YY/T 0127.10-2009Biological evaluation of medical devices used in dentistry - Unit 2: Test method - Salmonella typhimurium reverse mutation assay (Ames mutagenicity test) (English PDF)

Foreword

"Oral Biological evaluation of medical devices" the first series of standards unit 1, YY/T 0268-2008 "Dentistry Oral Health Medical Devices Evaluation was Module 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 "Biological Evaluation of Dental Materials Unit 2 Test Method" is divided into the following sections.

--- YY/T 0127.1-1993 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 route;

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 Quality application test;

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 0127.10-2009 Oral Biological evaluation of medical devices Unit 2. Test methods for Salmonella typhimurium 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;

--- YY/T 0127.12-2008 Dentistry Oral Biological evaluation of medical devices Module 2. Test methods micronucleus test;

--- YY/T 0127.13-2009 Oral Biological evaluation of medical devices Module 2. Test methods to stimulate the oral mucosa test;

--- YY/T 0127.14-2009 Oral Biological evaluation of medical devices Unit 2. Test methods for acute oral systemic toxicity test;

--- YY/T 0244-1996 Test method for short-term biological material of oral systemic toxicity test. oral route. This section YY/T Part of 100,127.

This section instead of YY/T 0127.10-2001 "Biological Evaluation of Dental Materials Unit 2. Biological test methods of dental materials rats Salmonella Salmonella reverse mutation assay (Ames test). " Section compared with YY/T 0127.10-2001, main variations of the following.

--- Standard name to read. "Oral Biological evaluation of medical devices Unit 2. Test methods for Salmonella typhimurium reply projections Variable test (Ames test) ";

--- Normative references made amended accordingly;

--- Extract dose consisted of 200mg/mL to the highest dose;

--- Test sample consisted of five doses to at least three doses. It is the highest dose group, 1/2 highest dose group and the highest agent 1/4 Volume group;

--- Increase curing type material sample preparation requirements. "For curing type material, considering the state of the cured material is mutagenic when recommended Curing 24h ± 2h samples tested. That put the sample after curing at room temperature, sealed 24h ± 2h. Also be based on Its use of features to choose when to be tested, but should be indicated in the report ";

--- Because PCBs in domestic and foreign is no longer used, so the "PCBs" to "phenobarbital or 3-methyl-MCA And beta-phenylpropyl flavonoids "as an inducer. This section of Appendix A normative appendix.

1 Scope

YY/T 0127 provisions of this part of the oral medical equipment Salmonella typhimurium reverse mutation assay methods.

This test can be used to determine the cause Salmonella gene replacement and/or Dental Materials and frameshift mutations induced depends on histidine (His-) does not depend on the strains of histidine (his +) mutations. One of the mutagenicity test to detect oral medical devices.

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 7919-1987 cosmetic safety evaluation procedures and methods

GB 15193.4-2003 Salmonella typhimurium/mammalian microsomal enzyme test

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 Instrument

3.2 clean bench, incubator, water bath, low speed centrifuge, a deep freezer (-80 °C) or liquid nitrogen cans.

4 Preparation of media and reagents

Preparation of media and reagents in Appendix A.

5 Strain preparation, identification and storage