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YY/T 1292.2-2015: Test for reproductive and developmental toxicity of medical devices - Part 2: Prenatal developmental toxicity test
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Test for reproductive and developmental toxicity of medical devices - Part 2: Prenatal developmental toxicity test
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YY/T 1292.2-2015
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Basic data | Standard ID | YY/T 1292.2-2015 (YY/T1292.2-2015) | | Description (Translated English) | Test for reproductive and developmental toxicity of medical devices - Part 2: Prenatal developmental toxicity test | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C30 | | Classification of International Standard | 11.040.01 | | Word Count Estimation | 15,124 | | Date of Issue | 2015-03-02 | | Date of Implementation | 2016-01-01 | | Quoted Standard | GB/T 16886.1; GB/T 16886.2; GB/T 16886.3; GB/T 16886.12 | | Regulation (derived from) | The State Food and Drug Administration Announcement 2015 No. 8 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This Standard specifies the method for medical instruments or materials embryo toxicity tests. This section applies to medical devices or materials reproductive and developmental toxicity test. | YY/T 1292.2-2015: Test for reproductive and developmental toxicity of medical devices - Part 2: Prenatal developmental toxicity test
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Test for reproductive and developmental toxicity of medical devices Part 2. Prenatal developmental toxicity test
ICS 11.040.01
C30
People's Republic of China pharmaceutical industry standards
Medical Devices reproductive and developmental toxicity test
Part 2. The embryo toxicity test
Part 2. Prenataldevelopmentaltoxicitytest
Issued on. 2015-03-02
2016-01-01 implementation
China Food and Drug Administration released
Foreword
YY/T 1292 "Medical Devices reproductive and developmental toxicity test" intended to divide part of the publication, currently plans to release
The following components.
--- Part 1. Screening test;
--- Part 2. embryo toxicity test;
This section YY/T 1292 Part 2.
This section drafted in accordance with GB/T 1.1-2009 given rules.
Some elements 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 section drafted by. State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center, Sichuan medical device biomaterial
Materials and products inspection center, Beijing Union Medical College New Drug Safety Evaluation and Research Center Chinese Academy of Medical Sciences.
Drafters of this section. Zhaozeng Lin, Liucheng Hu, Zou, Jie Liang, including the Czech Republic.
Introduction
Detect potential reproductive GB/T 16886.3 given and test methods for developmental toxicity substances are the Organization for Economic Cooperation and Development
(OECD) method "chemical testing guidelines" set forth, but these methods are made for the development of chemical properties, but did not give details
Test procedure, and therefore not suitable for the direct detection of medical devices or materials. The original part of the basic reference test method OECD414
Then, and according to the characteristics of medical devices or materials test methods were appropriate modifications, it provides detailed test procedure can be used as
GB/T 16886.3 to one standard method of reproductive and developmental toxicity test.
Reproductive medical devices or materials and developmental toxicity potential has a very important influence on human health. Especially for medical resorbable
Devices containing leachables or medical devices. GB/T 16886.3 recommended the following medical devices or materials, in the absence of exclusion of reproductive and developmental toxicity
Lower risk evidence, should be considered reproductive and developmental toxicity test.
a) with possible reproductive tissue or embryo (fetus) direct long-term or permanent contact devices (including resorbable or leachable substances, such as
Silicone gel breast implants);
b) storage of medical devices.
This section provides the contact during pregnancy pregnancy maternal medical devices and general information on development of the embryo, the main effect is the parent
Shall, death, fetal deformity or change evaluation. This section does not include the contents of functional defects.
Due to the limitations of the impact of the test sample preparation and test method validation, etc., in determining the embryonic developmental toxicity test
Before, should take full account of GB/T 16886.1 and GB/T 16886.18 requirements. It should lead to embryonic development drug use in the evaluation of medical devices
Basis of risk, based on the decision to be tested shall be demonstrated.
Of resorbable or leachable medical devices containing filter material, if there is in the absorption, metabolism, distribution and research sufficiently reliable data, or
Medical devices or materials are identified in the extract all the ingredients were not embryonic developmental toxicity, no longer need to be tested. Medical devices
After an acceptable biological risk assessment, such as the risk of embryonic development has been excluded, then no further testing.
Medical Devices reproductive and developmental toxicity test
Part 2. The embryo toxicity test
1 Scope
This section YY/T 1292 specifies the medical device materials or methods of embryo toxicity test.
This section applies to medical devices or materials reproductive and developmental toxicity test.
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
3 Terms and Definitions
GB/T 16886.1, GB/T 16886.3 and GB/T 16886.12 defined and the following terms and definitions apply to this document.
3.1
Developmental Toxicology developmentaltoxicology
Offspring before birth, perinatal exposure to sexual maturity or after the birth of the medical device body caused developmental toxicity. Including. machine
Body of death, structural abnormalities, altered growth and functional defects. Developmental toxicology usually refers Teratology.
3.2
Altered growth alteredgrowth
Offspring organ or body weight change in size.
3.3
Abnormalities (abnormal) alterations (anomalies)
During the development of structural abnormalities, including deformities and variations.
3.3.1
Malformation (main exception) malformation (majorabnormality)
Test animals are considered harmful structural changes (which may have fatal), usually rare.
3.3.2
Variation (small exception) variation (minorabnormality)
The test is considered less harmful or harmless animal structural changes; can be a transient appears and the control group, the frequency of occurrence is relatively high.
3.4
Conceptus conceptus
From the number of fertilized eggs after fertilization before delivery to the various development stages of the entire process derived, including membranes and the embryo or fetus.
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