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