Hohenstein Medical, a division of Hohenstein Laboratories and a GLP-certified provider of testing, research and certification services for medical devices, will debut its expanded ISO 18562 gas pathway testing capabilities for respiratory devices at MD&M West next month. The program supports testing of devices operating across temperature ranges from -20°C to 50°C.
Gas pathway testing supports biological assessment of a device or accessory intended for ventilation or the supply of substances via the respiratory tract. The laboratory’s ISO 18562 gas pathway testing is supported by a climate-controlled chamber (~10 ft × 10 ft × 8 ft; ~800 cubic feet) designed to accommodate complete respiratory systems, supporting evaluations that reflect full-device configuration and intended use conditions. This expanded gas pathway testing offering is just one example of the continuous investment in and optimization of Hohenstein Medical’s high-capacity testing facilities.
In addition, Hohenstein Medical offers ISO 10993-18 analytical chemistry testing for medical devices, and will offer a particulate characterization package exclusive to MD&M West attendees at no additional cost as part of its chemical characterization services. The package is designed to provide additional context around particulate size and distribution when visual particulate observations are identified. Particulates are a common challenge in biocompatibility assessments and can raise questions during regulatory review.
Drawing on in-house biological and chemical expertise, Hohenstein Medical works with manufacturers to define fit-for-purpose biocompatibility strategies, anticipate regulatory questions and support patient-focused risk assessment.
Hohenstein Medical is among the few ISO/IEC 17025 and GLP-certified medical device testing labs accredited in chemical, physical and biological testing—providing a coordinated, integrated approach to medical product evaluation. This full-scope capability supports consistent, efficient studies, producing data of the highest integrity, aligned with FDA, MDR, ISO 10993 and other global regulatory requirements to reduce handoffs and support consistent, regulator-ready data across studies.
