YY/T 0127.17-2014 Active Industry standards-Medicine

YY/T 0127.17-2014 Biological evaluation of medical devices used in dentistry—Part 17:Mouse lymphoma cells(TK)gene mutation test

YY/T 0127.17-2014 Biological evaluation of medical devices used in dentistry—Part 17:Mouse lymphoma cells(TK)gene mutation test

Publish Date: 2014-06-17 Implement Date: 2015-07-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0127.17-2014

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Dental instruments, equipment, and materials

ICS Name: Dental materials

Publish Date: 2014-06-17

Implement Date: 2015-07-01

Pages: 10 pages

Scope

This part of YY/T 0127 specifies the method for testing the mutation of the TK gene in mouse lymphoma cells for oral medical devices, including the operating steps, data processing, and result determination.
This part is applicable to determining the mutagenicity of oral medical devices.

Development Information

Word Count: 13 Thousand words Pages: 10 pages

Same series standard

YY/T 0127.3-2014 Biological evaluation of medical devices used in dentistry—Part 3:Endodontic usage test YY/T 0127.5-2014 Biological evaluation of medical devices used in dentistry—Part 5:Inhalation toxicity test YY/T 0127.11-2014 Biological evaluation of medical devices used in dentistry—Part 11:Pulp capping test

Referenced Standards

GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.3-1997 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity GB/T 16886.3-2008 Biological evaluation of medical devices—Part 3:Tests for genotoxicity,carcinogenicity and reproductive toxicity GB/T 16886.3-2019 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity 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