YY/T 1535-2017 English Version, YY/T 1535-2017 Medical devices for human in vitro assisted reproductive technology- Biological evaluation-Human sperm survival assay (English Version)

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YY/T 1535-2017 Medical devices for human in vitro assisted reproductive technology- Biological evaluation-Human sperm survival assay (English Version)
Standard No.:	YY/T 1535-2017	Status:	superseded remind me the status change Email:
Target Language:	English	File Format:	PDF
Word Count:	5500 words	Translation Price(USD):	160.0 remind me the price change Email:
Implemented on:	2018-4-1	Delivery:	via email in 1~3 business day

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Standard No.:	YY/T 1535-2017
English Name:	Medical devices for human in vitro assisted reproductive technology- Biological evaluation-Human sperm survival assay
Chinese Name:	人类体外辅助生殖技术用医疗器械生物学评价人精子存活试验
Professional Classification:	YY Professional Standard - Pharmaceutics
Source Content Issued by:	China Food and Drug Adminstration
Issued on:	2017-03-28
Implemented on:	2018-4-1
Status:	superseded
Superseded by:	YY/T 1535-2024 Medical devices for human assisted reproductive technology — Human sperm viability assay (HSVA)
Superseded on:	2025-7-20
Target Language:	English
File Format:	PDF
Word Count:	5500 words
Translation Price(USD):	160.0
Delivery:	via email in 1~3 business day

Standard

YY/T 1535-2017 Medical devices for human in vitro assisted reproductive technology- Biological evaluation-Human sperm survival assay (English Version)
Standard No.	YY/T 1535-2017
Status	superseded
Language	English
File Format	PDF
Word Count	5500 words
Price(USD)	160.0
Implemented on	2018-4-1
Delivery	via email in 1~3 business day

Detail of YY/T 1535-2017

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Introduction of YY/T 1535-2017

本标准规定了直接/间接与精子接触的人类体外辅助生殖技术用耗材及试剂的精子毒性试验方法。
本标准适用于评价在人类体外辅助生殖技术用医疗器械中与精子直接接触的培养液类及器具/耗材类产品可能产生的毒性风险，也适用于评价与卵母细胞或胚胎直接接触的培养液类及器具/耗材类产品可能产生的毒性风险。

Contents of YY/T 1535-2017

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