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YY/T 0870.4-2014 English PDF

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YY/T 0870.4-2014: Test for genotoxicity of medical devices. Part 4: Mammalian bone marrow erythocyte micronucleus test
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Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
YY/T 0870.4-2014	English	189	Add to Cart	3 days [Need to translate]	Test for genotoxicity of medical devices. Part 4: Mammalian bone marrow erythocyte micronucleus test	Valid	YY/T 0870.4-2014

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Standard similar to YY/T 0870.4-2014

YY/T 0841 YY/T 1057 YY/T 0708 YY/T 0870.8 YY/T 0870.7 YY/T 0870.3

Basic data

Standard ID	YY/T 0870.4-2014 (YY/T0870.4-2014)
Description (Translated English)	Test for genotoxicity of medical devices. Part 4: Mammalian bone marrow erythocyte micronucleus test
Sector / Industry	Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C30
Classification of International Standard	11.040.01
Word Count Estimation	8,834
Date of Issue	6/17/2014
Date of Implementation	7/1/2015
Quoted Standard	GB/T 16886.1; GB/T 16886.2; GB/T 16886.3; GB/T 16886.12; YY/T 0870.2-2013
Regulation (derived from)	China Food and Drug Administration in 2014 Bulletin No. 30
Issuing agency(ies)	State Food and Drug Administration
Summary	This Standard applies to medical devices/materials to induce chromosomal aberrations in bone marrow test. This Standard specifies the mammalian erythrocyte micronucleus formation in bone marrow test methods.

YY/T 0870.4-2014: Test for genotoxicity of medical devices. Part 4: Mammalian bone marrow erythocyte micronucleus test

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Test for genotoxicity of medical devices Part 4. Mammalian bone marrow erythocyte micronucleus test ICS 11.040.01 C30 People's Republic of China pharmaceutical industry standards Medical Devices genetic toxicity tests Part 4. Mammalian bone marrow erythrocyte micronucleus test Part 4. Mammalianbonemarrowerythocytemicronucleustest Issued on. 2014-06-17 2015-07-01 implementation China Food and Drug Administration released

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. Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents. This part is proposed by the China Food and Drug Administration. This part of the National Biological evaluation of medical devices Standardization Technical Committee (SAC/TC248) centralized. This part mainly drafted by. State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center. Participated in the drafting of this section. Sichuan biomaterials and medical devices products and test center, the State Food and Drug Administration Peking University Medical Device Quality Supervision and Inspection Center. The main drafters of this section. Hou Li, Wang Xin, Liucheng Hu Yuan Tun, Lin Hong, Han Jianmin.

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. Medical Devices genetic toxicity tests Part 4. Mammalian bone marrow erythrocyte micronucleus test

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. 3.1 Micronuclei micronuclei In late mitosis by lagging chromosome fragments or whole chromosomes generated, isolated or attached to the main cell nucleus small nuclei. 3.2 Positive red cells normochromaticerythrocyte; NCE Mature red blood cells, due to lack of a ribosome, the ribosome can be selective dye and immature polychromatic erythrocytes distinction. 3.3 Polychromatic erythrocytes polychromaticerythrocyte; PCE Immature red blood cells, in the medium-term development, still contains ribosomes, it can be used to selectively dye mature ribosomal positive erythrocytes distinguish.

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

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