YY/T 0127.11-2014 English PDFUS$209.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0127.11-2014: Biological evaluation of medical devices used in dentistry. Part 11: Pulp capping test Status: Valid YY/T 0127.11: Historical versions
Basic dataStandard ID: YY/T 0127.11-2014 (YY/T0127.11-2014)Description (Translated English): Biological evaluation of medical devices used in dentistry. Part 11: Pulp capping test Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C33 Classification of International Standard: 11.060.10 Word Count Estimation: 9,963 Date of Issue: 6/17/2014 Date of Implementation: 7/1/2015 Older Standard (superseded by this standard): YY/T 0127.11-2001 Quoted Standard: GB/T 16886.2 Adopted Standard: ISO 7405-2008, MOD Regulation (derived from): China Food and Drug Administration in 2014 Bulletin No. 30 Issuing agency(ies): State Food and Drug Administration Summary: This Standard applies to the evaluation and pulp pulp capping material biocompatibility. Methods of operation and process materials required in the clinical application is also included in this evaluation. This Standard specifies test methods for dental m YY/T 0127.11-2014: Biological evaluation of medical devices used in dentistry. Part 11: Pulp capping test---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order. Biological evaluation of medical devices used in dentistry.Part 11. Pulp capping test ICS 11.060.10 C33 People's Republic of China pharmaceutical industry standards Replacing YY/T 0127.11-2001 Biological Evaluation of Medical Devices Oral Part 11. Test pulp capping Part 11. Pulpcappingtest (ISO 7405.2008, MOD) Issued on. 2014-06-17 2015-07-01 implementation China Food and Drug Administration released ForewordThis section is YY/T 0127 Biological evaluation of medical devices mouth of a standard series of standards. YY/T 0268 "Dentistry Oral Biological evaluation of medical devices Module 1. Evaluation and testing" oral biology Medical Devices Evaluation of the pilot project selection criteria as a guide. --- YY/T 0127 standard oral medical equipment specific biological test method standards, where YY/T 0127 is divided into the following several section. --- YY/T 0127.1 Test methods for dental materials biological hemolysis test; --- YY/T 0127.2 Biological evaluation of medical devices oral Unit 2. Test methods for acute systemic toxicity test. Intravenous way; --- YY/T 0127.3 Oral Biological evaluation of medical devices - Part 3. Application Test of the root canal; --- YY/T 0127.4 Oral Biological evaluation of medical devices Unit 2. Biological test methods of dental materials Bone implants trials; --- YY/T 0127.5 Oral Biological evaluation of medical devices - Part 5. inhalation toxicity test; --- YY/T 0127.6 Biological Evaluation of Dental Materials Unit 2. Biological test methods of dental materials dominant lethal test; --- YY/T 0127.7 Biological Evaluation of Dental Materials Unit 2. Biological test methods of dental materials Pulp and dentine usage test; Biological Evaluation --- YY/T 0127.8 Dental Materials Unit 2. Biological test methods of dental materials subcutaneous implantation test; --- YY/T 0127.9 Biological evaluation of medical devices oral Unit 2. Biological test methods of dental materials cytotoxicity test Test. agar overlay method and molecular filtration method; --- YY/T 0127.10 Biological evaluation of medical devices oral Unit 2. Test methods for Salmonella typhimurium reply projections Variable test (Ames test); --- YY/T 0127.11 dentistry for preclinical evaluation of biocompatibility of medical devices oral Unit 2. Dental Materials Biological test methods of pulp capping test; --- YY/T 0127.12 Dentistry Oral Biological evaluation of medical devices Module 2. Test methods micronucleus test; --- YY/T 0127.13 Biological evaluation of medical devices oral Unit 2. Test methods oral mucosa irritation test; --- YY/T 0127.14 Oral Biological evaluation of medical devices Unit 2. Test methods for acute oral systemic toxicity tests; --- YY/T 0127.15 Biological evaluation of medical devices oral Unit 2. Test methods subacute and subchronic systemic toxicity Test. the oral route; --- YY/T 0127.16 Oral Biological evaluation of medical devices Unit 2. Test methods for mammalian cells in vitro chromosomal Aberration test; --- YY/T 0127.17 Oral Biological evaluation of medical devices - Part 17. mouse lymphoma cells (TK) gene mutation test. This is Part 11 YY/T 0127 standards. This section drafted in accordance with GB/T 1.1-2009 given rules. This part is YY/T 0127.11-2001 "Dentistry for preclinical evaluation of biocompatibility of medical devices oral second single Element. Biological test methods of dental materials pulp capping test "amendments. This section instead of YY/T 0127.11-2001. This section of YY/T 0127.11-2001 following major technology