Depending on their intended use or purpose, medical devices must meet various performance requirements in terms of efficacy or functionality in addition to biological safety. Regardless of whether these requirements are specified by standards or defined individually by the manufacturer, Hohenstein supports you in testing your medical device for product-specific requirements.
Our services for
Individual requirements
Depending on the area of application and intended use, we offer numerous performance tests for your product:
- Antimicrobial efficacy of products against bacteria, yeasts and moulds or surrogate viruses, e.g. according to ISO 22196, ISO 20743, AATCC 100 and many more. - Normative and practical tests (Tier 1 - Proof of principle; Tier 2 - Simulated Use; analyses within the scope of Tier 3 - In-Use Evaluation/Field studies)
- Surface analysis using SEM/EDX:
- Surface condition/condition assessment in new condition and after use/reprocessing using scanning electron microscopy (SEM)
- Homogeneity and removal of coatings
- Material determination by energy dispersive X-ray spectroscopy (EDX)
- Damage analysis
- Recognisability of markings and labels (e.g. UDI - Unique Device Identification)
- Requirements for inclusion in the German medical aids directory
- Washability (reprocessing in standardised washing procedures according to DIN EN ISO 6330 (domestic laundry) and DIN EN ISO 15797 (industrial laundry, suitability for leasing) or individually according to manufacturer's specifications)
- Fit: Pattern service, fit testing, body measurement data / 3D scanning
- Comfort: skin and microclimate, breathability, thermal insulation
- Textile UV protection: Hohenstein tests clothing and shading textiles for their UV protection factor based on international standards such as UV STANDARD 801, the Australian-New Zealand standard (AS/NZS 4399), the European standard (DIN EN 13758-1) or the American standard (AATCC TM 183)
- Allergen reduction: pollen, house dust and animal allergens
- Odour management: performance of the product against sweat, urine and blood odours
- Wearing tests with test subjects
- Barrier function: we test the penetration of water, chemicals, active ingredients or microorganisms using standardised or customised test setups
- Washout/residues of biological components (e.g. coatings, active ingredients) using radioactive labelling and LSC
- Detection of biological coatings and active ingredients: We collect valuable preclinical data for you using innovative test setups
Is your product or question not listed here? Just get in touch with us. We are also happy to develop customised test setups to test your product.