Objective 01
Apply the standards within different geographic regions
Objective 02
Obtain essential information from within the different sections of the standards
Objective 03
Apply new points of the third edition which are not covered in the second edition for existing and new devices
Objective 04
Implement risk management principles for electrical medical equipment and systems as well as integrate these principles while performing risk analysis under ISO 14971 requirements
Objective 05
Employ classification and terminology to further study the requirements of the IEC 60601-1 edition 3.1 standard and related collaterals
Objective 06
Establish correct and required markings for equipment, controls and instruments as well as recognize which safety signs are compulsory
Objective 07
Identify the specific requirements and classification of medical electrical equipment
Objective 08
Apply the requirements with regard to applicable mechanical testing
Objective 09
Comprehend the changes with regard to mechanical testing since revision 2 of the standard and apply updates to existing devices wherever required
Objective 10
Comprehend the design and related testing requirements to ensure protection against thermal and other hazards
Objective 11
Apply the critical component requirements
- Medical Device Industry Managers, Supervisors, Employees
- Electronic Industry Managers, Supervisors, Employees
- Quality Assurance Personnel
- Notified Body Auditors
- Technical Consultants