YY/T 1292.4-2017 Translated English of Chinese Standard. (YYT 1292.4-2017, YY/T1292.4-2017, YYT1292.4-2017): Test for Reproductive and Developmental Toxicity of Medical Devices - Part 4: Two-generation Reproductive Toxicity Testhttps://www.chinesestandard.net, 2018 M09 1 - 17 pages This Part of YY/T 1292 specifies methods of testing two-generation reproductive toxicity of medical devices/materials. This Part is applicable to two-generation reproductive and developmental toxicity evaluation of medical devices/materials. |
Contents
| 3 | |
Introduction | 4 |
Scope | 6 |
Test Principle | 7 |
Sample Preparation | 8 |
Result Observation | 10 |
Test Data and Report | 14 |
Result Explanation | 17 |
Common terms and phrases
abnormal adopted analysis of sperms applicable Biological Evaluation breast-feeding cell childbirth control group death deferens developmental toxicity test estrus cycle Evaluation of Medical experimental animals experimental group F1 and F2 F1 animals female mouse fetus filial generation F1 filial mice following information regarding genital organs gross anatomy high dose group influence is found lactation low dose group male and female maximum dose group medical devices/materials mice’s OECD ovary parental and filial parental animals pregnancy primitive follicles quantity of animals record report shall include reproductive and developmental reproductive function reproductive system Reproductive Toxicity Test Sample Preparation secondary mating selected for mating sexual maturity specific test sperm morphology Standard supply of test tail of epididymis target organs Test for Reproductive test is completed Test report test sample test substance tissues toxic reaction Toxicity of Medical toxicokinetic treatment-related influence two-generation reproductive toxicity uterus vaginal smear vas deferens weight YY/T