Decoding Essential Performance in IEC 60601-1: The Hidden Difference

In this session, we’ll cut through the confusion around Essential Performance in IEC 60601-1, a critical yet often misunderstood concept in medical device compliance. You’ll learn how to distinguish Essential Performance from Basic Safety and understand its broader role in compliance, particularly in EMC immunity testing. We’ll also explore why IEC TS 60601 4-2 highlights the importance of ‘performance that is not essential for safety’. Leave with actionable insights to apply immediately in your work. Presented by: Beat Keller, Managing Director, Regulatory Expert, SMDC Swiss Medical Device Consulting GmbH This recording was broadcasted during an Aligned Sharpen your Skills event. Start a free trial: https://www.aligned.ch/free-trial Visit our website: https://www.aligned.ch