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YY/T 0870.8-2024: Test for genotoxicity of medical devices - Part 8: Unscheduled DNA synthesis test with mammalian liver cells in vivo
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Test for genotoxicity of medical devices - Part 8: Unscheduled DNA synthesis test with mammalian liver cells in vivo
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YY/T 0870.8-2024
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Basic data | Standard ID | YY/T 0870.8-2024 (YY/T0870.8-2024) | | Description (Translated English) | Test for genotoxicity of medical devices - Part 8: Unscheduled DNA synthesis test with mammalian liver cells in vivo | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C30 | | Classification of International Standard | 11.040.01 | | Word Count Estimation | 10,162 | | Date of Issue | 2024-07-08 | | Date of Implementation | 2025-07-20 | | Issuing agency(ies) | State Drug Administration | YY/T 0870.8-2024: Test for genotoxicity of medical devices - Part 8: Unscheduled DNA synthesis test with mammalian liver cells in vivo
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ICS 11.040.01
CCSC30
Pharmaceutical Industry Standards of the People's Republic of China
Genotoxicity testing for medical devices Part 8.In vivo
Unscheduled DNA synthesis in mammalian hepatocytes
Released on 2024-07-08
2025-07-20 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 8 of YY/T 0870 “Genetic Toxicity Testing for Medical Devices”. YY/T 0870 has been published in the following parts.
--- Part 1.Bacterial reverse mutation test;
--- Part 2.In vitro mammalian cell chromosome aberration test;
--- Part 3.TK gene mutation test using mouse lymphoma cells;
--- Part 4.Mammalian bone marrow erythrocyte micronucleus test;
--- Part 5.Mammalian bone marrow chromosome aberration test;
--- Part 6.In vitro mammalian cell micronucleus test;
--- Part 7.In vivo alkaline comet test in mammals;
--- Part 8.In vivo unscheduled DNA synthesis test in mammalian hepatocytes.
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 Biological Evaluation of Medical Devices (SAC/TC248).
This document was drafted by. Shandong Medical Device and Drug Packaging Inspection Institute, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Institute, Beijing Institute of Medical Device Inspection (Beijing Medical Biological Protection Equipment Inspection and Research Center).
The main drafters of this document are. Wang Luanluan, Liu Xin, Song Wei, Sun Jiao, Zhang Ao, Chu Xiangyu and Che Guoxi.
Introduction
The test method for detecting potential genotoxic substances given in GB/T 16886.3 does not provide detailed test steps and is therefore not suitable for
Directly used for testing medical devices. YY/T 0870 provides detailed test steps based on the characteristics of medical devices and can be used as
Supplementary method standard for genetic toxicity test in GB/T 16886.3.
This document provides a method for evaluating the genotoxic effects of medical devices on mammals to determine the potential
The resulting DNA damage and repair.
YY/T 0870 aims to establish specific test methods for genetic toxicity of medical devices and is intended to consist of 8 parts.
--- Part 1.Bacterial reverse mutation test. The purpose is to provide detailed test results for bacterial reverse mutation test of medical devices/materials
method.
--- Part 2.In vitro mammalian cell chromosome aberration test. The purpose is to give the in vitro mammalian cell chromosome aberration test of medical devices/materials.
Detailed test method for cell chromosome aberration test.
--- Part 3.TK gene mutation test using mouse lymphoma cells. The purpose is to provide medical devices/materials using mice
Detailed test method for TK gene mutation test performed on lymphoma cells.
--- Part 4.Mammalian bone marrow erythrocyte micronucleus test. The purpose is to give the medical device/material mammalian bone marrow erythrocyte micronucleus test
Detailed test method for micronucleus test.
--- Part 5.Mammalian bone marrow chromosome aberration test. The purpose is to give the medical device/material mammalian bone marrow chromosome
Detailed test method for distortion test.
--- Part 6.In vitro mammalian cell micronucleus test. The purpose is to give the in vitro mammalian cell micronucleus test of medical devices/materials
Detailed test method for the test.
--- Part 7.Alkaline comet test in mammals. The purpose is to give the alkaline comet test in mammals for medical devices/materials.
Detailed test method for the test.
--- Part 8.In vivo mammalian hepatocyte unscheduled DNA synthesis test. The purpose is to give the in vivo mammalian hepatocyte DNA synthesis test results of medical devices.
Detailed experimental method for the unscheduled DNA synthesis assay in animal liver cells.
Genotoxicity testing for medical devices Part 8.In vivo
Unscheduled DNA synthesis in mammalian hepatocytes
1 Scope
This document describes a test method for in vivo unscheduled DNA synthesis in mammalian hepatocytes in medical devices.
This document is applicable to the evaluation of whether medical devices have the potential to cause unplanned DNA damage in mammalian liver cells by measuring the unplanned DNA damage caused by medical devices.
Has potential genotoxic effects.
NOTE. In vivo mammalian hepatocyte ex vivo DNA synthesis assays of nanomaterials may require specific revisions to the methods in this document, but this document
No description given.
2 Normative references
The contents of the following documents constitute 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 14925 Experimental Animal Environment and Facilities
GB/T 16886.2 Biological evaluation of medical devices Part 2.Animal welfare requirements
GB/T 16886.3 Biological evaluation of medical devices Part 3.Tests for genotoxicity, carcinogenicity and reproductive toxicity
GB/T 16886.12 Biological evaluation of medical devices Part 12.Sample preparation and reference materials
3 Terms and definitions
The terms and definitions defined in GB/T 16886.3 and GB/T 16886.12 and the following apply to this document.
3.1
DNA synthesis that occurs outside the semiconservative DNA program during the S phase of the cell cycle.
4 Test Principle
The in vivo mammalian hepatocyte UDS test is an in vivo somatic cell genetic toxicology test conducted using mammals.
Compared with “short-range repair” (1 to 3 base pairs), UDS test can effectively remove and replace the bases in the damaged DNA.
The UDS test can detect the entire genome and has a high sensitivity.
DNA damage is not repaired, mismatch repair or misreplication leads to mutations that cannot fully and accurately reflect the DNA repair process.
There is some compensation.
The genetic endpoint of the UDS test is DNA damage in hepatocytes and its subsequent repair. Freshly isolated mammalian hepatocytes are placed in
Culture the cells in a medium containing 5-ethynyl-2'-deoxyuridine (EdU) for a period of time. If the test substance causes DNA damage in the cells,
During the repair process, EdU is integrated into the DNA chain and reacts with the fluorescent probe under the action of Cu.
The labeled azide compound undergoes a click reaction (i.e., a copper-catalyzed covalent reaction of an azide group with an alkyne terminal), and the newly synthesized DNA
Labeled with fluorescent probes, the amount of EdU incorporated is observed by fluorescence intensity to evaluate the potential mutagenicity of medical devices.
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