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 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…
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…
ANSI/ADA 173-2019: Dental Implants Designation System
Here are some facts about missing teeth you should know: the average American has lost 12 teeth by age 50; 69% of American adults are…
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…
IAF MD 9:2022 – Changes in Medical Device Quality Management Systems
IAF MD 9:2022, Application of ISO/IEC 17021-1 in the Field of Medical Device Quality Management Systems specifies normative criteria for conformity assessment bodies (CABs) auditing…