Medical devices like implants, inhalators, catheters, wound dressings and a great variety of similar products have to meet the highest quality standards possible to guarantee a flawless function of the product. An important quality issue of medical devices having direct or indirect contact with the body tissue is the biocompatibility of the product. According to the statutory ISO 10993-1 the biocompatibility of these products has to be tested before they are admitted to the market (CE-certification).
To avoid and, possibly replace, unnecessary (and costly) animal experiments the first step in biocompatibility testing is in vitro testing. The most important in vitro test in medical device biocompatibility testing is the cytotoxicity test according to ISO 10993-5. In these tests mammalian cells, such as mice connective tissue cells, are cultivated having direct contact to the medical device materials or an material extract of the medical device is pipetted onto the precultivated mice cells to test the cell vitality.
Cytotoxicity tests are cost-effective, rapidly performed, reliable and their results are significant.
The cytotoxicity test provides quantitative data, which allows a direct comparison of the quality of the tested product with that of other products.
Changes in market structures in the medical device area has expanded the area of application of this test procedure:
- Testing for CE-certification of a medical device
- Testing the product quality of suppliers
- Batch testing during medical device production
- Comparative testing of biocompatibility of competitor products
- Evaluating the influence of sterilization, packaging und material surface treatment processes on the biocompatibility of the product.
For marketing purposes the cytotoxicity test is also used outside the medical device market on textiles, home healthcare, Ambient Assisted Living (AAL) and consumer products, because successfully tested products can be advertised as “animal-free tested for biocompatibility”.
Please request an offer for cytotoxicity testing at info[at]cytox.de