T/GDMDMA 0003-2022 Active
T/GDMDMA 0003-2022 Fully Automatic Nucleic Acid Extraction System
Abstract
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.
General Product Information
| Document Type | Group standards |
|---|---|
| Standard Status | Active |
| Standard Code | T/GDMDMA 0003-2022 |
| CCS | Medical devices |
| ICS | Diagnostic equipment |
| Implement Date | 2022-08-22 |