Land Use and Development
Rules & Regulations
Content DescriptionThis Technical Report gives guidance and practical techniques for responsible organizations, medical device manufacturers and providers of other information technology in the application of IEC 80001-1:2010 for the risk management of distributed alarm systems. This Technical Report applies to the transmission of alarm conditions between sources, integrator and receivers where at least one source is a medical device and at least one communication path utilizes a medical IT-network. It provides recommendations for the integration, communication of responses and redirection (to another operator) of alarm conditions from one or more sources to ensure safety, effectiveness and data and systems security.
The Association for the Advancement of Medical Instrumentation® (AAMI) is a nonprofit organization founded in 1967. It is a diverse community of more than 8,000 professionals united by one important mission—the development, management, and use of safe and effective health technology.
AAMI is the primary source of consensus standards, both national and international, for the medical device industry, as well as practical information, support, and guidance for healthcare technology and sterilization professionals. AAMI helps members:
Stay on top of new technology and policy developments
Add value in healthcare organizations
Improve professional skills
Enhance patient care
AAMI provides a unique and critical forum for a variety of professionals including clinical and biomedical engineers and technicians, physicians, nurses, hospital administrators, educators, scientists, manufacturers, distributors, government regulators, and others with an interest in healthcare technology. AAMI fulfills its mission through:
Courses, conferences, and continuing education, including certification programs.
Collaborative initiatives, including summits with the FDA
A rich array of resources, including peer-reviewed journals, technical documents, books, videos, podcasts, and other products.