YY/T 0127.4-2023 (YY/T 0127.4-2009) PDF EnglishUS$140.00 · In stock · Download in 9 seconds
YY/T 0127.4-2009: Biological evaluation of medical devices used in dentistry - Part 2: Test method - Bone implant test Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Obsolete YY/T 0127.4: Historical versions
Similar standardsYY/T 0127.4-2009: Biological evaluation of medical devices used in dentistry - Part 2: Test method - Bone implant test---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT0127.4-2009 ICS 11.040.99 C 40 INDUSTRY STANDARD Biological evaluation of medical devices used in dentistry Part 2.Test method Bone implant test Issued on: DECEMBER 30, 2009 Implemented on: JUNE 01, 2011 Issued by. The State Food and Drug Administration Table of ContentsForeword... 3 1 Scope... 6 2 Normative References... 6 3 Sample Preparation... 6 4 Test Cycles... 7 5 Experimental Animals... 7 6 Test Position... 7 7 Surgical Procedure... 8 8 Post-operative Evaluation... 8 9 Killing of Animal... 8 10 Biological Reaction Evaluation... 8 Appendix A... 13 References... 16 Translation References and Original Chinese Documents... 17ForewordThis Standard is one of the series standards of “Dental Medical device Biology Assessment”. The 1st unit, YY/T 0268.2008 “Dentistry. Biological evaluation of medical devices used in dentistry. Part 1.Evaluation and test” of Dental Medical device Biology Assessment series standards, is an option for dental medical device biology assessment and test items; it is a guideline standard. The 2nd unit of the series standards is “Dental medical devices specific biological test methods”. It is divided into the following sections. 1.YY/T 0127.1-93 Dental materials biological test methods Hemolysis test 2.YY/T 0127.2-2009 Biological evaluation of medical devices used in dentistry. Part 2. Test method. Acute systemic toxicity. intravenous path 3.YY/T 0127.3-1998 Biological evaluation of dental materials - Unit 2.Biological evaluation method of dental materials - Endodontic usage test 4.YY/T 0127.4-2009 Biological evaluation of medical devices used in dentistry. Part 2. Test method Bone implant test 5.YY/T 0127.5-1999 Biological evaluation of dental materials - Unit 2.Biological test methods of dental materials - Inhalation toxicity test 6.YY/T 0127.6-1998 Biological evaluation of dental materials - Unit 2.Biological test methods of dental materials - Dominant lethal test 7.YY/T 0127.7-2001 Biological evaluation of dental materials. Part 2.Biological evaluation test method of dental materials. Pulp and dentine usage test 8.YY/T 0127.8-2001 Biological evaluation of dental materials. Part 2.Biological evaluation test method of dental materials. Subcutaneous implant test 9.YY/T 0127.9-2009 Biological evaluation of medical devices used in dentistry. Part 2. Test method - Cytotxicity tests. Agar diffusion test and filter diffusion test 10.YY/T 0127.10-2009 Biological evaluation of medical devices used in dentistry. Part 2. Test method. Salmonella typhimurium reverse mutation assay (Ames mutagenicity test) 11.YY/T 0127.11-2001 Dentistry - Preclinical evaluation of biocompatibility of medical devices used in dentistry. Part 2.Biological evaluation test method of dental materials - Pulp capping test 12.YY/T 0127.12-2008 Dentistry. Biological evaluation of medical devices used in dentistry Part 2.Test method - Micronucleus test 13.YY/T 0127.13-2009 Dentistry. Biological evaluation of medical devices used in dentistry Part 2.Test method - Micronucleus test 14.YY/T 0244-1996 Biological test methods of dental materials - Short term systemic toxicity test. dental route 15.YY/T 0127.14-2009 Biological evaluation of medical devices used in dentistry. Part 2. Test method. Acute oral toxicity test 16.YY/T 0127.15-2009 Biological evaluation of medical devices used in dentistry. Part 2. Test method Subacute and subchronic toxicity test - Oral route This Standard is Part 4 of YY/T 0127 series standards. This Standard is the revised version of YY/T 0127.4-1998 “Biological evaluation of medical devices used in dentistry. Part 2.Test method Bone implant test”. During the drafting process, it references to the ISO 10993.6-2007 “Biological evaluation of medical devices - Part 6.Tests for local