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YY/T 0870.6-2019: Test for genotoxicity of medical devices - Part 6: In vitro mammalian cell micronucleus test
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Test for genotoxicity of medical devices - Part 6. In vitro mammalian cell micronucleus test
ICS 11.040.01
C30
People's Republic of China Pharmaceutical Industry Standard
Medical device genotoxicity test
Part 6. Micronucleus test of mammalian cells in vitro
Testforgenotoxicityofmedicaldevices-Part 6. Invitromammaliancel
Micronucleustest
Published on.2019-07-24
2020-08-01 implementation
State Drug Administration issued
Foreword
YY/T 0870 "Medical Toxicity Test for Medical Devices" consists of the following components.
--- Part 1. Bacterial back mutation test;
--- Part 2. In vitro mammalian cell chromosome aberration test;
--- Part 3. TK gene mutation test using mouse lymphoma cells;
--- Part 4. Mammalian bone marrow erythrocyte micronucleus test;
--- Part 5. Mammalian bone marrow chromosome aberration test;
--- Part 6. Micronucleus test of mammalian cells in vitro.
This part is part 6 of YY/T 0870.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This part is proposed by the State Drug Administration.
This part is under the jurisdiction of the National Technical Committee for Standardization of Medical Device Biology Evaluation (SAC/TC248).
This section drafted by. Shandong Province Medical Device Product Quality Inspection Center, Shenzhen Drug Inspection Institute (Shenzhen Medical Device Inspection
Test center).
The main drafters of this section. Wang Wei, Wang Wei, Cao Ping, Wang Xiaotong, Lin Zhongshi.
introduction
The test methods for detecting potentially genotoxic substances given in GB/T 16886.3 are the Organization for Economic Co-operation and Development (OECD).
The methods specified in the Academic Testing Guide, but these methods are developed for the characteristics of the chemical, and no detailed test procedures are given.
Therefore, it is not suitable for direct use in the detection of medical devices/materials. YY/T 0870 refers to the basic principles of the OECD test method and is based on medical care
The characteristics of the device/material have been modified as appropriate, and detailed test procedures have been specified, which can be used as a legacy in GB/T 16886.3.
Supplementary method standards for toxicity testing.
This part of YY/T 0870 refers to the OECD 487 (2016) method, in the presence or absence of a metabolic activation system, in cultured cells and
Medical devices/materials are treated with a cell cytokinesis blocker (such as cytochalasin B) for treatment by the presence of binuclear cells.
The micronucleus of the milk animal cells was analyzed to evaluate the potential for teratogenicity of the test sample.
The purpose of this section of YY/T 0870 is to screen for micronuclei potential in mammalian cells that cause cytoplasmic formation in mammalian cells.
The substance of energy. The micronuclei can be derived from a chromosome fragment that is not centromere or a whole stain that cannot be moved to the cell poles after the mitosis.
body. The test is for detecting that the test substance induces breakage and non-holism to cells undergoing division during or after exposure of the cells to the test substance.
The activity of ploidy. This part of YY/T 0870 requires the use of an exogenous metabolic activation system. However, this exogenous system cannot be completely
Simulate the condition of the mammal in vivo. Avoid false positive results that may result from changes in pH, osmotic pressure, or high levels of cytotoxicity.
This section of YY/T 0870 uses established cell lines, primary cells of human or rodent origin. According to culture capacity, nuclear
Type stability (including the number of chromosomes) and micronucleus background frequency selection cells for the test. Currently, although the available data cannot be presented exactly
Recommendations, but when assessing chemical hazards, consider p53 status, genetic (karyotypic) stability, DNA repair capacity, and source (rodents and
The choice of human beings is very important. Therefore, users of this section can consider the performance of these and other cell characteristics for cell line detection of micronuclei.
Impact.
Medical device genotoxicity test
Part 6. Micronucleus test of mammalian cells in vitro
1 Scope
This part of YY/T 0870 specifies the micronucleus test method for mammalian cells in vitro for medical devices/materials. This section applies to
Determining the number of micronuclei in vitro in mammalian cells produced by medical devices/materials, and screening for potential genotoxicity of medical devices/materials
effect.
Note. The relevant tests for nanomaterials can be referred to this section.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management
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
The following terms and definitions as defined in GB/T 16886.1, GB/T 16886.3 and GB/T 16886.12 apply to this document.
3.1
Aneuploid aneugen
Interaction with components involved in cell mitosis and meiosis cycles, causing aneuploidy formation in cells or organisms
Any substance.
3.2
Aneuploid aneuploidy
One or more of the normal diploid (or haploid) chromosome numbers are missing or added, but not the entire set of chromosomes (polyploid).
3.3
Cell proliferation celproliferation
As a result of cell mitosis, the number of cells increases.
3.4
Centromere centromere
A region of DNA in which two chromatids within a chromosome are joined together.
3.5
Breaking agent clastogen
Any substance that causes aberrations in the chromosome structure of a cell population or eukaryote.
3.6
Cytokinesis cytokinesis
The nucleus forms a cytoplasmic separation process of two daughter cells after mitosis, and each daughter cell has a nucleus.
