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…
ISO 10993-17:2023— Toxicological Risk Assessment
Risk assessment is a multi-step process which produces estimates of risk of an adverse health effect occurring as a consequence of ingesting, inhaling, and/or absorbing…
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,…
Standard for Medical Face Masks, ASTM F2100-23
Some 16 million people work in the healthcare sector, doing the work that keeps the rest of us alive. Personal protective equipment (PPE), such as…
ASTM F2077-22: Intervertebral Body Fusion Devices
You are taller in the morning and in outer space. The lack of gravity from lying down to sleep or being in outer space causes…