EN ISO 3990:2023
(Main)Dentistry - Evaluation of antibacterial activity of dental restorative materials, luting materials, fissure sealants and orthodontic bonding or luting materials (ISO 3990:2023)
Dentistry - Evaluation of antibacterial activity of dental restorative materials, luting materials, fissure sealants and orthodontic bonding or luting materials (ISO 3990:2023)
This document specifies test methods for the evaluation of dental restorative materials, luting materials, fissure sealants and orthodontic bonding or luting materials that are claimed by their respective manufacturers to exert “antibacterial” effects.
NOTE Materials for pulp capping (e.g. calcium hydroxide formulations), endodontic filling materials, dental implants or implant systems, nightguards and additive manufactured (e.g. 3D-printed) materials are not covered in this document.
This document does not cover tests on the effectiveness of sterilization or disinfection procedures. This document cannot be used to demonstrate a lack of microbial contamination of medical devices used in dentistry.
Zahnheilkunde - Bewertung der antibakteriellen Wirkung von dentalen Restaurationswerkstoffen, Befestigungswerkstoffen, Fissurenversieglern und kieferorthopädischen Klebe- oder Befestigungswerkstoffen (ISO 3990:2023)
Dieses Dokument legt Prüfverfahren zur Evaluierung von dentalen Restaurationswerkstoffen, Befestigungswerkstoffe, Fissurenversiegelern und kieferorthopädischen Klebe- oder Befestigungswerkstoffen fest, die laut ihren jeweiligen Herstellern „antibakterielle“ Wirkung haben.
ANMERKUNG Materialien zur Pulpaüberkappung (z. B. Calciumhydroxid-Präparate), endodontische Füllmaterialien, Dentalimplantate oder implantatsysteme, Knirscherschienen, sowie additiv gefertigte (z. B. 3D gedruckte) Materialien werden von diesem Dokument nicht abgedeckt.
Dieses Dokument deckt keine Prüfungen zur Wirksamkeit von Sterilisations- oder Desinfektionsverfahren ab. Dieses Dokument kann nicht für den Abwesenheitsnachweis mikrobieller Verunreinigungen an in der Zahnheilkunde verwendeten Medizinprodukten verwendet werden.
Médecine bucco-dentaire - Évaluation de l'activité antibactérienne des matériaux de restauration dentaire, matériaux de scellement, produits de comblement des fissures et matériaux de collage ou de scellement orthodontiques (ISO 3990:2023)
Le présent document spécifie les méthodes d’essai pour l'évaluation des matériaux de restauration dentaire, matériaux de scellement, produits de comblement des fissures et matériaux de collage ou de scellement orthodontiques qui sont revendiqués par leurs fabricants respectifs pour exercer des effets «antibactériens».
NOTE Les matériaux de coiffage pulpaire (par exemple, formulations à base d'hydroxyde de calcium), les matériaux de remplissage endodontiques, les implants ou systèmes d’implants dentaires, les gouttières et les matériaux produits par fabrication additive (par exemple, par impression 3D) ne sont pas couverts par le présent document.
Le présent document ne couvre pas les essais portant sur l’efficacité des modes opératoires de stérilisation ou de désinfection. Il ne peut pas être utilisé pour prouver l’absence de contamination microbienne des dispositifs médicaux utilisés en médecine bucco-dentaire.
Zobozdravstvo - Vrednotenje protibakterijskega delovanja zobozdravstvenih obnovitvenih materialov, zalivnih cementov, tesnilnih mas za fisure in ortodontskih lepilnih ali zalivnih materialov (ISO 3990:2023)
Ta dokument določa preskusne metode za vrednotenje zobozdravstvenih obnovitvenih materialov, za katere proizvajalci trdijo, da imajo »protibakterijske« učinke.
