Certification of medical beds

In addition to various types of beds, stretchers, transport and examination chairs, this group of products also includes aids for the disabled or injured persons, such as crutches or walkers, but also, for example, operating tables.

What is tested?

This group of products is tested mainly from a mechanical point of view, ie:

mechanical strength
resistance to static and dynamic forces
reliability of construction
static stability even when moving
protection of the patient from capture
ergonomics

Of course, today a large part of these products is equipped with electrical parts and therefore electrical safety, electromagnetic compatibility and parameters associated with it are also tested:

network connection
insulating elements
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

And last but not least, the durability and legibility of labels and markings are also tested.

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
low mechanical resistance of stressed elements (eg rails or locking mechanisms of the sides of the beds, castors for mobile products, but also eg lifting mechanisms of various patient supports or equipment).
insufficient stability