Auditing ISO 14971 and Risk Management Quiz 4. Auditing ISO 14971 and Risk Management Quiz This is a pop quiz for the Auditing ISO 14971 and risk management lesson. FacebookThis field is for validation purposes and should be left unchanged.Name First Last Company Company Name Title Email PhonePlease answer the following questions by checking the appropriate option. You are permitted to look up answers for this quiz (i.e., “open book” and “open notes”). A passing score is 3 out of 4 questions correct. After completing this quiz, the final result will be displayed on the screen. Save the information on the screen as your training record for the successfully completing the quiz. You will also receive an email of your results. That email can also be used as part of your training record.1- 1. Which standard has to do with usability?(Required) IEC 62304 – Prob = 100% AAMI TIR57 – Exploitability ISO 14971 – dFMEA IEC 62366 – URRA 2. What is the definition of clause 3.3 for Harm?(Required) Is a “potential source of harm” [ISO/IEC Guide 51:1999, definition 3.5] Is a “physical injury or damage to the health of people, or damage to property or the environment” Is a “potential source of physical injury or harm to health” Combination of the probability of occurrence of harm (3.3) and the severity (3.27) of that harm (3.3) 3. How many times do you need to do the PMS Loop?(Required) Once a month Not at all One and done At least once a year 4-Clause 7.1 is part of which ISO standard?(Required) 14971:2019 19011:2014 19204 14205 Δ
