Medical Electrical Equipment

Medical Electrical Equipment Testing Services

What is medical electrical equipment testing?

Medical electrical equipment testing is the process of the evaluation and assessment of the safety, performance, and compliance of electrical devices utilized in healthcare settings. The primary objective of conducting electrical safety testing on medical devices is to safeguard patients, aiming to assess the possible mechanical and electrical risks during product operation.

All electrical medical equipment must adhere to applicable standards and regulations. At STERIS, we offer technical support and testing services in accordance with relevant performance and safety standards, including the IEC 60601 and IEC 61010 family of guidelines.

What is the difference between the IEC 60601 and IEC 61010 testing standards?

IEC 60601 is the medical electrical equipment standard focusing on the safety and performance requirements of medical electrical equipment. IEC 60601 highlights medical devices and systems, such as patient monitoring devices, and provides specific requirements to ensure patient safety.

IEC 61010 is the safety requirements for electrical equipment for measurement control and laboratory use. IEC 61010 has a broader range of scope and covers the general electrical equipment and focuses on electrical safety aspects such as grounding, temperature, and protection against electrical shock. Since the standard covers a range of applications, it may be less specific and tailored to hazards or risks associated with medical devices.

Test methods include:

Vibration (IEC 60068-2-6, IEC 60068-2-64)
Temperature and humidity (IEC 60068-2-1, IEC 60068-2-2, IEC 60068-2-14, IEC 60068-2-30, IEC 60068-2-38, IEC 60068-2-78)
Atmospheric pressure/altitude
Mechanical shock (IEC 60068-2-27)
Drop, push, impact (IEC 60068-2-31)
Ingress protection (IP) testing (IEC, ISO, and DIN standards)
Insulation resistance
Earth current leakage
Mold stress relief
Device/component cleaning

Medical electrical equipment/product examples include:

Sensors, analyzers, and patient monitoring equipment
Scanners and diagnostic equipment
Ventilators
Insulin pumps and blood glucose monitors
Emergency medical equipment
Surgical equipment
Home healthcare
Wearable devices

Technical Support

Our technical support team can also offer guidance in:

Design review
Risk assessment review
Test plan development
Identifying suitable standards
Test method development and validation
Technical file and regulatory support