Dentistry - Laser welding and filler materials (ISO 28319:2018)

ISO 28319:2018 specifies requirements and test methods for laser welding and the filler materials thereto used in the dental laboratory for welding of metallic restorations and appliances.
For filler materials used in laser welding, this document also specifies the information given in the instructions for use, marking and labelling.

Zahnheilkunde - Laserschweißen und Zulegematerialien (ISO 28319:2018)

Dieses Dokument legt Anforderungen und Prüfverfahren für Zusatzwerkstoffe für das Laserschweißen im zahntechnischen Labor fest, die zum Schweißen von metallischem Zahnersatz und dazugehörige Anwendungen geeignet sind.
Anforderungen an Angaben, Gebrauchsanweisung, Kennzeichnung und Etikettierung für Zusatzwerkstoffe für das Laserschweißen werden ebenfalls festgelegt.

Médecine bucco-dentaire - Soudage par laser et matériaux d'apport (ISO 28319:2018)

L'ISO 28319:2018 spécifie les exigences et les méthodes d'essai du soudage par laser et des matériaux d'apport utilisés à cet effet dans le laboratoire dentaire pour le soudage de restaurations métalliques et d'applications.
Pour les matériaux d'apport utilisés dans le soudage par laser, le présent document spécifie également les informations données dans les instructions d'utilisation, le marquage et l'étiquetage.

Zobozdravstvo - Varjenje z laserjem in polnila (ISO 28319:2018)

Ta dokument določa zahteve in preskusne metode za varjenje z laserjem in polnila, ki se za te namene uporabljajo v zobozdravstvenem laboratoriju za varjenje kovinskih vsadkov in aparatov.
Za polnila, ki se uporabljajo pri varjenju z laserjem, ta dokument določa tudi podatke, ki so navedeni v navodilih za uporabo, označevanje in etiketiranje.

General Information

Status
Published
Publication Date
15-May-2018
Technical Committee
Drafting Committee
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
16-May-2018
Completion Date
16-May-2018

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SLOVENSKI STANDARD
SIST EN ISO 28319:2018
01-november-2018
1DGRPHãþD
SIST EN ISO 28319:2010
Zobozdravstvo - Varjenje z laserjem in polnila (ISO 28319:2018)
Dentistry - Laser welding and filler materials (ISO 28319:2018)
Zahnheilkunde - Laserschweißen (ISO 28319:2018)

Médecine bucco-dentaire - Soudage par laser et matériaux d'apport (ISO 28319:2018)

Ta slovenski standard je istoveten z: EN ISO 28319:2018
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
SIST EN ISO 28319:2018 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 28319:2018
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SIST EN ISO 28319:2018
EN ISO 28319
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2018
EUROPÄISCHE NORM
ICS 11.060.10 Supersedes EN ISO 28319:2010
English Version
Dentistry - Laser welding and filler materials (ISO
28319:2018)

Médecine bucco-dentaire - Soudage par laser et Zahnheilkunde - Laserschweißen (ISO 28319:2018)

matériaux d'apport (ISO 28319:2018)
This European Standard was approved by CEN on 15 March 2018.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,

Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 28319:2018 E

worldwide for CEN national Members.
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SIST EN ISO 28319:2018
EN ISO 28319:2018 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 28319:2018
EN ISO 28319:2018 (E)
European foreword

This document (EN ISO 28319:2018) has been prepared by Technical Committee ISO/TC 106

“Dentistry” in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which

is held by DIN.

This European Standard shall be given the status of a national standard, either by publication of an

identical text or by endorsement, at the latest by November 2018, and conflicting national standards

shall be withdrawn at the latest by November 2018.

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 28319:2010.

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, Former Yugoslav Republic of Macedonia,

France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,

Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
Endorsement notice

The text of ISO 28319:2018 has been approved by CEN as EN ISO 28319:2018 without any modification.

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SIST EN ISO 28319:2018
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SIST EN ISO 28319:2018
INTERNATIONAL ISO
STANDARD 28319
Second edition
2018-04
Dentistry — Laser welding and filler
materials
Médecine bucco-dentaire — Soudage par laser et matériaux d'apport
Reference number
ISO 28319:2018(E)
ISO 2018
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SIST EN ISO 28319:2018
ISO 28319:2018(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2018

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved
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SIST EN ISO 28319:2018
ISO 28319:2018(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

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 Filler material ..................................................................................................................................................................... 2

4.1.3 Hazardous elements in filler material ........................................................................................................... 2

4.2 Biocompatibility .................................................................................................................................................................................... 2

4.3 Mechanical strength of laser welded joint (tensile strength) ......................................................................... 2

4.4 Corrosion resistance .......................................................................................................................................................................... 3

4.4.1 Static immersion test ................................................................................................................................................... 3

4.4.2 Appearance after corrosion exposure ........................................................................................................... 3

4.5 Laser welding process ...................................................................................................................................................................... 3

5 Sampling ........................................................................................................................................................................................................................ 3

6 Preparation of specimens ........................................................................................................................................................................... 3

6.1 General ........................................................................................................................................................................................................... 3

6.2 Specimens for tensile testing ...................................................................................................................................................... 4

