MCT Beginning

1. The quantitative risk assessment appeared over the years:

• 1650
• 1792
• 2004
• 2009

2. The purpose of reviewing the information collected is to determine whether:

• New hazards have occurred
• New hazardous situations have occurred
• The state of the art has evolved
• The risk of a hazardous situation has become unacceptable
• The overall residual risk has become unacceptable
• The overall residual risk has become unacceptable

3. Risk reduction is confirmed by:

• Checking the implementation of the control measure
• Verifying the effectiveness of the control measure
• Carrying out tests with users
• Recording the results of veryfying the effectiveness of control measures

4. The characteristics of a MD, relating to safety, concern:

• How the MD works
• Inteded use
• Reasonably foreseeable misuse
• Materials in contact with the patient
• User error

5. The risk analysis takes into account:

• The impact of risk
• The likelihood of the risk occurring
• Risk control measures
• The root causes of risk
• Interaction with other risks