YY/T 0127.18-2016 English PDF

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YY/T 0127.18-2016: Biological evaluation of medical devices used in dentistry－Part 18: Dentine barrier cytotoxicity test
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Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0127.18-2016	259	Add to Cart	3 days	Biological evaluation of medical devices used in dentistry－Part 18: Dentine barrier cytotoxicity 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 0127.17   

Basic data

Standard ID: YY/T 0127.18-2016 (YY/T0127.18-2016)
Description (Translated English): Biological evaluation of medical devices used in dentistry��Part 18: Dentine barrier cytotoxicity test
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C33
Classification of International Standard: 11.060.10
Word Count Estimation: 13,119
Date of Issue: 2016-01-26
Date of Implementation: 2017-01-01
Quoted Standard: GB/T 16886.5; GB/T 16886.12; ISO 7405-AMD-2013
Adopted Standard: ISO 7405-2008, NEQ
Regulation (derived from): China Food and Drug Administration Bulletin 2016 No.25
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies the dental material dentin barrier cytotoxicity test method. This standard is applicable to the evaluation of the effects of tooth-related materials and dental implants on the cytotoxicity of the related materials and their leachable components after dentin barrier.

YY/T 0127.18-2016: Biological evaluation of medical devices used in dentistry－Part 18: Dentine barrier cytotoxicity 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 18. Dentine barrier cytotoxicity test ICS 11.060.10 C33 People's Republic of China Pharmaceutical Industry Standard Biology Evaluation of Oral Medical Devices Part 18. Dentin barrier cytotoxicity test Part 18. Dentinebarriercytotoxicitytest 2016-01-26 release 2017-01-01 Implementation State Food and Drug Administration issued

Foreword

YY/T 0127 "oral medical device biological evaluation" is divided into 18 parts. YY/T 0127.1 Oral material Biological test method Hemolysis test --- YY/T 0127.2 Biological evaluation of oral medical devices Unit 2. Test methods Acute systemic toxicity test. intravenous way; - YY/T 0127.3 Biological evaluation of oral medical devices - Part 3. Application test in root canals; - YY/T 0127.4 Biological evaluation of oral medical devices - Unit 2. Test methods - Bone implantation test; - YY/T 0127.5 Biological evaluation of oral medical devices - Part 5. Inhalation toxicity test; - YY/T 0127.6 Biology evaluation of oral materials Unit 2. Biological test methods for oral materials - Explicit lethal test; --- YY/T 0127.7 Biology Evaluation of Oral Materials Unit 2. Biological Test Methods for Dental Materials Dental Implants Application test; - YY/T 0127.8 Biological evaluation of oral materials Unit 2. Biological test methods for oral materials Subcutaneous implantation test; - YY/T 0127.9 Biological evaluation of oral medical devices Unit 2. Test methods Cytotoxicity test. Agar diffusion method And membrane diffusion method; --- YY/T 0127.10 Biological evaluation of oral medical devices Unit 2. Test method Salmonella typhimurium recovery Variable test (Ames test); - YY/T 0127.11 Biological evaluation of oral medical devices - Part 11. Covering pulp test; - YY/T 0127.12 Dental Oral Medical Device Biological Evaluation Unit 2. Test Method Micronucleus Test; - YY/T 0127.13 Biological evaluation of oral medical devices - Unit 2. Test methods - Oral mucosal irritation test; - YY/T 0127.14 Biological evaluation of oral medical devices - Unit 2. Test methods Acute oral toxicity test; - YY/T 0127.15 Biological evaluation of oral medical devices Unit 2. Test methods Subacute and subchronic systemic toxicity Test. Oral route; - YY/T 0127.16 Biological evaluation of oral medical devices Unit 2. Test methods In vitro chromosomes of mammalian cells Distortion test; - YY/T 0127.17 Biological evaluation of oral medical devices - Part 17. Mutation of mouse lymphoma cells (TK) test; Oral medical devices - Biological evaluation - Part 18. Dentine barrier - Cytotoxicity test YY/T 0127.18. This section is part 18 of YY/T 0127. This part is drafted in accordance with the rules given in GB/T 1.1-2009. This section refers to ISO 7405..2008 "Evaluation of biocompatibility of dental devices for dental use in dentistry" Appendix B "Dentine barrier fine Cytotoxicity test ". Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents. This section is proposed by the State Food and Drug Administration. This part is headed by the National Standardization Technical Committee for Dental Materials and Equipment (SAC/TC99). This part of the drafting unit. State Food and Drug Administration Peking University Medical Device Quality Supervision and Inspection Center. This part of the main drafters. Lin Hong, Jiang Ruodan, Zheng Gang. Biology Evaluation of Oral Medical Devices Part 18. Dentin barrier cytotoxicity test

1 Scope

This part of YY/T 0127 specifies the cytotoxicity test method for dental material dentin barrier. This part applies to the evaluation of tooth filling materials and dental cavities related to the treatment of materials and filterable components after the dentin barrier to fine The effect of cytotoxicity.

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. GB/T 16886.5 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity test (GB/T 16886.5-2003, ISO 10993-5..1999, IDT) GB/T 16886.12 Biological evaluation of medical devices - Part 12. Sample preparation and reference samples (GB/T 16886.12- 2005, ISO 10993-12..2002) ISO 7405-AMD..2013 Dentistry-Evaluation ofbiocompatibilityofmedicaldevicesusedinden- tistry (evaluation of biocompatibility of dental instruments for dental use)

3 purpose

This test was used to evaluate the cytotoxicity of the dental filling material by means of cell culture. Cells and materials are barrier to a dentin Separated, so as to simulate the clinical dental cavity with the repair material filling situation. If the use of agar or filter filtration method obtained cytotoxicity of 0 to 1, you do not have to carry out the test.

4 appliances and materials

4.1 cells Cells that have established cell lines have been used, for example, from ATCC (AmericanTypeCultureColection) [e.g. ATCCCCL1 (NCTCclone929) mouse fibroblasts] or cells that are selected to clone SV40 large T antigen genes, such as those derived from calf Dental papilla cells. Cells should be maintained in growth medium (37 ± 2) ° C, humidified air containing 5% CO2. Can also be used Other cells that have similar to the nature of the odontoblast or have established cell lines that have physiologically related properties to the pulp tissue. 4.2 medium The culture medium should be suitable for the selected cell line, for example provided by ATCC or similar institutions. Note. See the instructions for HTTP.//WWW.ATCC.ORG. The clonal SV40 large T antigen gene transfected cells were grown in medium containing 20% Fetal heart serum (FBS) MEMα, 150 IU/mL penicillin, 150 μg/mL streptomycin, 0.125 μg/mL amphotericin B and 0.1 mg/mL hereditary Mycamycin. ......

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