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Medical devices for human assisted reproductive technology. Terminology and definitions
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YY/T 0995-2015
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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 | 10,126 | | 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 ---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
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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