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

Standard No.
YY/T 0127.10-2009
Language
Chinese, Available in English version
Release Date
2009
Published By
Professional Standard - Medicine
Latest
YY/T 0127.10-2009
Replace
YY/T 0127.10-2001
Scope
This part of YY/T 0127 specifies the Salmonella typhimurium reverse mutation test method for oral medical devices. This test is used to determine the production of histidine (his-)-independent gene mutations in histidine (his-)-dependent strains induced by oral materials that can cause gene replacement and/or frameshift mutations in Salmonella. It is one of the mutagenic tests for detecting oral medical devices.

YY/T 0127.10-2009 Referenced Document

  • GB 15193.4-2003 Salmonella typhimurium/mammals microsomal enzyme test(Ames test)
  • GB 7919-1987 Procedures and methods of safety evaluation for cosmetics
  • GB/T 16886.12 Biological Evaluation of Medical Devices Part 12: Sample Preparation and Reference Materials*2023-11-27 Update

YY/T 0127.10-2009 history

  • 2011 YY 1042-2011 Dentistry.Polymer-based restorative materials
  • 2003 YY 1042-2003 Dentistry—Polymer-based filling,restorative and luting materials
  • 1970 YY 91042-1999 dental composite resin filling material
Biological evaluation of medical devices used in dentistry.Part 2:Test method.Salmonella typhimurium reverse mutation assay(Ames mutagenicity test)



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