Seals & Certificates
Seal of approval: Medically tested
1. Skin irritation test
Test procedure:
DIN EN ISO 10993-23:2021-10A Biological evaluation of medical devices – In conjunction with: DIN EN ISO 10993-1:2021-05 Biological evaluation of medical devices.
Result:
The determined viability of over 50% for both solvents shows that the product can be considered non-irritating.
2. Test for skin sensitization / allergy and contact dermatitis
Test procedure:
SOP-QM-11.BM.03.116:2023-09 In conjunction with: DIN EN ISO 10993-12:2021-08 Biological evaluation of medical devices
Result:
Under the specified conditions, the sweat extract of the sample in this test shows no biological activity.
No sensitization potential was identified.
(Meaning: Antiallergic effect)
3. Biological compatibility test
Test procedure:
DIN EN ISO 10993-5: 2009-10A Biological evaluation of medical devices - In vitro cytotoxicity tests - In conjunction with DIN EN ISO 10993-1: 2021-05 Assessment and testing within a risk management system and DIN EN ISO 10993-12: 2021-08
Result:
The determined growth inhibition of less than 30% demonstrates that the substances released from the test specimen have no cytotoxic effects and are therefore biologically compatible.
Test seal: Breathability
Breathability testing
Test procedure:
According to DIN EN ISO 11092 : 2014-12A
Test device:
Thermoregulation model of human skin
Result:
With a water vapor transmission resistance Ret m²Pa/W of 2.5, the sample tested has a very good water vapor transmission resistance and is therefore exceptionally breathable.
Seal of approval: Antibacterial
Testing for antibacterial activity
Test procedure:
Determination of antibacterial activity - DIN EN ISO 20743A:2021-10
Control:
The biological activity of the test strains and the results of the control experiments were satisfactory, thus confirming the validity of the experimental procedure.
Result:
Under given test conditions, a significant antibacterial activity/effect was demonstrated for the sample examined compared to the control material (PES/CO tissue) against the test strains Staphylococcus aureus ATCC 6538 and Klebsiella pneumoniae ATCC 4352.