IEC 60601-1: Risk Management as Part of Electrical Safety Testing
In this training, we go through the IEC 60601-1 series of standards as part of approvals for different market areas. We explore the content of IEC 60601-1 by technical requirements. Based on the standard IEC 60601-1 ed. 3.2, we familiarize ourselves with the requirements for testing, electrical safety of medical devices, and risk management. All these factors are elementary points in the design of a medical device.
In training, we focus especially on risk management, which strongly guides the design requirements, testing, and documentation of medical devices. In addition, we consider the requirements for both the accompanying documents and design documents from a testing point of view.
Welcome to hear how the requirements affect the design of your own medical device.
Training is conducted in Finnish.