AAMI Updates Steam Sterilizer Standard for Medical Device Manufacturers
The revised ANSI/AAMI ST8:2026 standard adds new testing requirements, updates terminology, and revises manufacturer instructions for hospital steam sterilization systems.
The revised ANSI/AAMI ST8:2026 standard adds new testing requirements, updates terminology, and revises manufacturer instructions for hospital steam sterilization systems.
The FDA has added one new and three revised AAMI sterilization documents, including guidance on ethylene oxide, to its list of Recognized Consensus Standards.
AAMI has updated its primary guidance on chemical sterilization and high-level disinfection in healthcare facilities, addressing safety and regulatory concerns for hospital staff using ethylene oxide (EO) for device sterilization.
The revised ANSI/AAMI ST8:2026 standard adds new testing requirements, updates terminology, and revises manufacturer instructions for hospital steam sterilization systems.
AAMI has released guidance detailing best practices for sterile processing of dilators and ultrasound probes in healthcare settings.
Read MoreAAMI has issued an updated guidance document on ethylene oxide sterilization, responding to industry concerns amid cost constraints and regulatory changes prompted by recent Environmental Protection Agency emissions requirements.
Read MoreAAMI announced the winners of several 2024 AAMI Awards recognizing individuals who have made contributions to science and standards.
Read MoreAAMI has released its comprehensive Leadership Development Guide aimed at healthcare technology management (HTM) professionals, offering valuable insights, best practices, and practical advice for advancing careers and preparing staff for leadership roles in the face of staffing shortages and growing demand for specialized skills in the HTM field.
Read MoreThe Association for the Advancement of Medical Instrumentation (AAMI) announces that the U.S. FDA has officially extended complete recognition to AAMI’s guidance document on medical device cybersecurity, ANSI/AAMI SW96.
Read MoreAAMI announces that it is now accepting nominations for its annual “Bright Ideas” program, which recognizes HTM departments that are implementing creative solutions to challenges.
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AAMI announces that the FDA has added 13 guidance documents produced by AAMI or its standards committees to its database of Recognized Consensus Standards.