ISO 14971 Annex C Pre–Risk Analysis Questionnaire - Medical Device Design: Innovation from Concept to Market - page 331

Questions Applicable Not Applicable Comments

Factors that should be considered include:
C.2.29.8 Can the user interface be used to initiate user
actions?
Factors that should be considered include:
C.2.30 Does the medical device use an alarm system?
2.30.1 Factors that should be considered are the risk of
false alarms, missing alarms, disconnected alarm systems,
unreliable remote alarm systems, and the medical staff's
possibility of understanding how the alarm system works.
Guidance for alarm systems is given in IEC 60601-1-8.
C.2.31 In what way(s) might the medical device be deliberately
misused?
Factors that should be considered are:
2.31.1 Incorrect use of connectors;
2.31.2 Disabling safety features or alarms;
2.31.3 Neglect of manufacturer's recommended
maintenance.
C.2.32 Does the medical device hold data critical to patient care?
2.32.1 Factors that should be considered include the
consequence of the data being modified or corrupted.
C.2.33 Is the medical device intended to be mobile or portable?
Factors that should be considered are:
2.33.1 The necessary grips;
2.33.2 Handles;
2.33.3 Wheels;
2.33.4 Brakes;
2.33.5 Mechanical stability and durability.
C.2.34 Does the use of the medical device depend on essential
performance?
2.34.1 Factors that should be considered are, for example,
the characteristics of the output of life-supporting devices
or the operation of an alarm. See IEC 60601-1 for a
discussion of essential performance of medical electrical
equipment and medical electrical systems.