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YY/T 0127.10-2009 English PDF

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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: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 0127.10-2009English389 Add to Cart 3 days [Need to translate] 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
YY/T 0127.10-2001English399 Add to Cart 3 days [Need to translate] Biological evaluation of dental materials. Part 2: Biological evaluation test method of dental materials. Salmonella typhimurium reverse mutation assay (Ames mutagenicity test) Obsolete YY/T 0127.10-2001

PDF similar to YY/T 0127.10-2009


Standard similar to YY/T 0127.10-2009

YY/T 0127.13   YY/T 0127.7   YY/T 0268   YY/T 0127.4   YY/T 0127.19   YY/T 0127.15   

Basic data

Standard ID YY/T 0127.10-2009 (YY/T0127.10-2009)
Description (Translated English) Biological evaluation of medical devices used in dentistry. Part 2: Test method. Salmonella typhimurium reverse mutation assay (Ames mutagenicity test)
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C33
Classification of International Standard 11.060.10
Word Count Estimation 11,121
Date of Issue 2009-06-16
Date of Implementation 2010-12-01
Older Standard (superseded by this standard) YY/T 0127.10-2001
Quoted Standard GB 7919-1987; GB 15193.4-2003; GB/T 16886.12
Regulation (derived from) Industry standard filing Notice 2009 No. 9
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the Oral medical Salmonella typhimurium reverse mutation test methods. This test for the determination of Salmonella may cause gene replacement and/or frameshift mutations induced dental materials depends on the histidine (his-) strains is not dependent on the histidine (his +) mutations. Medical devices for the detection of oral one 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)


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Biological evaluation of medical devices used in dentistry.Part 2. Test method.Salmonella typhimurium reverse mutation assay (Ames mutagenicity test) ICS 11.060.10 C33 Medical industry standards People's Republic of China Replacing YY/T 0127.10-2001 Biological Evaluation of Medical Devices Oral Unit 2. Test methods Salmonella typhimurium reverse mutation assay Posted 2009-06-16 2010-12-01 implementation State Food and Drug Administration issued

Foreword

"Oral Biological evaluation of medical devices" the first series of standards unit 1, YY/T 0268-2008 "Dentistry Oral Health Medical Devices Evaluation was Module 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 "Biological Evaluation of Dental Materials Unit 2 Test Method" is divided into the following sections. --- YY/T 0127.1-1993 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 route; Biological Evaluation --- YY/T 0127.3-1998 Dental Materials Unit 2. Biological test methods of dental materials within the root canal should Test; --- YY/T 0127.4-1998 Biological Evaluation of Dental Materials Unit 2. Biological test methods of dental materials Bone implants test; Biological Evaluation --- YY/T 0127.5-1999 Dental Materials Unit 2. Biological test methods of dental materials inhalation toxicity test; --- YY/T 0127.6-1998 Biological Evaluation of Dental Materials Unit 2. Biological test methods of dental materials dominant lethal test; Biological Evaluation --- YY/T 0127.7-2001 Dental Materials Unit 2. Biological test methods of dental materials of the dental pulp Quality application test; Biological Evaluation --- YY/T 0127.8-2001 Dental Materials Unit 2. Biological test methods of dental materials implanted subcutaneously test; --- YY/T 0127.9-2001 Biological Evaluation of Dental Materials Unit 2. Biological test methods of dental materials cytotoxic Test (agar overlay method and molecular filtration method); --- YY/T 0127.10-2009 Oral Biological evaluation of medical devices Unit 2. Test methods for Salmonella typhimurium Reverse mutation assay (Ames test); Preclinical evaluation of biocompatibility of medical devices Module 2 --- YY/T 0127.11-2001 dentistry for the oral cavity. the mouth Biological test method cavity material pulp capping test; --- YY/T 0127.12-2008 Dentistry Oral Biological evaluation of medical devices Module 2. Test methods micronucleus test; --- YY/T 0127.13-2009 Oral Biological evaluation of medical devices Module 2. Test methods to stimulate the oral mucosa test; --- YY/T 0127.14-2009 Oral Biological evaluation of medical devices Unit 2. Test methods for acute oral systemic toxicity test; --- YY/T 0244-1996 Test method for short-term biological material of oral systemic toxicity test. oral route. This section YY/T Part of 100,127. This section instead of YY/T 0127.10-2001 "Biological Evaluation of Dental Materials Unit 2. Biological test methods of dental materials rats Salmonella Salmonella reverse mutation assay (Ames test). " Section compared with YY/T 0127.10-2001, main variations of the following. --- Standard name to read. "Oral Biological evaluation of medical devices Unit 2. Test methods for Salmonella typhimurium reply projections Variable test (Ames test) "; --- Normative references made amended accordingly; --- Extract dose consisted of 200mg/mL to the highest dose; --- Test sample consisted of five doses to at least three doses. It is the highest dose group, 1/2 highest dose group and the highest agent 1/4 Volume group; --- Increase curing type material sample preparation requirements. "For curing type material, considering the state of the cured material is mutagenic when recommended Curing 24h ± 2h samples tested. That put the sample after curing at room temperature, sealed 24h ± 2h. Also be based on Its use of features to choose when to be tested, but should be indicated in the report "; --- Because PCBs in domestic and foreign is no longer used, so the "PCBs" to "phenobarbital or 3-methyl-MCA And β- phenylpropyl flavonoids "as an inducer. This section of Appendix A normative appendix. This part is proposed by the State Food and Drug Administration. This part of the jurisdiction of the National Standardization Technical Committee of Dental Materials and Devices and equipment. This part by the State Food and Drug Administration Peking University Medical Device Quality Supervision and Testing Center is responsible for drafting. The main drafters of this section. Lin Hong, Li Shenglin, Fu Jia, Wang Yi Xiang, Hao Peng. This section was first released in 2001. In 2009, the first revision. This part of the standard replaces the previous editions are. --- YY 0127.10-2001. Biological Evaluation of Medical Devices Oral Unit 2. Test methods Salmonella typhimurium reverse mutation assay

