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Content DescriptionThe second edition of this technical report was prepared by the Secretariat of IEC/SC 62A to summarize those changes cited in Amendment 1 that were assessed during the development process as having a moderate to significant impact on users of IEC 60601-1. The tables from the first edition of this technical report were retained in the second edition because there are counties that have not fully transitioned to the third edition of IEC 60601-1. Therefore, the original contents of IEC/TR 62348 remain useful in those countries.This book also exists in the following packages...About AAMIThe 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:
Contain costs
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.
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