SIST EN ISO 9333:2023
(Main)Dentistry - Brazing materials (ISO 9333:2022)
Dentistry - Brazing materials (ISO 9333:2022)
This document specifies the requirements and test methods for dental brazing materials suitable for
use in metallic restorations.
Brazing materials with silver as the main component are excluded from this document.
Zahnheilkunde - Hartlote (ISO 9333:2022)
Dieses Dokument legt Anforderungen an und Prüfverfahren für dentale Hartlote fest, die zur Anwendung an metallischem Zahnersatz geeignet sind.
Ausgenommen sind Hartlote mit Silber als Hauptkomponente.
Médecine bucco-dentaire - Produits pour brasage (ISO 9333:2022)
Le présent document spécifie les exigences et les méthodes d’essai relatives aux produits pour brasage dentaire dont l'utilisation convient pour effectuer des restaurations métalliques.
Les produits pour brasage contenant de l’argent comme composant principal sont exclus du présent document.
Zobozdravstvo - Materiali za spajkanje (ISO 9333:2022)
Ta dokument določa zahteve in preskusne metode za dentalne materiale za spajkanje, primer za
uporabo pri kovinskih restavracijah.
Materiali za spajkanje, katerih glavna sestavina je srebro, niso vključeni v ta dokument.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 9333:2023
01-januar-2023
Nadomešča:
SIST EN ISO 9333:2006
Zobozdravstvo - Materiali za spajkanje (ISO 9333:2022)
Dentistry - Brazing materials (ISO 9333:2022)
Zahnheilkunde - Hartlote (ISO 9333:2022)
Médecine bucco-dentaire - Produits pour brasage (ISO 9333:2022)
Ta slovenski standard je istoveten z: EN ISO 9333:2022
ICS:
11.060.10 Zobotehnični materiali Dental materials
SIST EN ISO 9333:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 9333:2023
EN ISO 9333
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2022
EUROPÄISCHE NORM
ICS 11.060.10 Supersedes EN ISO 9333:2006
English Version
Dentistry - Brazing materials (ISO 9333:2022)
Médecine bucco-dentaire - Produits pour brasage (ISO Zahnheilkunde - Hartlote (ISO 9333:2022)
9333:2022)This European Standard was approved by CEN on 3 September 2022.
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
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 9333:2022 E
worldwide for CEN national Members.---------------------- Page: 3 ----------------------
SIST EN ISO 9333:2023
EN ISO 9333:2022 (E)
Contents Page
European foreword ....................................................................................................................................................... 3
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EN ISO 9333:2022 (E)
European foreword
This document (EN ISO 9333:2022) 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 April 2023, and conflicting national standards shall be
withdrawn at the latest by April 2023.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 9333:2006.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 9333:2022 has been approved by CEN as EN ISO 9333:2022 without any modification.
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SIST EN ISO 9333:2023
INTERNATIONAL ISO
STANDARD 9333
Third edition
2022-08
Dentistry — Brazing materials
Médecine bucco-dentaire — Produits pour brasage
Reference number
ISO 9333:2022(E)
© ISO 2022
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SIST EN ISO 9333:2023
ISO 9333:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022
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
© ISO 2022 – All rights reserved
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SIST EN ISO 9333:2023
ISO 9333:2022(E)
Contents Page
Foreword ..........................................................................................................................................................................................................................................v
1 S c op e ................................................................................................................................................................................................................................. 1
2 Nor m at i ve r ef er enc e s ..................................................................................................................................................................................... 1
3 Terms and definitions .................................................................................................................................................................................... 1
4 R e qu i r ement s .......................................................................................................................................................................................................... 2
4.1 Chemical composition ...................................................................................................................................................................... 2
4.1.1 Metallic materials to be joined .............................................................................................................................. 2
4.1.2 R eported composition ................................................................................................................................................... 2
4.1.3 Permitted deviation from the reported composition ........................................................................ 2
4.1.4 Hazardous elements ........................................................................................................................................................ 2
4.2 Biocompatibility .................................................................................................................................................................................... 2
4.3 M echanical tensile strength of brazed joints .............................................................................................................. 2
4.4 C orrosion resistance ......................................................................................................................................................................... 3
4.4.1 S tatic immersion test ...................................................................................................................................................... 3
4.4.2 A ppearance after corrosion exposure ............................................................................................................ 3
4.5 M elting range ........................................................................................................................................................................................... 3
5 S a mpl i n g ....................................................................................................................................................................................................................... 3
6 P reparation of specimens ..........................................................................................................................................................................3
6.1 General ........................................................................................................................................................................................................... 3
6.1.1 Test specimen ........................................................................................................................................................................ 3
6.1.2 C asting ......................................................................................................................................................................................... 3
6.1.3 Other methods ...................................................................................................................................................................... 4
6.1.4 Treatment of specimens ........................................................................................................................................... .... 4
6.2 Sp ecimens for corrosion testing ............................................................................................................................................. 4
6.2.1 G eneral ........................................................................................................................................................................................ 4
6.2.2 P rocedure ................................................................................................................................................................................. 4
6.3 S pecimens for tensile testing ..................................................................................................................................................... 4
6.3.1 G eneral ........................................................................................................................................................................................ 4
6.3.2 Procedure ................................................................................................................................................................................. 4
6.3.3 Additional testing .............................................................................................................................................................. 5
7 M easurement and test methods ..........................................................................................................................................................6
7.1 Vi sual inspection .................................................................................................................................................................................. 6
