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YY/T 0995-2015Medical devices for human assisted reproductive technology—Terminology and definitions (English PDF)

人类辅助生殖技术用医疗器械术语和定义

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

March 2, 2015

Implementation date

January 1, 2016

Scope

YY/T 0995-2015 is the English-translated version of 人类辅助生殖技术用医疗器械术语和定义.

YY/T 0995-2015 is the Chinese pharmaceutical industry standard that fixes the terminology and definitions for the medical devices used in human assisted reproductive technology, in in vitro fertilisation and embryo transfer and in the techniques derived from them.

It names the devices, the media and the procedures of this field and defines them, so that the standards and the documents written under it use the same words. Issued on 2 March 2015, it has applied since 1 January 2016.

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Document preview — YY/T 0995-2015

National Standard of the People's Republic of China

ICS: 11.040.30
Classification: C 30

Issued by: National Medical Products Administration of the People's Republic of China

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

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules.

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

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

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

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 reproduction aspiration needle

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

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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

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