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YY/T 1434-2016 PDF English

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YY/T 1434-2016: Medical devices for human in vitro assisted reproductive technology. In vitro mouse embryo assay
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YY/T 1434-2016English179 Add to Cart 3 days [Need to translate] Medical devices for human in vitro assisted reproductive technology. In vitro mouse embryo assay

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Basic data

Standard ID YY/T 1434-2016 (YY/T1434-2016)
Description (Translated English) Medical devices for human in vitro assisted reproductive technology. In vitro mouse embryo assay
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C30
Classification of International Standard 11.040.30
Word Count Estimation 9,926
Date of Issue 2016-01-26
Date of Implementation 2017-01-01
Quoted Standard GB/T 16886.2; GB/T 16886.12; YY/T 0955-2015
Regulation (derived from) China Food and Drug Administration Bulletin 2016 No.25
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies an in vitro mouse embryo test method that is suitable for the safety evaluation of medical devices for in vitro assisted reproductive technology in contact with gametes and/or embryos.

YY/T 1434-2016: Medical devices for human in vitro assisted reproductive technology. In vitro mouse embryo assay




---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 in vitro assisted reproductive technology in vitro mouse embryo assay ICS 11.040.30 C30 People's Republic of China Pharmaceutical Industry Standard Human in vitro assisted reproductive technology In vitro mouse embryos for medical devices 2016-01-26 release 2017-01-01 Implementation State Food and Drug Administration issued

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents. This standard is proposed by the State Food and Drug Administration. This standard by the China Food and Drug Research Institute. The drafting of this standard. China Food and Drug Research Institute, Institute of Genetics and Developmental Biology, Chinese Academy of Sciences. The main drafters of this standard. Han Qianqian, Feng Xiaoming, Dai Jianwu, Xiao Zhifeng, Yin Yanyun, Xu Liming, Zhang Na. Human in vitro assisted reproductive technology In vitro mouse embryos for medical devices

1 Scope

This standard specifies an in vitro mouse embryo test method for use with a gamete and/or embryo for human in vitro assisted reproductive technology with a medical device Safety evaluation of the equipment.

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. GB/T 16886.2 Biological evaluation of medical devices - Part 2. Animal welfare GB/T 16886.12 Biological evaluation of medical devices - Part 12. Sample preparation and reference samples Terminology and definitions of medical devices for human - assisted reproductive technology YY/T 0995-2015 3 terms, definitions and abbreviations 3.1 terms, definitions YY/T 0995-2015 and the following terms apply to this document. Note. The following embryos refer to mouse embryos. 3.1.1 Blastocyst blastocyst An embryo with a blastocyst cavity formed by cleavage. 3.1.2 1-cell embryos 1-CelEmbryo Fertilized but not yet cleavage zygote. 3.1.3 2-cell embryos 2-CelEmbryo Complete the first cleavage of embryos containing two blastomere. 3.2 abbreviations PMSG. pregnant horse serum gonadotropin (pregnantmareserumgonadotrophin) hCG. Human chorionic gonadotropin (humanchorionicgonadotrophin)

4 test method

4.1 Overview This experiment is the use of mouse embryos in vitro conventional culture system, from the fertilized egg to the blastocyst culture process, according to the function of the product to be tested ...

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