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.

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 and length of patient exposure.

The following are some of the biological effects that are frequently tested for¹:

• 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)

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FAQs

1. What is membrane biocompatibility?

   It refers to the compatibility of a membrane with living tissues and biological systems, ensuring patient safety.

2. Why is biocompatibility testing important?

   It reduces the risk of immunological, toxic, or irritating responses from medical devices during patient exposure.

3. Which biological effects are commonly tested?

   Tests include cytotoxicity, hemocompatibility, skin sensitization, mutagenicity, systemic toxicity, and irritation after injection.

4. What standard governs biocompatibility testing?

   ISO 10993-1:2018 provides guidelines for biological evaluation and testing within a risk management process.

5. Does testing apply only to membranes?

   No. Testing must be performed on the complete medical device, not just individual components.

References

1. ISO 10993-1: 2008 Biological evaluation of medical devices. Part 1- Evaluation and testing within a risk management process

Author bio

Jacques Hestres, Manager for Media and 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 of Science in Biology from the University of Puerto Rico.

Joseph Vickers, Former Product  Manager — Membrane and Media
A former Product Manager, 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, Former Product  - Manager Media and Membrane
A former Product Manager,  responsible for Media and Membrane portfolio. He has worked with key opinion leaders and developed commercial and technical knowledge. Antoine holds an MBA from Rice University and Bachelor of Arts/Sciences in Interdisciplinary Social Sciences from the University of South Florida.