Medical Design Standards for Power Supplies （医疗电源的设计标准）.pdfVIP

IEC 60601-1 Medical Design Standards for Power Supplies IEC 60601-1 Medical Design Standards for Power Supplies 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. IEC 60601-1 OVERVIEW WHAT IS IEC 60601-1? IEC 60601 is a series of technical standards for the safety and effectiveness of medical electrical equipment. THE PRIMARY STANDARD The primary standard governing medical device design is formally known as IEC 60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. More simply it is referred to as IEC 60601-1 or just “60601,” and compliance with this standard has become a de facto requirement for bringing new medical devices to market in many countries. We will look at the global adoption of the standard in more detail later, but it is worth noting that there are European (EN 60601-1) and Canadian