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YY/T 0127.19-2023 English PDF

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YY/T 0127.19-2023: Biological evaluation of medical devices used in dentistry - Part 19: Subacute and subchronic systemic toxicity test - Implant route
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YY/T 0127.19-2023English359 Add to Cart 4 days [Need to translate] Biological evaluation of medical devices used in dentistry - Part 19: Subacute and subchronic systemic toxicity test - Implant route Valid YY/T 0127.19-2023

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YY/T 0127.13   YY/T 0127.7   YY/T 0127.4   YY/T 0127.15   YY/T 0127.18   YY/T 0127.17   

Basic data

Standard ID YY/T 0127.19-2023 (YY/T0127.19-2023)
Description (Translated English) Biological evaluation of medical devices used in dentistry - Part 19: Subacute and subchronic systemic toxicity test - Implant route
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C33
Classification of International Standard 11.060.10
Word Count Estimation 18,144
Date of Issue 2023-11-22
Date of Implementation 2024-12-01
Issuing agency(ies) State Drug Administration
Summary This standard specifies the systemic toxicity test methods for subacute and subchronic implantation routes of oral medical devices. This standard is applicable to subacute and subchronic systemic toxicity tests to evaluate oral medical device implantation routes.

YY/T 0127.19-2023: Biological evaluation of medical devices used in dentistry - Part 19: Subacute and subchronic systemic toxicity test - Implant route


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ICS 11.060.10 CCSC33 Pharmaceutical Industry Standards of the People's Republic of China Biological evaluation of oral medical devices Part 19. Subacute and subchronic systemic toxicity tests. Implantation route Released on 2023-11-22 2024-12-01 implementation The State Drug Administration issued

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents" Drafting. This document is part 19 of YY/T 0127 Biological Evaluation of Oral Medical Devices. YY/T 0127 has been published for the following part. ---YY/T 0127.1 Biological test methods for oral materials-Hemolysis test; ---YY/T 0127.3 Biological evaluation of oral medical devices Part 3.Root canal application test; ---YY/T 0127.4 Biological evaluation of oral medical devices Part 4.Bone implantation test; ---YY/T 0127.5 Biological evaluation of oral medical devices Part 5.Inhalation toxicity test; ---YY/T 0127.6 Biological evaluation of oral materials Unit 2.Biological test methods for oral materials Dominant lethal test; ---YY/T 0127.7 Biological evaluation of oral medical devices. Part 7.Application tests on pulp and dentin; ---YY/T 0127.8 Biological evaluation of oral materials Unit 2.Biological test methods for oral materials Subcutaneous implantation test; ---YY/T 0127.9 Biological evaluation of oral medical devices Unit 2.Test methods Cytotoxicity test. Agar diffusion method and membrane diffusion method; ---YY/T 0127.10 Biological evaluation of oral medical devices Unit 2.Test method Salmonella typhimurium reversion mutation Variation test (Ames test); ---YY/T 0127.11 Biological evaluation of oral medical devices Part 11.Pulp capping test; ---YY/T 0127.12 Dentistry Biological evaluation of oral medical devices Unit 2.Test methods Micronucleus test; ---YY/T 0127.13 Biological evaluation of oral medical devices Part 13.Oral mucosal irritation test; ---YY/T 0127.14 Biological evaluation of oral medical devices Unit 2.Test methods Acute oral systemic toxicity test; ---YY/T 0127.15 Biological evaluation of oral medical devices Part 15.Subacute and subchronic systemic toxicity tests. Oral way; ---YY/T 0127.16 Biological evaluation of oral medical devices Unit 2.Test methods Chromosomes in vitro of mammalian cells Distortion test; ---YY/T 0127.17 Biological evaluation of oral medical devices Part 17.Mouse lymphoma cell (TK) gene mutation test; ---YY/T 0127.18 Biological evaluation of oral medical devices Part 18.Dentin barrier cell toxicity test; ---YY/T 0127.19 Biological evaluation of oral medical devices Part 19.Subacute and subchronic systemic toxicity tests. Implantation way. Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents. This document is proposed by the State Food and Drug Administration. This document is under the jurisdiction of the National Technical Committee for Standardization of Dental Materials and Instruments (SAC/TC99). This document was drafted by. Oral Medical Device Testing Center, Peking University School of Stomatology, Sichuan University (Sichuan Medical Device Biomaterials and Product Inspection Center), the Ninth People's Hospital affiliated to Shanghai Jiao Tong University School of Medicine. The main drafters of this document are. Han Jianmin, Liang Jie, Liu Xin, Chai Yuan, Wu Yang, Dai Zhengning, Jia Lifang, Yuan Tun, Sun Jiao, Ren Xinxin, and Lu Hua.

Introduction

There are many types of oral medical devices. When evaluating the systemic toxicity of medical devices that come into contact with the oral cavity, the following should be considered. The test route and cycle are specifically selected based on the characteristics of the test and the characteristics of contact with oral tissue. In most cases, the subacute test implantation time is 28 days for chronic test and 90 days for subchronic test. Biological evaluation of oral medical devices Part 19. Subacute and subchronic systemic toxicity tests. Implantation route

1 Scope

This document describes the systemic toxicity test methods for subacute and subchronic implantation routes of medical devices for oral health. This document is applicable to subacute and subchronic systemic toxicity tests for evaluating oral medical devices for implantation routes.

2 Normative references

The contents of the following documents constitute the essential clauses of this document through normative references in this document. For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to This document. GB/T 16886.2 Biological evaluation of medical devices Part 2.Animal welfare requirements GB/T 16886.6 Biological evaluation of medical devices Part 6.Local reaction test after implantation GB/T 16886.11 Biological evaluation of medical devices Part 11.Systemic toxicity tests GB/T 16886.12 Biological evaluation of medical devices Part 12.Sample preparation and reference materials GB/T 16886 (all parts) Biological evaluation of medical devices

3 Terms and definitions

GB/T 16886 (all parts) and the following terms and definitions apply to this document. 3.1 dose; dosage The amount of test sample given per unit body weight or surface area (e.g., volume, mass). g, mg), or the surface area or mass of the test sample per unit surface area or body weight of the animal (cm2/m2, m2/m2, mg/kg, g/kg). 3.2 Degradable biodegradable The material may be induced to break down by the biological environment or the breakdown products may be assimilated by cells and/or tissues.

4 Purpose and Principles

4.1 Purpose In this test, oral medical devices are implanted in animals for a certain period of time (such as 28 days, 90 days) to measure their effects on the experimental animals in order to determine Whether it has potential subacute or subchronic systemic toxic effects. 4.2 Test principles In the process of evaluating the systemic toxicity characteristics of oral medical devices, whether to conduct subacute or subchronic systemic toxicity tests for implantation is appropriate.

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