YY/T 0127.4-2009 Translated English of Chinese Standard. (YYT 0127.4-2009, YY/T0127.4-2009, YYT0127.4-2009): Biological evaluation of medical devices used in dentistry - Part 2: Test method - Bone implant testhttps://www.chinesestandard.net, 2014 M04 5 - 17 pages This Standard specifies the test method of bone implantation of dental medical devices. This Standard shall be used to evaluate the biological reactions of bone tissue of which the dental bone issue is planned to contact with dental medical devices in long-term. |
Contents
3 | |
Scope | 6 |
Test Cycles | 7 |
Surgical Procedure | 8 |
Appendix A | 13 |
Translation References and Original Chinese Documents | 17 |
Common terms and phrases
26 weeks 5-10/phf Severe infiltration animal biocompatibility biodegradable materials Biological evaluation test biological reaction Biological test methods Bone implant test bone resorption bone tissue regenerated capillaries with fibroblasts Comparison material Comparison Sample cortical bone cut tissue degradation dental materials Dental Medical device dentistry device Biology Assessment documents so quoted draining lymph nodes ethanol evaluation of dental evaluation of medical evaluation test method Fatty infiltration femur or medial fibroblasts structural support Fibrosis Group total implantation GB/T implanting position infiltration Full vision inflammation iodine lymphocytes macrophages material is deemed Medical device Biology method Bone implant method of dental Micronucleus test Necrosis Neovascularization plasma cells Polymorphonuclear leukocytes reaction evaluation system Reaction Score Sample preparation semi-quantitative scoring system series standards Severe infiltration Full side of tibial slicing Stimulation index Subtotal Table A2 test cycle Test method Bone test samples Threaded implant tissue arrangement tissue interface tissue reaction classification tissue samples toxicity test YY/T