GB/T 16886.11-1997
Replaced
T/CIQA 123-2025
Active
Group standards
Technical Specifications for the Rapid Nucleic Acid Detection Instrument T/CIQA 123-2025
T/CIQA 123-2025 Fast nucleic acid testing instrument testing technical regulations
Price:
$ 20.00
Basic Information
Standard Code:
T/CIQA 123-2025
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
-
ICS Name:
Integrated medical equipment
Publish Date:
2025-06-12
Implement Date:
2025-06-12
Scope
Main technical content: This document specifies the terminology, classification, and methodological principles of rapid nucleic acid detectors, the composition and performance of the instruments, laboratory requirements, sample processing, analysis steps and methods, quality control, result reporting, and biosafety requirements. This document is applicable to the integrated operation of nucleic acid release, purification, and gene amplification steps, and the use and performance assessment of rapid nucleic acid detectors based on isothermal and temperature-controlled gene amplification technologies.
Development Information
Related Standards
GB/T 16886.3-1997
Replaced
GB/T 16886.3-1997 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity
GB/T 16886.6-1997
Replaced
GB/T 16886.6-1997 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation
GB/T 16886.1-2001
Replaced
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.13-2001
Replaced
GB/T 16886.13-2001 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices
GB/T 16886.7-2001
Replaced