YY/T 0870.7-2023_English: PDF (YY/T0870.7-2023)
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Standard ID | YY/T 0870.7-2023 (YY/T0870.7-2023) | Description (Translated English) | (Genotoxicity Tests for Medical Devices - Part 7: Alkaline Comet Test in Mammals) | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | Classification of International Standard | 11.040.01 | Word Count Estimation | 10,137 | Date of Issue | 2023-01-13 | Date of Implementation | 2024-01-15 | Drafting Organization | Shandong Medical Device and Drug Packaging Inspection Research Institute, Sichuan University (Sichuan Medical Device Biomaterials and Products Inspection Center), Beijing Medical Device Inspection Institute | Administrative Organization | National Medical Device Biological Evaluation Standardization Technical Committee (SAC/TC 248) | Proposing organization | State Drug Administration | Issuing agency(ies) | State Drug Administration | Summary | This standard specifies the alkaline comet test method in mammals in the genotoxicity test of medical devices/materials. This standard is applicable to screening whether medical devices/materials have potential genotoxic effects by measuring DNA strand breaks in mammalian cells caused by medical devices/materials. |
YY/T 0870.7-2023
ICS 11.040.01
CCSC30
Pharmaceutical Industry Standard of the People's Republic of China
Medical Device Genotoxicity Test
Part 7.Alkaline comet test in mammals
Released on 2023-01-13
2024-01-15 Implementation
Released by the State Drug Administration
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 7 of YY/T 0870 "Genetoxicity Tests for Medical Devices". YY/T 0870 has issued the following parts.
--- Part 1.Bacterial reverse mutation test;
--- Part 2.Chromosomal aberration test of mammalian cells in vitro;
--- Part 3.TK gene mutation test with 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.
Please note that some contents of this document may refer to patents. The issuing agency of this document assumes no responsibility for identifying patents.
This document is proposed by the State Drug Administration.
This document is under the jurisdiction of the National Standardization Technical Committee for Biological Evaluation of Medical Devices (SAC/TC248).
This document was drafted by. Shandong Medical Device and Drug Packaging Inspection Research Institute, Sichuan University (Sichuan Medical Device Biomaterials and Manufacturing
Product Inspection Center), Beijing Medical Device Inspection Institute.
The main drafters of this document. Sun Lingxiao, Liu Zengxiang, Jia Lifang, Dai Zhengning, Wang Guowei, Li Qiu, He Xueying, Fan Chunguang.
introduction
The alkaline comet test in mammals is recommended in the subsequent evaluation steps of the genotoxicity test strategy specified in GB/T 16886.3
An in vivo test method. The test methods for detecting potential genotoxicity recommended in GB/T 16886.3 have all been listed in the Economic Co-operation and Development Group
Organization (OECD) "Guidelines for Testing Chemicals", but these methods are formulated for the characteristics of chemicals, and no detailed testing is given.
Therefore, it is not suitable for direct use in the testing of medical devices/materials. This document is given in GB/T 16886.3 for the detection of potential genetic
On the basis of the basic principles of safety, detailed test procedures are stipulated according to the characteristics of medical devices/materials, which can be used as the legacy of GB/T 16886.3.
Supplementary to the method of toxicity test.
YY/T 0870 aims to establish specific test methods for genotoxicity of medical devices, and it is planned to consist of 7 parts.
--- Part 1.Bacterial reverse mutation test. The purpose is to give detailed tests for bacterial reverse mutation tests of medical devices/materials
method.
--- Part 2.Chromosomal aberration test in mammalian cells in vitro. The purpose is to give medical devices/materials in vitro mammalian
Detailed test method of cytochromosomal aberration test.
--- Part 3.TK gene mutation test with mouse lymphoma cells. The purpose is to give mice for medical devices/materials
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 medical devices/materials to mammalian bone marrow red blood cells
Detailed test method for the micronucleus test.
--- Part 5.Mammalian bone marrow chromosome aberration test. The purpose is to give medical equipment/material mammalian bone marrow chromosome
Detailed test method for distortion test.
--- Part 6.In vitro mammalian cell micronucleus test. The purpose is to give medical devices/materials in vitro mammalian cell micronuclei
The detailed test method of the test.
--- Part 7.In vivo alkaline comet test in mammals. The purpose is to give medical devices/materials alkaline comets in mammalian bodies
The detailed test method of the test.
Medical Device Genotoxicity Test
Part 7.Alkaline comet test in mammals
1 Scope
This document specifies the mammalian in vivo alkaline comet test method for genotoxicity testing of medical devices/materials.
This document is applicable to the screening of medical devices by measuring the breakage of DNA strands in the nucleus of mammalian cells caused by medical devices/materials
whether the machinery/material has potential genotoxic effects.
NOTE. In vivo alkaline comet assays in mammals for nanomaterials and cross-linkers may require specific revisions to the methods in this document, but this paper
The item is not described.
2 Normative references
The contents of the following documents constitute the essential provisions of this document through normative references in the text. Among them, dated references
For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to
this document.
GB/T 16886.1 Biological evaluation of medical devices Part 1.Evaluation and testing in the risk management process
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.Genotoxicity, Carcinogenicity and Reproductive Toxicity Tests
GB/T 16886.12 Biological evaluation of medical devices - Part 12.Sample preparation and reference materials
3 Terms and Definitions
The following terms and definitions defined in GB/T 16886.1, GB/T 16886.3 and GB/T 16886.12 apply to this document.
3.1
comet comet
The tailing phenomenon of damaged DNA fragments after being subjected to an electric field.
NOTE. Under the microscopic image, the "comet" head is nuclear DNA, and the tail is composed of damaged DNA fragments that migrated out of the nucleus in the electric field.
3.2
critical variable
A test parameter for which small changes can have a large impact on test results.
NOTE. Key variables may be tissue-specific. In an experiment, changing key variables can lead to changes in the results of the experiment, for example. positive control and negative
Dosage and type of sex control.
3.3
Tail DNA % tailDNA
The ratio of comet tail DNA content to total DNA content (sum of head and tail DNA content).
NOTE. Tail DNA percentage reflects the relative degree of DNA damage expressed as a percentage.
3.4
"Hedgehog"-shaped cells hedgehogcels
Microscopic image of cells consisting of small or indistinct heads with large diffuse tails.
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