YY/T 0127.14-2009Biological evaluation of medical devices used in dentistry - Part 2: Test method - Acute oral toxicity test (English PDF)

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.

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.

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