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YY/T 0870.2-2019

Chinese Standard: 'YY/T 0870.2-2019'
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YY/T 0870.2-2019English359 Add to Cart Days<=4 Test for genotoxicity of medical devices - Part 2: In vitro mammalian chromosome aberration test Valid YY/T 0870.2-2019
YY/T 0870.2-2019Chinese17 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]  

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Detail Information of YY/T 0870.2-2019; YY/T0870.2-2019
Description (Translated English): Test for genotoxicity of medical devices - Part 2: In vitro mammalian chromosome aberration test
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C30
Classification of International Standard: 11.040.01
Word Count Estimation: 18,182
Date of Issue: 2019-05-31
Date of Implementation: 2020-06-01
Drafting Organization: Shandong Medical Device Product Quality Inspection Center, Sichuan University (Sichuan Medical Device Biomaterials and Products Inspection Center)
Administrative Organization: National Technical Committee for Standardization of Medical Device Biology Evaluation (SAC/TC 248)
Proposing organization: State Drug Administration
Issuing agency(ies): State Drug Administration

YY/T 0870.2-2019
Test for genotoxicity of medical devices - Part 2. In vitro mammalian chromosome aberration test
ICS 11.040.01
C30
People's Republic of China Pharmaceutical Industry Standard
Replacing YY/T 0870.2-2013
Medical device genotoxicity test Part 2.
In vitro mammalian cell chromosome aberration test
Testforgenotoxicityofmedicaldevices-
Part 2. Invitromammalianchromosomeaberrationtest
Published on.2019-05-31
2020-06-01 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.
This part is the second part of YY/T 0870.
This part is drafted according to the rules given in GB/T 1.1-2009.
This part replaces YY/T 0870.2-2013 "Medical equipment genotoxicity test Part 2. In vitro mammalian cell chromosome aberrations
Change test, compared with YY/T 0870.2-2013, except for editorial changes, the main technical changes are as follows.
--- Added terminology. aneuploidy (see 3.1); chromatid cleavage (see 3.2); chromatid cleft (see 3.3); chromosomal cleavage agent
(see 3.6); mutation (see 3.8); p53 status (see 3.11); relative cell growth (see 3.12); relative population doubling
(see 3.13); S9 liver homogenate (see 3.14); S9 mixture (see 3.15); untreated control (see 3.17);
--- Added a note to S9 (see Chapter 5);
--- Increased cell line selection (see Chapter 6);
--- Added notes on the preparation of sample preparation methods (see Chapter 8);
--- Increased the selection principle of positive controls (see 9.2);
--- Increased the evaluation method of cytotoxicity in the pre-experiment (see 10.1);
--- Added "laboratory capabilities" (see 10.6);
--- Added "historical comparison data" (see 10.7);
--- Increased the "acceptance criteria" (see 12.1);
--- Added "positive judgment criteria" (see 12.2.1);
--- Added "negative criteria" (see 12.2.2);
--- Added "interpretation of results" (see 12.2.3).
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, Sichuan University (Sichuan Medical Device Biomaterials and Product Inspection
Test center).
The main drafters of this section. Wang Wei, Gai, Yuan Yu, Liang Jie, Zhan Yang.
The previous versions of the standards replaced by this section are.
---YY/T 0870.2-2013.
introduction
The test methods for detecting potentially genotoxic substances given in GB/T 16886.3 are issued by the Organisation for Economic Co-operation and Development (OECD).
The methods specified in the Chemical Testing Guide, but these methods are developed for the characteristics of the chemical and no detailed test steps 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 according to the doctor
The characteristics of the device/material have been modified as appropriate, and detailed test procedures have been specified, which can be used as GB/T 16886.3.
Supplementary method criteria for genotoxicity testing.
This part of YY/T 0870 refers to the OECD 473 (2016) method and uses cultured cells with or without a metabolic activation system.
After the medical device/material is contacted, it is treated with a metaphase split phase blocker (such as colchicine or colchicine).
The chromosomal aberrations of mammalian cells in the mid-crack were analyzed to evaluate the potential for teratogenicity of the test samples.
The purpose of this section is to screen for substances in medical devices/materials that have the potential to cause chromosomal structural aberrations in mammalian cells.
