TEXTILES.ORG
At this year’s MD&M [Medical Design & Manufacturing] West showin February, 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. The program supports testing of devices operating across temperature ranges from -20°C to 50°C.
“Respiratory devices often operate across a wide range of environmental conditions, which introduces additional considerations under ISO 18562,” said Dr. Timo Hammer, CEO of Hohenstein Medical. “Enhancing our testing capabilities allows us to support designs that more accurately reflect intended use and evolving regulatory expectations.”
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.
Gas testing for respiratory devices often incorporates textiles, particularly for devices where fabrics are part of the breathing circuit, such as in filters, masks, or masks with fabric seals. While the primary focus of ISO 18562 (the standard for evaluating breathing gas pathways) is often on plastics and silicone, fiber-based components are frequently part of the tested system.
The company will offer a particulate characterization package for 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, the company works with manufacturers to define fit-for-purpose biocompatibility strategies, anticipate regulatory questions and support patient-focused risk assessment. It is a global, GLP-certified and ISO/IEC 17025-accredited laboratory, conducting biocompatibility testing for medical devices, including chemical screenings, biological in-vitro tests and microbiological evaluations such as bioburden and barrier effectiveness.