SAFETY AND PERFORMANCE
Product Categories
• Electronic Clinical Thermometers
• Infrared Thermometers
• Electronic Sphygmomanometers
• Electronic Laparoscopes
• Electronic Endoscopes
• Electrocardiographs
• Multi-parameter Monitors
• Pulse Oximeters
• Therapeutic Lamps
• Humidifiers
• Nerve and Muscle Stimulators
• High-potential Therapeutic Apparatus
• Electro-therapeutic Equipment
• Magnetic Therapy Equipment
• Hearing Aid
 
Test Items and Standards
Test Item    
Standard
General Standard
General Requirements
IEC / EN 60601-1
Collateral Standards
Usability
IEC / EN 60601-1-6; IEC / EN 62366
Alarm System
IEC / EN 60601-1-8
Medical Electrical Equipment for Home Healthcare
IEC / EN 60601-1-11
Particular Requirements
Nerve and Muscle Stimulators
IEC / EN 60601-2-10
ECG Related Equipment
IEC / EN 60601-2-25; IEC/EN 60601-2-27; IEC / EN 60601-2-47
Sphygmomanometers
IEC / EN 80601-2-30; IEC/EN 60601-2-34; ISO / EN ISO 81060-1
Multi-parameter Monitors
IEC / EN 60601-2-49
Thermometers
ISO / EN ISO 80601-2-56
Light Source Equipmen
IEC / EN 60601-2-22; IEC / EN 60601-2-57
Pulse Oximeters
ISO / EN ISO 80601-2-61
Hearing Aids
IEC / EN 60601-2-66
More Particular Requirements
IEC / EN 60601-2-XX; IEC / EN 80601-2-XX,
ISO / EN ISO 80601-2-XX; ISO / EN ISO XXXX
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