1 Scope

YY/T 0127 provisions of this part of the oral medical equipment Salmonella typhimurium reverse mutation assay methods. This test can be used to determine the cause Salmonella gene replacement and/or Dental Materials and frameshift mutations induced depends on histidine (His-) does not depend on the strains of histidine (his +) mutations. One of the mutagenicity test to detect oral medical devices.

2 Normative references

The following documents contain provisions which, through reference YY/T 0127 to the present, constitute provisions of this section. For dated reference documents Member, all subsequent amendments (not including errata content) or revisions do not apply to this section, however, encouraged to reach under this section Parties to research agreement to use the latest versions of these documents. For undated reference documents, the latest versions apply to this section. GB 7919-1987 cosmetic safety evaluation procedures and methods GB 15193.4-2003 Salmonella typhimurium/mammalian microsomal enzyme test GB/T 16886.12 Biological evaluation of medical devices - Part 12. Sample preparation and reference materials (GB/T 16886.12- 2005, ISO 10993.12.2002, IDT)

3 Instrument

3.1 commonly used laboratory equipment. 3.2 clean bench, incubator, water bath, low speed centrifuge, a deep freezer (-80 ℃) or liquid nitrogen cans.

4 Preparation of media and reagents

Preparation of media and reagents in Appendix A. 5 strain preparation, identification and storage 5.1 Strain Using histidine auxotrophic Salmonella typhimurium total of four --- TA97, TA98, TA100, TA102. 5.2 Storage strain Strain stored in the added dimethylsulfoxide (spectroscopically pure) in a fresh inoculum, the volume ratio of 0.09.1, mixed, packed in small Inner tube or pipe strain, the dry ice-acetone solution (-75 ℃) or liquid nitrogen (-196 ℃) frozen at -80 ℃ -196 ℃ liquid nitrogen refrigerator or long-term Storage. 5.3 enrichment culture Scraped from stored frozen bacterial strains tube set 5mL nutrient broth, after 37 ℃ shaking (100 times/min) cultured 10h ~ 12h, number of viable cells should be up to 109/mL (OD600≈0.4). After the bacterial culture was removed from the 37 ℃, should be immediately placed in 4 ℃ for use. Test required Good day incubation with fresh bacteria.

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