Standard Number: YY/T 1717-2020(YY/T1717-2020)
Chinese:核酸提取试剂盒（磁珠法）
English:Nucleic acid extraction kit（magnetic beads method）
Effective Date:2021-04-01
ICS:11.040
Standard Applicability:This standard specifies the terms and definitions, classification, technical requirements, test methods, labeling, labeling and instructions for use, packaging, transportation and storage of nucleic acid extraction kits (magnetic bead method) (hereinafter referred to as “kits”). This standard applies to the use of magnetic beads method from serum, plasma, whole blood, cerebrospinal fluid, breast milk, saliva, urine, sputum, swabs, tissue or paraffin-embedded tissue and other types of clinical samples, extraction, purification of human genome nucleic acid and its fragments, pathogen nucleic acid kit. Pathogen nucleic acids include deoxyribonucleic acid (DNA), ribonucleic acid (RNA) and so on. This standard does not apply to nucleic acid extraction reagents contained in closed systems where the nucleic acid extraction product cannot be removed for testing.
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