YY/T 1717-2020 Active Industry standards-Medicine

YY/T 1717-2020 Nucleic acid extraction kit(magnetic beads method)

Publish Date: 2020-03-31 Implement Date: 2021-04-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1717-2020

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: Medical equipment

Publish Date: 2020-03-31

Implement Date: 2021-04-01

Pages: 7 pages

Scope

This standard specifies the terms and definitions, classification, technical requirements, test methods, marking, labels and user manuals, packaging, transportation, and storage of nucleic acid extraction kits (magnetic bead method) (hereinafter referred to as "kits").
This standard applies to kits that use the magnetic bead method to extract and purify human genomic nucleic acids and their fragments, pathogen nucleic acids from various clinical samples such as serum, plasma, whole blood, cerebrospinal fluid, milk, saliva, urine, sputum, swabs, tissues, or paraffin-embedded tissues. Pathogen nucleic acids include deoxyribonucleic acid (DNA) and ribonucleic acid (RNA).
This standard does not apply to nucleic acid extraction reagents contained in closed systems that cannot extract nucleic acid extraction products for testing.