Standards are an integral part of product design and development, and are certainly important in medical applications. While some technical standards — such as IEEE 802 for Wi-Fi — only define final performance, standards for medical design have evolved in recent years to go much deeper, covering design methodology and verification, safety and risk assessment, implementation, and
much more.
In this paper we will look at the IEC 60601-1 medical standard and its impact on power supply design. IEC 60601-1 provides general requirements, in a series of standards, that address the basic safety and essential performance requirements of medical electrical equipment. We will see how the standard has evolved, through to the 4th edition that establishes new “environments” when considering
electromagnetic compatibility (EMC) between medical electrical equipment and other electronic devices.
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