Aids for bed sores (decubitus)
Why test decubitus aids?
All aids for decubitus (mattresses and seat pads), which are listed in the medical appliances and aids registe (HMV) in product group 11, have to go through a series of specific product tests. The relevant tests required for each product and the associated costs can be found in the test matrix for product group 11. More requirements in addition to product testing have to be fulfilled; these are listed in the medical appliances and aids register for product group 11.
As well as the product testings for the medical appliances and aids register listed, Berlin Cert offers additional individually compiled tests for each step of the product development. Simply contact us – we will put together a suitable testing program for you.
As our status is that of an accredited testing laboratory, Berlin Cert is not permitted to offer consultations regarding product development which extend in scope beyond the applicable test (this includes the registration procedure for the medical aids and appliances register). Please contact a consulting company specializing in this service if needed.
We are an accredited testing laboratory according to DIN EN ISO/IEC 17025 and can therefore offer you the necessary electrical safety tests according to DIN EN 60601 which are needed to certify that your active health care products (e.g. alternating pressure systems) have met the basic requirements according to attachment I of directive 93/42/EEC.
Just contact us. We would be pleased to give you an individual quote.
Testing program mattresses and toppers
The following tests for mattresses and toppers are offered by Berlin Cert:
- Testing method PG 11-1 – functional properties, especially of foams
- Testing method PG 11-7 – functional properties hybrid systems, especially of foams
- Testing method PG 11-9 – function microstimulation systems, for each fracture strain and tensile strength according to DIN EN ISO 1798:2001-01, hardness drop based on DIN EN ISO 2439:2001-02 and compression set based on DIN EN ISO 1856:2001-03
- Testing method PG 11-2 – microclimate, microclimatic properties – transport properties regarding dampness and warmth
- Testing method PG 11-4 – pressure relief and shear forces,relative pressure relief and other relevant parameters as well as properties influencing shear forces (coefficient of friction, horizontal stiffness)
- Testing method PG 11-5 – sound level operational sound level based on ISO 3744
Testing program for seat pads
The following tests for seat pads are offered by Berlin Cert:
- Testing method PG 11-10 – microclimate microclimatic properties – transport properties regarding dampness and warmth
- Testing method PG 11-11 – pressure relief and shear forces relative pressure relief before and after continuous load testing and other relevant parameters as well as properties influencing shear forces (coefficient of friction, horizontal stiffness)