Electrical Safety
Medical Devices
IEC 60601-1 Testing Services
Medical electrical safety testing of medical devices as per the IEC 60601-1 standard and the U.S. Food and Drug Administration (FDA) requirements. Compliance with these standards and requirements is essential to ensure that medical devices are safe for their intended use. EN 60601-1 encompasses a set of standards that address the safety and fundamental performance requirements for medical electrical equipment and associated systems. Sigma Scientific is ISO/IEC 17025 accredited and also FDA ASCA accredited as a medical device safety and performance test laboratory to perform electrical safety testing of medical products.
60601-1 Test Methods
As per the IEC 60601-1 and ANSI AAMI ES60601-1 standards, covering electrical aspects such as insulation, grounding, electrical leakage, and resistance to electrical stress. It also covers labeling requirements, as well as mechanical safety, software safety, and environmental safety. EN 60601-1 Part One, also known as the General Standard, addresses fundamental safety requirements and essential performance criteria applicable to all medical electrical equipment.
Test Reporting
Measurements and test reports include, among others:
- Leakage current
- Dielectric strength
- Protection against mechanical hazards
- Labeling compliance
- Environmental compliance
- Accuracy of controls and instruments
- ME systems