IEC EN 60601 – 1

Course Program:

  • Background and Introduction
  • Risk Management and General Requirements
  • Protection Against Electrical Shock, and verifying Electrical Insulation
  • Medical Electrical Systems and Protection Against Mechanical Hazards
  • Protection Against Thermal and Other Hazards and Components


Learning Objectives:

Upon successful completion of this program, learners will be able to successfully:

  • Apply the standards within the different geographic regions
  • Obtain essential information from within the different sections of the standards, and collaterals
  • Apply new points of the third edition compared to second edition for existing and new devices
  • Implement risk management principles for electrical medical equipment and systems as well as integrate these principles when performing a risk analysis
  • Employ classification and terminology to further study the requirements of the IEC 60601-1 ed 3.1 standard and related collaterals
  • Establish the correct and required markings for equipment, controls and instruments as well as recognize which safety signs are needed
  • Identify the particular requirements and classification of medical electrical equipment
  • Apply the requirements with regards to the applicable mechanical testing
  • Comprehend the changes with regards to mechanical testing since revision 2 of the standard and apply updates to existing devices where needed
  • Comprehend the design and related testing requirements to ensure protection against thermal and other hazards.
  • Apply the critical component requirements
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