Dentistry - Corrosion test methods for metallic materials (ISO 10271:2020)

This document specifies test methods and procedures to determine the corrosion behaviour of metallic
materials used in the oral cavity. It is intended that these test methods and procedures be referred to in
individual International Standards specifying such metallic materials.
This document is not applicable to dental instruments.

Zahnheilkunde - Korrosionsprüfverfahren für metallische Werkstoffe (ISO 10271:2020)

Dieses Dokument legt Prüfverfahren und Prüfpläne zur Bestimmung des Korrosionsverhaltens von metallischen Werkstoffen fest, die in der Mundhöhle verwendet werden. Es ist vorgesehen, dass auf diese Prüfverfahren und Prüfpläne in den individuellen Internationalen Normen, die diese metallischen Werkstoffe spezifizieren, verwiesen wird.
Dieses Dokument ist nicht anwendbar für Dentalinstrumente.

Médecine bucco-dentaire - Méthodes d'essai de corrosion des matériaux métalliques (ISO 10271:2020)

Le présent document spécifie des méthodes et des protocoles d'essai permettant de déterminer le comportement à la corrosion des produits métalliques utilisés dans la cavité buccale. Il est prévu que ces méthodes et protocoles d'essai soient évoqués dans les Normes internationales individuelles spécifiant ces matériaux métalliques.
Le présent document n'est pas applicable aux instruments dentaires.

Zobozdravstvo - Preskusne metode ugotavljanja korozije za kovinske materiale (ISO 10271:2020)

General Information

Status
Published
Public Enquiry End Date
09-Jul-2019
Publication Date
11-Oct-2020
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
02-Oct-2020
Due Date
07-Dec-2020
Completion Date
12-Oct-2020

RELATIONS

Buy Standard

Standard
SIST EN ISO 10271:2020
English language
43 pages
sale 10% off
Preview
sale 10% off
Preview

e-Library read for
1 day

Standards Content (sample)

SLOVENSKI STANDARD
SIST EN ISO 10271:2020
01-november-2020
Nadomešča:
SIST EN ISO 10271:2011
Zobozdravstvo - Preskusne metode ugotavljanja korozije za kovinske materiale
(ISO 10271:2020)
Dentistry - Corrosion test methods for metallic materials (ISO 10271:2020)

Zahnheilkunde - Korrosionsprüfverfahren für metallische Werkstoffe (ISO 10271:2020)

Médecine bucco-dentaire - Méthodes d'essai de corrosion des matériaux métalliques

(ISO 10271:2020)
Ta slovenski standard je istoveten z: EN ISO 10271:2020
ICS:
11.060.10 Zobotehnični materiali Dental materials
SIST EN ISO 10271:2020 en

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

---------------------- Page: 1 ----------------------
SIST EN ISO 10271:2020
---------------------- Page: 2 ----------------------
SIST EN ISO 10271:2020
EN ISO 10271
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2020
EUROPÄISCHE NORM
ICS 11.060.10 Supersedes EN ISO 10271:2011
English Version
Dentistry - Corrosion test methods for metallic materials
(ISO 10271:2020)

Médecine bucco-dentaire - Méthodes d'essai de Zahnheilkunde - Korrosionsprüfverfahren für

corrosion des matériaux métalliques (ISO 10271:2020) metallische Werkstoffe (ISO 10271:2020)

This European Standard was approved by CEN on 28 August 2020.

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, 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

© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10271:2020 E

worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 10271:2020
EN ISO 10271:2020 (E)
Contents Page

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

---------------------- Page: 4 ----------------------
SIST EN ISO 10271:2020
EN ISO 10271:2020 (E)
European foreword

This document (EN ISO 10271:2020) 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 March 2021, and conflicting national standards shall

be withdrawn at the latest by March 2021.

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 10271:2011.

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, Turkey and the

United Kingdom.
Endorsement notice

The text of ISO 10271:2020 has been approved by CEN as EN ISO 10271:2020 without any modification.

---------------------- Page: 5 ----------------------
SIST EN ISO 10271:2020
---------------------- Page: 6 ----------------------
SIST EN ISO 10271:2020
INTERNATIONAL ISO
STANDARD 10271
Third edition
2020-08
Dentistry — Corrosion test methods
for metallic materials
Médecine bucco-dentaire — Méthodes d'essai de corrosion des
matériaux métalliques
Reference number
ISO 10271:2020(E)
ISO 2020
---------------------- Page: 7 ----------------------
SIST EN ISO 10271:2020
ISO 10271:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

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 2020 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 10271:2020
ISO 10271:2020(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Test methods ............................................................................................................................................................................................................. 3

4.1 Static immersion test ......................................................................................................................................................................... 3

4.1.1 Information required ................................................................................................................................................... 3

4.1.2 Application ............................................................................................................................................................................ 3

4.1.3 Reagents .................................................................................................................................................................................. 3

4.1.4 Apparatus ............................................................................................................................................................................... 3

4.1.5 Solution preparation .................................................................................................................................................... 4

