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YY/T 1434-2016Medical devices for human in vitro assisted reproductive technology—In vitro mouse embryo assay (English PDF)

人类体外辅助生殖技术用医疗器械体外鼠胚试验

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

January 26, 2016

Implementation date

January 1, 2017

Scope

YY/T 1434-2016 is the English-translated version of 人类体外辅助生殖技术用医疗器械体外鼠胚试验.

YY/T 1434-2016 is the Chinese pharmaceutical industry standard that gives the mouse embryo assay used to evaluate the safety of medical devices that contact gametes or embryos in human assisted reproduction.

It sets out the mouse strain and the embryos, the culture conditions, the exposure to the device or its extract, the controls and the proportion of embryos that must reach the blastocyst stage for the result to be acceptable. Issued on 26 January 2016, it has applied since 1 January 2017.

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Document preview — YY/T 1434-2016

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

Foreword
1 Scope
2 Normative reference documents
3 Terms, definitions and abbreviations
4 Test method

Foreword

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

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 document. 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

An embryo with a blastocyst cavity formed by cleavage.

3.1.2 1-cell embryos

Fertilized but not yet cleavage zygote.

3.1.3 2-cell embryos

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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 23 pages — is available in the English PDF.

Referenced standards

Normative references

Cited by

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