YY/T 0870.1-2013Test for genotoxicity of medical devices - Part 1: Bacterial reverse mutation 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.

Genotoxicity tests related to other aspects of the standard of other parts. This section YY/T 0870 Part 1. This section drafted in accordance with GB/T 1.1-2009 given rules.

YY/T 0870 This section is a reference OECD471-1997 "bacterial reverse mutation test" in conjunction with medical equipment/materials itself Laid Point making.

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 0870 reference to OECD test method basic principle, and in accordance with medical Characteristics of equipment/material test methods were appropriate modifications, provides detailed test procedure can be used as GB/T 16886.3 of the left Biography supplement standard toxicity test method.

Under YY/T reference in this section OECDNo.471 0870 (1997) method, with or without metabolic activation system, the observation by doctors Sudden treatment equipment/materials induce histidine auxotrophic strains of Salmonella typhimurium (his-) and tryptophan auxotrophic E. coli strain Change in order to assess its potential mutagenicity.

Point mutation is the cause of many human genetic diseases. There is positive evidence that points somatic gene oncogenes and tumor suppressor Mutations in human and experimental animal tumor formation. Many test strain due to the many feature, such as a DNA sequence, locus fine reply Increased cell permeability to large molecules, deletions or DNA repair DNA repair system to improve the process of mismatches, etc., and make their projections Become more sensitive detection. Wherein the bacterial reverse mutation test have a quick, inexpensive and relatively easy to operate advantages, etc., can be used to detect DNA base pair substitutions, additions or deletions, providing useful information for genetic mutations induced by toxic substances.

1 Scope

YY/T 0870 provisions of this part of the Medical Devices/Materials bacterial reverse mutation assay methods. This section is recommended plate incorporation method.

NOTE: Ames test dental materials, see YY/T 0127.10.

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 16886.3 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

GB/T 16886.1 terms and definitions GB/T 16886.3 and GB/T 16886.12 defined apply to this document.

4 Major equipment

Biological safety cabinets, electric oven, incubator, constant temperature water bath, thermostatic shaking water bath, autoclave, away from the low-temperature high Effort, a deep freezer (-80 °C) or liquid nitrogen tank, a homogenizer, a colony counting instrument and electronic days equality.

5 Activation system, media and reagents

Test activation system (S9 and S9 mixture), media and reagent preparation or purchase a commercially available product according to the provisions of Appendix A and Appendix B of.

6 Strains and the identification and preservation