effects after implantation”. Test principles of ISO 10993.6-2007 are applicable to this Standard. Compared with the standard YY/T 0127.4-1998, the main changes are as follows. - Standard name is renamed as. “Biological evaluation of medical devices used in dentistry. Part 2.Test method Bone implant test”. - 3.1 Sample preparation adds samples with different types of materials. The sample quantity number of each test cycle is changed to at least 10. - 3.2, 4, 5, 6 add a variety of options. - 7 During surgical procedure, "25g/L iodine and 75% ethanol" are changed to "5g/L iodine". - 10 Biological evaluation is modified. - ADD Appendix A. Appendix A is an informative appendix. From the date of implementation, this Standard will replace the obsolete Y/T 0217.4-1998 “Biological evaluation of medical devices used in dentistry. Part 2.Test method - Bone implant test”. This Standard was proposed by the State Food and Drug Administration. This Standard is administered by the National Dental Materials and Appliances Equipment Standardization Technical Committee (SAC/TC 99). This Standard was responsibly drafted by Dental Medical Device Inspection Center, School of Stomatology of Peking University. The main drafters of this Standard. Lin Hong, Li Shenglin, and Hao Peng. This Standard was first-published in 1998, it is first-revised in 2009.The previous edition which is substituted by this Standard is. - YY/T 0127.4-1998 Biological evaluation of medical devices used in dentistry Part 2.Test method Bone implant test1 ScopeThis 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.2 Normative ReferencesThe articles contained in the following documents have become part of this Standard when they are quoted herein. For the dated documents so quoted, all the modifications (excluding corrections) or revisions made thereafter shall not be applicable to this Standard. For the undated documents so quoted, the latest edition shall be applicable to this Standard. GB/T 13810 Wrought titanium and titanium alloy for surgical implants GB/T 16886.6 Biological evaluation of medical devices - Part 6.Tests for local effects after implantation (GB/T 16886.6-1997, ISO 10993-6.1994, IDDT) GB/T 16886.12 Biological evaluation of medical devices - Part 12.Sample preparation and reference materials (GB/T 16886.12 2005, ISO 10993-12.2005, IDT)3 Sample Preparation3.1 CONDUCT preparation, processing, cleaning, and disinfection for the implanted materials according to the same method used for final product. At least 10 samples shall be used for each test cycle. 3.1.1 Solid sample. sample shall be made in cylinder with diameter of 2 mm, height of 6 mm, with smooth surface. same position; so as to ensure the minimum influence of relative movement between tissue and the implants. For cylindrical sample, the observation position shall be at the central part of the column; for slotted cylindrical implants, the central part of the slot and the top flat surface are suitable for evaluation. 10.1 Visual evaluation USE low-magnification loupe to observe the cut tissue from the implanting position; it shall include the evaluation of local draining lymph nodes. RECORD the characteristics and degree of the observed tissue reaction, including hematoma, edema, fiber wrapping and (or) any general findings. RECORD the implant’s state, shape and location, including the possible residues of biodegradable materials. Observation results shall be archived with photographs. In addition, when observing the implanting position, if the animal exhibits pathological or reaction to the implant, gross necropsy shall be carried out if necessary. 10.2 Sampling and preparation of tissue sample In order to evaluate the local biological reaction, cut tissue samples shall include those sufficient unaffected tissue from the implanting position and surrounding areas. If the implant is not obvious in the observation position (biodegradable material/ absorbable material), it shall expand the sampling area, including those normal tissue located within few millimeters. For non-degradable materials, it shall include the abnormal draining lymph nodes shown by the result of gross pathology. For biod... ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. |
