Nucleic acid extraction instrument and other industry standards new release!


Release Time:

2023-09-11

 

On September 7, 2023, the State Food and Drug Administration issued a notice (No. 118 of 2023) on 45 medical device industry standards such as YY 0304-2023 "Plasma Sprayed Hydroxyapatite Coated Titanium Dental Implants", including the nucleic acid extractor industry standard, which will be implemented from September 15, 2024.

1

Standard No.

Standard Name

Scope of application

Implementation Date

YY/T 1908-2023

nucleic acid extraction instrument

This document specifies the requirements, test methods, labeling, identification and instructions for use, packaging, transportation and storage of the nucleic acid extractor. This document is applicable to automatic pretreatment instruments such as extraction and purification of nucleic acids from clinical samples.

September 15, 2024