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YY/T 0127.12-2008 English PDF

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YY/T 0127.12-2008: Dentistry. Biological evaluation of medical devices used in dentistry. Part 2: Test method. Micronucleus test
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YY/T 0127.12-2008English249 Add to Cart 3 days [Need to translate] Dentistry. Biological evaluation of medical devices used in dentistry. Part 2: Test method. Micronucleus test   YY/T 0127.12-2008

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Standard similar to YY/T 0127.12-2008

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 0127.12-2008 (YY/T0127.12-2008)
Description (Translated English) Dentistry. Biological evaluation of medical devices used in dentistry. Part 2: Test method. Micronucleus test
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C33
Classification of International Standard 11.060.10
Word Count Estimation 7,722
Date of Issue 2008-04-25
Date of Implementation 2009-06-01
Quoted Standard GB/T 16886.12
Regulation (derived from) SFDA [2008] No. 192
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the Oral medical genetic toxicity bone marrow micronucleus test methods and technical requirements. This standard applies to detect oral medical devices and their components, or extract the possible mutagenic effect.

YY/T 0127.12-2008: Dentistry. Biological evaluation of medical devices used in dentistry. Part 2: Test method. Micronucleus test


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Dentistry.Biological evaluation of medical devices used in dentistry.Part 2. Test method.Micronucleus test ICS 11.060.10 C33 People's Republic of China pharmaceutical industry standards Oral Biological evaluation of medical devices dentistry Unit 2. Test methods micronucleus test Posted 2008-04-25 2009-06-01 implementation State Food and Drug Administration issued

Foreword

"Biological Evaluation of Dental Materials' second unit, is divided into the following sections. --- YY/T 0127.1-1993 Test methods for dental materials biological hemolysis test --- YY/T 0127.2-1993 Test methods for dental materials biological intravenous acute systemic toxicity test 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 Application of the test substance 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 0127.10-2001 Biological Evaluation of Dental Materials Unit 2. Biological test methods of dental materials typhimurium sand Door coli 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 Biological Evaluation --- YY/T 0127.12-2007 Dentistry Dental Devices Unit 2. micronucleus test --- YY/T 0279-1995 Test Method for biological dental materials oral mucous membrane irritation test --- YY/T 0244-1996 Test method for short-term biological material of oral systemic toxicity test. the oral route This section YY/T Part of 120,127. This section is one of the specific test methods for biological evaluation of medical devices oral Series Standard Test Method for biological genetic toxicity tests. This part mainly based on ISO 10993.3.2003 "Biological evaluation of medical devices - Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity Test "method recommended OECD474 and reference of GB/T 15193.5-2003" food safety toxicology evaluation procedures And the method "developed. OECD474 "bone marrow micronucleus test," the scope of chemical substances. GB/T 15193.5-2003 scope is food Goods. Since most medical equipment/dental materials is insoluble, the test mainly to extract the test substance. Therefore, this standard test dose The level of selection and sampling time with those standards. This standard was proposed by the State Food and Drug Administration. This standard by the National Standardization Technical Committee of Dental Materials and Devices and equipment. This standard is drafted by. Sichuan biomaterials and medical devices products inspection center. Participated in the drafting of this Standard. State Food and Drug Administration, Peking University Medical Device Quality Supervision and Inspection Center. The main drafters of this standard. Sichuan biomaterials and medical devices products inspection center. Zhu Wei Jing, Tan Yan Fei, Zhang Lingli, Jie Liang; national food North and Drug Administration Medical Device Quality Supervision and Inspection Center. Lin Hong, Liu a. Oral Biological evaluation of medical devices dentistry Unit 2. Test methods micronucleus test

1 Scope

YY/T 0127 This section provides the dental instrument genotoxicity --- bone marrow micronucleus test methods and technical requirements. This section applies to detect oral medical devices and their components or extracts possible mutagenic effect.

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/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 appliance

Anatomy equipment, biological microscope slide.

4 Reagents

Reagents were analytical grade with test water is distilled water. 4.1 calf serum Sterilized by filtration calf serum, set 56 ℃ ± 1 ℃ water bath tank insulation 0.5h ~ 1h inactivated. Stored at 4 ℃ refrigerator. Also available Instead of mouse or rat serum. Take Giemsa dye 3.8g, built a mortar, add methanol 375mL, grinding, until the dye is completely dissolved, then add glycerin 125mL, set 37 ℃ incubator insulation 48h, shaking several times. After filtration at room temperature for two weeks or longer. spare. Take 1 part of Giemsa stock solution to prepare a mixed, temporary use when adding 6 parts of phosphate buffer solution (pH6.8 ~ 7.0). 2/15mol disodium hydrogen phosphate; 2/15mol potassium dihydrogen phosphate. 4.5 methanol

5 test animals

5.1 kinds of Selection. Recommended use mice or rats may also be used other suitable mammalian germline. Test using healthy young adult mice. Usually seven weeks to 12 weeks old, weighing 25g ~ 30g Kunming mice, body weight, or 150g ~ 200g Wistar rats or SD rats of 130g ~ 170g. 5.2 If each animal with both sexes, at least the male and female of each five. If using a single male animals, each at least six. After the purchase of animals to Less adapt to the environment 3d.

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