IEC 60601-1 Test Report Labs

EMC Testing for Medical Electrical Equipment

There is a widely acknowledged need for specific electromagnetic compatibility (EMC) standards for medical electrical equipment and systems. This is particularly crucial for electromagnetic emissions, which are vital to protect safety operations, other medical equipment or systems, and radio communication. Additionally, standards for electromagnetic immunity are essential to ensure the safety of medical electrical equipment and systems. Manufacturers, responsible parties, and operators must share the responsibility to ensure that medical electrical equipment and systems are designed and operate as intended. Consequently, the International Electrotechnical Commission (IEC) has issued the IEC 60601-1-2 standard for electromagnetic compatibility requirements and tests for medical electrical equipment.

Latest Versions

- International Electrotechnical Commission: IEC 60601-1-2:2014/A1:2020

- European Version: EN 60601-1-2:2015/A1:2021

Testing Capabilities

China JJR Laboratory fully meets all the testing capabilities required for IEC/EN 60601-1-2 certification for electronic and electrical medical devices or systems. It has received the latest CNAS accreditation, meeting the testing requirements for large, high-power medical devices or systems with three-phase power supply.

IEC 60601 Testing Items

EMI (Electromagnetic Interference):

- Conducted Emissions

- Radiated Emissions

- Harmonic Current

- Voltage Fluctuations and Flicker

EMS (Electromagnetic Susceptibility):

- Electrostatic Discharge

- RF Radiated Electromagnetic Fields

- Near Fields from RF Wireless Communication Equipment

- Electrical Fast Transient/Burst

- Surge

- Injected Currents

- Power Frequency Magnetic Fields

- Voltage Dips and Interruptions

- Proximity Magnetic Field Immunity

IEC 60601 Test Sample Requirements

A complete functional prototype is required for testing.

IEC 60601 Testing Instruments/Examples

Conducted Emissions:

- Supports three-phase high-current medical electrical equipment or systems, with each phase current up to 200A.

Radiated Emissions:

- Supports three-phase high-current medical electrical equipment or systems, with each phase current up to 300A.

- Meets the requirements for 3-meter and 10-meter test sites.

Electrostatic Discharge:

- Maximum voltage up to 30kV, fully meeting the 15kV test requirements for medical equipment.

- Supports three-phase high-current medical electrical equipment or systems.

Radiated Immunity:

- Fully meets the special non-sinusoidal modulation requirements of medical electrical equipment standards.

- Supports three-phase high-current medical electrical equipment or systems.

Injected Currents:

- Supports three-phase high-current medical electrical equipment or systems.

Harmonic Current, Voltage Fluctuations, Voltage Dips:

- Supports three-phase high-current medical electrical equipment or systems.

- Meets the testing capability for currents greater than 16A and up to 75A.

Surge:

- Supports three-phase high-current medical electrical equipment or systems.

Electrical Fast Transient/Burst:

- Supports three-phase high-current medical electrical equipment or systems.

Power Frequency Magnetic Field:

- Supports three-phase high-current medical electrical equipment or systems.

- Supports testing of large products up to 2x2.6m in size.

China JJR Laboratory is an IEC 17025 accredited laboratory and an NB recognized laboratory, providing IEC 60601-1 test services for medical devices. Please provide product specifications to obtain a quote.