iec60601-1医疗设计标准第三版-IEC60601-1.PDF

IEC 60601-1 Medical Design rd Standards-3 Edition rd IEC 60601 Medical Design Standards - 3 Edition Standards are an integral part of product design and development, and are clearly important in medical applications. However, there is an additional aspect to standards for medical devices: while some technical standards — such as IEEE 802 for Wi-Fi — only define final performance, standards for medical design go much deeper, covering design methodology and verification, safety and risk assessment, implementation, and much more. Here we look at the medical standard IEC 60601-1 and the recent shift to the 3rd edition. IEC 60601-1 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 governing medical device design is IEC 60601-1 (medical electrical equipment - Part 1: general requirements for basic safety and essential performance). Often referred to simply as “60601,” compliance with the standard has become FIGURE 1: The shift to IEC 60601-1 3rd edition standards for a de facto requirement to bring new medical devices medical devices, now in force in Europe, Canada, and the US, has significant implications for medical device design. to market in many countries. IEC 60601-1 EVOLUTION Many of today’s products appear simple; yet embed The IEC 60601 standard has a long history with a sophisticated circuits and software that are invisible number of revisions. The original IEC 60601-1 was to the user. The IEC 60601-1 standard manages