T/GDMDMA 0003-2022 Active Group standards

T/GDMDMA 0003-2022 Fully Automatic Nucleic Acid Extraction System

Publish Date: 2022-08-22 Implement Date: 2022-08-22 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Price: $ 20.00

Download

Basic Information

Standard Code: T/GDMDMA 0003-2022

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Diagnostic equipment

Publish Date: 2022-08-22

Implement Date: 2022-08-22

Pages: 16 pages

Scope

Scope: This document specifies the requirements, test methods, labels, markings, and user manuals, packaging, transportation, and storage for fully automatic nucleic acid extraction instruments. This document is applicable to fully automatic nucleic acid extraction instruments (hereinafter referred to as extraction instruments) that use magnetic bead technology to extract and purify human genomic nucleic acids and pathogen nucleic acids, including deoxyribonucleic acid (DNA) and ribonucleic acid (RNA), from clinical samples. Main technical contents: appearance, pipetting range, pipetting accuracy and precision, temperature accuracy, temperature uniformity, temperature stability, oscillation or rotation speed error, magnetic flux, extraction hole differences, extraction efficiency, cross-contamination rate, functionality, safety requirements, electromagnetic compatibility, and environmental requirements, making the standard more professional and practical.