Land Use and Development
Rules & Regulations
Content DescriptionAdresses methods of elimination and inactivation of transmissible spongiform encephalopathies (TSE agents) from animal tissues to be used in medical devices. The methods addressed will include those designed for:  inactivating infectivity (preferred method to reduce opportunities for cross-contamination); and  physically removing TSE agents (without complete inactivation). Includes inactivation and elimination methods to be used in the product manufacturing process and in facilities and equipment designed for utilizing animal tissue products.
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.