YY/T 0127.17-2014 English PDF

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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
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0127.17-2014	259	Add to Cart	3 days	Biological evaluation of medical devices used in dentistry. Part 17: Mouse lymphoma cells (TK) gene mutation test	Valid

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YY/T 0127.13   YY/T 0127.7   YY/T 0127.4   YY/T 0127.19   YY/T 0127.15   YY/T 0127.18   

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

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
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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