YY/T 1535-2017 (YY/T1535-2017, YYT 1535-2017, YYT1535-2017) & related versions
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Medical devices for human in vitro assisted reproductive technology—Biological evaluation—Human sperm survival assay
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YY/T 1535-2017: PDF in English (YYT 1535-2017)
YY/T 1535-2017
Medical devices for human in vitro assisted reproductive technology-Biological evaluation-Human sperm survival assay
ICS 11.040.30
C30
People's Republic of China pharmaceutical industry standards
Medical equipment for human extracorporeal assisted reproductive technology
Biology Evaluator sperm survival test
2017-03-28 Posted
2018-04-01 implementation
State Food and Drug Administration released
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of this document may be patentable. The issuing agencies of this document do not bear the responsibility of identifying these patents.
This standard proposed by the State Food and Drug Administration.
This standard by the China Institute of Food and Drug Control centralized.
This standard was drafted unit. Shanghai Institute of Family Planning Science, CITIC Xiangya Reproductive and Genetic College Hospital, China Food and Drug Control
Institute.
The main drafters of this standard. Shi Huijuan, Lin Ge, Sun Zhengyi, Gu a Hua, Zhang Na, Xu Liming, Lu Guangtao, Huang Guoning.
Medical equipment for human extracorporeal assisted reproductive technology
Biology Evaluator sperm survival test
1 Scope
This standard specifies the human external assisted reproductive technology medical devices used in human sperm survival test biological evaluation of the test
method.
This standard applies to the evaluation of human in vitro assisted reproductive technology with medical devices and sperm in direct contact with the culture fluid and equipment/consumption
Material products may produce toxicity risk, but also for evaluation of oocytes or embryos in direct contact with the culture medium and equipment/supplies category
Product may have a toxicity risk.
This standard does not apply to sperm brake agent (resulting in a significant decline in sperm motility), hyaluronidase (affecting the sperm membrane, thereby affecting the fine
Sub-exercise), gametes/embryo freezing and thawing solution (significantly detrimental to sperm motility) testing.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version applies to this article
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 16886.12 Biological evaluation of medical devices - Part 12. Sample preparation and reference samples (ISO 10993-12.2002,
IDT)
Terms and definitions of medical device for human assisted reproductive technology YY/T 0995
3 Terms, definitions and abbreviations
3.1 Terms and definitions
YY/T 0995 as defined in the following terms and definitions apply to this document.
3.1.1
Human sperm survival test humanspermsurvivalassay
The use of human sperm and test sample or its extract after incubation of sperm motility changes to indirectly determine the test substance on sperm, eggs or embryos
Potential toxicity of the fetus.
3.1.2
Sperm motility spermmotility
Sperm motility in semen, previously expressed as a percentage of total motility for progressive motility (PR).
3.1.3
Sperm motility testforspermmotility
Determination of sperm motility.
3.1.4
Sperm motility graded spermmotilitygrading
Divided into forward movement, non-forward movement and inactivity.
Progressive movement (PR) refers to the sperm active linear or along a large circular movement, regardless of speed.
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| Standard ID | YY/T 1535-2017 (YY/T1535-2017) | | Description (Translated English) | Medical devices for human in vitro assisted reproductive technology--Biological evaluation--Human sperm survival assay | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C30 | | Classification of International Standard | 11.040.30 | | Word Count Estimation | 10,126 | | Date of Issue | 2017-03-28 | | Date of Implementation | 2018-04-01 | | Drafting Organization | Shanghai Institute of Family Planning Science, CITIC Xiangya Reproductive and Genetic College Hospital, China Institute of Food and Drug Control | | Administrative Organization | China Institute of Food and Drug test | | Proposing organization | China Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration |
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