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…
ASA/ANSI S3.6-2018 (R2023): Specification For Audiometers
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…
CLSI EP07-Ed3 (R2022): Interference Testing In Chemistry
Interferences with clinical laboratory tests can create discrepancies in test results that may lead to patient harm. Although performance is monitored by internal quality control…
IEC/TR 60878:2022 – Medical Electrical Equipment
The caduceus, a staff with two snakes coiled around it and surmounted by wings, is considered a symbol of medicine. It is the official insignia…
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…
Medical Advancements That Promote Patient Independence
Here are some medical and technological breakthroughs that help patients remain independent. Remote Patient Monitoring Equipment Advances in communication technologies have been especially beneficial to…