Essays about: "Svenska Institutet för Standarder"

Found 3 essays containing the words Svenska Institutet för Standarder.

  1. 1. MDR’s Impact on Standards Usages and the Relevance for In-house Production of Medical Devices

    University essay from KTH/Medicinteknik och hälsosystem

    Author : Alexander Söderberg; Birante Soumare; [2022]
    Keywords : In-house production; MDR; Reprocessing; 3D-printing; Swedish Institute for Standards; Standards; Egentillverkning; MDR; Reprocessing; 3D-printing; Svenska Institutet för Standarder; Standarder;

    Abstract : The current regulation for Medical Devices (MDR) entered into force on 26 May 2021, which has entailed major changes to relevant legislation for in-house production of medical devices in healthcare. The relevance for updating existing, or the development of new standards is currently not well documented and determined and the aim of this report is to make recommendations for how the development of standards may be improved and how departments of medical technology (DMT) in practice apply standards at in-house production of medical devices. READ MORE

  2. 2. The Medical Device Regulation : What Impact Will the New Regulation Have on the Medical Device Industry and How Will Companies Use Standards to Meet the New Requirements

    University essay from KTH/Medicinteknik och hälsosystem

    Author : Emelie Thunborg; Emma Österberg; [2021]
    Keywords : Medical Device Regulation; MDR; Swedish Institute of Standards; European Commission; Standardization; Standards; CE marking; Notified body; Medical Technology; Medicinteknisk förordning; MDR; Svenska Institutet för Standarder; Europeiska kommissionen; Standardisering; Standarder; CEmärkning; Anmält organ; medicinteknisk utrustning;

    Abstract : The New Medical Device Regulations (MDR) will become affective on 26 May, 2021. The new regulation entails higher requirements for companies that develop medical devices, but also for all parties involved in the medical device industry. READ MORE

  3. 3. Experimental Tests of Pre - placed Aggregate Concrete for Concrete Repairs

    University essay from KTH/Betongbyggnad

    Author : Husseen Hassan; Abdifatah Sahal; [2020]
    Keywords : Shrinkage; Compressive strength; Splitting tensile strength; Freeze-thaw; resistance; Pre-placed aggregate concrete; PREPAC; Slag; Krympning; Tryckhållfasthet; Spräckhållfasthet; Frostbeständighet; Injekteringsbetong; PREPAC; Slagg;

    Abstract : Since a large part of the hydropower structures in Sweden was built in the 1950s and 1960s, many of them are slowly but surely exhibiting deterioration. The hydropower companies are facing big challenges and are consequently investing in effective repairing methods since a hydropower structure failure could pose serious consequences and dangers to people, the environment, and the community. READ MORE