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The Association for the Advancement of Medical Instrumentation (AAMI) is an organization for advancing the development, and safe and effective use of medical technology founded in 1965 by Robert D. Hall Jr. and Robert J. Allen, President and Vice President respectively of Tech/Reps, Inc. (a medical Instrumentation marketing firm in Needham, Massachusetts).
The practice of reusing medical devices labeled for only one use began in hospitals in the late 1970s. [8] After a thorough review by the U.S. FDA in 1999 and 2000, [8] the agency released a guidance document for reprocessed SUDs that began regulating the sale of these reprocessed devices on the market, [9] under the condition that third-party reprocessors would be treated as the manufacturer ...
Sterile dental instruments from hospital central supply (barcoded label indicating sterilization date, expiry date and contents). The central sterile services department (CSSD), also called sterile processing department (SPD), sterile processing, central supply department (CSD), or central supply, is an integrated place in hospitals and other health care facilities that performs sterilization ...
Endomicroscopy is a technique for obtaining histology-like images from inside the human body in real-time, [1] [2] [3] a process known as ‘optical biopsy’. [ 4 ] [ 5 ] It generally refers to fluorescence confocal microscopy , although multi-photon microscopy and optical coherence tomography have also been adapted for endoscopic use.
The general standard IEC 60601-1 – Medical electrical equipment – Part 1: General requirements for basic safety and essential performance – gives general requirements of the series of standards. 60601 is a widely accepted benchmark for medical electrical equipment and compliance with IEC60601-1 has become a requirement for the commercialisation of electrical medical equipment in many ...
This category contains images taken at the time of endoscopy of the GI tract, using esophagogastroduodenoscopy, colonoscopy, double-balloon enteroscopy, or ERCP. Media in category "Endoscopic images" The following 9 files are in this category, out of 9 total.
rigid endoscope: A rigid endoscope is a prismatic optical system with advantages of clear imaging, multiple working channels and multiple viewpoints. flexible endoscope: A flexible endoscope is an optical-fiber-based system. Notable features of a flexible endoscope include that the lens can be manipulated by the operator to change direction ...
ISO 14971 Medical devices — Application of risk management to medical devices is a voluntary consensus standard, [1] published by International Organization for Standardization (ISO) for the first time in 1998, and specifies terminology, principles, and a process for risk management of medical devices.