ISO 14971 Annex C Pre–Risk Analysis Questionnaire - Medical Device Design: Innovation from Concept to Market - page 330

Questions Applicable Not Applicable Comments

2.25.1 Factors that should be considered include the waste
products that are generated during the disposal of the
medical device itself.
2.25.2 Toxic or hazardous material;
2.25.3 Material recyclable?
C.2.26 Does installation or use of the medical device require
special training or special skills?
2.26.1 Factors that should be considered include the
novelty of the medical device and the likely skill and
training of the person installing the device.
C.2.27 How will information for safe use be provided?
Factors that should be considered include:
2.27.1 Whether information will be provided directly
to the end-user by the manufacturer or will involve the
participation of third parties such as installers, care
providers, healthcare professionals or pharmacists and
whether this will have implications for training;
2.27.2 Commissioning and handing over to the end-user
and whether it is likely/possible that installation can be
carried out by people without the necessary skills;
2.27.3 Based on the expected life of the device, whether
re-training or re-certification of operators or service
personnel would be required.
C.2.28 Will new manufacturing processes need to be established
or introduced?
2.28.1 Factors that should be considered include new
technology or a new scale of production.
C.2.29 Is successful application of the medical device critically
dependent on human factors such as the user interface?
C.2.29.1 Can the user interface design features contribute
to use error?
Factors that should be considered are user interface design
features that can contribute to use error. Examples of interface
design features include:
C.2.29.2 Is the medical device used in an environment
where distractions can cause use error?
Factors that should be considered include:
C.2.29.3 Does the medical device have connecting parts or
accessories?
Factors that should be considered include:
C.2.29.4 Does the medical device have a control interface?
Factors that should be considered include:
C.2.29.5 Does the medical device display information?
Factors that should be considered include:
C.2.29.6 Is the medical device controlled by a menu?
Factors that should be considered include:
C.2.29.7 Will the medical device be used by persons with
special needs?