YY/T 0127.17-2014Biological evaluation of medical devices used in dentistry - Part 17: Mouse lymphoma cells(TK)gene mutation test (English PDF)

Foreword

This section is "Oral Biological evaluation of medical devices" series standard part of the standard. "Biological Evaluation of Medical Devices Oral series of standards" in the YY/T 0268 "Dentistry Oral Biological evaluation of medical devices Unit 1. Evaluation and testing "is the choice of oral biological evaluation of medical devices with the pilot project, as a guide standard.

--- YY/T 0127 oral medical equipment specific biological test method standards, where YY/T 0127 is divided into the following sections.

--- YY/T 0127.1 Test methods for dental materials biological hemolysis test;

--- YY/T 0127.2 Biological evaluation of medical devices oral Unit 2. Test methods for acute systemic toxicity test. Intravenous way;

--- YY/T 0127.3 Oral Biological evaluation of medical devices - Part 3. Application Test of the root canal;

--- YY/T 0127.4 Oral Biological evaluation of medical devices Unit 2. Biological test methods of dental materials Bone implants trials;

--- YY/T 0127.5 Oral Biological evaluation of medical devices - Part 5. 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 Unit 2. Biological test methods of dental materials Pulp and dentine usage test;

Biological Evaluation --- YY/T 0127.8 Dental Materials Unit 2. Biological test methods of dental materials subcutaneous implantation test;

--- YY/T 0127.9 Biological Evaluation of Dental Materials Unit 2. Biological test methods of dental materials cytotoxicity test. Joan Fat cover method and molecular filtration method;

--- YY/T 0127.10 Biological evaluation of medical devices oral Unit 2. Test methods for Salmonella typhimurium reply projections Variable test (Ames test);

--- YY/T 0127.11 dentistry for preclinical evaluation of biocompatibility of medical devices oral Unit 2. Dental Materials Standard Test Method for pulp capping test;

--- YY/T 0127.12 Dentistry Oral Biological evaluation of medical devices Module 2. Test methods micronucleus test;

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

--- YY/T 0127.14 Oral Biological evaluation of medical devices Unit 2. Test methods for acute oral systemic toxicity tests;

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

--- YY/T 0127.16 Oral Biological evaluation of medical devices Unit 2. Test methods for mammalian cells in vitro chromosomal Aberration test;

--- YY/T 0127.17 Oral Biological evaluation of medical devices - Part 17. mouse lymphoma cells (TK) gene mutation test. This section YY/T 0127 Part 19. This section drafted in accordance with GB/T 1.1-2009 given rules.

1 Scope

YY/T 0127 provisions of this part of the oral medical equipment mouse lymphoma cells (TK) gene mutation assay method comprising the step operation Step, data processing and results determined.

This section applies to the determination of mutagenicity of dental instruments.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document.

GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation of the risk management process and Test

GB/T 16886.3 Biological evaluation of medical devices - Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity

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

3 Terms and Definitions

GB/T 16886.1, GB/T 16886.3 and GB/T 16886.12 defined and the following terms and definitions apply to this document.