Biocompatibility

The basis for the biological assessment of medical devices is the DIN EN ISO 10993 series of standards. DIN EN ISO 10993-1 specifies which endpoints you must consider in the biological risk assessment of your product.

Product Finder - Biological Assessment of Medical Products

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1

Type/Category of medical device

Surface medical device (comes into contact with body surfaces) Externally communicating medical device (comes into contact with the inside of the body from the outside) Implant medical device

2

Nature of body contact

Contact with intact skin Contact with mucosal membrane Contact with breached or compromised surface

2

Nature of body contact

Contact with the blood path (indirect) Contact with tissue, bone or dentin Contact with circulating blood

2

Nature of body contact

Contact with tissue or bone Contact with blood

3

Contact duration

limited (less than 24 hours) prolonged (24 hours to 30 days) long term (over 30 days)

Result

Currently, no relevant standards are available for the test request you have selected. If you still require proof of efficacy, we will be happy to put together a test offer and adapt existing standards for you. Please send your request to medical@hohenstein.com

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Hohenstein tests non-animal according to recognised in vitro methods.

Chemical characterisation according to DIN EN ISO 10993-18
In the chemical characterisation of materials for medical devices, components are recorded that can be released from the product. The chemical substances are determined by means of GC/MS. The test provides data for the biological assessment and the evaluation of the toxicological hazard potential within the framework of risk management.
Cytotoxicity according to DIN EN ISO 10993-5
The cell culture test uses skin cells to detect cell-damaging substances (cytotoxins) that can be released from the sample material. The test thus allows the assessment of a hazard potential for cell damage. This is recorded as a sum parameter.
Cytotoxicity for elastane-containing products (e.g. compression stockings) in conjunction with Wiegand, C. et al. (2017) *.
* Optimized protocol for the biocompatibility testing of compression stockings and similar products with close skin contact in vitro. The journal of the textile institute, Vol. 109, No. 7, 891-902.
Testing for skin irritation according to DIN EN ISO 10993-23
The in vitro test for skin irritation utilises human three-dimensional skin models, which are composed of different cell layers analogous to the human epidermis. The test procedure is used to predict the irritation potential of extracts from medical products and their components via the viability of the RhE models.
Test for irritation / mucosal damage
The HET-CAM according to DB-ALM Method Summary n° 96 is a recognised alternative to the animal test on the rabbit eye (Draize test), which is required according to DIN EN 10993-10. In the HET-CAM, coagulation, haemorrhage and lysis of blood vessels are determined on the chorionallantoic membrane of chicken eggs and three degrees of irritation are recorded as a result (no to mild / moderate / severe irritation).
In vitro alternative method for sensitisation
In the cell culture test, the allergy potential (sensitisation potential) of substances that can be released from the sample material is recorded with the help of immune cells (so-called "guard cells"). The sensitisation test thus allows the assessment of an allergenic hazard potential of the examined sample.
Further tests on request
Please also contact us on the subject of biocompatible coatings for medical devices. With our innovative test set-ups, we collect valuable preclinical data on this topic.

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Hohenstein Medical

+49 7143 271-440 Phone medical@hohenstein.comEmail