AAMI TIR109:2025—External Transport of Medical Devices
The U.S. healthcare transportation market was valued at $21.82 billion in 2017 and is projected to grow to $31.51 billion globally by 2026. This growth…
AAMI TIR17:2024—Sterilization of Health Care Products
Medical professionals are legally obligated to provide patients with a standard of care, which includes proper sterilization of medical equipment. This helps to assure that…
ANSI/AAMI ST58:2024—Health Care Facility Sterilization
Achieving disinfection and sterilization through the use of disinfectants and sterilization practices is critical for preventing medical and surgical instruments from transmitting infectious pathogens to…
AAMI CR513:2024— Radiation Sterilization Validation
A radiation sterilization validation is used to determine the appropriate sterilization dose for a product, helping establish the pertinent sterilization parameters for health care reprocessing instructions….
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…
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…
ANSI/AAMI ST79: Guide to Steam Sterilization
A consolidation of several previous standards, ANSI/AAMI ST79:2017 offers a Comprehensive Guide To Steam Sterilization And Sterility Assurance In Health Care Facilities. How Steam Sterilization…
ISO 11607 2019 Revisions, Sterilized Medical Device Packaging
Both standards in the international series for the packaging for terminally sterilized medical devices have been revised: ISO 11607-1:2019, which addresses materials, sterile barrier systems,…
ANSI/AAMI/ISO 11737-1:2018 – Determination of a Population of Microrganisms on Products for Sterilization
ANSI/AAMI/ISO 11737-1:2018 – Sterilization of health care products – Microbiological methods – Part 1: Determination of a population of microrganisms on products has been released….