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YY/T 0995-2015: Medical devices for human assisted reproductive technology. Terminology and definitions
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Basic data

Standard ID YY/T 0995-2015 (YY/T0995-2015)
Description (Translated English) Medical devices for human assisted reproductive technology. Terminology and definitions
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C30
Classification of International Standard 11.040.30
Word Count Estimation 10,136
Date of Issue 2015-03-02
Date of Implementation 2016-01-01
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 human assisted reproductive technology in vitro fertilization - embryo transfer technology and its derivative technology terms and definitions used in medical devices. This Standard applies to the human in vitro assisted reproductive technology medical devices.

YY/T 0995-2015: Medical devices for human assisted reproductive technology. Terminology and definitions




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Medical devices for human assisted reproductive technology.Terminology and definitions ICS 11.040.30 C30 People's Republic of China pharmaceutical industry standards Human assisted reproductive technology medical devices Terms and Definitions Issued on. 2015-03-02 2016-01-01 implementation China Food and Drug Administration released

Table of Contents

Preface Ⅰ 1 Scope 1 2 Basic terms 1 3 auxiliary genitals with categories 1 4 assisted reproductive medium and storage solution Class 2 Reference 4 Index 5

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules. Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents. This standard was proposed by the China Food and Drug Administration. The standard by the China Research Institute of Food and Drug test. This standard was drafted. Chinese Academy of Food and Drug test, the Guangdong Provincial Family Planning Institute of Science and Technology. The main drafters. Zhang Na, Xu Liming, Song Ge, Shao Anliang, Hanqian Qian, Feng Xiaoming, Wang Chunren. Human assisted reproductive technology medical devices Terms and Definitions

1 Scope

This standard specifies the Human Assisted Reproductive Technology in vitro fertilization - embryo transfer technology and its derivative technology used in medical devices Terms and definitions. This standard applies to the human in vitro assisted reproductive technology medical devices.

2 Basic terms

2.1 Human Assisted Reproductive Technology humanassistedreproductivetechnology; ART The use of medical technology and methods of gametes, zygotes, embryos manual operation, so that infertile couples pregnancy technologies, including artificial insemination and body External fertilization - embryo transfer technology and its various derivatives. 2.2 Artificial insemination artificialinsemination; AI Non-sexual way artificial sperm injection treatment within the female reproductive tract in a way to get pregnancy. According to the source of semen is not Same, divided into AIH and for artificial insemination. 2.3 IVF - invitrofertilizationandembryotransfer; IVF-ET Remove the eggs from the female body, in vitro sperm joined by processed until after the egg is fertilized, continue to cultivate early embryo (cleavage stage embryos Fetal or blastocyst) when, and then transferred into the uterus in order to move along the bed of technology. 2.4 In vitro fertilization - embryo transfer technology derived relevanttechniquesofIVF-ET Gamete or zygote intrafallopian transfer, intracytoplasmic sperm injection, preimplantation genetic diagnosis and screening of human gametes and Embryo freezing and recovery.

3 auxiliary genitals with categories

3.1 Assisted Reproductive puncture needle is assistedreproductionaspirationneedles In vitro fertilization - embryo transfer process of technical operations and its derivatives, and for women with ovarian follicle puncture to obtain special oocytes instrument. 3.2 Assisted Reproductive graft tube and its annex assistedreproductionembryotransfercathetersandaccessories Gametes in vitro fertilization (IVF) and gamete intrafallopian transfer generated by the zygote, the fertilized egg, blastocyst or cleavage stage embryos to the uterine cavity Inside or within the fallopian transfer (GIFT) use of special equipment.
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