Electrical Safety for Medical Devices and IVDs
Understanding Electrical Safety in Medical Devices
Electrical safety is a fundamental requirement for medical devices that rely on electrical power or contain electronic components. The primary goal is to protect patients, users, and service personnel from electrical hazards such as shock, burns, or fire.
To ensure this, manufacturers must comply with international standards – most notably the IEC 60601 series, which outlines general and specific safety requirements for medical electrical equipment.
Key aspects of electrical safety include:
- Protection against electric shock through insulation, grounding, and leakage current limits.
- Risk management integrated throughout the product lifecycle, identifying and mitigating hazards early in the design phase.
- Verification and validation of safety features, including testing under normal and fault conditions.
- Compliance with labelling and documentation requirements to ensure safe use and maintenance
At GBA Key2Compliance, this topic is actively addressed in internal resources such as the blog post “IEC 60601 – Meeting the Electrical Safety Standards of Medical Devices” and a related webinar that introduces the standard and its practical implications [1] [2]. These resources emphasize the importance of early consideration of standards, proper component selection, and the role of embedded software in safety-critical systems.
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