6.2.1 General...................................................................................................................................................................................... 4

6.2.2 Procedure ............................................................................................................................................................................... 4

6.3 Specimens for corrosion testing .............................................................................................................................................. 5

6.3.1 General...................................................................................................................................................................................... 5

6.3.2 Seam geometry .................................................................................................................................................................. 5

7 Measurement and test methods ........................................................................................................................................................... 6

7.1 Visual inspection ................................................................................................................................................................................... 6

7.2 Chemical composition ...................................................................................................................................................................... 6

7.3 Tensile testing .......................................................................................................................................................................................... 6

7.3.1 General...................................................................................................................................................................................... 6

7.3.2 Evaluation of tensile testing results ................................................................................................................ 6

7.3.3 Calculation of tensile strength ............................................................................................................................. 7

7.4 Corrosion resistance by static immersion test ............................................................................................................ 7

7.4.1 Reagents .................................................................................................................................................................................. 7

7.4.2 Apparatus ............................................................................................................................................................................... 7

7.4.3 Test solution......................................................................................................................................................................... 7

7.4.4 Test procedure ................................................................................................................................................................... 7

7.4.5 Analysis .................................................................................................................................................................................... 7

7.4.6 Microscopic inspection ............................................................................................................................................... 8

7.4.7 Report ........................................................................................................................................................................................ 8

8 Instruction for use .............................................................................................................................................................................................. 8

9 Marking and labelling ..................................................................................................................................................................................... 8

9.1 Marking ......................................................................................................................................................................................................... 8

9.2 Labelling ....................................................................................................................................................................................................... 8

10 Test report ................................................................................................................................................................................................................... 9

Annex A (informative) Laser welding process .........................................................................................................................................10

Bibliography .............................................................................................................................................................................................................................13

© ISO 2018 – All rights reserved iii
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SIST EN ISO 28319:2018
ISO 28319:2018(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 on 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 the following

URL: www .iso .org/iso/foreword .html.

This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 2,

Prosthodontic materials.

This second edition cancels and replaces the first edition (ISO 28319:2010), which has been technically

revised.
The main changes compared to the previous edition are as follows:

a) reference to the corrosion standard ISO 10271:2011, for corrosion test methods and measurements

has been added;
b) a corrosion limit for the static corrosion test has been specified;
c) Annex A has been revised in order to describe the laser welding process.
iv © ISO 2018 – All rights reserved
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SIST EN ISO 28319:2018
INTERNATIONAL STANDARD ISO 28319:2018(E)
Dentistry — Laser welding and filler materials
1 Scope

This document specifies requirements and test methods for laser welding and the filler materials

thereto used in the dental laboratory for welding of metallic restorations and appliances.

For filler materials used in laser welding, this document also specifies the information given in the

instructions for use, marking and labelling.
2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 1942, Dentistry — Vocabulary

ISO 6344-1, Coated abrasives — Grain size analysis — Part 1: Grain size distribution test

ISO 10271:2011, Dentistry — Corrosion test methods for metallic materials

ISO 15223-1:2016, Medical devices — Symbols to be used with medical device labels, labelling and

information to be supplied — Part 1: General requirements

ISO 22674:2016, Dentistry — Metallic materials for fixed and removable restorations and appliances

3  Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 1942, ISO 22674 and the

following apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— IEC Electropedia: available at http: //www .electropedia .org/
— ISO Online browsing platform: available at https: //www .iso .org/obp
3.1
laser welding

method for joining similar or dissimilar metallic materials, using a laser beam as the heat source, with

or without a metallic filler material (welding rod), which produces coalescence by melting abutting

zones of metallic material components thereby creating a common fusion zone
3.2
filler material
metallic filling material used for laser welding (3.1)
© ISO 2018 – All rights reserved 1
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SIST EN ISO 28319:2018
ISO 28319:2018(E)
4 Requirements
4.1 Chemical composition
4.1.1 Metallic materials to be joined

The metallic materials to be joined shall conform to ISO 22674:2016, 5.1 and 5.2.

4.1.2 Filler material
4.1.2.1 Chemical composition

For all elements that are present in excess of 1,0 % (mass fraction), the percentage by mass of each of

the constituent elements shall be declared by the manufacturer and shall be reported to a precision of

0,1 % (mass fraction).

Any element that is present in a concentration in excess of 0,1 % (mass fraction), but not in excess of

1,0 % (mass fraction), shall be identified either by name or symbol.
4.1.2.2 Permitted deviation from the reported composition

For silver or noble-metal elements in filler materials, the percentage shall not deviate by more than

0,5 % (mass fraction) from the values stated in the instructions for use.

For base-metal elements in filler materials, all elements, present with more than 20 % (mass fraction)

shall not deviate from the value stated in the instructions for use by more than 2 % (mass fraction).

Those present in excess of 1 % (mass fraction) but not in excess of 20 % (mass fraction) shall not deviate

from the value stated in the instructions for use by more than 1 % (mass fraction).

4.1.3  Hazardous elements in filler material
4.1.3.1 Recognized hazardous elements
For the purposes of this document the elements ni
...

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