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