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  2. Imipenem/cilastatin/relebactam - Wikipedia

    en.wikipedia.org/wiki/Imipenem/cilastatin/relebactam

    The European Committee on Antimicrobial Susceptibility Testing (EUCAST) provided a susceptibility clinical breakpoint of ≤2 mg/L for Enterobacterales, P. aeruginosa, and Acinetobacter spp., while The Clinical & Laboratory Standards Institute (CLSI) provided a susceptibility clinical breakpoint of ≤1 mg/L for Enterobacterales and ≤2 mg/L ...

  3. Validation and verification (medical devices) - Wikipedia

    en.wikipedia.org/wiki/Validation_and...

    To establish a reference range, the Clinical and Laboratory Standards Institute (CLSI) recommends testing at least 120 patient samples. In contrast, for the verification of a reference range, it is recommended to use a total of 40 samples, 20 from healthy men and 20 from healthy women, and the results should be compared to the published reference range.

  4. Closed system drug transfer device - Wikipedia

    en.wikipedia.org/wiki/Closed_system_drug...

    It remains that new solutions to increasing safety of handling hazardous drugs have to be developed. Conceptually, through operating in a closed system, CSTDs should significantly reduce risks to nurses. However, the robustness of product design and extent of proper usage by nurses affects the efficacy of the CSTD in achieving OSH.

  5. Mobile-device testing - Wikipedia

    en.wikipedia.org/wiki/Mobile-device_testing

    Mobile-device testing functions to assure the quality of mobile devices, like mobile phones, PDAs, etc.It is conducted on both hardware and software, and from the view of different procedures, the testing comprises R&D testing, factory testing and certificate testing.

  6. Food and Drug Administration - Wikipedia

    en.wikipedia.org/wiki/Food_and_Drug_Administration

    The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...

  7. US FDA proposes standardized testing to detect asbestos in ...

    www.aol.com/news/us-fda-proposes-standardized...

    In its proposed rule, the FDA would require manufacturers to test a sample of each batch of a talc-containing cosmetic product for asbestos by using methods such as polarized light and ...

  8. AliveCor - Wikipedia

    en.wikipedia.org/wiki/Alivecor

    This device gained FDA approval in 2012, and it was available for sale only to doctors for $200. [10] To secure the FDA-clearance, AliveCor ran a clinical trial to test both the device hardware and the associated iPhone app. The study investigated how the single-lead ECG compared to a traditional 12-lead device. [11]

  9. Mobile application testing - Wikipedia

    en.wikipedia.org/wiki/Mobile_application_testing

    Mobile application testing is a process by which application software developed for handheld mobile devices is tested for its functionality, usability and consistency. [1] Mobile application testing can be an automated or manual type of testing . [ 2 ]