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Content DescriptionSpecifies requirements for the information to be provided by the medical device manufacturer for the processing of a medical device that requires cleaning followed by disinfection and/or sterilization to ensure that the device is safe and effective for its intended use. This includes information for processing prior to use or reuse of the medical device. The provisions of this standard are applicable to medical devices that are intended for invasive or other direct or indirect patient contact. Processing instructions are not defined in this standard. Rather, this standard specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that consist of the following activities where applicable: a) Pre-treatment at the point of use before processing; b) Preparation before cleaning; c) Cleaning; d) Disinfection; e) Drying; f) Inspection, maintenance and functionality testing; g) Packaging; h) Sterilization; i) Storage; j) TransportationThis 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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