ISO 7405:2008
Dentistry — Evaluation of biocompatibility of medical devices used in dentistry
ISO 7405:2008 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.
ISO 7405:2008 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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Scope
Normative references
Terms and definitions
Categorization of medical devices
Categorization by nature of contact
General
Non-contact devices
Surface-contacting devices
External communicating devices
Implant devices used in dentistry
Categorization by duration of contact
General
Limited exposure devices
Prolonged exposure devices
Permanent contact devices
Biological evaluation process
General
Selection of tests and overall assessment
Selection of test methods
Types of test
Re-evaluation of biocompatibility
Test procedures specific to dental materials
Recommendations for sample preparation
General
General recommendations for sample preparation
Specific recommendations for light curing materials
Specific recommendations for chemically setting materials
Agar diffusion test
Objective
Cell line
Culture medium, reagents and equipment
Sample preparation
Controls
Test procedure
Parameters of assessment
Assessment of results
Test report
Filter diffusion test
Objective
Cell line
Culture medium, reagents and equipment
Sample preparation
Controls
Test procedure
Assessment of cell damage
Assessment of results
Test report
Pulp and dentine usage test
Objective
Animals and animal welfare
Test procedure
Preparation of animals
Treatment of teeth
Preparation of slides
Assessment of dentine and dental pulp
Odontoblast cell survival analysis (optional)
Assessment of results
Test report
Pulp capping test
Objective
Animals and animal welfare
Test procedure
Preparation of animals
Treatment of teeth
Preparation of slides
Assessment of dental pulp
Assessment of results
Test report
Endodontic usage test
Objective
Animals and animal welfare
Test procedure
Preparation of animals
Treatment of teeth
Preparation of slides
Assessment of tissues
Assessment of results
Test report
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Related Information
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BS 3520:1962
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BS 3886:1965
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BS 4284:1981
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Scope
Normative references
Terms and definitions
Categorization of medical devices
Categorization by nature of contact
General
Non-contact devices
Surface-contacting devices
External communicating devices
Implant devices used in dentistry
Categorization by duration of contact
General
Limited exposure devices
Prolonged exposure devices
Permanent contact devices
Biological evaluation process
General
Selection of tests and overall assessment
Selection of test methods
Types of test
Re-evaluation of biocompatibility
Test procedures specific to dental materials
Recommendations for sample preparation
General
General recommendations for sample preparation
Specific recommendations for light curing materials
Specific recommendations for chemically setting materials
Agar diffusion test
Objective
Cell line
Culture medium, reagents and equipment
Sample preparation
Controls
Test procedure
Parameters of assessment
Assessment of results
Test report
Filter diffusion test
Objective
Cell line
Culture medium, reagents and equipment
Sample preparation
Controls
Test procedure
Assessment of cell damage
Assessment of results
Test report
Pulp and dentine usage test
Objective
Animals and animal welfare
Test procedure
Preparation of animals
Treatment of teeth
Preparation of slides
Assessment of dentine and dental pulp
Odontoblast cell survival analysis (optional)
Assessment of results
Test report
Pulp capping test
Objective
Animals and animal welfare
Test procedure
Preparation of animals
Treatment of teeth
Preparation of slides
Assessment of dental pulp
Assessment of results
Test report
Endodontic usage test
Objective
Animals and animal welfare
Test procedure
Preparation of animals
Treatment of teeth
Preparation of slides
Assessment of tissues
Assessment of results
Test report