GB/T 16886.11-1997
Replaced
T/CITS 147-2024
Active
Group standards
T/CITS 147-2024 Automated nucleic acid testing system quality control specifications
T/CITS 147-2024 Automated nucleic acid testing system quality control specifications
Price:
$ 20.00
Basic Information
Standard Code:
T/CITS 147-2024
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical laboratory equipment
ICS Name:
Integrated medical equipment
Publish Date:
2024-09-24
Implement Date:
2024-09-24
Scope
Scope: This document specifies the management requirements, technical requirements, process control requirements, and quality control requirements for automated nucleic acid detection systems. This document applies to the quality control of nucleic acid detection systems and equipment based on the principle of polymerase chain reaction (PCR) technology. This document does not apply to the quality control of rapid nucleic acid detection equipment. Main technical content: 1. Scope 2. Normative reference documents 3. Terms and definitions 4. Management requirements 5. Technical requirements 6. Process control requirements 7. Quality control References
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