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

Who will Benefit

Two medical professionals in white coats review information on a computer and tablet in a clinical or laboratory setting.
  • Medical Device Industry Managers, Supervisors, Employees
  • Electronic Industry Managers, Supervisors, Employees
  • Quality Assurance Personnel
  • Notified Body Auditors
  • Technical Consultants