In this blog, we will refer to the membrane; however, when completing biocompatibility testing, the membrane is just a component, and it is imperative that the medical device is tested as a complete unit.
Biocompatibility testing is a vital part of a biological risk evaluation. It determines the compatibility of a membrane with an organ or biological system.
Examining the relationship between living tissues, cells, and the membrane, it is important to conduct biocompatibility testing to ensure patients are kept safe when exposed to the membrane.
Biocompatibility requirements are guidelines set up to help reduce the risk that the membrane, as a component of the finished device, does not create immunological, toxic, or irritating responses that may harm the end user.
Test types largely depend on device/device component types and the type of patient exposure.
The following are some of the biological effects that are frequently tested for (1):
- Cytotoxicity (how toxic a substance is)
- Hemocompatibility (how compatible a substance is with blood)
- Skin sensitization (does it cause an immunological response when exposed to skin)
- Mutagenicity (the capacity to induce mutations)
- Toxicity after systemic injection (adverse effects following oral or dermal administration of a substance)
- Irritation after intracutaneous injection (irritation after injection within the skin)
- Pathology after implantation (local pathological effects on living tissue of a sample of a medical device that is surgically implanted)
- Characterization of physical and chemical properties (description of the distinct nature of physical and chemical properties)
If you have questions related to this content or other filtration concepts or how they apply to your specific application, please contact us.
References
- ISO 10993-1: 2009 Biological evaluation of medical devices. Part 1- Evaluation and testing within a risk management process.
Author bio
Jacques Hestres, Product Manager for Media
— Membrane
Focusing primarily in Medical OEM applications. Throughout his over 25-year career, Jacques has held various positions in Customer and Technical Service, Operations Planning, and Product Management. This experience has given him the knowledge of the products, the manufacturing processes used to produce these materials, and an understanding of applications where these are used. Jacques holds a Bachelor’s of Science Degree in Biology from the University of Puerto Rico.
Joseph Vickers, Portfolio Lead
— Membrane and Media
A Global Portfolio Leader, responsible for the Membranes and Media portfolio. He has previous experience in global marketing and operations, holding an MEng in Chemical Engineering from the University of Surrey.
Antoine Pozniak, Product Manager Media
— Membrane
Antoine has held various roles in sales and marketing throughout his 4-year career in the medical device industry. Throughout those 4 years he has worked with Key Opinion Leaders and developed commercial and technical expertise. Antoine holds an MBA from Rice University and Bachelor of Arts/Sciences in Interdisciplinary Social Sciences from The University of South Florida.