SAFETY & PERFORMANCE

 

STC offers Safety & Performance Testing services for medical device products such as:

  • Electronic Clinical Thermometers
  • Infrared Thermometers
  • Electronic Sphygmomanometers
  • Electronic Laparoscopes
  • Electronic Endoscopes
  • Electrocardiographs
  • Multi-parameter Monitors
  • Pulse Oximeters
  • Therapeutic Lamps
  • Humidifiers
  • Nerve & Muscle Stimulators
  • High-potential Therapeutic Apparatus
  • Electro-therapeutic Equipment
  • Magnetic Therapy Equipment
  • Hearing Aid
 

General Standard

  • General Requirements (EC / 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 & 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)
  • Additional Requirements (IEC / EN 60601-2-XX; IEC / EN 80601-2-XX, ISO / EN ISO 80601-2-XX; ISO / EN ISO XXXX)

 

For more information about our services, please feel free to contact us.