YY/T 0127.2-2009Biological evaluation of medical devices used in dentistry - Unit 2: Test method - Acute systemic toxicity: intravenous route (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", is divided into the following sections.

--- YY/T 0127.1-1993 Test methods for dental materials biological hemolysis test;

--- YY/T 0127.2-2009 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 Section 20127 of.

This section instead of YY/T 0217.2-1993 "Test methods for dental materials biological intravenous acute systemic toxicity test." Section compared with YY/T 0217.2-1993, major changes in the following.

--- Standard name to read. "Oral Biological evaluation of medical devices Unit 2. Test methods for acute systemic toxicity test. Intravenous way";

--- Make changes in the number of experimental animals, from "20" to "10";

--- Modify Normative references to. GB/T 16886.12 "Biological evaluation of medical devices - Part 12. Sample preparation and reference Samples "(ISO 10993.12, IDT);

--- 4.3.2 adds support for curing type material requirements;

--- 4.3.2.4 The pore size 4.5µm ~ 9µm of a sintered funnel to a pore size of 1µm sterile filtration membranes;

--- Remove Appendix A.

This part of ISO 10993-11:2006 "Biological evaluation of medical devices - Part 11. Tests for systemic toxicity" increased compared to solid Class material requirements and increase the result of the determination of specific targets.

1 Scope

YY/T 0127 provisions of this part of the dental instrument acute systemic toxicity test. Test methods intravenous route.

This section applies to the proposed oral contact with the blood of medical devices acute systemic toxicity evaluation.

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 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 Research into whether the parties to the agreement to use the latest versions of these documents. For undated references, the latest version applies 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 Terms and Definitions

The following terms and definitions apply YY/T 0127 to the present section.

3.5 14d after injection of extracts or fewer adverse reactions observation period of several days. Test Method 4

3.4 Extracts away from the injection site adverse reactions occurred

3.2 Extracting material from the resulting liquid extraction medium