Biological Evaluation of Medical Devices Used in Dentistry - Part 2：Test Method - Salmonella Typhimurium Reverse Mutation Assay (Ames Mutaaenicity Test)
1 Scope
This part of YY/T 0127 specifies the method of Salmonella typhimurium reverse mutation assay for medical devices used in dentistry.
This test is used to determine the genemutation (histidine (his ˉ)-depending bacterial strain becomes histidine (his ˉ)-undepending bacterial strain) which is generated by bacterial strain evoked by the dentistry materials which may cause salmonella genesubstitution and/or phase shift mutation. It is belongs to one of the mutagenicity tests for inspecting the medical devices.
2 Normative References
The provisions of the following normative references belong to this part after being quoted by this part of YY/T 0127. For dated reference, subsequent amendments to (excluding the correction), or revisions of, any of these publications do not apply this part. However, parties entered into agreements based on this Part are encouraged to investigate whether the most recent editions of the standards is applicable or not. For undated references, its latest editions are applicable to this Part.
Contents
1 Scope
2 Normative References
3 Instruments
4 Preparation of culture Medium and Reagents
5 Preparation, Identification and Storage of Bacterial Strain
6 Induction and Preparation of the Metabolic Activation Agent [Rat Hepatomicrosome (S -9)]
7 Preparation of Tested Sample and Selection of Dosage
8 Induction of Mutation Test Method
9 Evaluation of Result
Appendix A
(Normative)
Preparation of Culture Medium and Reagents
