ISO/IEEE 11073-10410: 2019— Insulin Pump
Insulin pumps can be recommended for people with diabetes who have trouble managing their blood sugar levels or who have a lifestyle that makes it difficult…
3D Printing: Revolutionizing Medical Care With Personalized Precision
The field of medicine is undergoing a significant transformation thanks to advancements in 3D printing technology. This innovative process, which creates three-dimensional objects from digital…
ISO 21802:2019— Assistive Products
A study found that individuals with cognitive disability experienced lower scores in general self-efficacy and time management skills than with individuals without cognitive disability. Luckily,…
ANSI/RESNA WC-1:2019—Wheelchairs and Scooters
An estimated 5.5 million Americans use a wheelchair, as do 65 million people worldwide. Wheelchairs are thereby commonly used assistive devices that help people with…
IEC 60601-2-57 Ed. 2.0 b:2023— Medical Electrical Equipment
Patients in hospitals can be exposed to electromagnetic fields and optical radiation. This exposure may be associated with risks and hazards. IEC 60601-2-57 Ed. 2.0…
AAMI 80001-GS:2011— Getting Started With IEC 80001
Medical errors occur far too frequently: over 7 million American patients are impacted by medical errors each year; there are 7,000 to 9,000 Americans who…
AAMI TIR16:2023—Ethylene Oxide Sterilization
Ethylene oxide (EO or EtO) gas is one of the most common ways to sterilize medical devices, as approximately 50% of sterile medical devices are treated…
ISO 10555-1:2023— Intravascular Catheters
Intravascular catheters are an indispensable tool in modern-day medical practice, both for patients with acute injuries and for those with chronic illnesses. Approximately 90% of patients…
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…