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BSI Group headquarters building in Gunnersbury, West London, featuring the BSI Group logo. BSI was founded as the Engineering Standards Committee in London in 1901. [5] [2] It subsequently extended its standardization work and became the British Engineering Standards Association in 1918, adopting the name British Standards Institution in 1931 after receiving a Royal Charter in 1929. [2]
However, BMETs do specialize and focus on specific kinds of medical devices and technology management—(i.e., an imaging repair specialist, laboratory equipment specialist, healthcare technology manager) and works strictly on medical imaging and/or medical laboratory equipment as well as supervises and/or manages HTM departments.
Body substance isolation is a practice of isolating all body substances (blood, urine, feces, tears, etc.) of individuals undergoing medical treatment, particularly emergency medical treatment of those who might be infected with illnesses such as HIV, or hepatitis so as to reduce as much as possible the chances of transmitting these illnesses. [1]
This requires that a quality system shall be in place for all the relevant entities and processes that may impact safety and effectiveness over the whole medical device lifecycle. The medical device engineering area is among the most heavily regulated fields of engineering, and practicing biomedical engineers must routinely consult and ...
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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 ...
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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.
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