YY/T 0127.12-2008Dentistry—Biological evaluation of medical devices used in dentistry - Part 2: Test method—Micronucleus test (English PDF)

Foreword

"Biological Evaluation of Dental Materials' second unit, is divided into the following sections.

--- YY/T 0127.1-1993 Test methods for dental materials biological hemolysis test --- YY/T 0127.2-1993 Test methods for dental materials biological intravenous acute systemic toxicity test Biological Evaluation --- YY/T 0127.3-1998 Dental Materials Unit 2. Biological test methods of dental materials within the root canal should Test --- YY/T 0127.4-1998 Biological Evaluation of Dental Materials Unit 2. Biological test methods of dental materials Bone implants test Biological Evaluation --- YY/T 0127.5-1999 Dental Materials Unit 2. Biological test methods of dental materials inhalation toxicity test --- YY/T 0127.6-1998 Biological Evaluation of Dental Materials Unit 2. Biological test methods of dental materials dominant lethal test Biological Evaluation --- YY/T 0127.7-2001 Dental Materials Unit 2. Biological test methods of dental materials of the dental pulp Application of the test substance Biological Evaluation --- YY/T 0127.8-2001 Dental Materials Unit 2. Biological test methods of dental materials implanted subcutaneously test --- YY/T 0127.9-2001 Biological Evaluation of Dental Materials Unit 2. Biological test methods of dental materials cytotoxic Test (agar overlay method and molecular filtration method)

--- YY/T 0127.10-2001 Biological Evaluation of Dental Materials Unit 2. Biological test methods of dental materials typhimurium sand Door coli reverse mutation assay (Ames test)

Preclinical evaluation of biocompatibility of medical devices Module 2 --- YY/T 0127.11-2001 dentistry for the oral cavity. the mouth Biological test method cavity material pulp capping test Biological Evaluation --- YY/T 0127.12-2007 Dentistry Dental Devices Unit 2. micronucleus test --- YY/T 0279-1995 Test Method for biological dental materials oral mucous membrane irritation test --- YY/T 0244-1996 Test method for short-term biological material of oral systemic toxicity test. the oral route This section YY/T Part of 120,127.

This section is one of the specific test methods for biological evaluation of medical devices oral Series Standard Test Method for biological genetic toxicity tests.

This part mainly based on ISO 10993.3:2003 "Biological evaluation of medical devices - Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity Test "method recommended OECD474 and reference of GB/T 15193.5-2003" food safety toxicology evaluation procedures And the method "developed.

OECD474 "bone marrow micronucleus test," the scope of chemical substances. GB/T 15193.5-2003 scope is food Goods. Since most medical equipment/dental materials is insoluble, the test mainly to extract the test substance. Therefore, this standard test dose The level of selection and sampling time with those standards.

1 Scope

YY/T 0127 This section provides the dental instrument genotoxicity --- bone marrow micronucleus test methods and technical requirements.

This section applies to detect oral medical devices and their components or extracts possible mutagenic effect.

2 Normative references

The following documents contain provisions which, through reference YY/T 0127 to the present, constitute provisions of this section. For dated reference documents Member, all subsequent amendments (not including errata content) or revisions do not apply to this section, however, encouraged to reach under this section Parties to research agreement to use the latest versions of these documents. For undated reference documents, the latest versions apply to this section.

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

3 Appliance

Anatomy equipment, biological microscope slide.

4 Reagents

Reagents were analytical grade with test water is distilled water.

5 Test animals