YY/T 0127.11-2014Biological evaluation of medical devices used in dentistry - Part 11: Pulp capping test (English PDF)

Foreword

This 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.

1 Scope

YY/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 references

The 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 requirements

3 Sample

Modulation test materials by manufacturers requirements.

4 Reference material

Select 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 welfare