IEC 60601-1 Electrical Medical Device Testing

Eurocert provides IEC 60601-1 medical conformity testing for electrical medical devices. IEC 60601-1 has become a requirement for many companies whose electrical products fall within the risks tied to electronic medical equipment. It applies to electrical equipment and covers all medical devices.

Our services, delivered by knowledgeable and experienced specialists, cover the following:

• Testing
• Determining compliance with IEC 60601-1 and with the standard and required performance under ISO 14971 risk management
• Product labeling
• Provision of required documentation

IEC 60601-1 applies to all medical electrical equipment.

IEC 60601-1 defines medical electrical equipment as electronic products that connect to a particular electrical supply and are intended to diagnose, treat, or monitor a patient under medical supervision through physical or electrical contact with the patient. IEC 60601-1 has become the global benchmark for medical electrical devices, and many companies require IEC 60601-1 compliance for product registration, such as for the CE, UL, and CSA marks. The latest version, IEC 60601-1:2005, requires compliance with all referenced standards in order to meet IEC 60601-1.

Some of the risks associated with medical equipment include:

• Excessive currents that result in an electric shock to the user or patient
• Ventricular fibrillation caused by high leakage currents
• Burns caused by high-frequency surgical equipment

Some of the requirements of the standard include:

• Mechanical requirements
• IEC 60601 markings, including information on electrical requirements, model number, and manufacturer, must appear on the product label
• Protective earth: the device must be connected to the earth or safety earth of an electrical power supply to provide grounding in the event of an electrical fault