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…
Understanding American National Standards for Dental Practices
American National Standards developed by the American Dental Association allow patients across the nation to receive standardized care of the highest quality. ANSI/ADA 35-2019, for…
ANSI/PDA Standard 001-2020: Medical Purchasing Controls
Concerns related to the efficacy and safety of medical drugs have caused most governments to develop regulatory agencies to oversee development and marketing of drug products and…
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,…
ISO 8432:1987— Liquid Chromatography For Essential Oils
Essential oils are concentrated plant extracts that retain the natural smell and flavor of their source. Since most of their components are volatile (i.e., a…
ISO 8586:2023—Selection And Training Of Sensory Assessors
In the early 1950s, a milestone for sensory evaluation occurred when the Quartermaster Food and Container Institute developed the nine-point hedonic scale: a category scaling…
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…