YY/T 1155-2019 Active
YY/T 1155-2019 Automatic luminescence immunoassay analyzer
Abstract
This standard specifies the requirements, test methods, labels, markings, and user manuals, packaging, transportation, and storage for fully automatic luminescence immunoassay analyzers.
This standard applies to fully automatic luminescence immunoassay analyzers (hereinafter referred to as analyzers) used in medical laboratories. The analyzers use luminescence systems and immunoassay methods to quantitatively or qualitatively detect various analytes in human serum, plasma, or other body fluids, including luminescence immunoassay analyzers based on principles such as chemiluminescence, electrochemiluminescence, and fluorescence.
This standard does not apply to:
- luminescence immunoassay analyzers based on image recognition;
- fully automatic luminescence immunoassay analyzers for point-of-care testing (POCT).
General Product Information
| Document Type | Industry standards-Medicine |
|---|---|
| Standard Status | Active |
| Standard Code | YY/T 1155-2019 |
| CCS | Medical laboratory equipment |
| ICS | Laboratory medicine |
| Implement Date | 2020-06-01 |