ISO 10993-6:2026 — Implantation Effects Testing
When a medical device is implanted into the human body (whether temporarily or permanently) it triggers a biological response. The difference between safe integration and…
Minimizing Micro-Mistakes in Medical Manufacturing: A Closer Look
In medical manufacturing, even the smallest deviation is more than a cosmetic issue. It represents real risk. A micron of excess material, a slightly rough…
ANSI/ASHRAE/ASHE 170-2025: Ventilation of Health Care Facilities
In health care facilities, ventilation goes beyond environmental comfort. Air handling and distribution systems, ultimately, control the transmission of airborne infection. This places a prime importance…
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…