There may be two types of chromosome structural aberrations, namely chromosomal type and chromatid type. For toxic chemicals contained in medical devices/materials
In most cases, it induces chromatid aberrations, but sometimes it can also cause chromosomal aberrations. Polyploidy can occur in in vitro chromosome aberration test
Increase in the number of (including intranuclear replication), polyploid itself does not indicate a strong potential to induce aneuploidy, only showing cell cycle interference
Or cytotoxicity. However, this section does not apply to the detection of aneuploid mutagens and the aberrations of the number of chromosomes. This section needs to be used outside
Source metabolic activation system. However, this exogenous system does not fully mimic the in vivo condition of mammals. Should pay attention to avoid by pH, seepage
False positive results may result from changes in osmotic pressure or high levels of cytotoxicity.
This section uses established cell lines, primary cells of human or rodent origin. According to culture capacity, karyotype stability (including
The number of chromosomes) and the frequency of chromosome aberration spontaneous selection experiments. Currently, although the available data cannot provide exact recommendations,
However, when assessing chemical hazards, consider p53 status, genetic (karyotypic) stability, DNA repair capacity, and source (rodents and humans)
The choice is very important. Therefore, users of this section should consider these and other cell characteristics for cell lineage to detect chromosomal aberrations.
The impact of energy.
Medical device genotoxicity test Part 2.
In vitro mammalian cell chromosome aberration test
1 Scope
This part of YY/T 0870 specifies test methods for chromosomal aberrations in mammalian cells in vitro for medical devices/materials.
This section applies to the evaluation of test samples by analyzing the chromosomal aberrations of animal cells in the middle of mitosis.
Test method for potential teratogenicity.
Note 1. In vitro mammalian cell chromosome aberration test of oral materials is given in YY/T 0127.16.
Note 2. In vitro mammalian cell chromosomal aberration test of nanomaterials may require specific revisions to the methods in this section, but this section does not give
description.
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 aneuploidy
One or more of the normal diploid (or haploid) chromosome numbers are missing or added, but not the entire set of chromosomes (polyploid).
3.2
Chromatid break chromatidbreak
The discontinuity of the chromatid, which has a distinct asymmetric chromatid.
3.3
Chromatid clot chromatidgap
The chromatin-free region present on a single chromatid has a width that is less than the width of the cross-section of the chromatid. There is a staining list
The smallest misalignment of the body.
3.4
Chromatid type distortion chromatid-typeaberration
It is characterized by chromatid breakage or chromosomal structural damage between chromosomal breaks and reconnections.
3.5
Chromosome aberration chromosome-typeaberration
It is manifested as damage to the chromosome structure of the two chromatids at the same site.
YY/T 0870.2-2019
Test for genotoxicity of medical devices - Part 2. In vitro mammalian chromosome aberration test
ICS 11.040.01
C30
People's Republic of China Pharmaceutical Industry Standard
Replacing YY/T 0870.2-2013
Medical device genotoxicity test Part 2.
In vitro mammalian cell chromosome aberration test
Testforgenotoxicityofmedicaldevices-
Part 2. Invitromammalianchromosomeaberrationtest
Published on.2019-05-31
2020-06-01 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.
This part is the second part of YY/T 0870.
This part is drafted according to the rules given in GB/T 1.1-2009.
This part replaces YY/T 0870.2-2013 "Medical equipment genotoxicity test Part 2. In vitro mammalian cell chromosome aberrations
Change test, compared with YY/T 0870.2-2013, except for editorial changes, the main technical changes are as follows.
--- Added terminology. aneuploidy (see 3.1); chromatid cleavage (see 3.2); chromatid cleft (see 3.3); chromosomal cleavage agent
(see 3.6); mutation (see 3.8); p53 status (see 3.11); relative cell growth (see 3.12); relative population doubling
(see 3.13); S9 liver homogenate (see 3.14); S9 mixture (see 3.15); untreated control (see 3.17);
--- Added a note to S9 (see Chapter 5);
--- Increased cell line selection (see Chapter 6);
--- Added notes on the preparation of sample preparation methods (see Chapter 8);
--- Increased the selection principle of positive controls (see 9.2);
--- Increased the evaluation method of cytotoxicity in the pre-experiment (see 10.1);
--- Added "laboratory capabilities" (see 10.6);
--- Added "historical comparison data" (see 10.7);
--- Increased the "acceptance criteria" (see 12.1);
--- Added "positive judgment criteria" (see 12.2.1);
--- Added "negative criteria" (see 12.2.2);
--- Added "interpretation of results" (see 12.2.3).
