BIOMEDICAL ENGINEERING
TEST #3 QUESTIONS AND
COMPLETE SOLUTIONS GRADED
A+
Your Exam Plug
, What are the overall objectives for the risk management section? - Answer: - Gain an overview
of what is meant by risk and specifically, risk management regulations in biomedical
engineering.
- Recognize the international standard for risk management for medical devices, ISO14971.
- Learn the definitions or basic concepts related to risk management including:
--- Risk
--- Harm, Hazard and Hazardous Situation
--- Severity and Occurrence
- Understand the principle activities in Risk Management including:
--- Risk Analysis, Risk Evaluation, Risk Control and Production/Postproduction information.
- Recognize some of the tools for Risk Analysis including:
--- FMEA and FTA
- Understand how risk management fits into engineering design and design control.
What is an indirect harm or an injury to a person, and an example of this? - Answer: When the
harm does not come directly from the devices but as a result of an action taken based on what
info device gave.
A wrong blood sugar reading.
What is the standard for risk management for medical devices? - Answer: EN ISO 14971:2012
Medical devices - Application of risk management to medical devices. (previous versions of
2000, 2007, and 2009)
Risk Management Definition: - Answer: The systematic application of management policies,
procedures, and practices to the task of analyzing, evaluating and controlling risk.
Risk Management Example: - Answer: All of the polices a company writes for their system of risk
management.
TEST #3 QUESTIONS AND
COMPLETE SOLUTIONS GRADED
A+
Your Exam Plug
, What are the overall objectives for the risk management section? - Answer: - Gain an overview
of what is meant by risk and specifically, risk management regulations in biomedical
engineering.
- Recognize the international standard for risk management for medical devices, ISO14971.
- Learn the definitions or basic concepts related to risk management including:
--- Risk
--- Harm, Hazard and Hazardous Situation
--- Severity and Occurrence
- Understand the principle activities in Risk Management including:
--- Risk Analysis, Risk Evaluation, Risk Control and Production/Postproduction information.
- Recognize some of the tools for Risk Analysis including:
--- FMEA and FTA
- Understand how risk management fits into engineering design and design control.
What is an indirect harm or an injury to a person, and an example of this? - Answer: When the
harm does not come directly from the devices but as a result of an action taken based on what
info device gave.
A wrong blood sugar reading.
What is the standard for risk management for medical devices? - Answer: EN ISO 14971:2012
Medical devices - Application of risk management to medical devices. (previous versions of
2000, 2007, and 2009)
Risk Management Definition: - Answer: The systematic application of management policies,
procedures, and practices to the task of analyzing, evaluating and controlling risk.
Risk Management Example: - Answer: All of the polices a company writes for their system of risk
management.
