ISO 14971 Annex C Pre–Risk Analysis Questionnaire - Medical Device Design: Innovation from Concept to Market - page 326

APPENDIX C

ISO 14971 Annex C Pre-Risk Analysis
Questionnaire

Questions Applicable Not Applicable Comments

C.2.1 What is the intended use and how is the medical device to
be used?
2.1.1 What is the medical device's role relative to:
2.2.1.1 Diagnosis, prevention, monitoring, treatment
or alleviation of disease;
2.2.1.2 Compensation for injury or handicap;
2.2.1.3 Replacement or modification of anatomy, or
control of conception?
2.1.2 What are the indications for use (e.g. patient population)?
2.1.3 Does the medical device sustain or support life?
2.1.4 Is special intervention necessary in the case of failure of
the medical device?
C.2.2 Is the medical device intended to be implanted?
Factors that should be considered include:
2.2.1 The location of implantation;
2.2.2 The characteristics of the patient population;
2.2.3 Age;
2.2.4 Weight;
2.2.5 Physical activity;
2.2.6 The effect of ageing on implant performance;
2.2.7 The expected lifetime of the implant;
2.2.8 The reversibility of the implantation.
C.2.3 Is the medical device intended to be in contact with the
patient or other persons?
Factors that should be considered include the nature of the
intended contact:
2.3.1 Surface contact;
2.3.2 Invasive contact;
2.3.3 Implantation and, for each, the period and frequency
of contact.
C.2.4 What materials or components are utilized in the medical
device or are used with, or are in contact with, the medical device?
Factors that should be considered include:
2.4.1 Compatibility with relevant substances;
2.4.2 Compatibility with tissues or body fluids;
2.4.3 Whether characteristics relevant to safety are known;