Introduction to Safety for Electrical Medical Devices and IEC 60601

Curriculum10 - 16 hours

• Introduction
• Course goals
• Welcome
• Why consider general safety - and what is it?
• Quiz - Why consider general safety - and what is it?
• Which types of medical devices are in scope of IEC 60601?
• Quiz - Which types of medical devices are in scope of IEC 60601?
• When to address IEC 60601 in the design process
• Quiz - When to address IEC 60601 in the design process
• The changing world of regulatory requirements and standards
• Quiz - The Changing world of regulatory requirements and standards
• Structure of the 60601 series of standards
• Introduction to the 60601 series of standards
• Quiz - Introduction to the 60601 series of standards
• The general standard
• Quiz - The general standard
• Relationship with ISO 14971 on risk management
• Quiz - Relationship with ISO 14971 on risk management
• Key terminology
• Basic safety and essential performance
• Quiz - Basic safety and essential performance
• How to determine which parts are applied parts
• Identifying patient connections
• Quiz - Identifying patient connections
• How to categorise applied parts
• Quiz - How to categorise applied parts
• Explanation of means of protection (MOP)
• Quiz - Explanation of means of protection (MOP)
• Proactive safety by design
• Where most manufacturers go wrong
• Quiz - Where most manufacturers go wrong
• How to integrate with the risk management process - Part 1
• Quiz - How to integrate with the risk management process - Part 1
• How to integrate with the risk management process - Part 2
• Quiz - How to integrate with the risk management process - Part 2
• How to manage requirements
• Quiz - How to manage requirements
• Effective identification of applicable risks and requirements
• Quiz - Effective identification of applicable risks and requirements
• Iterative concept development, coupled with safety by design
• Quiz - Iterative concept development, coupled with safety by design
• Define your documentation architecture - Risk management file records related to safety
• Quiz - Define your documentation architecture - Risk management file records related to safety
• Identifying and managing requirements
• Hazards, risks, test method, test level acceptance criteria
• Quiz - Hazards, risks, test method, test level acceptance criteria
• Systematic review and translation of the standards
• Quiz - Systematic review and translation of the standards
• Development of the insulation diagram
• Quiz - Development of the insulation diagram
• Identifying and managing critical components
• Quiz - Identifying and managing critical components
• Classifications according to the standard
• Quiz - Classifications according to the standard
• Identifying insulation requirements - Part 1
• Quiz - Identifying insulation requirements - Part 1
• Identifying insulation requirements - Part 2
• Quiz - Identifying insulation requirements - Part 2
• Defining test plans and protocols
• Design and development
• The objective: Safe in NC and SFC
• Quiz - The objective: Safe in NC and SFC
• Critical components vs redundant design
• Power supplies and batteries
• Quiz - Power supplies and batteries
• Enclosure material and design (fire encl., IP)
• Quiz - Enclosure material and design (fire encl., IP)
• Indicator lights
• Quiz - Indicator lights
• General requirements
• General requirements related to safety
• Quiz - General requirements related to safety
• General requirements related to electromagnetic compatibility
• Quiz - General requirements related to electromagnetic compatibility
• General requirements related to usability engineering
• Quiz - General requirements related to usability engineering
• Lifecycle management of software
• Quiz - Lifecycle management of software
• Internal verification
• Minimum requirements for inhouse testing
• Quiz - Minimum requirements for inhouse testing
• Documentation: records, test plans and test reports
• Confidence in results and conclusions
• Third party test and certification
• On third party testing, accreditation and 'CB Scheme'
• Quiz - On third party testing, accreditation and 'CB Scheme'
• Selection of laboratory
• Quiz - Selection of laboratory
• Request for quote
• Preparing the documentation
• Pre-testing
• Quiz - Pre-testing
• Preparing for test
• Managing the test process
• Evaluating the test results, reports and certificates
• Product maintenance
• Change control
• Reasons for change
• Impact assessment and gap analysis
• Retesting
• Quiz - Retesting
• Summary and conclusion
• Summary and conclusion
• Final exam
• Final exam
• Course evaluation
• Course evaluation