YY/T 0870.6-2019
Test for genotoxicity of medical devices - Part 6. In vitro mammalian cell micronucleus test
ICS 11.040.01
C30
People's Republic of China Pharmaceutical Industry Standard
Medical device genotoxicity test
Part 6. Micronucleus test of mammalian cells in vitro
Testforgenotoxicityofmedicaldevices-Part 6. Invitromammaliancel
Micronucleustest
Published on.2019-07-24
2020-08-01 implementation
State Drug Administration issued
Foreword
YY/T 0870 "Medical Toxicity Test for Medical Devices" consists of the following components.
--- Part 1. Bacterial back mutation test;
--- Part 2. In vitro mammalian cell chromosome aberration test;
--- Part 3. TK gene mutation test using mouse lymphoma cells;
--- Part 4. Mammalian bone marrow erythrocyte micronucleus test;
--- Part 5. Mammalian bone marrow chromosome aberration test;
--- Part 6. Micronucleus test of mammalian cells in vitro.
This part is part 6 of YY/T 0870.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This part is proposed by the State Drug Administration.
This part is under the jurisdiction of the National Technical Committee for Standardization of Medical Device Biology Evaluation (SAC/TC248).
This section drafted by. Shandong Province Medical Device Product Quality Inspection Center, Shenzhen Drug Inspection Institute (Shenzhen Medical Device Inspection
Test center).
The main drafters of this section. Wang Wei, Wang Wei, Cao Ping, Wang Xiaotong, Lin Zhongshi.
introduction
The test methods for detecting potentially genotoxic substances given in GB/T 16886.3 are the Organization for Economic Co-operation and Development (OECD).
The methods specified in the Academic Testing Guide, but these methods are developed for the characteristics of the chemical, and no detailed test procedures are given.
Therefore, it is not suitable for direct use in the detection of medical devices/materials. YY/T 0870 refers to the basic principles of the OECD test method and is based on medical care
The characteristics of the device/material have been modified as appropriate, and detailed test procedures have been specified, which can be used as a legacy in GB/T 16886.3.
Supplementary method standards for toxicity testing.
This part of YY/T 0870 refers to the OECD 487 (2016) method, in the presence or absence of a metabolic activation system, in cultured cells and
Medical devices/materials are treated with a cell cytokinesis blocker (such as cytochalasin B) for treatment by the presence of binuclear cells.
The micronucleus of the milk animal cells was analyzed to evaluate the potential for teratogenicity of the test sample.
The purpose of this section of YY/T 0870 is to screen for micronuclei potential in mammalian cells that cause cytoplasmic formation in mammalian cells.
The substance of energy. The micronuclei can be derived from a chromosome fragment that is not centromere or a whole stain that cannot be moved to the cell poles after the mitosis.
body. The test is for detecting that the test substance induces breakage and non-holism to cells undergoing division during or after exposure of the cells to the test substance.
The activity of ploidy. This part of YY/T 0870 requires the use of an exogenous metabolic activation system. However, this exogenous system cannot be completely
Simulate the condition of the mammal in vivo. Avoid false positive results that may result from changes in pH, osmotic pressure, or high levels of cytotoxicity.
This section of YY/T 0870 uses established cell lines, primary cells of human or rodent origin. According to culture capacity, nuclear
Type stability (including the number of chromosomes) and micronucleus background frequency selection cells for the test. Currently, although the available data cannot be presented exactly
Recommendations, but when assessing chemical hazards, consider p53 status, genetic (karyotypic) stability, DNA repair capacity, and source (rodents and
The choice of human beings is very important. Therefore, users of this section can consider the performance of these and other cell characteristics for cell line detection of micronuclei.
Impact.
Medical device genotoxicity test
Part 6. Micronucleus test of mammalian cells in vitro
1 Scope
This part of YY/T 0870 specifies the micronucleus test method for mammalian cells in vitro for medical devices/materials. This section applies to
Determining the number of micronuclei in vitro in mammalian cells produced by medical devices/materials, and screening for potential genotoxicity of medical devices/materials
effect.
Note. The relevant tests for nanomaterials can be referred to this section.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management
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
The following terms and definitions as defined in GB/T 16886.1, GB/T 16886.3 and GB/T 16886.12 apply to this document.
3.1
Aneuploid aneugen
Interaction with components involved in cell mitosis and meiosis cycles, causing aneuploidy formation in cells or organisms
Any substance.
3.2
Aneuploid aneuploidy
One or more of the normal diploid (or haploid) chromosome numbers are missing or added, but not the entire set of chromosomes (polyploid).
3.3
Cell proliferation celproliferation
As a result of cell mitosis, the number of cells increases.
3.4
Centromere centromere
A region of DNA in which two chromatids within a chromosome are joined together.
3.5
Breaking agent clastogen
Any substance that causes aberrations in the chromosome structure of a cell population or eukaryote.
3.6
Cytokinesis cytokinesis
The nucleus forms a cytoplasmic separation process of two daughter cells after mitosis, and each daughter cell has a nucleus.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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