YY/T 0127.10-2009 Active Industry standards-Medicine

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)

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)

Publish Date: 2009-06-16 Implement Date: 2010-12-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0127.10-2009

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Dental instruments, equipment, and materials

ICS Name: Dental materials

Publish Date: 2009-06-16

Implement Date: 2010-12-01

Pages: 10 pages

Scope

This part of YY/T 0127 specifies the test method for reverse mutation of Salmonella typhimurium in oral medical devices. This test is used to determine the dependence of Salmonella typhimurium on histidine (his-) and the production of gene mutations that do not depend on histidine (his+) induced by oral materials that can cause gene replacement and/or frameshift mutations of Salmonella typhimurium. It is one of the tests used to detect the mutagenicity of oral medical devices.

Development Information

Word Count: 16 Thousand words Pages: 10 pages

Same series standard

YY/T 0127.2-2009 Biological evaluation of medical devices used in dentistry—Part 2:Test method—Acute systemic toxicity:intravenous path YY/T 0127.4-2009 Oral medical device biocontamination evaluation. The second unit: test methods, Bone implant test YY/T 0127.9-2009 Biological evaluation of oral medical devices, Unit 2: Test methods, Cytotoxicity test: Agar diffusion method and filter membrane diffusion method YY/T 0127.13-2009 Biological evaluation of medical devices used in dentistry—Part 2:Test method—Oral mucous membrane irritation test YY/T 0127.14-2009 Biological evaluation of medical devices used in dentistry—Part 2:Test method—Acute oral toxicity test YY/T 0127.16-2009 Oral Medical Devices Biological Evaluation, Unit 2: Test Methods - In Vitro Chromosome Aberration Test in Mammalian Cells

Replace the following standards

YY/T 0127.10-2001 Biological evaluation of dental materials—Part 2:Biological evaluation test method of dental materials—Salmonella typhimurium reverse mutation assay(Ames mutagenicity test)

Referenced Standards

GB 7919-1987 Procedures and methods of safety evaluation for cosmetics GB 15193.4-2003 salmonella typhimurium /mammals microsomes enzyme test(Ames test) GB/T 16886.12-2000 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.12-2005 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.12-2017 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.12-2023 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials

Related Standards

GB/T 6387-1986 Replaced

GB/T 6387-1986 Vocabulary of dental materials

Publish Date: 1986-05-14

YY 0270-2003 Replaced

YY 0270-2003 Dentistry—Denture base polymers

Publish Date: 2003-06-20

YY 0462-2003 Replaced

YY 0462-2003 Dental gypsum products

Publish Date: 2003-06-20

YY 0463-2003 Replaced

YY 0463-2003 Dental phosphate-bonded casting investments

Publish Date: 2003-06-20

YY 1042-2003 Replaced

YY 1042-2003 Dentistry—Polymer-based filling,restorative and luting materials

Publish Date: 2003-06-20

YY 0493-2004 Replaced

YY 0493-2004 Dentistry—Elastomeric impression materials

Publish Date: 2004-11-08