4.1.6 Samples .................................................................................................................................................................................... 4

4.1.7 Test procedure ................................................................................................................................................................... 5

4.1.8 Elemental analysis .......................................................................................................................................................... 6

4.1.9 Test report ............................................................................................................................................................................. 6

4.2 Electrochemical test ........................................................................................................................................................................... 6

4.2.1 Information required ................................................................................................................................................... 6

4.2.2 Application ............................................................................................................................................................................ 6

4.2.3 Reagents .................................................................................................................................................................................. 6

4.2.4 Apparatus ............................................................................................................................................................................... 7

4.2.5 Solution preparation .................................................................................................................................................... 7

4.2.6 Samples .................................................................................................................................................................................... 7

4.2.7 Test procedure ................................................................................................................................................................... 9

4.2.8 Test report ..........................................................................................................................................................................12

4.3 Sulfide tarnish test (cyclic immersion) ...........................................................................................................................13

4.3.1 Information required ................................................................................................................................................13

4.3.2 Application .........................................................................................................................................................................13

4.3.3 Reagents ...............................................................................................................................................................................13

4.3.4 Apparatus ............................................................................................................................................................................13

4.3.5 Solution preparation .................................................................................................................................................14

4.3.6 Samples .................................................................................................................................................................................14

4.3.7 Test procedure ................................................................................................................................................................14

4.3.8 Inspection ...........................................................................................................................................................................15

4.3.9 Test report ..........................................................................................................................................................................15

4.4 Sulfide tarnish test (static immersion) ...........................................................................................................................15

4.4.1 Information required ................................................................................................................................................15

4.4.2 Application .........................................................................................................................................................................15

4.4.3 Reagents ...............................................................................................................................................................................15

4.4.4 Apparatus ............................................................................................................................................................................15

4.4.5 Solution preparation .................................................................................................................................................16

4.4.6 Samples .................................................................................................................................................................................16

4.4.7 Test procedure ................................................................................................................................................................17

4.4.8 Inspection ...........................................................................................................................................................................17

4.4.9 Test report ..........................................................................................................................................................................17

4.5 Static immersion test with periodic analysis .............................................................................................................18

4.5.1 Information required ................................................................................................................................................18

4.5.2 Application .........................................................................................................................................................................18

4.5.3 Reagents ...............................................................................................................................................................................18

4.5.4 Apparatus ............................................................................................................................................................................18

4.5.5 Solution preparation .................................................................................................................................................18

4.5.6 Samples .................................................................................................................................................................................19

4.5.7 Test procedure ................................................................................................................................................................20

© ISO 2020 – All rights reserved iii
---------------------- Page: 9 ----------------------
SIST EN ISO 10271:2020
ISO 10271:2020(E)

4.5.8 Elemental analysis .......................................................................................................................................................21

4.5.9 Test report ..........................................................................................................................................................................21

4.6 Dental amalgam...................................................................................................................................................................................22

4.7 Crevice corrosion ...............................................................................................................................................................................22

4.7.1 Principle ...............................................................................................................................................................................22

4.7.2 Application .........................................................................................................................................................................22

4.7.3 Test medium .....................................................................................................................................................................22

4.7.4 Materials ..............................................................................................................................................................................22

4.7.5 Apparatus ............................................................................................................................................................................22

4.7.6 Specimen..............................................................................................................................................................................23

4.7.7 Procedure ............................................................................................................................................................................24

4.7.8 Inspection ...........................................................................................................................................................................24

4.7.9 Test report ..........................................................................................................................................................................24

Annex A (informative) Corrosion test method development ...................................................................................................26

Bibliography .............................................................................................................................................................................................................................32

iv © ISO 2020 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 10271:2020
ISO 10271:2020(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 10271:2011), which has been technically

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

— in the Scope, the statement about this document not being applicable to “appliances for orthodontics”

and “dental amalgam” has been removed;

— in 4.1.6.3, a NOTE has been added to the static immersion test method acknowledging that “measuring

the total surface area of orthodontic appliances can be difficult” and, therefore, if required in the

appropriate standard, “it is acceptable for the ion release for each element of a set of orthodontic

brackets to be reported in terms of µg in seven days for a specified number of orthodontic brackets”;

— since sodium sulfide hydrate (approximately 35 % Na S) analytical grade is not available in every

country, text was added to the appropriate test methods indicating that sodium sulfidenonahydrate

(Na S·9H O), ≤ 98 % may be used;
2 2

— this document has been harmonized with ISO 22674:2016 by making changes in the preparation

sections of the various test methods that reflect changes that were made for the preparation of

metals supplied for metal-ceramic restorations in ISO 22674:2016;

— subclause 4.6 “Dental amalgam” has been added, which refers the user to ISO/TS 17988 when testing

the corrosion behaviour of dental amalgam;

— subclause 4.7 “Crevice corrosion” has been added, which provides a test method to evaluate the

susceptibility of a dental metallic material to crevice corrosion.

