YY/T 1688-2021 English PDF

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YY/T 1688-2021: Medical devices for human assisted reproductive technology - A method for blastocyst cell staining and counting
Status: Valid

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Basic data

Standard ID: YY/T 1688-2021 (YY/T1688-2021)
Description (Translated English): Medical devices for human assisted reproductive technology - A method for blastocyst cell staining and counting
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C30
Word Count Estimation: 6,669
Issuing agency(ies): State Drug Administration

YY/T 1688-2021: Medical devices for human assisted reproductive technology - A method for blastocyst cell staining and counting

---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 - A method for blastocyst cell staining and counting ICS 11.040.30 C30 People's Republic of China Pharmaceutical Industry Standards Medical devices for human assisted reproductive technology Blastocyst cell staining and counting method Released on 2021-03-09 2022-04-01 implementation Issued by the National Medical Products Administration

Foreword

This standard was 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 issuing agency of this document is not responsible for identifying these patents. This standard was proposed by the State Drug Administration. This standard is under the jurisdiction of China Food and Drug Control Research Institute. Drafting organizations of this standard. China Institute for Food and Drug Control, Nanjing Uer Biotechnology Development Co., Ltd., Chinese Academy of Sciences Institute of Developmental Biology. The main drafters of this standard. Han Qianqian, Jin Xingliang, Yin Yanyun, Wang Ying, Fang Yu, Wang Chunren. Medical devices for human assisted reproductive technology Blastocyst cell staining and counting method

1 Scope

This standard specifies the test methods for staining and counting mouse blastocyst cells. This standard applies to the safety evaluation of medical devices used in human assisted reproductive technology that come into direct or indirect contact with gametes and/or embryos.

2 Normative references

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article Pieces. For undated reference documents, the latest version (including all amendments) is applicable to this document. YY/T 0995 Terms and definitions of medical devices used in human assisted reproductive technology YY/T 1434 In vitro mouse embryo test for medical devices used in human in vitro assisted reproductive technology 3 Terms, definitions and abbreviations The following terms and definitions apply to this document. 3.1 Terms and definitions The following terms and definitions defined in YY/T 0995 and YY/T 1434 apply to this document. 3.1.1 Expanded blastocyst The blastocyst cavity has been fully expanded and the zona pellucida is thinned. 3.1.2 Hatching or hatching blastocyst A blastocyst in which some or all of the blastocyst cells escape from the zona pellucida. 3.1.3 Innercelmass A group of cells in the inner layer of a blastocyst, distributed in clusters, and eventually develop into a fetus. 3.1.4 Trophectodermcel The outer cells of the blastocyst will eventually develop into the placenta. 3.2 Abbreviations The following abbreviations apply to this document. PBS. phosphate buffer saline Hoechst33342.bisbenzimide PFA. paraformaldehyde BSA. Bovine Serum Albumin (bovineserum albumin) ......

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