YY/T 1657-2019 Active Industry standards-Medicine

YY/T 1657-2019 Preimplantation chromosomal aneuploidies detection kits (Sequencing)

Publish Date: 2019-07-24 Implement Date: 2020-08-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: YY/T 1657-2019

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Surgical instruments and materials

Publish Date: 2019-07-24

Implement Date: 2020-08-01

Pages: 12 pages

Scope

This standard specifies the naming and classification, technical requirements, testing methods, labeling and user manuals, packaging, transportation, and storage of pre-implantation chromosomal aneuploidy detection kits (sequencing method). This standard applies to the quality control of pre-implantation testing kits that detect chromosomal aneuploidy and large segment deletions or duplications in pre-implantation embryos through low-depth high-throughput gene sequencing, thereby selecting normal embryos for implantation. Pre-implantation chromosomal aneuploidy detection kits typically include whole-genome amplification and library construction reagents, and may contain high-throughput sequencing reagents. If the pre-implantation chromosomal aneuploidy detection kits do not contain high-throughput sequencing reagents, the manufacturer shall provide instructions or specify compatible high-throughput sequencing kits. This standard applies to pre-implantation chromosomal aneuploidy detection kits used in clinical screening.