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YY/T 0127.14-2009: Biological evaluation of medical devices used in dentistry. Part 2: Test method. Acute oral toxicity test
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Biological evaluation of medical devices used in dentistry. Part 2: Test method. Acute oral toxicity test
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YY/T 0127.14-2009
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Basic data | Standard ID | YY/T 0127.14-2009 (YY/T0127.14-2009) | | Description (Translated English) | Biological evaluation of medical devices used in dentistry. Part 2: Test method. Acute oral toxicity test | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C33 | | Classification of International Standard | 11.060.10 | | Word Count Estimation | 9,959 | | Date of Issue | 2009-06-16 | | Date of Implementation | 2010-12-01 | | Quoted Standard | GB/T 16886.12; GB 15193.3-2003 | | 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 acute oral systemic toxicity test methods. This standard applies to evaluation of oral medical devices by the oral route of acute systemic toxicity. | YY/T 0127.14-2009: Biological evaluation of medical devices used in dentistry. Part 2: Test method. Acute oral toxicity test
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Biological evaluation of medical devices used in dentistry.Part 2. Test method.Acute oral toxicity test
ICS 11.060.10
C33
People's Republic of China pharmaceutical industry standards
Biological Evaluation of Medical Devices Oral
Unit 2. Test methods
Acute oral systemic toxicity tests
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 methods" is divided into the following sections.
--- YY/T 0127.1-1993 Test methods for dental materials biological hemolysis test;
--- YY/T 0127.2-2009 Oral Biological evaluation of medical devices 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 140,127.
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, Hao Peng, Li Shenglin, Ge Xi source, pay Kerry.
Biological Evaluation of Medical Devices Oral
Unit 2. Test methods
Acute oral systemic toxicity tests
1 Scope
YY/T 0127 provisions of this part of the dental instrument acute oral systemic toxicity testing.
This section applies to the evaluation of medical devices through the oral-oral route of acute systemic toxicity.
2 Normative references
The following documents contain provisions which, through reference YY/T 0127 and become part of the provisions of this section. For dated references,
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 preparation and reference materials (GB/T 16886.12- sample
2005, ISO 10993.12.2002, IDT)
GB/T 15193.3-2003 acute toxicity test
3 General
Acute oral toxicity test is a way to evaluate the toxicity of the material properties through short-term oral exposure may provide health hazards letter
interest. The test results can be used as basis for classification and labeling of toxic material identification. Acute oral toxicity test is a sub-chronic test and other tests determined
Fixed-dose exposure mode first test step, and may provide material information regarding the toxicity of the mode of action.
4 Terms and Definitions
The following terms and definitions apply YY/T 0127 to the present section.
4.1
Once or several times within 24h after oral administration of the test animals, the test substance, animals health damage effect in the short term.
4.2
It is to accept the number of the test substance. In weight of test substance (g, mg) or animals receiving unit weight of the weight of test substance (mg/kg or
g/kg) to represent.
4.3
After oral administration of the test substance once, causing experimental animal population was half the dose of the poison of death. Animal unit weight pick
Test substance by weight (mg/kg or g/kg) to represent.
5 Test principle
Gavage administered orally each test group of animals with different doses of the test substance, each with a dose, the dose can be determined by a pre-selection test
set. Animals were observed after exposure to toxicity and death. Dead animals during the test are subjected to necropsy at the end of the test surviving
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