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, Sichuan University (Sichuan Medical Device Biomaterials and Product Inspection
Test center).
The main drafters of this section. Wang Wei, Gai, Yuan Yu, Liang Jie, Zhan Yang.
The previous versions of the standards replaced by this section are.
---YY/T 0870.2-2013.
introduction
The test methods for detecting potentially genotoxic substances given in GB/T 16886.3 are issued by the Organisation for Economic Co-operation and Development (OECD).
The methods specified in the Chemical Testing Guide, but these methods are developed for the characteristics of the chemical and no detailed test steps 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 according to the doctor
The characteristics of the device/material have been modified as appropriate, and detailed test procedures have been specified, which can be used as GB/T 16886.3.
Supplementary method criteria for genotoxicity testing.
This part of YY/T 0870 refers to the OECD 473 (2016) method and uses cultured cells with or without a metabolic activation system.
After the medical device/material is contacted, it is treated with a metaphase split phase blocker (such as colchicine or colchicine).
The chromosomal aberrations of mammalian cells in the mid-crack were analyzed to evaluate the potential for teratogenicity of the test samples.
The purpose of this section is to screen for substances in medical devices/materials that have the potential to cause chromosomal structural aberrations in mammalian cells.
There may be two types of chromosome structural aberrations, namely chromosomal type and chromatid type. For toxic chemicals contained in medical devices/materials
In most cases, it induces chromatid aberrations, but sometimes it can also cause chromosomal aberrations. Polyploidy can occur in in vitro chromosome aberration test
Increase in the number of (including intranuclear replication), polyploid itself does not indicate a strong potential to induce aneuploidy, only showing cell cycle interference
Or cytotoxicity. However, this section does not apply to the detection of aneuploid mutagens and the aberrations of the number of chromosomes. This section needs to be used outside
Source metabolic activation system. However, this exogenous system does not fully mimic the in vivo condition of mammals. Should pay attention to avoid by pH, seepage
False positive results may result from changes in osmotic pressure or high levels of cytotoxicity.
This section uses established cell lines, primary cells of human or rodent origin. According to culture capacity, karyotype stability (including
The number of chromosomes) and the frequency of chromosome aberration spontaneous selection experiments. Currently, although the available data cannot provide exact recommendations,
However, when assessing chemical hazards, consider p53 status, genetic (karyotypic) stability, DNA repair capacity, and source (rodents and humans)
The choice is very important. Therefore, users of this section should consider these and other cell characteristics for cell lineage to detect chromosomal aberrations.
The impact of energy.
Medical device genotoxicity test Part 2.
In vitro mammalian cell chromosome aberration test
1 Scope
This part of YY/T 0870 specifies test methods for chromosomal aberrations in mammalian cells in vitro for medical devices/materials.
This section applies to the evaluation of test samples by analyzing the chromosomal aberrations of animal cells in the middle of mitosis.
Test method for potential teratogenicity.
Note 1. In vitro mammalian cell chromosome aberration test of oral materials is given in YY/T 0127.16.
Note 2. In vitro mammalian cell chromosomal aberration test of nanomaterials may require specific revisions to the methods in this section, but this section does not give
description.
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 aneuploidy
One or more of the normal diploid (or haploid) chromosome numbers are missing or added, but not the entire set of chromosomes (polyploid).
3.2
Chromatid break chromatidbreak
The discontinuity of the chromatid, which has a distinct asymmetric chromatid.
3.3
Chromatid clot chromatidgap
The chromatin-free region present on a single chromatid has a width that is less than the width of the cross-section of the chromatid. There is a staining list
The smallest misalignment of the body.
3.4
Chromatid type distortion chromatid-typeaberration
It is characterized by chromatid breakage or chromosomal structural damage between chromosomal breaks and reconnections.
3.5
Chromosome aberration chromosome-typeaberration
It is manifested as damage to the chromosome structure of the two chromatids at the same site.
Related standard:   YY/T 0870.3-2019  YY/T 0870.6-2019
   
 
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