ISO/FDIS 7405

Dentistry — Evaluation of biocompatibility of medical devices used in dentistry

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.

Médecine bucco-dentaire — Évaluation de la biocompatibilité des dispositifs médicaux utilisés en médecine bucco-dentaire

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.

General Information

• Status: Not Published
• ICS: 11.060.10 - Dental materials
• ICS: 11.100.99 - Other standards related to laboratory medicine
• Technical Committee: ISO/TC 106 - Dentistry
• Drafting Committee: ISO/TC 106 - Dentistry
• Current Stage: 5020 - FDIS ballot initiated: 2 months. Proof sent to secretariat
• Start Date: 25-Mar-2025
• Due Date: 25-Mar-2025
• Completion Date: 25-Mar-2025

Relations

• Revises: ISO 7405:2018 - Dentistry — Evaluation of biocompatibility of medical devices used in dentistry
• Effective Date: 06-Jun-2022

Standards Content (Sample)

FINAL DRAFT
International
Standard
ISO/TC 106
Dentistry — Evaluation of
Secretariat: SCC
biocompatibility of medical devices
Voting begins on:
used in dentistry
2025-03-25
Médecine bucco-dentaire — Évaluation de la biocompatibilité des
Voting terminates on:
dispositifs médicaux utilisés en médecine bucco-dentaire
2025-05-20
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 SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/CEN PARALLEL PROCESSING LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
FINAL DRAFT
International
Standard
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
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 SUPPOR TING DOCUMENTATION.
© ISO 2025
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ii
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 .6
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 .8
6.2.3 Culture medium, reagents and equipment .8
6.2.4 Sample preparation .9
6.2.5 Control materials .9
6.2.6 Test procedure.9
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 .11
6.3.1 Objective .11
6.3.2 Cell line .11
6.3.3 Culture medium, reagents and equipment . 12
6.3.4 Sample preparation . 12
6.3.5 Control materials . 12
6.3.6 Test procedure. 12
6.3.7 Assessment of cell damage . 13

iii
6.3.8 Assessment of results . 13
6.3.9 Test report .14
6.4 Pulp and dentine usage test .14
6.4.1 Objective .14
6.4.2 Animals and animal welfare .14
6.4.3 Test procedure.14
6.4.4 Assessment of results . 20
6.4.5 Test report . 20
6.5 Pulp capping test . 20
6.5.1 Objective .
...

ISO/TC 106
Secretariat: SCC
Date: 2024-12-192025-03-11
Dentistry — Evaluation of biocompatibility of medical devices used
in dentistry
Médecine bucco-dentaire — Évaluation de la biocompatibilité des dispositifs médicaux utilisés en médecine
bucco-dentaire
FDIS stage
ISO/CDFDIS 7405:20232025(en)
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'sISO’s member body in the country of the requester.
ISO Copyright Officecopyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
Email: [e-mail]
E-mail: [e-mail]
Website: www.iso.orgwww.iso.org
Published in Switzerland.
ii
ii
Contents Page
Foreword . viii
Introduction . x
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
4.2 Categorization by duration of contact . 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
5.5 Re-evaluation of biocompatibility . 7
6 Test procedures specific to dental materials . 7
6.1 Recommendations for sample preparation . 7
6.2 Agar diffusion test . 9
6.3 Filter diffusion test . 13
6.4 Pulp and dentine usage test . 16
6.5 Pulp capping test . 23
6.6 Endodontic usage test . 26
Annex A (informative) Types of test to be considered for evaluation of biocompatibility of
medical devices used in dentistry . 30
Annex B (informative) Dentine barrier cytotoxicity test . 33
Annex C (informative) Endosseous dental implant usage test . 43
Annex D (informative) Antioxidant responsive element (ARE) reporter assay oxidative stress
test . 48
Annex E (informative) Margin of safety (MoS) for medical devices used in dentistry . 60
Bibliography . 70

Foreword . 8
Introduction . 9
1 Scope . 11
2 Normative references . 11
3 Terms and definitions . 12
4 Categorization of medical devices . 13
4.1 Categorization by nature of contact . 13
4.1.1 General . 13
iii
ISO/CDFDIS 7405:20232025(en)
4.1.2 Non-contact devices . 13
4.1.3 Surface-contacting devices . 14
4.1.4 External communicating devices . 14
4.1.5 Implant devices used in dentistry . 14
4.2 Categorization by duration of contact . 14
4.2.1 General . 14
4.2.2 Limited exposure devices . 14
4.2.3 Prolonged exposure devices . 14
4.2.4 Long-term exposure devices . 15
5 Biological evaluation process . 15
5.1 General . 15
5.2 Selection of tests and overall assessment . 15
5.3 Selection of test methods . 15
5.4 Types of test . 16
5.4.1 General . 16
5.4.2 Physical and chemical characterization . 16
5.4.3 Group I . 16
5.4.4 Group II . 17
5.4.5 Group III . 17
5.5 Re-evaluation of biocompatibility . 17
6 Test procedures specific to dental materials . 18
6.1 Recommendations for sample preparation . 18
6.1.1 General . 18
6.1.2 General recommendations for sample preparation . 18
6.1.3 Specific recommendations for light curing materials . 18
6.1.4 Specific recommendations for chemically setting materials . 19
6.1.5 Positive control material . 19
6.2 Agar diffusion test . 19
6.2.1 Objective . 19
6.2.2 Cell line . 20
6.2.3 Culture medium, reagents and equipment . 20
6.2.4 Sample preparation . 20
6.2.5 Control materials . 21
6.2.6 Test procedure . 21
6.2.7 Parameters of assessment . 21
6.2.8 Assessment of results . 22
6.2.9 Test report . 23
6.3 Filter diffusion test . 23
6.3.1 Objective . 23
6.3.2 Cell line . 23
6.3.3 Culture medium, reagents and equipment . 23
6.3.4 Sample preparation . 24
6.3.5 Control materials . 24
6.3.6 Test procedure . 24
6.3.7 Assessment of cell damage . 25
6.3.8 Assessment of results . 26
6.3.9 Test report . 26
6.4 Pulp and dentine usage test . 26
6.4.1 Objective . 26
iv
iv
6.4.2 Animals and animal welfare .
...