Testing and Certification Services for Active Medical Devices

STC is accredited by HOKLAS (Hong Kong), CNAS (China), FDA (USA), CE (Europe), DAkkS (Germany), and more.

Scope of Services

- Safety and performance tests for medical electrical equipment: IEC/EN 60601 series standards
- Safety and EMC requirements for laboratory equipment: IEC/EN 61010, IEC/EN 61326 series standards
- Biocompatibility test: ISO 10993, ISO 18562 series standards
- Electromagnetic compatibility (EMC), Radio Frequency (RF) tests
- Performance test for medical face mask: ASTM F2100
- Hong Kong OFCA certification for RF medical devices

General Requirements

- Safety requirements: IEC/EN 60601-1, IEC/EN 61010-1
- EMC requirements: IEC/EN 60601-1-2, IEC/EN 61326-1, IEC/EN 61326-2-6
- Requirements for alarm systems: IEC/EN 60601-1-8
- Home healthcare environment: IEC/EN 60601-1-11
- Emergency medical services environment: IEC/EN 60601-1-12
- OFCA type acceptance and type approval: HKCA 1007, 1052

Particular Requirements

- Nerve and muscle stimulators: IEC/EN 60601-2-10
- Electromyographs and evoked response equipment: IEC/EN 60601-2-40
- Thermometers: ISO/EN ISO 80601-2-56, ASTM E 1965, ASTM E 1112
- Sphygmomanometers: IEC/EN 80601-2-30, IEC/EN 60601-2-34, ISO/EN ISO 81060-1
- Pulse oximeter equipment: ISO/EN ISO 80601-2-61
- Electrocardiographic equipment: IEC/EN 60601-2-25, IEC/EN 60601-2-27, IEC/EN 60601-2-47
- Electroencephalograph: IEC/EN 60601-2-26
- Multifunction patient monitors: IEC/EN 80601-2-49
- Heating pad or heating blanket: IEC/EN 80601-2-35
- Endoscopic equipment: IEC/EN 60601-2-18
- Medical beds: IEC/EN 60601-2-52
- Dental equipment: ISO/EN ISO 80601-2-60
- Light source equipment: IEC/EN 60601-2-22, IEC/EN 60601-2-57, IEC/EN 60601-2-83
- Hearing aids: IEC/EN 60601-2-66
- In Vitro Diagnostic (IVD) medical equipment: IEC/EN 61010-2-101