Preface
This standard is drafted according to the rules given in GB / T 1.1-2009.
Please note that some content of this document may involve patents. The issuing
authority of this document is not responsible for identifying these patents.
This standard is put forward by China Food and drug administration.
This Standard is centralized by the National Institutes for Food and Drug Control.
This standard was drafted by SIPPR, CITIC Huya Reproductive & Genetic Hospital
of CITIC-Xiangya and National Institutes for Food and Drug Control.
This standard is mainly drafted by: Shi Huijuan, Lin Ge, Sun Zhengyi, Gu Yizhang,
Zhang Na, Xu Liming, Lu Guangzhen, Huang Guoning.
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Medical devices for human in vitro assisted reproductive technology
Biological evaluation Human sperm survival assay
- Scope
This standard specifies assay methods for the biological evaluation of human in
vitro assisted reproductive technology for the biological evaluation of human sperm
survival tests.
This standard is applicable to the evaluation of possible toxicity risks of culture
fluids and appliances / consumables that are in direct contact with sperm in medical
devices for human in vitro assisted reproductive technology. It is also applicable to the
evaluation of the risk of toxicity produced by products such as culture fluids and
appliances/ consumables that are in direct contact with oocytes or embryos.
This standard is not applicable to the detection of sperm immobilizing agents
(resulting in a significant decrease of sperm motility), hyaluronidase (affects the
sperm motility by affecting the sperm membranes ), and gamete/embryonic
cryopreservation fluid (obviously not conducive to sperm motility). - Normative references
The following documents are indispensable for the application of this document.
For dated 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 16886.12 Biological evaluation of medical devices Part 12: Sample
preparation and reference samples (ISO 10993-12, 2002, IDT)
YY / T 0995 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 and the following terms are applicable to this
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document
