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…
ANSI/ADA 128-2022: Hydrocolloid Impression Materials
Hydrocolloids were the first elastic impression materials available to dentists. When mixed, they form a viscous liquid that can be seated over oral structures. The liquid…
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 9842:2003— Oil Of Rose
Rosa Damascena is the most widely used rose variety in perfumery. Classified in the rose family, Rosa Damascena rose essential oil is one of the best-known…
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…
ASTM F1929-23: Seal Leaks In Porous Medical Packaging
Products in pharmaceutical industries are prone to spoilage, and leaks in the packages or bottle seals can lead to air penetration, making the product unsafe for…
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…