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…
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…
Amendment to ANSI/AAMI/IEC 62304:2006 – Medical Device Software – Software Life Cycle Processes
ANSI/AAMI/IEC 62304:2006/A1:2016 – Medical device software – Software life cycle processes – Amendment has been released. This document is an amendment to the existing ANSI/AAMI/IEC…
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…
Cardiovascular Implant Standards
Cardiovascular implants are particularly delicate devices, even compared to other medical devices, frequently quite literally holding someone’s heart in their embrace. Cardiovascular implants can be…