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ISO 7405 Biological Evaluation Test of Dental Materials

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Update time : 2024-11-05

This document describes the evaluation of the biocompatibility of medical devices used in dentistry. It is intended to be used in conjunction with the ISO 10993 series of standards. This standard contains special tests for which dentistry has extensive experience and recognizes the special needs of dentistry.

ISO 7405 Biological Evaluation Test of Dental Materials(图1)

Only test methods for which the committee members believe that sufficient published data have been included are included. In recommending test methods, the need to minimize the number and amount of exposure and the number of animals involved in the experiment have been given high priority. The decision to conduct the tests involved is critical and will only be made after a thorough and careful review of the evidence indicating that similar results cannot be achieved by other types of testing. In order to keep the number of animals required for testing to an absolute minimum while achieving the stated objectives, it may be appropriate to conduct more than one test on the same animal at the same time, such as pulp and dentin use tests and capping tests.


However, in accordance with the requirements of ISO 10993-2, these tests are conducted simultaneously in an efficient and humane manner. In all cases where animal testing was performed, these tests were conducted humanely according to standardized procedures described for each test. This document does not explicitly describe test methods for occupationally related risks.


       ISO 7405 Table A.1 - Types of tests to be considered in evaluating the biocompatibility of dental medical devices

Nature of physical contact

Contact time

General Requirements

Group 1

Group 2

Group 3


A- short-term
(≤24 hours)
B- long-term
(>24
hours to
30 days)
C- permanent
(>30 days)

Physical and/or chemical data

Cytotoxicity assay

Cytotoxicity assay

Cytotoxicity assay

Delayed hypersensitivity reaction

Irritation or intradermal reaction

Acute systemic toxicity

Subchronic
(subacute) systemic toxicity

Genotoxicity

Implantation

Tests on pulp and dentin

Grouting test

Endodontic test

Endosseous dental implant use trial


iso10 99 3-5

ISO7405, 6.2 and 6.3

iso10 99 3-5

ISO7405,
Annex B

iso10993
−10

iso10993
−10

iso10993
−11

iso10993
−11

iso109 93 -3

ISO 10993-6

ISO7405
，
6.4

ISO7405
，
6.5

ISO7405， 6.6

ISO7405,
Annex C


Surface contact

A

x

AND

AND

—

AND

AND

—

—

—

—

—

—

—

—


B

x

AND

AND

—

AND

AND

AND

AND

—

AND

—

—

—

—


C

x

AND

AND

—

AND

AND

AND

AND

AND

AND

—

—

—

—


External access

A

x

AND

AND

AND

AND

AND

AND

—

—

—

AND

—

—

—


B

x

AND

AND

AND

AND

AND

AND

AND

AND

AND

AND

—

—

—


C

x

AND

AND

AND

AND

AND

AND

AND

AND

AND

AND

—

—

—


Implantation

A

x

AND

AND

—

AND

AND

—

—

—

—

—

AND

—

—


B

x

AND

AND

—

AND

AND

AND

AND

AND

AND

—

AND

—

AND


C

x

AND

AND

—

AND

AND

AND

AND

AND

AND

—

AND

AND

AND


NOTE 1: X refers to prerequisite information required for the risk assessment.
NOTE 2: E refers to the endpoint to be evaluated in the risk assessment (either by using existing data, additional testing for the specific endpoint, or a rationale for why an additional data set is not required to evaluate the endpoint). If the medical device is manufactured from a new material, not previously used in a medical device application, and no toxicology data are available in the literature, endpoints other than those marked as “E” in this table should be considered. For a specific medical device, it may be appropriate to include more or fewer endpoints than those indicated.
NOTE 3 See also ISO 10993-1, Table A.1.



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