YY/T 0870.4-2014Test for genotoxicity of medical devices - Part 4: Mammalian bone marrow erythrocyte micronucleus test (English PDF)

Foreword

YY/T 0870 "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 4.

Genotoxicity tests related to other aspects of the standard of other parts. This section drafted in accordance with GB/T 1.1-2009 given rules.

This portion of the reference OECDNo.474 (1997) "mammalian erythrocyte micronucleus 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 OECDNo.474 (1997) method, by analyzing the rodent bone marrow samples in test animals addicted Polychromatic erythrocytes to evaluate medical equipment/materials into erythrocytes induced mitotic chromosome or damage.

Medical equipment/materials genotoxic substances acting on the body may cause lagging chromosome fragments or whole chromosomes Loss Injury and the formation of micronuclei, YY/T 0870 this part of the animal bone marrow samples by testing erythrocyte micronucleus formation for evaluation of medical Instruments/Materials genotoxic potential.

YY/T 0870 This section is particularly useful for those who need to consider the evaluation of in vivo metabolism, pharmacokinetics and DNA repair processes And other factors mutagenic hazard. YY/T 0870 in this section for further study in vitro system has detected the mutagenic effects have also use. If there is evidence that in the test substance or active metabolite can not reach the appropriate target tissue, the YY/T 0870 is not part of the present Be applicable.

1 Scope

YY/T 0870 provisions of this part of the erythrocyte micronucleus test methods for forming medical devices/materials inducing mammalian bone marrow.

NOTE: mammal dental materials erythrocyte micronucleus test see YY/T 0127.12.

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 16886.12 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 16886.2, GB/T 16886.3 and GB/T 16886.12 defined and the following terms and definitions apply In this document.

4 Major equipment

Pressure steam sterilizer, anatomical equipment, biological microscope.

5 Reagents

According to the method of reagent YY/T in Appendix B 0870.2-2013 prescribed preparation or purchase commercially available. Unless otherwise indicated, all reagents are […]