Therapeutic apparatus

These are predominantly active medical devices used alone or in combination with other medical devices to support, alter, modify or restore biological functions or structures for the treatment or alleviation of disease, injury or disability.

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
durability and legibility of labels and markings

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

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