In-Vitro Diagnostic (IVD) Equipment
In-vitro diagnostic (IVD) products mainly consist of diagnostic equipment (instruments) and diagnostic reagents. According to the Medical Device Classification Catalog standard of China's National Medical Products Administration (NMPA), IVD equipment belongs to the category of clinical laboratory analysis instruments. The quality inspection of IVD equipment focuses on safety, performance, product reliability, and electromagnetic compatibility. The laboratory can provide electrical safety testing, reliability and environmental testing, EMC testing, and related performance testing services for biochemical analysis equipment, immunoassay equipment, molecular biology analysis equipment, microbiology analysis equipment, and blood and body fluid (urine, feces, and secretions) analysis equipment.
Electrical Safety Tests: Temperature rise, dielectric strength, leakage current, input power, single fault test, etc.
EMC Tests: Electrical fast transient/burst, surge, electrostatic discharge, conducted radio-frequency immunity, voltage dips and short interruptions, radiated radio-frequency electromagnetic field immunity, power frequency magnetic field immunity, harmonic current, voltage changes, voltage fluctuations and flicker limits, terminal disturbance voltage, radiated electromagnetic disturbance.
Environmental Tests: Service life validity verification aging test.
Packaging Transportation Tests: Vibration, low air pressure, etc.
YY 0648 Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use - Part 2-101: Particular Requirements for in Vitro Diagnostic (IVD) Medical Equipment;
GB 4793.6 Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use - Part 6: Particular Requirements for Laboratory Equipment for the Heating of Materials;
GB 4793.7 Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use - Part 7: Particular Requirements for Laboratory Centrifuges;
YY 9706.102 Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests;
GB 4824 Industrial, Scientific and Medical Equipment - Radio-Frequency Disturbance Characteristics - Limits and Methods of Measurement;
GB/T 18268.26 Electrical Equipment for Measurement, Control and Laboratory Use - EMC Requirements - Part 26: Particular Requirements - In Vitro Diagnostic (IVD) Medical Equipment, etc.
CNAS
