This standard is drafted according to the rules given in GB / T 1.1-2009.
Please note that some contents of this document may involve the issue of patents. The
issuing authority of this document shall not bear any responsibility for the identification
of these patents.
This standard is put forward by China Food and drug administration.
This standard is centralized by CFDA.
This standard was drafted by: National Institutes for Food and Drug Control, and
Institute of Genetics and Developmental Biology, Chinese Academy of Sciences.
This standard is mainly drafted by: You Qianqian, Feng Xiaoming, Dai Jianwu, Xiao
Zhifeng, Yin Yanyun, Xu Liming and Hao Na.
Medical devices for human in vitro assisted reproductive
technology—In vitro mouse embryo assay
This standard specifies the in vitro mouse embryo assay method, which is
applicable to the safety evaluation of medical devices for human in vitro assisted
reproductive technology that contact with gametes and / or embryos.
- Normative references
The following documents are essential for the application of this document. For
undated references, only the dated version is applicable to this document. For undated
references, the latest version (including all amendments) is applicable 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
YY / T 0995-2015 Medical Devices for Human Assisted Reproductive Technology,
Terms and Definitions
- Terms, Definitions and Abbreviations
3.1 Terms and Definitions
Those specified in YY / T 0995-2015 and the following terms are applicable to this
Note: the following embryos all refer to mouse embryos
An embryo with a blastocoele formed by the cleavage of a fertilized egg
- 1-Cell Embryo, a zygote which is fertilized but not yet cleaved.
2-cell Embryo, an embryo contains two blastomeres and finishesthe first cleavage.
PMSG: pregnant mare serum gonadotropin
HCG: human chorionic gonadotropin
- Test method
This experiment adopted the routine culture system of mouse embryos in vitro. In
the process of culture from fertilized eggs to blastocysts, it used the extract liquid of the
liquid products or utensils products to be tested in the corresponding culture stages
according to the function and the nature of the products to be tested, and then evaluated
the potential toxicity of the products to the embryo development by observing the
development of the early embryos from the sperm eggs to the blastocysts.
There are 1-cell method and 2-cell method for in vitro mouse embryo assay. But
the test procedure of either methods used for mouse embryo assay should simulate as
much as possible for the product to be used for human assisted reproduction culture.
This test shall be carried out in a clean laboratory where corresponding conditions.
Note: the 1-cell method is recommended.