Biocompatibility is one of the biggest hurdles for any new product—it is also one of the most important. Interestingly, there are no established regulations for the biocompatibility testing of medical equipment and medical devices. This leaves it up to medical device manufacturers and their vendors to determine the most effective way to test for biocompatibility that will also meet FDA expectations.
Evolving regulatory standards
Standards for biocompatibility are continuing to evolve and expand—for example, with respiratory devices, the International Organization for Standardization (ISO) (www.iso.org) is developing new standards that address the risk of potentially harmful substances being transmitted to patients via the air stream in their respiratory devices.
There are also multiple biocompatibility standards to deal with (for example, USP and ISO) that utilize different test methods.
Evolving regulatory standards can significantly impact the design and compliance requirements of new devices. Because the biocompatibility standards outlined in ISO 10993-1 prescribe specific tests for medical devices dependent upon intended use, design engineers must sort through standards to determine which ones apply to their device and then try to source components that will meet those standards. Without doing so, design engineers run the risk of discovering components or sub-systems that do not comply after the design is complete—this can cause project schedule delays and adversely impact project development costs.
Pre-approved biocompatible components
One of the easiest and most effective ways to prepare for the approval process is using components or sub-systems that have already been tested to certain biocompatible standards. This can speed up the design process of pneumatic control circuits for ventilators and anesthesia work stations.
An example of a component that has been evaluated for biocompatibility is Parker’s VSO-MI miniature proportional valve. The VSO-MI miniature proportional valve is specifically designed for medical devices and systems that serve the respiratory segment, such as anesthesia workstations, ventilators, and oxygen therapy. The valve is oxygen service clean and has been shown by registered laboratories to meet the biocompatibility guidelines established within the ISO 10993-1:2009 matrix and the USP standards. It is also the only valve of its kind that meets both USP and ISO testing requirements, providing a broader set of data that can accelerate the regulatory approval process.
Working with a strategic partner such as Parker that provides biocompatible components will save time, speed up approval, reduce overall costs and expand the opportunities for innovative engineering and product design in Life Sciences.
Learn more about biocompatibility by downloading the white paper entitled “Biocompatibility of Anesthesia/Respiratory Products” at or call 603-595-1500 to speak with an engineer.
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