Embryonic Toxicity Test of Medical Devices for Human Assisted Reproductive Technology / 中国医疗器械杂志

OBJECTIVE@#To introduce the test methods of embryo toxicity applied to medical devices for human assisted reproductive technology (ARTMD), and provide the evaluation reference.@*METHODS@#The embryo toxicity test methods of ARTMD were summarized, and the key procedures and challenges in their safety evaluation were also discussed.@*RESULTS@#Establishing sensitive and stable test system is important to guarantee the safety and efficacy of ARTMD.@*CONCLUSIONS@#It remains development opportunities in improving sample preparation, extending test technology and expending evaluation method.

Quality Control of Appliance Products of Medical Devices for Human Assisted Reproductive Technology / 中国医疗器械杂志

Infertility has become one of the global problems, with the continuous improvement and penetration of human assisted reproductive technology, appliance products of medical devices for assisted reproductive technology, such as aspiration needles, micromanipulator and embryo transfer catheter, have been widely used. In order to ensure the safety and effectiveness of such products, it is necessary to establish an appropriate quality control system. This paper mainly discusses the quality control points of human assisted reproductive medical devices from the aspects of raw materials, product design, production process, key performance, packaging, preservation and transportation, so as to provide technical reference for the research and development, production and supervision of such products.

The Status of Industry and Supervision of Medical Devices for Human Assisted Reproductive Technology in China / 中国医疗器械杂志

This study summarizes the status of domestic industries of medical devices for assisted reproductive technology, product category, the status of product classification management, the status of technical review, the progress of quality evaluation technology, and the progress of standardization. The domestic industry of medical devices for assisted reproductive technology in my country has begun to take shape, and a solid foundation has been laid for standardization and supervision technology. These will become an important driving force and guarantee for the subsequent development of medical devices for assisted reproductive technology. Under the guidance of the new development concept and the trend of accelerating the construction of the main body of the domestic cycle, my country's independent and controllable assisted reproductive medical device industry is gaining momentum.

An Ethical Reflection on Agential Maternity and Its Realistic Value / 中国医学伦理学

Concerning the dilemma between legal and ethical issues in the evolution and development of agential maternity for infertile women,this paper focuses on related ethical issues,including moral conflicts,rights and obligations,and moral evaluation,etc.The realistic value of agential maternity is also explored.

Medical Ethics Adjustments of ART & Ethics Committee of Medical Organizations / 中国医学伦理学

One of the important missions of modern medical ethics is to strengthen the adjustment of medical ethics and advance the infiltration of medical ethics spirits to medical science to solve the basic ethical problems caused by ART.The adjustment of Medical ethics on ART are affected through ethical regulation,exampling, leading, educating etc.Medical Ethics Committee is an important form of realizing this kind of function,and it is also the evidence of the system of medical ethics. It has been an international practice to set up ethics committee in order to carry on ethics supervision for relevant medical course.The application and development in a healthy way of ART in our country is calling for the ethics committee of medical organizations to play effective role.