ANSI/AAMI HE75:2025—Medical Device Design
Medical devices are essential to modern healthcare, but their safety and effectiveness rely heavily on human factors engineering (HFE). HFE helps reduce use errors (a…
Reimagining Higher Education: The Power of Building New Pathways to Success
The joint Workcred, Higher Learning Commission, and League for Innovation in the Community College Certification + Degree (C+D) pathway project fostered a fundamental shift in…
ASTM Standards for MRI Safety and Testing
MRI’s history traces back to the 1930s with Isidor Rabi’s discovery of nuclear magnetic resonance, which demonstrated that atoms could emit radio waves in a magnetic…
ANSI Z136.3-2024: Safe Use of Lasers in Health Care
Blasting a laser into your flesh or skin generally isn’t the brightest idea. Nonetheless, in health care facilities, lasers, of varying types and wavelengths (measured…
ASTM F1929-23: Seal Leaks In Porous Medical Packaging
Products in pharmaceutical industries are prone to spoilage, and leaks in the packages or bottle seals can lead to air penetration, making the product unsafe for…
AAMI TIR12:2020 (R2023)— A Guide for Device Manufacturers
Medical device manufacturers are required to design and build quality into their products. This means that they must have processes and procedures in place to ensure…
IEC 62779-1 Ed. 1.0 b:2016— Semiconductors for Human Body
What if we could use the human body itself to transfer and collect information? This area of research is known as human body communication (HBC,…
ISO 14971:2019–Risk Management To Medical Devices
Flint knives, saws, and drills were used for surgery, amputation, and trepanation during the Upper Paleolithic and Mesolithic times in 6000 BCE. These were the…
ANSI/AAMI SW96:2023—Medical Device Security
The steps that involve manufacturing, regulation, planning, assessment, acquisition, and management of medical devices are complex but essential to guarantee their quality, safety, and compatibility…