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 2020 – All rights reserved v
---------------------- Page: 11 ----------------------
SIST EN ISO 10271:2020
ISO 10271:2020(E)
Introduction

This document was developed from the original Technical Report (ISO/TR 10271 ) as a result of

worldwide demand for standard test methods to determine the acceptability of metallic materials for

oral restorations in relation to corrosion.

Specific qualitative and quantitative requirements for freedom from biological hazard are not included

in this document, but it is recommended that reference be made to ISO 10993-1 and ISO 7405 for

assessing possible biological or toxicological hazards.

The testing of the corrosion behaviour of metallic materials in dentistry is complicated by the diversity

of the materials themselves, their applications and the environment to which they are exposed.

Variation occurs between devices and within the same device during the exposure time. The type of

corrosion behaviour or effect can also vary with exposure time. Accordingly, it is not possible to specify

a single test capable of covering all situations, nor is it a practical proposition to define a test for each

situation. This document, therefore, gives detailed procedures for test methods that have been found to

be of merit as evidenced by considerable use.

In the second edition, two new test methods were added. To supplement the existing static immersion

test, a static immersion test with periodic analysis was added. A major reason for the addition of this

test is that the rate of corrosion of most dental metallic materials varies over time. Thus, the aim of

this supplementary test is to provide information on this variation in the corrosion of a dental metallic

material. A classification scheme to interpret the rate of corrosion of a tested material with time (i.e.

steady, decreasing, increasing) was not included as part of the static immersion test with periodic

analysis. It is intended to monitor the use of the test through appropriate working groups of ISO/TC 106

to ascertain whether a classification scheme is needed in a future revision of this document. In this

third edition, a classification scheme is still not included.

To supplement the sulfide tarnish test (cyclic immersion), a sulfide tarnish test (static immersion) was

also added to the second edition of this document. This test has been used successfully for many years

to evaluate the corrosion of silver alloys.

In addition, the second edition added Annex A, which sets out a procedure for each element of the test

system such that a consistent approach can be taken for the development of further test methods.

Equally, it is recognized that any element can represent only the current recommendation, but changes

in the future are unlikely to change the framework.

The third edition differs from the second by the removal of the statement in the Scope about

the document not being applicable to “appliances for orthodontics” and “dental amalgam”. With

the appliances for orthodontics change in mind, a NOTE was added to the static immersion test

acknowledging that “measuring the total surface area of orthodontic appliances can be difficult” and

stating that, if required in the appropriate standard, “it is acceptable for the ion release for each element

of a set of orthodontic brackets to be reported in terms of µg in seven days for a specified number of

orthodontic brackets”. Also, with reference to dental amalgam, a subclause on dental amalgam (see 4.6)

has been added, which refers the user to ISO/TS 17988 when testing the corrosion behaviour of dental

amalgam. Additionally, there is a clarification statement that the test methods given in 4.1 to 4.5 are

still not applicable to the evaluation of dental amalgam.

The third edition was harmonized with ISO 22674:2016 by adding to the preparation sections of the

various test methods the following change concerning metals supplied for metal-ceramic restorations:

— “Following the manufacturer’s instructions, simulate the oxidation procedure and four ceramic

firings at the highest temperature recommended for fusing ceramic to the metallic material.

Remove and place the specimens on a ceramic plate (which is at room temperature) to cool to room

temperature after the oxidation and ceramic firing simulation.”
1) Withdrawn document.
vi © ISO 2020 – All rights reserved
---------------------- Page: 12 ----------------------
SIST EN ISO 10271:2020
ISO 10271:2020(E)

Additionally, since sodium sulfide hydrate (approximately 35 % Na S) analytical grade is not available

in every country, this third edition includes a statement, which was added to the appropriate test

methods, indicating that sodium sulfide nonahydrate (Na S·9H2O), ≤ 98 % may be used.

Also of importance, a test method to evaluate the susceptibility of a dental metallic material to crevice

corrosion was added as 4.7.

It is not the purpose of this document to propose corrosion test methods for specific applications or to

set limits as precise as those that may be required in a standard relating to a type of product and its

application.
© ISO 2020 – All rights reserved vii
---------------------- Page: 13 ----------------------
SIST EN ISO 10271:2020
---------------------- Page: 14 ----------------------
SIST EN ISO 10271:2020
INTERNATIONAL STANDARD ISO 10271:2020(E)
Dentistry — Corrosion test methods for metallic materials
1 Scope

This document specifies test methods and procedures to determine the corrosion behaviour of metallic

materials used in the oral cavity. It is intended that these test methods and procedures be referred to in

individual International Standards specifying such metallic materials.
This document is not applicable to dental instruments.
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 1042, Laboratory glassware — One-mark volumetric flasks
ISO 1942, Dentistry — Vocabulary
ISO 3585, Borosilicate glass 3.3 — Properties
ISO 3696, Water for analytical laboratory use — Specification and test methods

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

ISO 7183, Compressed-air dryers — Specifications and testing
ISO/TS 17988, Dentistry — Corrosion test methods for dental amalgam
3 Terms and definitions

For 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 http:// www .electropedia .
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.