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…
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….
ISO Health Care Product Sterilization Standards Adopted By AAMI
A health care product is not sterile unless it is free of microorganisms. Sterilization is assured with these products and their materials and components through…
AAMI TIR59: Integrating Human Factors into Medical Devices
Human factors, or ergonomics, strives to understand the interactions among humans and the other elements of a system. Integrating human factors engineering, otherwise known as…
Sterilization of Medical Devices: Guidance for Manufacturers and Health Care Providers in Reprocessing
Guidance for Manufacturers For medical devices, sterilization is, unsurprisingly, crucial to patient health. For the best results, sterilization needs to begin with the manufacturers, who…