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Agenda

Start, hh:mm Topic Duration, h
  Day 1:  
8:15 1 General
  • Family of standards
  • Exercise 1 - Identify standards
  • Transition dates, Impact
  • Medical equipment, medical system 
  • Equipment types, classifications
  • Labeling
  • Exercise 2 - Specify classifications
2.00
10:15 Morning break 0.25
10:30 1 General -- con't

2 Safety Philosophy
  • Relationship of IEC 60601 and ISO 14971
  • IEC 60601-1
    • Basic Safety and Essential Performance
    • Normal Use, Reasonably Foreseeable Misuse, Abuse
    • Normal Condition, Single Fault Condition, High Integrity
  • What's New in Ed 3.1
1.50
12:00 Lunch 0.25
13:00 3 Risk Acceptability
  • Risk Management
  • Risk Estimation
  • Risk Evaluation
    • Regulatory perspective
      • FDA, EU Annex ZA, NB Consensus Paper
    • International standards
    • Generally Acknowledged State of the Art
    • Good yesterday. Good today?
  • Exercise 3 - Risk assess and control
1.75
15:00 Afternoon break 0.25
15:15 3 Risk Acceptability -- con't 1.75
17:00 End of Day 1
  Day 2:  
8:30 3 Risk Acceptability -- con't 1.50
10:00 Morning break 0.25
10:15 4 Usability
  • What is Usability Engineering?
  • Key similarities & differences between RM and UE
  • How to implement UE for legacy devices
  • Key updates with IEC 62366-1:2015
0.75
11:00 5 Electrical
  • Accessible limits
  • 2 Means of protection
  • Risk assess MOPP/MOOP categories
  • Exercise 4 - Categorize MOPP/MOOP surfaces
  • Insulation diagrams
  • Exercise 5.1 - Specify insulation types and voltages
  • Specify Insulation
  • Exercise 5.2 - Specify insulation parameters
  • Verify insulation
1.00
12:00 Lunch 1.00
13:00 5 Electrical -- con't 2.00
15:00 Afternoon break 0.25
15:15 5 Electrical -- con't 1.75
17:00 End of Day 2
  Day 3:  
8:30 5 Electrical -- con't 1.00
9:30 6 Mechanical
  • Motion
  • Support
  • Enclosure Strength, Rough handling
  • Sound 
  • Pressure Systems
0.50
10:00 Morning break 0.25
10:15 7 Thermal, Other
  • Temperatures
  • Fire risk control
  • Fluids, Cleaning
  • Radiation
  • Exercise 6 - Risk result for spillage

8 Software
  • PEMS, Software, SOUP
  • Development Life Cycle
  • Configuration Management
1.75
12:00 Lunch 1.00
13:00 9 Systems
  • Non-Medical Equipment
  • Patient Environment
  • Risk control for Medical Leakage Current
  • Exercise 7 - Endoscopic system

10 Components
  • Mains
  • Capacitors
  • Batteries
  • Isolation components
  • External power supplies
  • Specifying safety critical components in Test Report Form
2.00
15:00 Afternoon break 0.25
15:15 11 Testing
  • 1st party and 3rd party certification schemes
  • Drivers for 3rd party certification
  • Test laboratory requirements
  • Typical test program
  • Exercise 8 - Specify test program
Feedback Forms and Certificates of Participation
1.75
17:00 End of Day 3