Standard No.:	YY/T 1657-2019
English Name:	Preimplantation chromosomal aneuploidies detection kits (Sequencing)
Chinese Name:	胚胎植入前染色体非整倍体检测试剂盒（测序法）
Chinese Classification:	C30    Medical apparatus and devices in general
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.30 11.040.30    Surgical instruments and materials 11.040.30
Source Content Issued by:	National Medical Products Adminstration
Issued on:	2019-07-24
Implemented on:	2020-8-1
Status:	valid
Target Language:	English
File Format:	PDF
Word Count:	7500 words
Translation Price(USD):	225.0
Delivery:	via email in 1~3 business day

本标准规定了胚胎植入前染色体非整倍体检测试剂盒（测序法）的命名和分类、技术要求、试验方法、标签和使用说明书、包装、运输和贮存等。本标准适用于通过低深度高通量基因测序检测植入前胚胎是否有染色体非整倍体以及大片段缺失、重复异常，从而选择正常的胚胎进行植入的胚胎植入前检测试剂盒的质量控制。胚胎植入前染色体非整倍体检测试剂盒一般包括全基因组扩增、文库构建试剂组分，可包含高通量测序试剂，如胚胎植入前染色体非整倍体检测试剂盒内，不含有高通量测序试剂组分，由制造商说明或指定配套高通量测序试剂盒。本标准适用于应用于临床筛查的胚胎植入前染色体非整倍体检测试剂盒。