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A design history file is a compilation of documentation that describes the design history of a finished medical device.The design history file, or DHF, is part of regulation introduced in 1990 when the U.S. Congress passed the Safe Medical Devices Act, which established new standards for medical devices that can cause or contribute to the death, serious illness, or injury of a patient.
Every medical treatment facility should have policies and processes on equipment control and asset management. Equipment control and asset management involves the management of medical devices within a facility and may be supported by automated information systems (e.g., enterprise resource planning (ERP) systems are often found in U.S. hospitals, and the U.S. military health system uses an ...
Specifically, ISO 14971 is a nine-part standard which first establishes a framework for risk analysis, evaluation, control, and review, and also specifies a procedure for review and monitoring during production and post-production. [6][7] ISO 14971:2012 was harmonized with respect to the three European Directives associated with medical devices ...
ISO 13485. ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [1] published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices.
A biomedical engineering/equipment technician/technologist ('BMET ') or biomedical engineering/equipment specialist (BES or BMES) is typically an electro-mechanical technician or technologist who ensures that medical equipment is well-maintained, properly configured, and safely functional. In healthcare environments, BMETs often work with or ...
Hemodialysis, a process of purifying the blood of a person whose kidneys are not working normally. Biomedical engineering (BME) or medical engineering is the application of engineering principles and design concepts to medicine and biology for healthcare applications (e.g., diagnostic or therapeutic purposes).
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to test motor reflexes of the body. Sphygmomanometer. to measure the patient's blood pressure. Stethoscope. to hear sounds from movements within the body like heart beats, intestinal movement, breath sounds, etc. Suction device. to suck up blood or secretions. Surgical scissors. used for dissecting or cutting.