changes, these changes are based on ISO 7405.2008 and carried out Modifications. --- Normative references GB/T 16886.2 canceled reign; --- The "reference material" to "reference material." The reference material is not required by, and reference material, for example a "note" form Lists; --- Chapter 5, "test animal" to "animals and animal welfare." Select test animals added ferrets; --- For disinfecting the tooth surface and the operating area, to slightly more than one polyethylene containing iodine or chlorhexidine disinfectants; --- For the filling after pulp capping materials, to "recommend the use of acid-modified polyethylene resin-based composite or resin-modified glass ionomer cement Bottom, then use adhesive resin-based composite restoration "; --- The number of teeth of each test cycle test material filled from at least 7 to 10; --- Tissue slice thickness from 5μm ~ 10μm to 5μm ~ 7μm; --- Expanded to explain the inflammatory response index calculation of "total income of each slice after slice grading score divided by the sum of the observed number"; --- Added description of the nature of dentin bridge; --- Deleted YY/T 0127.11-2001 Chapter 10 part on the results of the evaluation. This section uses redrafted law revision using ISO 7405.2008 "biocompatibility of medical devices used in dentistry oral evaluation" 6.5 "pulp capping test." This section lists the reg and 7405 ISO in Appendix A.2008 reg control list numbered. This section 7405 and ISO .2008 main difference is as follows. --- In the preparation of the format, for ease of use users, according to a general description of the test method was reclassified as an increase. Chapter 1 Range; Chapter 2 Normative references; Chapter 3 samples; Chapter 4, reference material; --- Chapter 5 of animals and animal welfare, will be distributed in the standard in relation to other animals and teeth everywhere, all focused on this Zhang described in detail; --- 7.3.1 from "tissue fixative after shooting apical X-ray" with "pulp capping after 7d ± 2d 70d ± 5d and after using After fixative or tissue. suitable anesthetic anesthetized animals, and each test dental X-ray taken "and add" note Shoot apical X-ray film. " Please note that some of the content of this document may involve patents. The issuing authority of this document should not bear the responsibility to identify these patents. This part is proposed by the China Food and Drug Administration. The oral part of the National Standardization Technical Committee materials and appliances and equipment (SAC/TC99) centralized. Drafting this Part. North State Food and Drug Administration Medical Device Quality Supervision and Inspection Center, Peking University, Oral Medicine College. The main drafters of this section. Lin Hong, Han Jianmin, Yue Lin. Biological Evaluation of Medical Devices Oral Part 11. Test pulp capping1 ScopeYY/T 0127 provisions of this part of the dental materials pulp capping test methods. This test method is used to evaluate the raw pulp capping and pulp Biocompatible. Also in clinical applications include materials necessary for the operation of some of the evaluation process. Note 1. This test after slight modifications, it can be used for pulpotomy tests. Note 2. The pulp dentine and pulp capping test application tests can be performed on the same tooth different animals.2 Normative referencesThe following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. GB/T 16886.2 Biological evaluation of medical devices - Part 2. Animal welfare requirements3 SampleModulation test materials by manufacturers requirements.4 reference materialSelect the appropriate reference material. Note. Analysis purity calcium oxide mixed into 0.9% (by mass) of a certain consistency sterile saline can be used as a suitable reference material.5 animals and animal welfare5.1 Animal Welfare Animal welfare should be observed. a) GB/T 16886.2 or b) experimental animals national regulatory requirements. Note. Animals should be GB/T 16886.2 requires farmers, and free access to food and water. 5.2 Experimental Animals Using the same system of non-rodent mammals, suitable for the age of the animal has been formed dentition contains apical (apical mature) intact Permanent. Monkeys, dogs, miniature pigs and ferrets are suitable animal germline. Other species of animals can be used for a special purpose system. Select animal germ line should be in the most Animal welfare at low cost to meet the minimum requirements of scientific research. Animal selection should be demonstrated and documented. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0127.11-2014_English be delivered?Answer: Upon your order, we will start to translate YY/T 0127.11-2014_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. 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