Medical Device IEC 60601 Safety and Performance Testing

China JJR Laboratory, an IEC 17025 and GLP accredited lab, offers safety and performance testing services for medical devices, including:

- Electronic thermometers

- Infrared thermometers

- Electronic blood pressure monitors

- Electronic laparoscopes

- Electronic endoscopes

- ECG machines

- Multi-parameter monitors

- Pulse oximeters

- Therapy lamps

- Nebulizers

- Neuromuscular stimulators

- High-voltage therapy devices

- Electrotherapy devices

- Magnetotherapy devices

- Hearing aids

General Standards

- General requirements (IEC/EN 60601-1)

- Collateral requirements:

  - Usability (IEC/EN 60601-1-6; IEC/EN 62366)

  - Alarm systems (IEC/EN 60601-1-8)

  - Home healthcare environment (IEC/EN 60601-1-11)

Specific Requirements

- Neuromuscular stimulators (IEC/EN 60601-2-10)

- ECG-related devices (IEC/EN 60601-2-25; IEC/EN 60601-2-27; IEC/EN 60601-2-47)

- Blood pressure monitors (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 equipment (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 specific requirements (IEC/EN 60601-2-XX; IEC/EN 80601-2-XX; ISO/EN ISO 80601-2-XX; ISO/EN ISO XXXX)