ISO 7405:2018
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.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Categorization of medical devices
4.1 Categorization by nature of contact
4.1.1 General
4.1.2 Non-contact devices
4.1.3 Surface-contacting devices
4.1.4 External communicating devices
4.1.5 Implant devices used in dentistry
4.2 Categorization by duration of contact
4.2.1 General
4.2.2 Limited exposure devices
4.2.3 Prolonged exposure devices
4.2.4 Permanent contact devices
5 Biological evaluation process
5.1 General
5.2 Selection of tests and overall assessment
5.3 Selection of test methods
5.4 Types of test
5.4.1 General
5.4.2 Physical and chemical characterization
5.4.3 Group I
5.4.4 Group II
5.4.5 Group III
5.5 Re-evaluation of biocompatibility
6 Test procedures specific to dental materials
6.1 Recommendations for sample preparation
6.1.1 General
6.1.2 General recommendations for sample preparation
6.1.3 Specific recommendations for light curing materials
6.1.4 Specific recommendations for chemically setting materials
6.1.5 Positive control material
6.2 Agar diffusion test
6.2.1 Objective
6.2.2 Cell line
6.2.3 Culture medium, reagents and equipment
6.2.4 Sample preparation
6.2.5 Controls
6.2.6 Test procedure
6.2.7 Parameters of assessment
6.2.8 Assessment of results
6.2.9 Test report
6.3 Filter diffusion test
6.3.1 Objective
6.3.2 Cell line
6.3.3 Culture medium, reagents and equipment
6.3.4 Sample preparation
6.3.5 Controls
6.3.6 Test procedure
6.3.7 Assessment of cell damage
6.3.8 Assessment of results
6.3.9 Test report
6.4 Pulp and dentine usage test
6.4.1 Objective
6.4.2 Animals and animal welfare
6.4.3 Test procedure
6.4.4 Assessment of results
6.4.5 Test report
6.5 Pulp capping test
6.5.1 Objective
6.5.2 Animals and animal welfare
6.5.3 Test procedure
6.5.4 Assessment of results
6.5.5 Test report
6.6 Endodontic usage test
6.6.1 Objective
6.6.2 Animals and animal welfare
6.6.3 Test procedure
6.6.4 Assessment of results
6.6.5 Test report
Annex A (informative) Types of test to be considered for evaluation of biocompatibility of medical devices used in dentistry
Annex B (informative) Dentine barrier cytotoxicity test
Annex C (informative) Endosseous dental implant usage test
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Categorization of medical devices
4.1 Categorization by nature of contact
4.1.1 General
4.1.2 Non-contact devices
4.1.3 Surface-contacting devices
4.1.4 External communicating devices
4.1.5 Implant devices used in dentistry
4.2 Categorization by duration of contact
4.2.1 General
4.2.2 Limited exposure devices
4.2.3 Prolonged exposure devices
4.2.4 Permanent contact devices
5 Biological evaluation process
5.1 General
5.2 Selection of tests and overall assessment
5.3 Selection of test methods
5.4 Types of test
5.4.1 General
5.4.2 Physical and chemical characterization
5.4.3 Group I
5.4.4 Group II
5.4.5 Group III
5.5 Re-evaluation of biocompatibility
6 Test procedures specific to dental materials
6.1 Recommendations for sample preparation
6.1.1 General
6.1.2 General recommendations for sample preparation
6.1.3 Specific recommendations for light curing materials
6.1.4 Specific recommendations for chemically setting materials
6.1.5 Positive control material
6.2 Agar diffusion test
6.2.1 Objective
6.2.2 Cell line
6.2.3 Culture medium, reagents and equipment
6.2.4 Sample preparation
6.2.5 Controls
6.2.6 Test procedure
6.2.7 Parameters of assessment
6.2.8 Assessment of results
6.2.9 Test report
6.3 Filter diffusion test
6.3.1 Objective
6.3.2 Cell line
6.3.3 Culture medium, reagents and equipment
6.3.4 Sample preparation
6.3.5 Controls
6.3.6 Test procedure
6.3.7 Assessment of cell damage
6.3.8 Assessment of results
6.3.9 Test report
6.4 Pulp and dentine usage test
6.4.1 Objective
6.4.2 Animals and animal welfare
6.4.3 Test procedure
6.4.4 Assessment of results
6.4.5 Test report
6.5 Pulp capping test
6.5.1 Objective
6.5.2 Animals and animal welfare
6.5.3 Test procedure
6.5.4 Assessment of results
6.5.5 Test report
6.6 Endodontic usage test
6.6.1 Objective
6.6.2 Animals and animal welfare
6.6.3 Test procedure
6.6.4 Assessment of results
6.6.5 Test report
Annex A (informative) Types of test to be considered for evaluation of biocompatibility of medical devices used in dentistry
Annex B (informative) Dentine barrier cytotoxicity test
Annex C (informative) Endosseous dental implant usage test
Bibliography