AAMI CR515:2025—Cybersecurity in ML Medical Devices
While medical devices are designed to heal, monitor, or save lives, they could instead become a tool for harm if compromised. The healthcare sector is…
ISO 11608-1:2022—Needle-Based Injection Systems
Needle-based injection systems (NISs) are extremely common and represent the primary method for drug delivery, with at least 16 billion NISs injections administered globally each year. Therefore,…
ISO 10993-1:2025—Biological Evaluation of Medical Devices
Medical devices range from simple bandages to complex implantable devices like pacemakers and prosthetics. Regardless of their complexity, all medical devices must undergo rigorous testing…
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…
ISO/IEC 3532-1:2023—3D Printing in Medicine
3D printing technology has caused a revolution in health care delivery. It is being widely adopted for various applications, including anatomical modeling, surgical planning, the creation…
What’s New in the 2025 ASA/ANSI S3.6 Audiometer Standard?
According to the National Institute of Health (NIH), approximately 15% of American adults (37.5 million) aged 18 and over report some trouble hearing, about one…
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…
IEEE 2621.1-2022: Wireless Diabetes Device Security
A growing number of people with diabetes are turning to wireless diabetes devices to monitor and manage their condition in an automated fashion. As diabetes…
AAMI TIR109:2025—External Transport of Medical Devices
The U.S. healthcare transportation market was valued at $21.82 billion in 2017 and is projected to grow to $31.51 billion globally by 2026. This growth…