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YY/T 1292.3-2016: Test for reproductive/developmental toxicity of medical devices--Part 3: One-generation reproductive toxicity test
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Test for reproductive/developmental toxicity of medical devices--Part 3: One-generation reproductive toxicity test
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YY/T 1292.3-2016
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Basic data | Standard ID | YY/T 1292.3-2016 (YY/T1292.3-2016) | | Description (Translated English) | Test for reproductive/developmental toxicity of medical devices--Part 3: One-generation reproductive 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 | 8,868 | | Date of Issue | 2016-01-26 | | Date of Implementation | 2017-01-01 | | Quoted Standard | GB/T 16886.1; GB/T 16886.2; GB/T 16886.3; GB/T 16886.12 | | Adopted Standard | OECD 415-1983, NEQ | | Regulation (derived from) | China Food and Drug Administration Bulletin 2016 No.25 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the medical device/material generation of reproductive toxicity test method. | YY/T 1292.3-2016: Test for reproductive/developmental toxicity of medical devices--Part 3: One-generation reproductive toxicity test
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Test for reproductive/developmental on medical devices - Part 3. One-generation reproductive test
ICS 11.040.01
C30
People's Republic of China Pharmaceutical Industry Standard
Reproductive and developmental toxicity test of medical devices
Part 3. Generation of Reproductive Toxicity Test
Part 3. One-generationreproductivetoxicitytest
2016-01-26 release
2017-01-01 Implementation
State Food and Drug Administration issued
Foreword
YY/T 1292 "Medical Device Reproductive and Developmental Toxicity Test" is divided into three parts.
- Part 1. screening test;
- Part 2. Embryonic development toxicity test;
Part 3. Generation of Reproductive Toxicity Test.
This section is part 3 of YY/T 1292.
There will be other parts of the medical device reproductive and developmental toxicity tests on other aspects.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
This part is based on the OECD415-1983 "Generation of Reproductive Toxicity Test" and the basis of the characteristics of medical devices/materials
Made on.
Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents.
This section is proposed by the State Food and Drug Administration.
This part of the National Medical Device Biology Evaluation Standardization Technical Committee (SAC/TC248) centralized.
This part of the drafting unit. the State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center, Shenzhen, medical equipment testing
center.
This part of the drafters. Zhao Zenglin, car Guoxi, Lin Zhenhua, Cao Ping, Liu Yao, Wu Shifu.
Introduction
The test methods for the detection of potential reproductive and developmental toxicological substances given in GB/T 16886.3 are the Organization for Economic Co-operation and Development
(OECD) guidelines for chemical testing, but these methods are based on the characteristics of chemicals developed, and did not give a detailed
Of the test steps, and therefore not suitable for direct use in medical devices/materials testing. This part of YY/T 1292 is based on the OECD415 test
The basic principles of the method, and according to the characteristics of medical equipment/materials on the test method of the appropriate changes, provides a detailed test steps,
Can be used as a methodological standard in the reproductive and developmental toxicity test in GB/T 16886.3.
Reproductive and developmental risks of medical devices/materials have a very important impact on human health. Especially for absorbable medical care
Instruments or medical devices containing leachable materials. GB/T 16886.3 recommended the following medical equipment/materials, in the absence of exclusion of reproductive and developmental toxicity
In the case of sexual risk evidence, reproductive and developmental toxicity tests should be considered.
a) devices that are likely to be in direct or permanent contact with the reproductive system or embryo (fetus), absorbable or leachable substances such as silicone
Latex implants);
b) energy storage medical equipment.
This part is to evaluate the effects of a test sample on male and female reproductive characteristics, such as gonadal function, estrous cycle, mating behavior,
Pregnancy, childbirth, breastfeeding and weaning. This section may also provide preliminary information on the reproductive toxicity of the test sample, such as newborns
Health rate, mortality, behavior and teratogenicity and provide guidance for subsequent trials. This section is not intended to determine the specific cause and circumstances in all cases
The results were also corrected in the study of the inhalation route when the test sample was given.
Due to the test sample preparation and test methods to confirm the limitations of the impact, in determining the part of the test before the charge should be filled
Consider GB/T 16886.1 and GB/T 16886.18 requirements. Should be used in the evaluation of the use of medical devices to trigger a generation of reproductive toxicity risk
On the basis of the decision to conduct a test to be demonstrated.
For medical devices that are absorbable or contain leachable substances, if there is sufficient reliable data on absorption, metabolism and distribution studies, or
In the medical device/material extract all the ingredients identified in the absence of generation of reproductive toxicity, the medical device for an acceptable biological wind
After the risk assessment, such as the risk of a generation of reproductive toxicity has been excluded, no further testing is required.
Reproductive and developmental toxicity test of medical devices
Part 3. Generation of Reproductive Toxicity Test
1 Scope
This part of YY/T 1292 gives a test method for the reproductive toxicity of medical devices/materials.
2 normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article
Pieces. For undated references, the latest edition (including all modifications) applies to this document.
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in risk management (GB/T 16886.1-
2011, ISO 10993-1..2009, IDT)
GB/T 16886.2 Biological evaluation of medical devices - Part 2. Animal welfare requirements (GB/T 16886.2-2011,
ISO 10993-2..2006, IDT)
GB/T 16886.3 Biological evaluation of medical devices - Part 3. Genotoxicity, carcinogenicity and reproductive toxicity test
(GB/T 16886.3-2008, ISO 10993-3..2003, IDT)
GB/T 16886.12 Biological evaluation of medical devices - Part 12. Sample preparation and reference samples (GB/T 16886.12-
2005, ISO 10993-12..2002, IDT)
3 terms and definitions
The terms and definitions defined in GB/T 16886.1, GB/T 16886.3 and GB/T 16886.12 apply to this document.
4 major equipment
Laboratory commonly used equipment, biological microscopes, stereomicroscope, vernier caliper, pathological examination equipment.
5 test principle
Different groups of test animals were given a specific dose of test sample. Such as the device is expected to be used in men, in order to obtain the test sample pairs
Sperm-forming side effects, males should be given a test sample during the growing season and include at least one complete sperm formation cycle (mouse approximately
56d, rat about 70d). In order to obtain the side effects of the test sample on the estrous cycle, the parental administration of the test sample should be at least
Including two complete estrus cycles, and then the animals are caged. During the cage, two sex animals were given test samples during pregnancy and feeding
Milk is given only to female animals.
6 experimental animals
6.1 General
All animal tests should be carried out in laboratories approved by national accreditation bodies and consistent with all applicable animal safety regulations,
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