YY/T 0870.5-2014Test for genotoxicity of medical devices - Part 5: Mammalian bone marrow chromosome aberration test (English PDF)

Foreword

YY/T 0870 the general title "Medical Device Genetic Toxicity Test", includes the following components.

--- Part 1. bacterial reverse mutation assay;

--- Part 2. In vitro mammalian chromosome aberration test;

--- Part 3. in vitro mammalian cell gene with mouse lymphoma cells mutation test;

--- Part 4. Mammalian bone marrow erythrocyte micronucleus test;

--- Part 5. Mammalian bone marrow chromosome aberration test. This section YY/T 0870 Part 5. This section drafted in accordance with GB/T 1.1-2009 given rules.

This section is a reference OECD475.1997 "mammalian bone marrow chromosome aberration test" in conjunction with the medical device/system characteristics of the material itself Given.

Introduction

Standard Test Method for detecting genotoxic potential material GB/T 16886.3 are given in the Organisation for Economic Cooperation and Development (OECD) "of The method of chemical testing guidelines "set forth, but these methods are developed for chemical properties from the same time did not give details of the test procedure, Therefore not suitable for the direct detection of medical equipment/materials. YY/T reference to this part of the basic principles of OECD Test Method 0870, and the The medical device/material properties of the test method appropriate modifications, provides detailed test procedure can be used as

GB/T 16886.3 genetic toxicity testing standards supplementary method.

YY/T 0870 with reference to this part of OECD475.1997 method, using metaphase cells blockers (such as colchicine and colchicine Amine) experimental animals were treated and analyzed by in mitotic metaphase chromosome in bone marrow cells of animals aberration to comment Potential price mutagenicity test sample.

YY/T 0870 in this section for detecting a test substance induced animals (usually rodents) chromosomal aberrations in bone marrow cells.

Chromosome aberrations can be divided into the number of structural aberrations and distortion of two kinds. Among them, the structure can be divided into chromosomal aberrations and chromatid type. most Chemical mutagen-induced chromatid mutations, but chromosome mutation may also occur. YY/T 0870 This section does not apply to the number of detections Mesh distortion.

This section of the General YY/T 0870 using rodents. Bone marrow is the target tissue, because it is rich in blood vessels, there are large quantities of easily isolated and Rapid cycling and treated cells. If there is evidence that the test substance or its active metabolite can not reach the target tissue, the YY/T 0870 This section does not apply.

1 Scope

YY/T 0870 provisions of this part of the medical equipment/materials mammalian bone marrow chromosome aberration test methods.

NOTE: mammalian chromosome aberration test dental materials are not included in the YY/T 0870 the scope of this.

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 16886.1 Biological evaluation of medical devices - Part 1. Evaluation of the risk management process and Test

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 16886.11 Biological evaluation of medical devices - Part 11. Tests for systemic toxicity

GB/T 16886.12 Biological evaluation of medical devices - Part 12. Sample preparation and reference materials

YY/T 0870.2-2013 genotoxicity tests of medical devices - Part 2. In vitro mammalian chromosome aberration test

3 Terms and Definitions

GB/T 16886.1, GB/T 16886.3, GB/T 16886.12 and YY/T 0870.2-2013 definition of terms and definitions apply This document.

4 Major equipment

Pressure steam sterilizer, optical microscopes, centrifuges, constant temperature water bath and anatomical equipment.

5 Reagents

According to the method of reagent YY/T 0870.2-2013 specified in Appendix B of preparation or purchase commercially available.

6 Animals