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YY/T 0127.13-2018 PDF English

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YY/T 0127.13-2018: Biological evaluation of medical devices used in dentistry - Part 13: Oral mucous irritation test
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YY/T 0127.13: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] deliveryName of Chinese StandardStatus
YY/T 0127.13-2018English140 Add to Cart 0-9 seconds. Auto-delivery Biological evaluation of medical devices used in dentistry - Part 13: Oral mucous irritation test Valid
YY/T 0127.13-2009English319 Add to Cart 3 days Biological evaluation of medical devices used in dentistry. Part 2: Tset method. Oral mucous membrane irritation test Obsolete

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YY/T 0127.13-2018: Biological evaluation of medical devices used in dentistry - Part 13: Oral mucous irritation 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/YYT0127.13-2018
YY PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.060.10 C 33 Replacing YY/T 0127.13-2009 Biological evaluation of medical devices used in dentistry - Part 13. Oral mucous irritation test Issued on: APRIL 11, 2018 Implemented on: MAY 01, 2019 Issued by. China Food and Drug Administration

Table of Contents

Foreword ... 3 1 Scope ... 6 2 Normative references ... 6 3 Test animals ... 6 4 Principles of test ... 6 5 Test materials ... 7 6 Materials that may not be tested for oral mucosal irritation ... 8 7 Test methods and procedures ... 8 8 Postoperative observation of animals ... 10 9 Animal execution and tissue sectioning ... 10 10 Evaluation of tissue’s response ... 10 11 Evaluation of results ... 12 12 Test report ... 12 References ... 13

Foreword

YY/T 0127 is the standard for specific biological test methods for medical devices used in dentistry, which are divided into the following parts. - YY/T 0127.1 Biotic experiment method for dental materials - Hemolysis test; - YY/T 0127.2 Biological evaluation of medical devices used in dentistry - Part 2. Test method - Acute systemic toxicity. intravenous path; - YY/T 0127.3 Biological evaluation of dental materials - Unit 2. Biological evaluation method of dental materials - Endodontic usage test; - YY/T 0127.4 Biological evaluation of dental materials - Unit 2. Biological evaluation method of dental materials - Bone implant test; - YY/T 0127.5 Biological evaluation of dental materials - Unit 2. Biological test methods of dental materials - 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 - Part 2. Biological evaluation test method of dental materials - Pulp and dentine usage test; - YY/T 0127.8 Biological evaluation of dental materials - Part 2. Biological evaluation test method of dental materials - Subcutaneous implant test - YY/T 0127.9 Biological evaluation of dental materials - Part 2. Biological evaluation test method of dental materials - Cytotoxicity tests. Agar diffusion test and filter diffusion test; - YY/T 0127.10 Biological evaluation of dental materials - Part 2. Biological evaluation test method of dental materials - Salmonella typhimurium reverse mutation assay (Ames mutagenicity test); - YY/T 0127.11 Dentistry - Preclinical evaluation of biocompatibility of medical devices used in dentistry - Part 2. Biological evaluation test method of dental materials - Pulp capping test; - YY/T 0127.12 Dentistry - Biological evaluation of medical devices used in dentistry - Part 2. Test method - Micronucleus test; - YY/T 0127.13 Biological evaluation of medical devices used in dentistry - Part 2. Test method - Oral mucous membrane irritation test; - YY/T 0127.14 Biological evaluation of medical devices used in dentistry - Biological evaluation of medical devices used in dentistry - Part 13. Oral mucous irritation test

1 Scope

This part of YY/T 0127 specifies the oral mucous irritation test method for medical devices. This part is intended to evaluate the irritating effects onto the oral mucosal tissue of short-term, long-term and long-lasting oral medical devices that are in contact with oral mucosal tissue or other medical devices that are in contact with oral mucosal tissue.

2 Normative references

The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) are applicable to this standard. GB/T 16886.12 Biological evaluation of medical devices - Part 12. Sample preparation and reference materials

3 Test animals

3.1 Healthy, young adult golden hamsters, in same strain, male or female. Female animals shall not be pregnant. 3.2 For the initial test, it shall use at least 3 animals to evaluate the test materials. 3.3 If the initial test’s reaction is suspicious or unclear, it shall repeat the test.

4 Principles of test

According to the contact time of medical devices and oral mucosa, they are divided into short-term contact devices, long-term contact devices, long-lasting contact devices. Medical devices that are in contact with oral mucosa for ≤ 24 h are short-term contact devices; medical devices that are in contact with oral mucosa for 24 h ~ 30 d are long-term contact devices; medical devices that are in contact with oral mucosa for > 30 d are long-lasting contact devices. as a negative control. The cheek pouch without the sample can be used as a blank control. When the specimen is a material extract, the extraction medium is its control sample. 5.5 Cleaning and disinfection According to the manufacturer’s instruction manual, select appropriate method to clean and disinfect the prepared solid specimen and the control specimen.

6 Materials that may not be tested for oral mucosal

irritation 6.1 Materials known as skin or eye irritants, pH ≤ 2 or pH ≥ 11.5 should not be tested for oral mucosal irritation, which is considered to be a potential oral mucosal irritant. 6.2 If the results of the intradermal reaction test show that the material has a difference between the average score of the sample and the control of not more than 1.0, the oral mucosal stimulation test may no longer be performed, and the material is considered to be non-irritating to the oral mucosa.

7 Test methods and procedures

7.1 Animal anesthesia Use a suitable anesthetic to anesthetize the animal. Use iodophor or other suitable disinfectant to clean the oral and external tissues of the animal. 7.2 Contact method 7.2.1 Long-term contact method It is suitable for long-term and long-lasting contact materials which are in contact with oral mucosa for ≥ 24 h. There are two test methods. suture contact method and collar method. 7.2.1.1 Suture contact method Respectively place the specimen and the control material on the surface of the entrance of the buccal mucosa on both sides of the golden hamster’s mouth. One side is the specimen, the other side is for control. Use the medical 5-0 suture thread to perform cheek-penetration and skin suture against the specimen and the control material’s test piece, to fix the test piece onto the surface of the buccal mucosa. The suturing force shall be such as that the test piece fits snugly against the mucosa, without compression. The contact time of tissue for hyperkeratosis, keratosis, spinous-layer hyperplasia, acanthosis, abnormal epithelial hyperplasia, epithelial atrophy, sponge formation, basal cell vacuolization, liquefaction, metaplasia, hyperplasia, other abnormal changes. 10.2.2 Histological scores According to the tissue reaction scoring system of Table 2, calculate the reaction score of the tissue of each animal. Add the microscopic evaluation scores of all the animals in a test group, divide it by the total number of observations, to obtain the average score of the test group. For the control group, use the same method for calculation. The maximum score for each group is 16. Table 2 -- Reaction scoring system of oral mucosal tissue Reaction Score 1. Epithelium Normal, intact 0 Cell degeneration or flattening 1 Tissue deformation 2 Partial erosion 3 Wide erosion 4 2. Leukocyte infiltration (each high-power field) None 0 Very few (less than 25) 1 Mild (26 ~ 50) 2 Moderate (51 ~ 100) 3 Severe (greater than 100) 4 Table 2 (continued) Reaction Score 3. Blood vessel congestion None 0 Very few 1 Mild 2 Moderate 3 Severe, with vascular rupture 4 4. Edema None 0 Very few 1 Mild 2 Moderate 3 Severe 4 ......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.


      

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