ISO 14971 Annex C Pre–Risk Analysis Questionnaire - Medical Device Design: Innovation from Concept to Market - page 329

Questions Applicable Not Applicable Comments

C.2.16 Does the medical device influence the environment?
Factors that should be considered include:
2.16.1 The effects on power and cooling supplies;
2.16.2 Emission of toxic materials;
2.16.3 The generation of electromagnetic disturbance.
C.2.17 Are there essential consumables or accessories
associated with the medical device?
2.17.1 Factors that should be considered include
specifications for such consumables or accessories and any
restrictions placed upon users in their selection of these.
C.2.18 Is maintenance or calibration necessary?
Factors that should be considered include:
2.18.1 Whether maintenance or calibration are to be
carried out by the operator or user or by a specialist;
2.18.1 Are special substances or equipment necessary for
proper maintenance or calibration?
C.2.19 Does the medical device contain software?
2.19.1 Factors that should be considered include whether
software is intended to be installed, verified, modified or
exchanged by the operator or user or by a specialist.
C.2.20 Does the medical device have a restricted shelf life?
2.20.1 Factors that should be considered include labeling
or indicators and the disposal of such medical devices
when the expiration date is reached.
C.2.21 Are there any delayed or long-term use effects?
Factors that should be considered include ergonomic and
cumulative effects:
2.21.1 Pumps for saline that corrode over time;
2.21.2 Mechanical fatigue;
2.21.3 Loosening of straps and attachments;
2.21.4 Vibration effects;
2.21.5 Labels that wear or fall off;
2.21.6 Long-term material degradation;
C.2.22 To what mechanical forces will the medical device be
subjected?
2.22.1 Factors that should be considered include whether
the forces to which the medical device will be subjected are
under the control of the user or controlled by interaction
with other persons.
C.2.23 What determines the lifetime of the medical device?
2.23.1 Factors that should be considered include ageing
and battery depletion.
C.2.24 Is the medical device intended for single use?
2.24.1 Factors that should be considered include: Does the
medical device self-destruct after use? Is it obvious that the
device has been used?
C.2.25 Is safe decommissioning or disposal of the medical
device necessary?