7.1.1 S pecimens ................................................................................................................................................................................. 6
7.1.2 I nstruction for use, packaging and labelling ............................................................................................. 6
7.2 Chemical composition ...................................................................................................................................................................... 6
7.3 T ensile testing ......................................................................................................................................................................................... 6
7.3.1 Apparatus ................................................................................................................................................................................. 6
7.3.2 Test procedure...................................................................................................................................................................... 6
7.3.3 Evaluation of the tensile test results ................................................................................................................ 7
7.4 Corrosion resistance ......................................................................................................................................................................... 7
7.4.1 G eneral ........................................................................................................................................................................................ 7
7.4.2 Analysis ...................................................................................................................................................................................... 7
7.4.3 Microscopic inspection ................................................................................................................................................. 7
7.4.4 C orrosion test report ...................................................................................................................................................... 7
7.5 M elting range ........................................................................................................................................................................................... 8
8 Te s t r ep or t .................................................................................................................................................................................................................. 8
9 I nstruction for use .............................................................................................................................................................................................8
10 M arking and labelling .................................................................................................................................................................................... 9
10.1 M arking ......................................................................................................................................................................................................... 9
10.2 Labelling ....................................................................................................................................................................................................... 9
10.3 Packaging .................................................................................................................................................................................................... 9
iii© ISO 2022 – All rights reserved
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SIST EN ISO 9333:2023
ISO 9333:2022(E)
Bibliography .............................................................................................................................................................................................................................10
© ISO 2022 – All rights reserved---------------------- Page: 10 ----------------------
SIST EN ISO 9333:2023
ISO 9333:2022(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 2,
Prosthodontic materials, 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 third edition cancels and replaces the second edition (ISO 9333:2006), which has been technically
revised.The main changes are as follows:
— the brazing materials with silver as the main component have been excluded from the scope;
— the definitions in Clause 3 have been clarified and harmonized with ISO 22674;— the corrosion requirements in 4.4 have been harmonized with ISO 22674 and ISO 10271;
— the analysis of corrosion elements has been added as a requirement in 7.4.2;— the melting range requirements (7.5) have been harmonized with ISO 22674;
— a requirement for a test report has been added as a new Clause 8;
— the IFU requirement for a working temperature has been added in Clause 9;
— the labelling requirement for marking of working temperature has been added in Clause 10 as
optional.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.© ISO 2022 – All rights reserved
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SIST EN ISO 9333:2023
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SIST EN ISO 9333:2023
INTERNATIONAL STANDARD ISO 9333:2022(E)
Dentistry — Brazing materials
1 S cope
This document specifies the requirements and test methods for dental brazing
...
SLOVENSKI STANDARD
oSIST prEN ISO 9333:2021
01-oktober-2021
Zobozdravstvo - Materiali za spajkanje (ISO/DIS 9333:2021)
Dentistry - Brazing materials (ISO/DIS 9333:2021)
Zahnheilkunde - Hartlote (ISO/DIS 9333:2021)
Médecine bucco-dentaire - Produits pour brasage (ISO/DIS 9333:2021)
Ta slovenski standard je istoveten z: prEN ISO 9333
ICS:
11.060.10 Zobotehnični materiali Dental materials
oSIST prEN ISO 9333:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------oSIST prEN ISO 9333:2021
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oSIST prEN ISO 9333:2021
DRAFT INTERNATIONAL STANDARD
ISO/DIS 9333
ISO/TC 106/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
2021-08-10 2021-11-02
Dentistry — Brazing materials
Médecine bucco-dentaire — Produits pour brasage
ICS: 11.060.10
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 9333:2021(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 2021
---------------------- Page: 3 ----------------------
oSIST prEN ISO 9333:2021
ISO/DIS 9333:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021
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 2021 – All rights reserved
---------------------- Page: 4 ----------------------
oSIST prEN ISO 9333:2021
ISO/DIS 9333:2021(E)
Contents Page
Foreword ..........................................................................................................................................................................................................................................v
1 Scope ................................................................................................................................................................................................................................. 1
2 Normative references ...................................................................................................................................................................................... 1
3 Terms and definitions ..................................................................................................................................................................................... 1
4 Requirements .......................................................................................................................................................................................................... 2
4.1 Chemical composition ...................................................................................................................................................................... 2
4.1.1 Metallic materials to be joined............................................................................................................................. 2
4.1.2 Reported composition ................................................................................................................................................. 2
4.1.3 Permitted deviation from the reported composition ....................................................................... 2
4.1.4 Hazardous elements ..................................................................................................................................................... 2
4.2 Biocompatibility .................................................................................................................................................................................... 3
4.3 Mechanical tensile strength of brazed joints ................................................................................................................ 3
4.4 Corrosion resistance .......................................................................................................................................................................... 3
4.4.1 Static immersion test ................................................................................................................................................... 3
4.4.2 Appearance after corrosion exposure ........................................................................................................... 3
4.5 Melting range ............................................................................................................................................................................................ 3
