The document discusses upcoming changes to the IEC 60601 standards for medical device safety and performance. Key points include: - IEC 60601-1 3rd Edition is expected to be published in late 2005, establishing risk management and identifying essential performance as requirements. - Essential performance is performance necessary to avoid unacceptable risk. Manufacturers will identify which functions are essential. - IEC 60601-1-2 for electromagnetic compatibility now requires testing essential performance and has expanded immunity test levels.