GB/T 16886.11-1997
Replaced
T/CITS 124-2024
Active
Group standards
\nT/CITS 124-2024 Glycated Hemoglobin Detection System Performance Verification
T/CITS 124-2024
Price:
$ 20.00
Basic Information
Standard Code:
T/CITS 124-2024
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical laboratory equipment
ICS Name:
Integrated medical equipment
Publish Date:
2024-08-09
Implement Date:
2024-08-09
Scope
Scope: This document describes the classification and methods of the glycated hemoglobin detection system (hereinafter referred to as the "detection system"), and stipulates the general requirements for performance verification of the detection system, preparations before performance verification, and the content of performance verification. This document is applicable to the verification of the analytical performance of the detection system in all levels and types of medical institutions. Main technical content: 1. Scope 2. Normative reference documents 3. Terms and definitions 4. Overview 5. General requirements 6. Preparations before performance verification 7. Verification content Appendix A 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