5 Sampling ........................................................................................................................................................................................................................ 3
6 Preparation of specimens ........................................................................................................................................................................... 4
6.1 General ........................................................................................................................................................................................................... 4
6.1.1 Test specimen ..................................................................................................................................................................... 4
6.1.2 Casting ...................................................................................................................................................................................... 4
6.1.3 Other methods ................................................................................................................................................................... 4
6.1.4 Treatment of specimens ............................................................................................................................................ 4
6.2 Specimens for corrosion testing .............................................................................................................................................. 4
6.2.1 General...................................................................................................................................................................................... 4
6.2.2 Procedure ............................................................................................................................................................................... 4
6.3 Specimens for tensile testing ...................................................................................................................................................... 5
6.3.1 General...................................................................................................................................................................................... 5
6.3.2 Procedure ............................................................................................................................................................................... 5
6.3.3 Additional testing ............................................................................................................................................................ 5
7 Measurement and test methods ........................................................................................................................................................... 6
7.1 Visual inspection ................................................................................................................................................................................... 6
7.1.1 Specimens .............................................................................................................................................................................. 6
7.1.2 Instruction for use, packaging and labelling ............................................................................................ 6
7.2 Chemical composition ...................................................................................................................................................................... 6
7.3 Tensile testing .......................................................................................................................................................................................... 6
7.3.1 Apparatus ............................................................................................................................................................................... 6
7.3.2 Test procedure ................................................................................................................................................................... 7
7.3.3 Evaluation of the tensile test results ............................................................................................................... 7
7.4 Corrosion resistance .......................................................................................................................................................................... 7
7.4.1 General...................................................................................................................................................................................... 7
7.4.2 Analysis .................................................................................................................................................................................... 7
7.4.3 Microscopic inspection ............................................................................................................................................... 8
7.4.4 Corrosion test report .................................................................................................................................................... 8
7.5 Melting range ............................................................................................................................................................................................ 8
8 Test report ................................................................................................................................................................................................................... 8
9 Instruction for use .............................................................................................................................................................................................. 9
10 Marking and labelling ..................................................................................................................................................................................... 9
10.1 Marking ......................................................................................................................................................................................................... 9
10.2 Labelling ....................................................................................................................................................................................................... 9
10.3 Packaging ..................................................................................................................................................................................................10
© ISO 2021 – All rights reserved iii---------------------- Page: 5 ----------------------
oSIST prEN ISO 9333:2021
ISO/DIS 9333:2021(E)
Bibliography .............................................................................................................................................................................................................................11
iv © ISO 2021 – All rights reserved---------------------- Page: 6 ----------------------
oSIST prEN ISO 9333:2021
ISO/DIS 9333:2021(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 2,
Prosthodontic materials.This third edition cancels and replaces the second edition (ISO 9333:2006), which has been technically
revised.The main changes compared to the previous edition are as follows:
— exclusion of brazing materials with silver as main component from the scope;
— clarification of definitions (Clause 3) and harmonisation with ISO/DIS 22674:2021;
— harmonization of corrosion requirements (4.4) with ISO/DIS 22674:2021 and ISO 10271;
— analysis of corrosion elements is required in 7.4.2;— harmonization of melting range requirements (7.5) with ISO/DIS 22674:2021;
— requirement for test report was added as Clause 8;
— IFU requirement for working temperature was added in Clause 9;
— labelling requirement for marking of working temperature was added in Clause 10 as optional.
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.© ISO 2021 – All rights reserved v
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oSIST prEN ISO 9333:2021
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oSIST prEN ISO 9333:2021
DRAFT INTERNATIONAL STANDARD ISO/DIS 9333:2021(E)
Dentistry — Brazing materials
1 Scope
This document specifies requirements and test methods for dental brazing materials suitable for use in
metallic restorations.Excluded are brazing materials with silver as main component.
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 — VocabularyISO 6344-1, Coated abrasives — Grain size analysis — Part 1: Grain size distribution test
ISO 10271:2020, Dentistry — Corrosion test methods for metallic materialsISO 15223-1:2021, Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied — Part 1: General requirementsISO 22674:2016, Dentistry — Metallic materials for fixed and removable restorations and appliances
3 Terms and definitionsFor 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 https:// www .electropedia .or
3.1
base metal
any metallic element with the exception of noble metals and silver
[SOURCE: ISO 22674:2016, 3.1, modified — text in parentheses was deleted in the definition.]
3.2brazing material
alloy suitable for use as a filler material in operations in which dental alloy parts are joined by brazing
to form dental appliances and restorationsNote 1 to entry: The process and principle of brazing are identical to soldering. Brazing is done at higher
temperatures than soldering.3.3
flux
chemical cleaning agent, flowing agent, or purifying agent supporting the flow of the molten brazing
material for wetting of the substr...
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