prEN ISO 7405

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO/DIS 7405:2024)

This document specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test.
This document does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.

Zahnheilkunde - Bewertung der Biokompatibilität von in der Zahnheilkunde verwendeten Medizinprodukten (ISO/DIS 7405:2024)

Médecine bucco-dentaire - Évaluation de la biocompatibilité des dispositifs médicaux utilisés en médecine bucco-dentaire (ISO/DIS 7405:2024)

Le présent document spécifie des méthodes d'essai pour l'évaluation des effets biologiques des dispositifs médicaux utilisés en médecine bucco-dentaire. Il inclut des essais de produits pharmacologiques qui font partie intégrante du dispositif soumis à essai.
Le présent document ne couvre pas les essais des matériaux et des dispositifs qui n'entrent pas en contact direct ou indirect avec le corps du patient.

Zobozdravstvo - Ovrednotenje biokompatibilnosti medicinskih pripomočkov v zobozdravstvu (ISO/DIS 7405:2024)

General Information

• Status: Not Published
• Publication Date: 13-Oct-2025
• ICS: 11.060.10 - Dental materials
• ICS: 11.100.99 - Other standards related to laboratory medicine
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55 - Dentistry
• Current Stage: 4060 - Closure of enquiry - Enquiry
• Start Date: 10-Jun-2024
• Completion Date: 10-Jun-2024
• Ref Project: oSIST prEN ISO 7405:2024 - Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO/DIS 7405:2024)

Relations

• Revises: EN ISO 7405:2018 - Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12)
• Effective Date: 19-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-maj-2024
Nadomešča:
SIST EN ISO 7405:2019
Zobozdravstvo - Ovrednotenje biokompatibilnosti medicinskih pripomočkov v
zobozdravstvu (ISO/DIS 7405:2024)
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO/DIS
7405:2024)
Zahnheilkunde - Bewertung der Biokompatibilität von in der Zahnheilkunde verwendeten
Medizinprodukten (ISO/DIS 7405:2024)
Médecine bucco-dentaire - Évaluation de la biocompatibilité des dispositifs médicaux
utilisés en médecine bucco-dentaire (ISO/DIS 7405:2024)
Ta slovenski standard je istoveten z: prEN ISO 7405
ICS:
11.060.10 Zobotehnični materiali Dental materials
11.100.20 Biološko ovrednotenje Biological evaluation of
medicinskih pripomočkov medical devices
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
International
Standard
ISO/DIS 7405
ISO/TC 106
Dentistry — Evaluation of
Secretariat: SCC
biocompatibility of medical devices
Voting begins on:
used in dentistry
2024-03-18
Médecine bucco-dentaire — Évaluation de la biocompatibilité des
Voting terminates on:
dispositifs médicaux utilisés en médecine bucco-dentaire
2024-06-10
ICS: 11.060.10; 11.100.99
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
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USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
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.
Reference number
ISO/DIS 7405:2024(en)
DRAFT
ISO/DIS 7405:2024(en)
International
Standard
ISO/DIS 7405
ISO/TC 106
Dentistry — Evaluation of
Secretariat: SCC
biocompatibility of medical devices
Voting begins on:
used in dentistry
Médecine bucco-dentaire — Évaluation de la biocompatibilité des
Voting terminates on:
dispositifs médicaux utilisés en médecine bucco-dentaire
ICS: 11.060.10; 11.100.99
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2024
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: [phone]
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 7405:2024(en)
ii
ISO/DIS 7405:2024(en)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Categorization of medical devices. 3
4.1 Categorization by nature of contact .3
4.1.1 General .3
4.1.2 Non-contact devices .3
4.1.3 Surface-contacting devices .3
4.1.4 External communicating devices .3
4.1.5 Implant devices used in dentistry .3
4.2 Categorization by duration of contact .4
4.2.1 General .4
4.2.2 Limited exposure devices .4
4.2.3 Prolonged exposure devices .4
4.2.4 Long-term exposure devices .4
5 Biological evaluation process . 4
5.1 General .4
5.2 Selection of tests and overall assessment .5
5.3 Selection of test methods .5
5.4 Types of test .5
5.4.1 General .5
5.4.2 Physical and chemical characterization .5
5.4.3 Group I .5
5.4.4 Group II .6
5.4.5 Group III .6
5.5 Re-evaluation of biocompatibility .7
6 Test procedures specific to dental materials . 7
6.1 Recommendations for sample preparation.7
6.1.1 General .7
6.1.2 General recommendations for sample preparation .7
6.1.3 Specific recommendations for light curing materials .7
6.1.4 Specific recommendations for chemically setting materials .8
6.1.5 Positive control material .8
6.2 Agar diffusion test .8
6.2.1 Objective .8
6.2.2 Cell line .9
6.2.3 Culture medium, reagents and equipment .9
6.2.4 Sample preparation .9
6.2.5 Control materials .9
6.2.6 Test procedure.10
6.2.7 Parameters of assessment .10
6.2.8 Assessment of results .11
6.2.9 Test report .11
6.3 Filter diffusion test . 12
6.3.1 Objective . 12
6.3.2 Cell line . 12
6.3.3 Culture medium, reagents and equipment . 12
6.3.4 Sample preparation . 12
6.3.5 Control materials . 13
6.3.6 Test procedure. 13
6.3.7 Assessment of cell damage .14

iii
ISO/DIS 7405:2024(en)
6.3.8 Assessment of results .
...