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YY/T 0127.17-2014: Biological evaluation of medical devices used in dentistry. Part 17: Mouse lymphoma cells (TK) gene mutation test
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Biological evaluation of medical devices used in dentistry. Part 17: Mouse lymphoma cells (TK) gene mutation test
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YY/T 0127.17-2014
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Basic data | Standard ID | YY/T 0127.17-2014 (YY/T0127.17-2014) | | Description (Translated English) | Biological evaluation of medical devices used in dentistry. Part 17: Mouse lymphoma cells (TK) gene mutation test | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C33 | | Classification of International Standard | 11.060.10 | | Word Count Estimation | 11,168 | | Date of Issue | 6/17/2014 | | Date of Implementation | 7/1/2015 | | Quoted Standard | GB/T 16886.1; GB/T 16886.3; GB/T 16886.12 | | Regulation (derived from) | China Food and Drug Administration in 2014 Bulletin No. 30 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This Standard applies to the determination of the mutagenicity of dental instruments. This Standard specifies the oral medical equipment mouse lymphoma cells (TK) gene mutation test methods, including procedures, data processing and result determination. | YY/T 0127.17-2014: Biological evaluation of medical devices used in dentistry. Part 17: Mouse lymphoma cells (TK) gene mutation test
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Biological evaluation of medical devices used in dentistry.Part 17. Mouse lymphoma cells (TK) gene mutation test
ICS 11.060.10
C33
People's Republic of China pharmaceutical industry standards
Biological Evaluation of Medical Devices Oral
Part 17.
Mouse lymphoma cells (TK) gene mutation test
Part 17. Mouselymphomacels (TK) genemutationtest
Issued on. 2014-06-17
2015-07-01 implementation
China Food and Drug Administration released
Foreword
This section is "Oral Biological evaluation of medical devices" series standard part of the standard.
"Biological Evaluation of Medical Devices Oral series of standards" in the YY/T 0268 "Dentistry Oral Biological evaluation of medical devices
Unit 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 oral medical equipment specific biological test method standards, where YY/T 0127 is divided into the following sections.
--- YY/T 0127.1 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
way;
--- YY/T 0127.3 Oral Biological evaluation of medical devices - Part 3. Application Test of the root canal;
--- YY/T 0127.4 Oral Biological evaluation of medical devices Unit 2. Biological test methods of dental materials Bone implants trials;
--- YY/T 0127.5 Oral Biological evaluation of medical devices - Part 5. inhalation toxicity test;
--- YY/T 0127.6 Biological Evaluation of Dental Materials Unit 2. Biological test methods of dental materials dominant lethal test;
--- YY/T 0127.7 Biological Evaluation of Dental Materials Unit 2. Biological test methods of dental materials Pulp and dentine usage
test;
Biological Evaluation --- YY/T 0127.8 Dental Materials Unit 2. Biological test methods of dental materials subcutaneous implantation test;
--- YY/T 0127.9 Biological Evaluation of Dental Materials Unit 2. Biological test methods of dental materials cytotoxicity test. Joan
Fat cover method and molecular filtration method;
--- YY/T 0127.10 Biological evaluation of medical devices oral Unit 2. Test methods for Salmonella typhimurium reply projections
Variable test (Ames test);
--- YY/T 0127.11 dentistry for preclinical evaluation of biocompatibility of medical devices oral Unit 2. Dental Materials
Standard Test Method for pulp capping test;
--- YY/T 0127.12 Dentistry Oral Biological evaluation of medical devices Module 2. Test methods micronucleus test;
--- YY/T 0127.13 Biological evaluation of medical devices oral Unit 2. Test methods oral mucosa irritation test;
--- YY/T 0127.14 Oral Biological evaluation of medical devices Unit 2. Test methods for acute oral systemic toxicity tests;
--- YY/T 0127.15 Biological evaluation of medical devices oral Unit 2. Test methods subacute and subchronic systemic toxicity
Test. the oral route;
--- YY/T 0127.16 Oral Biological evaluation of medical devices Unit 2. Test methods for mammalian cells in vitro chromosomal
Aberration test;
--- YY/T 0127.17 Oral Biological evaluation of medical devices - Part 17. mouse lymphoma cells (TK) gene mutation
test.
This section YY/T 0127 Part 19.
This section drafted in accordance with GB/T 1.1-2009 given rules.
Please note that some of the content of this standard may involve patents. The standard release mechanism should not bear the responsibility to identify these patents.
In this part, reference GB/T 16886.3-2008 (ISO 10993.3.2003) recommended OECDGUIDLINEFOR
THETESTINGOFCHEMICALS "InVitroMammalianCelGeneMutationTest" 476.1997 method
Making.
This part is proposed by the China Food and Drug Administration.
The oral part of the National Standardization Technical Committee materials and appliances and equipment (SAC/TC99) centralized.
This section is drafted. Sichuan biomaterials and medical devices products inspection center (Sichuan University), the State Food and Drug Administration North
Big Medical Device Quality Supervision and Inspection Center, Shanghai Biological Materials Research and Testing Center, Shenzhen medical equipment testing center.
The main drafters of this section. Jie Liang, Yuan Tun, Zhang Jin, Sun Jiao, Cao Ping, Lin Hong, Qiu, Zhu Wei Jing, Lu Hua, Liu Yao.
Biological Evaluation of Medical Devices Oral
Part 17.
Mouse lymphoma cells (TK) gene mutation test
1 Scope
YY/T 0127 provisions of this part of the oral medical equipment mouse lymphoma cells (TK) gene mutation assay method comprising the step operation
Step, data processing and results determined.
This section applies to the determination of mutagenicity of dental instruments.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation of the risk management process and Test
GB/T 16886.3 Biological evaluation of medical devices - Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity
GB/T 16886.12 Biological evaluation of medical devices - Part 12. Sample preparation and reference materials
3 Terms and Definitions
GB/T 16886.1, GB/T 16886.3 and GB/T 16886.12 defined and the following terms and definitions apply to this document.
3.1
Mutation frequency mutantfrequency
The number of mutant cells observed divided by the number of viable cells.
3.2
Relative total growth relativetotalgrowth
Treated longer than the number of cells increase cell growth and the negative control group over time, calculated relative suspension growth relative survival
Rate product.
3.3
Relative suspension growth relativesuspensiongrowth
The expression ratio of the number of cells treated with the growth end of the negative control group.
3.4
Vitality viability
After the expression of cell culture plates set when treated colony forming efficiency.
3.5
Relative survival relativesurvival; RS
Set processing cell colony forming efficiency when dealing with the end plate culture. Usually treated with the negative control group, the relative number of cell viability
FIG.
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