YY/T 0127.13-2018Biological evaluation of medical devices used in dentistry - Part 13: Oral mucous irritation test (English PDF)

Foreword

YY/T 0127 is the standard for specific biological test methods for medical devices used in dentistry, which are divided into the following parts.

- YY/T 0127.1 Biotic experiment method for dental materials - Hemolysis test;

- YY/T 0127.2 Biological evaluation of medical devices used in dentistry - Part 2. Test method - Acute systemic toxicity. intravenous path;

- YY/T 0127.3 Biological evaluation of dental materials - Unit 2. Biological evaluation method of dental materials - Endodontic usage test;

- YY/T 0127.4 Biological evaluation of dental materials - Unit 2. Biological evaluation method of dental materials - Bone implant test;

- YY/T 0127.5 Biological evaluation of dental materials - Unit 2. Biological test methods of dental materials - Inhalation toxicity test;

- YY/T 0127.6 Biological evaluation of dental materials - Unit 2. Biological test methods of dental materials - Dominant lethal test;

- YY/T 0127.7 Biological evaluation of dental materials - Part 2. Biological evaluation test method of dental materials - Pulp and dentine usage test;

- YY/T 0127.8 Biological evaluation of dental materials - Part 2. Biological evaluation test method of dental materials - Subcutaneous implant test - YY/T 0127.9 Biological evaluation of dental materials - Part 2. Biological evaluation test method of dental materials - Cytotoxicity tests. Agar diffusion test and filter diffusion test;

- YY/T 0127.10 Biological evaluation of dental materials - Part 2. Biological evaluation test method of dental materials - Salmonella typhimurium reverse mutation assay (Ames mutagenicity test);

- YY/T 0127.11 Dentistry - Preclinical evaluation of biocompatibility of medical devices used in dentistry - Part 2. Biological evaluation test method of dental materials - Pulp capping test;

- YY/T 0127.12 Dentistry - Biological evaluation of medical devices used in dentistry - Part 2. Test method - Micronucleus test;

- YY/T 0127.13 Biological evaluation of medical devices used in dentistry - Part 2. Test method - Oral mucous membrane irritation test;

1 Scope

This part of YY/T 0127 specifies the oral mucous irritation test method for medical devices.

This part is intended to evaluate the irritating effects onto the oral mucosal tissue of short-term, long-term and long-lasting oral medical devices that are in contact with oral mucosal tissue or other medical devices that are in contact with oral mucosal tissue.

2 Normative references

The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) are applicable to this standard.

GB/T 16886.12 Biological evaluation of medical devices - Part 12. Sample preparation and reference materials

3 Test animals

3.1 Healthy, young adult golden hamsters, in same strain, male or female. Female animals shall not be pregnant.

3.2 For the initial test, it shall use at least 3 animals to evaluate the test materials.

3.3 If the initial test's reaction is suspicious or unclear, it shall repeat the test.

4 Principles of test

According to the contact time of medical devices and oral mucosa, they are divided into short-term contact devices, long-term contact devices, long-lasting contact devices. Medical devices that are in contact with oral mucosa for <= 24 h are short-term contact devices; medical devices that are in contact with oral mucosa for 24 h ~ 30 d are long-term contact devices; medical devices that are in contact with oral mucosa for > 30 d are long-lasting contact devices. as a negative control. The cheek pouch without the sample can be used as a blank control. When the specimen is a material extract, the extraction medium is its control sample.

5 Test materials

6 Materials that

may not be tested for oral mucosal irritation 6.1 Materials known as skin or eye irritants, pH <= 2 or pH >= 11.5 should not be tested for oral mucosal irritation, which is considered to be a potential oral mucosal irritant.

6.2 If the results of the intradermal reaction test show that the material has a difference between the average score of the sample and the control of not more than 1.0, the oral mucosal stimulation test may no longer be performed, and the material is considered to be non-irritating to the oral mucosa.

7 Test methods and procedures

10 Evaluation of tissue's response