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

Status
Published
Publication Date
18-Jul-2023
Technical Committee
Drafting Committee
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
19-Jul-2023
Due Date
07-Apr-2024
Completion Date
19-Jul-2023

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SLOVENSKI STANDARD
SIST EN ISO 3990:2023
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
SIST EN ISO 3990:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 3990:2023

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SIST EN ISO 3990:2023


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.

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SIST EN ISO 3990:2023
EN ISO 3990:2023 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 3990:2023
EN ISO 3990:2023 (E)
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,
...

SLOVENSKI STANDARD
oSIST prEN ISO 3990:2022
01-junij-2022
Zobozdravstvo - Vrednotenje protibakterijskega delovanja zobozdravstvenih
obnovitvenih materialov, zalivnih cementov, tesnilnih mas za fisure in
ortodontskih lepilnih ali zalivnih materialov (ISO/DIS 3990:2022)
Dentistry - Evaluation of antibacterial activity of dental restorative materials, luting
cements, fissure sealants and orthodontic bonding or luting materials (ISO/DIS
3990:2022)
Zahnheilkunde – Bewertung der antibakteriellen Wirkung von dentalen
Restaurationswerkstoffen, Befestigungszementen, Fissurenversieglern und
kieferorthopädischen Klebe- oder Befestigungswerkstoffen (ISO/DIS 3990:2022)
Médecine bucco-dentaire - Évaluation de l'activité antibactérienne des matériaux de
restauration dentaire, ciments de scellement, produits de comblement des fissures et
matériaux de collage ou de scellement orthodontiques (ISO/DIS 3990:2022)
Ta slovenski standard je istoveten z: prEN ISO 3990
ICS:
11.060.10 Zobotehnični materiali Dental materials
oSIST prEN ISO 3990:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 3990:2022

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oSIST prEN ISO 3990:2022
DRAFT INTERNATIONAL STANDARD
ISO/DIS 3990
ISO/TC 106 Secretariat: SCC
Voting begins on: Voting terminates on:
2022-04-14 2022-07-07
Dentistry — Evaluation of antibacterial activity of dental
restorative materials, luting cements, fissure sealants and
orthodontic bonding or luting materials
Médecine bucco-dentaire — Évaluation de l'activité antibacterial des produits pour restauration dentaires
ICS: 11.060.10
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
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 3990:2022(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 2022

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oSIST prEN ISO 3990:2022
ISO/DIS 3990:2022(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
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Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
  © ISO 2022 – All rights reserved

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oSIST prEN ISO 3990:2022
ISO/DIS 3990:2022(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 .
...

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