Testing Medical Devices at Body Temperature
Recently, there has been a large demand for new and improved medical devices and biomaterials. In vitro mechanical testing allows these materials and devices to be evaluated outside of the body so that humans and animals are not put at risk of device failure. To best simulate the environment in which these products will be used, it is critical that many of these devices and materials be tested at 37° C (98.6° F), simulating a normal body temperature.
For various products, a heated fluid bath of water or saline can provide an accurate testing environment. For medical devices and materials that elongate beyond the testing space allowed by a heated bath, or for materials that cannot be submerged in a liquid, a different solution is required.
We recommend using the BioBox temperature chamber. It provides a heated polycarbonate enclosure that fits over any 5500, 3300, or 5900 standard-height, single-column electromechanical frame. The BioBox allows for full crosshead travel of the machine and use of most standard grips or fixtures that may not be suitable for a bath. A dual-door system allows for quick and easy access to the test space, while minimizing thermal leakage from the enclosure. The BioBox can be heated from ambient temperatures up to 40° C with an accuracy of ±2° C.
Read additional details on other testing equipment for medical devices, consumables, and equipment.
For many Medical Device and Pharmaceutical companies, records management compliance with FDA 21 CFR § 11 is non-negotiable . ComplianceBuilder™ (CB) is a stand-alone, add-on compliance solution that can be integrated with Instron's Bluehill® Software, providing features necessary to meet the latest FDA 21 CFR § 11 regulations.
The BioPuls submersible pneumatic side action grips and temperature-controlled bath with pneumatic lifting and lowering mechanism is the ideal testing solution for a wide variety of biomedical testing applications.
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Within the medical device industry, regulatory agencies often test internally-based devices and implants in a physiological state. The Instron® BioBox meets the growing trend of testing actual medical devices and biomaterials at body temperature (37°С). For large or long devices, testing in а liquid may not bе practical. As an alternative, testing inside а controlled air environment at body temperature provides а powerful solution. The BioBox can bе incorporated as а standard item on а new single column frame or in selected models already in operation. This bох permits the full travel test of sutures, catheter tubings, latex gloves, and а wide variety of other devices and biomaterials at physiologically relevant temperatures.
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