 2024-02-08
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
ICS: 11.040.30; 11.060.20
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
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USER PURPOSES, DRAFT INTERNATIONAL
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Reference number
NATIONAL REGULATIONS.
ISO/DIS 13402:2023(E)
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. © ISO 2023
ISO/DIS 13402:2023(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 13402
ISO/TC 170 Secretariat: DIN
Voting begins on: Voting terminates on:
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
ICS: 11.040.30; 11.060.20
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
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IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
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NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 13402:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
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TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023
ISO/DIS 13402:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General considerations / principle . 1
4.1 General . 1
4.2 Sampling plan . 1
5 Test report . 2
Annex A (normative) Boiling test in deionized water . 4
Annex B (normative) Boiling test in 0,9 % NaCl solution. 5
Annex C (normative) Copper sulfate test .7
Annex D (informative) Test in 0,3 % sodium chloride solution of austenitic steels .9
Annex E (informative) Test with Citric acid solution for austenitic steels .11
Annex F (informative) Testing the passive layer of martensitic and austenitic steels with ®
KorroPad .13
Annex G (informative) Thermal Test .14
Annex H (informative) Autoclav test .15
iii
ISO/DIS 13402:2023(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 170, Surgical instruments.
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 “Normative references”;
— addition of Clause 3 “Terms and definitions”;
— Addition of clause 4 “General considerations” and addition of table Sampling plan and table 2 with
an overview on test methods”;
— Addition of Clause 5 “Test report”.
— Addition of test methods in Annex A to Annex H.
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/DIS 13402:2023(E)
Introduction
The procedures described in this document are intended to form a harmonized series of tests that may
be referred to, individually or in combination, in other separate product Standards. The requirements
for such tests shall be 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, SurgicaI instruments - Non-cutting,
articulated instruments - General requirements and test methods; ISO 9173-1 Dental extraction forceps -
Part 7: Screw and pin joint types). However, the test procedures as stated in the product standards differ
in minor details. An alignment and a compilation was established.
The most important test methods for dental and surgical instruments have been brought together in
one general document.
Other, additional, tests may also be required in individual product standards; those procedures and
requirements will be determined by the members of the working groups concerned. When established,
it is intended that these additional test procedures are incorporated in this document as an addendum
or at the next revision. This document does not specify any test sequence nor any requirements related
to specific instruments. The requirements, the test sequence and the number of test cycles have to be
defined in the relevant product Standards or, if no Standard is available, it has to be left to the decision
of the purchaser and/or the manufacturer.
Apart from the boiling water test, the autoclave test applies for determining corrosion resistance. In
this sense, this International Standard specifies two test methods for determining corrosion resistance.
When placing an Order, it is intended that the purchaser state 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.
v
DRAFT INTERNATIONAL STANDARD ISO/DIS 13402:2023(E)
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.
The requirements for such tests are defined and stated in the product Standard along with the number
of cycles for each test procedure. Other, additional, tests may also be required (see the Introduction).
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 13018, Non-destructive testing — Visual testing — General principles
EN 13060, Small steam sterilizers
ISO 3696:1987, Water for analytical laboratory use — Specification and test methods
ISO 15883, — Washer-disinfectors — Part 1: General requirements, terms and definitions and tests
ISO 17664, Processing of health care products — Information to be provided by the medical device
manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
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 General considerations / principle
4.1 General
All test are type tests.
...
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