Oxygen Concentrators
According to the Medical Device Classification Catalog of China's National Medical Products Administration (NMPA), oxygen concentrator products belong to respiratory, anesthesia, and emergency devices (Class 08). Main product subdivisions include medical molecular sieve oxygen systems, medical molecular sieve oxygen concentrators, medical membrane separation oxygen systems, and medical membrane separation oxygen concentrators. The field of oxygen concentrators is broad, including not only the listed products but also supply chain components such as medical central oxygen systems, medical gas manifolds, medical central gas monitoring and alarm systems, medical gas compression systems, medical central oxygen supply systems, medical central suction systems, medical vacuum negative pressure machines, air compressors, and refrigerated dryers. Good safety, efficiency, stability, and electromagnetic compatibility are crucial for oxygen concentrators to continuously and stably provide high-quality oxygen in variable electromagnetic environments like hospitals, clinics, or homes, ensuring the safety and effectiveness of patient respiratory therapy. The laboratory provides comprehensive technical testing services for various oxygen concentrator devices, including but not limited to home, medical, and portable oxygen concentrators, as well as high-flow oxygen therapy equipment. These services include electrical safety testing, reliability and environmental adaptability testing, EMC testing and rectification, and performance evaluation. Through these services, we are committed to ensuring that every oxygen concentrator can operate stably in various use environments, providing safe and reliable oxygen supply to patients.
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 9706.102 Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests;
YY 9706.108 Medical Electrical Equipment - Part 1-8: General Requirements for Basic Safety and Essential Performance - Collateral Standard: General Requirements, Tests and Guidance for Alarm Systems in Medical Electrical Equipment and Medical Electrical Systems;
YY 9706.111 Medical electrical equipment - Part 1-11: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment;
YY 9706.112 Medical Electrical Equipment - Part 1-12: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Intended for Use in Emergency Medical Services Environments;
YY 9706.269 Medical Electrical Equipment - Part 2-69: Particular Requirements for Basic Safety and Essential Performance of Oxygen Concentrator Equipment;
GB 9706.1 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance, etc.
CNAS
