YY/T 0127.18-2016Biological evaluation of medical devices used in dentistry - Part 18: Dentine barrier cytotoxicity test (English PDF)

Foreword

YY/T 0127 "oral medical device biological evaluation" is divided into 18 parts.

YY/T 0127.1 Oral material Biological test method Hemolysis test --- YY/T 0127.2 Biological evaluation of oral medical devices Unit 2. Test methods Acute systemic toxicity test. intravenous way;

- YY/T 0127.3 Biological evaluation of oral medical devices - Part 3. Application test in root canals;

- YY/T 0127.4 Biological evaluation of oral medical devices - Unit 2. Test methods - Bone implantation test;

- YY/T 0127.5 Biological evaluation of oral medical devices - Part 5. Inhalation toxicity test;

- YY/T 0127.6 Biology evaluation of oral materials Unit 2. Biological test methods for oral materials - Explicit lethal test;

--- YY/T 0127.7 Biology Evaluation of Oral Materials Unit 2. Biological Test Methods for Dental Materials Dental Implants Application test;

- YY/T 0127.8 Biological evaluation of oral materials Unit 2. Biological test methods for oral materials Subcutaneous implantation test;

- YY/T 0127.9 Biological evaluation of oral medical devices Unit 2. Test methods Cytotoxicity test. Agar diffusion method And membrane diffusion method;

--- YY/T 0127.10 Biological evaluation of oral medical devices Unit 2. Test method Salmonella typhimurium recovery Variable test (Ames test);

- YY/T 0127.11 Biological evaluation of oral medical devices - Part 11. Covering pulp test;

- YY/T 0127.12 Dental Oral Medical Device Biological Evaluation Unit 2. Test Method Micronucleus Test;

- YY/T 0127.13 Biological evaluation of oral medical devices - Unit 2. Test methods - Oral mucosal irritation test;

- YY/T 0127.14 Biological evaluation of oral medical devices - Unit 2. Test methods Acute oral toxicity test;

- YY/T 0127.15 Biological evaluation of oral medical devices Unit 2. Test methods Subacute and subchronic systemic toxicity Test. Oral route;

- YY/T 0127.16 Biological evaluation of oral medical devices Unit 2. Test methods In vitro chromosomes of mammalian cells Distortion test;

- YY/T 0127.17 Biological evaluation of oral medical devices - Part 17. Mutation of mouse lymphoma cells (TK) test;

Oral medical devices - Biological evaluation - Part 18. Dentine barrier - Cytotoxicity test YY/T 0127.18. This section is part 18 of YY/T 0127.

This part is drafted in accordance with the rules given in GB/T 1.1-2009.

This section refers to ISO 7405.:2008 "Evaluation of biocompatibility of dental devices for dental use in dentistry" Appendix B "Dentine barrier fine Cytotoxicity test ".

1 Scope

This part of YY/T 0127 specifies the cytotoxicity test method for dental material dentin barrier.

This part applies to the evaluation of tooth filling materials and dental cavities related to the treatment of materials and filterable components after the dentin barrier to fine The effect of cytotoxicity.

2 Normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including all modifications) applies to this document.

GB/T 16886.5 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity test (GB/T 16886.5-2003,

ISO 10993-5.:1999, IDT)

GB/T 16886.12 Biological evaluation of medical devices - Part 12. Sample preparation and reference samples (GB/T 16886.12- 2005, ISO 10993-12.:2002)

ISO 7405-AMD..2013 Dentistry-Evaluation ofbiocompatibilityofmedicaldevicesusedinden-tistry (evaluation of biocompatibility of dental instruments for dental use)

3 Purpose

This test was used to evaluate the cytotoxicity of the dental filling material by means of cell culture. Cells and materials are barrier to a dentin Separated, so as to simulate the clinical dental cavity with the repair material filling situation.

If the use of agar or filter filtration method obtained cytotoxicity of 0 to 1, you do not have to carry out the test.

4 Appliances and materials