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In medicine, a nasopharyngeal airway (NPA), nasal trumpet (because of its flared end), or nose hose, is a type of airway adjunct, a tube that is designed to be inserted through the nasal passage down into the posterior pharynx to secure an open airway. It was introduced by Hans Karl Wendl in 1958. [1]
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.
The Medical Devices Directive (MDD 93/42/EEC) similarly lists several requirements regarding the design of a medical device. The Medical Devices Regulation (MDR (EU) 2017/745), replacing the MDD from 2021, requires information to allow the design stages applied to the device to be understood as part of the design and manufacturing information ...
These essential requirements are publicised in European directives or regulations. A manufacturer can use voluntarily European harmonised standards to demonstrate that a product complies with some (or all) of the EU essential requirements; alternatively, a notified body assess the conformity to these essential requirements.
Oropharyngeal airways are one of several different blind insertion airway devices. A blind insertion airway device (BIAD or blind insertion device) is a medical device used for airway management that ensures an open pathway between a patient's lungs and the outside world, as well as reducing the risk of aspiration, which can be placed without visualization of the glottis. [1]
Medical device cannot be classified as a class II device because insufficient information exists for the establishment of a performance standard to provide reasonable assurance of its safety and effectiveness of the device. Medical device is to be for use in supporting or sustaining human life, of substantial importance in preventing impairment ...
A woman who was brutally murdered in Queens more than three decades ago has finally been identified - through advanced DNA testing - as a mom who went missing soon after celebrating her daughter's ...
Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and placing on the market of medical devices for human use. It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).