Ta dokument ne zajema preskusov učinkovitosti postopkov sterilizacije ali dezinfekcije, niti se ne sme uporabljati za dokazovanje odsotnosti mikrobne kontaminacije medicinskih pripomočkov, ki se uporabljajo v zobozdravstvu.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2023
Zobozdravstvo - Vrednotenje protibakterijskega delovanja zobozdravstvenih
obnovitvenih materialov, zalivnih cementov, tesnilnih mas za fisure in
ortodontskih lepilnih ali zalivnih materialov (ISO 3990:2023)
Dentistry - Evaluation of antibacterial activity of dental restorative materials, luting
materials, fissure sealants and orthodontic bonding or luting materials (ISO 3990:2023)
Zahnheilkunde - Bewertung der antibakteriellen Wirkung von dentalen
Restaurationswerkstoffen, Befestigungszementen, Fissurenversieglern und
kieferorthopädischen Klebe- oder Befestigungswerkstoffen (ISO 3990:2023)
Médecine bucco-dentaire - Évaluation de l'activité antibactérienne des matériaux de
restauration dentaire, matériaux de scellement, produits de comblement des fissures et
matériaux de collage ou de scellement orthodontiques (ISO 3990:2023)
Ta slovenski standard je istoveten z: EN ISO 3990:2023
ICS:
11.060.10 Zobotehnični materiali Dental materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 3990
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2023
EUROPÄISCHE NORM
ICS 11.060.10
English Version
Dentistry - Evaluation of antibacterial activity of dental
restorative materials, luting materials, fissure sealants and
orthodontic bonding or luting materials (ISO 3990:2023)
Médecine bucco-dentaire - Évaluation de l'activité Zahnheilkunde - Bewertung der antibakteriellen
antibactérienne des matériaux de restauration Wirkung von dentalen Restaurationswerkstoffen,
dentaire, matériaux de scellement, produits de Befestigungszementen, Fissurenversieglern und
comblement des fissures et matériaux de collage ou de kieferorthopädischen Klebe- oder
scellement orthodontiques (ISO 3990:2023) Befestigungswerkstoffen (ISO 3990:2023)
This European Standard was approved by CEN on 1 July 2023.
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
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 3990:2023 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 3990:2023) 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 January 2024, and conflicting national standards shall
be withdrawn at the latest by January 2024.
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.
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 3990:2023 has been approved by CEN as EN ISO 3990:2023 without any modification.
INTERNATIONAL ISO
STANDARD 3990
First edition
2023-07
Dentistry — Evaluation of
antibacterial activity of dental
restorative materials, luting materials,
fissure sealants and orthodontic
bonding or luting materials
Médecine bucco-dentaire — Évaluation de l'activité antibactérienne
des matériaux de restauration dentaire, matériaux de scellement,
produits de comblement des fissures et matériaux de collage ou de
scellement orthodontiques
Reference number
ISO 3990:2023(E)
ISO 3990:2023(E)
© ISO 2023
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 3990:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 2
4.1 General . 2
4.2 Extract . . . 2
4.3 Direct contact . 2
5 Sample preparation and control material preparation . 3
5.1 General . 3
5.2 General requirements and recommendations for sample preparation . 3
5.3 Specific requirements and recommendations for light-curing materials . 4
5.4 Specific requirements and recommendations for chemically setting materials . 4
5.5 Specific requirements and recommendations for CAD/CAM milled or subtractive
manufactured materials . 5
5.6 Sterility of samples . 5
5.7 Preparation of liquid extracts of material . 5
5.7.1 Principles of extraction . 5
5.7.2 Extraction vehicle . 6
5.7.3 Extraction conditions . . 6
5.7.4 Consecutive elution cycles . 6
5.8 Preparation of materials for direct contact tests . 7
5.8.1 Form of samples . 7
5.8.2 Principles of direct contact tests . 7
6 Bacterial strains, nutrient broths and preparation of bacterial cultures .8
7 Test procedures . 8
7.1 General . 8
7.2 Test on extracts . . 9
7.2.1 Tests on extracts toward planktonic cultures of bacteria . 9
7.2.2 Test on extracts toward bacterial biofilms. 10
7.3 Test by direct contact . 11
7.3.1 Test by direct contact toward planktonic cultures of bacteria . 11
7.3.2 Test by direct contact toward bacterial biofilms .12
7.4 Determination of antibacterial effects . 13
7.4.1 General .13
7.4.2 A ssessment of the reduction of the bacterial ability to replicate .13
7.4.3 A ssessment of bacterial membrane damage . 14
7.4.4 A ssessment of the reduction in bacterial metabolic activity . 16
8 A ssessment of results .17
9 Final test report .17
Annex A (informative) Bacterial strains and corresponding nutrient broths .19
Bibliography .21
iii
ISO 3990:2023(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member
...
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