YY/T 0127.3-2014Biological evaluation of medical devices used in dentistry - Part 3: Endodontic usage test (English PDF)

Foreword

This part of oral biological evaluation of medical devices in 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 oral medical equipment specific biological test method standards, where YY/T 0127 is divided into the following sections.

--- 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 3 YY/T 0127 standards. This section drafted in accordance with GB/T 1.1-2009 given rules.

This part is YY/T 0127.3-1998 "Biological Evaluation of Dental Materials Unit 2. Biological test methods of dental materials in root canal App test "amendments. This section instead of YY/T 0127.3-1998.

This section of YY/T 0127.3-1998 following major technology changes, these changes are based on ISO 7405:2008 and carried out modify.

--- Delete references to normative documents "YY 0272-1995 Dental zinc oxide eugenol cement," adds "GB/T 16886.2 Animal protection requirements ";

--- The "negative control material" to "reference material";

--- In Chapter 6, "animal" added "animal welfare" content. Selection of experimental animals increased ferrets;

--- Test cycle from 28d ± 6d and 6 months, instead 28d ± 3d and 90d ± 5d;

--- For teeth and disinfection operation region, the concentration of hydrogen peroxide from 30% down to 3%, deleted disinfection iodine content, by Plus polyethylene containing slightly more than iodine or chlorhexidine disinfectants;

--- Will "expand the root canal up to 035 ~ 040 endodontic file thickness" with "in accordance with the length of the experimental work, using progressively increasing, sterile root Canal file root canal preparation, root canal until expanded to fill the appropriate size. ";

--- Modify the filling materials and types of base materials after root canal filling is completed;

--- Tissue slice thickness from 5µm ~ 10µm to 5µm ~ 7µm;

--- The evaluation is divided into 0-3 to level 0 to 4;

--- Deleted YY/T 0127.3-1998 result in 11.1 ~ 11.4 evaluation of the content;

--- Increase in the content of the test report.

This section uses redrafted law revision using ISO 7405:2008 "biocompatibility of medical devices used in dentistry oral evaluation" 6.6 "Application Test of the canal." 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 is defined in the definition of "work test length"; Chapter 4 samples;

--- Chapter 5 reference material;

--- Chapter 6 animals and animal welfare, will be distributed in the standard in relation to other animals and teeth everywhere, all concentrated in the This chapter specifically described;

--- 8.3 from the "shoot apical tissue fixative after X-ray", the words "after the filling (28 ± 3) d and (90 ± 5) d, the combined use After fixative or tissue. suitable anesthetic anesthetized animals, and each test dental X-ray taken note "and increase." Shoot apical X-ray ";

--- 8.2.1 clearly states placing a rubber dam;

--- 8.2.3 adds "If reconcile reconcile board test material and the reference material, should avoid microbiological contamination" content.

1 Scope

YY/T 0127 provisions of this section within the root canal dental materials application test methods. This test method is used to evaluate the apical pulp off End tissue and periapical tissue biocompatibility of the root canal material. Also it includes some materials during the operation in the clinical application of necessary Evaluation.

NOTE: biologically active material is appropriate root canal root canal trials evaluating applications, for example, whether it is filled or when the positive use of down filling, can promote the apical hard tissue Material.

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 Terms and Definitions

This section uses the following terms and definitions.

4 Sample

According to the manufacturer's instructions to reconcile, preparation and application materials.

5 Reference material

Select the appropriate reference material.

Note: zinc oxide eugenol cements used alone or in combination with other additives such as blocking agent Grossman additives, can be used as a suitable The reference material.

6 Animals and animal welfare