Certification and testing of various diagnostic and monitoring devices

These are mainly active medical devices used alone or in combination with other medical devices to provide information for the detection, diagnosis, monitoring or treatment of physiological conditions, health conditions, diseases or birth defects, mostly used in facilities with professional medical care.

What is tested?

network connection
insulating elements
protective covers
short circuit protection
connection to the earthing system
protection against injury caused by electric shock
protection against ingress of dust, solid foreign bodies and water
electrical strength
contact current, protective conductor current or patient current
surface pathways and air distances
durability tests and thermal tests
resistance to heat, fire and creeping currents resistance and legibility of labels and markings
functionality and accuracy

What is assessed

correct product classification (protection class, IP degree, operating mode,…)
marking outside and inside the product (nameplate, attachments, fuses, marking of terminals, controls, marks, safety signs, signs,…)
instructions
technical description
wire insulation colors
a set of risk management documentation
usability assessment documentation
evaluation of biocompatibility

The most common problems

insufficient or missing documentation
insufficient or missing information on the product
inappropriate (illegible, placed or insufficiently durable) markings and labels
improperly designed (or omitted) protective and / or functional ground connection
unsatisfactory electromagnetic resistance or radiation of products