Electrical Safety for Cardiac Pacemaker under RED
Electrical safety requirements protect users and third parties from electric shock, fire, and other hazards arising from electrical energy. The applicable standard depends on the product category and voltage range.
Applicable standard by product type
EN IEC 62368-1 covers audio/video, IT, and communications equipment. EN IEC 60335-1 covers household appliances. EN 60598-1 covers luminaires. Medical equipment falls under EN 60601-1. The correct standard is determined by the product's intended use and end-user environment.
Isolation and creepage distances
Adequate electrical isolation between mains and user-accessible parts is critical. Creepage and clearance distances specified in the applicable standard must be maintained in the final production design, not just the prototype. PCB layout reviews are a key part of the pre-compliance process.
Fault conditions
Products must remain safe under single fault conditions — including component failure, short circuits, and supply voltage variations. The risk assessment must identify credible fault conditions and demonstrate that no hazardous situation results.
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