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  • TI Isolators Comply with IEC 61010-1 3rd Edition Safety Requirements
    Significant changes have been made in the third edition of this standard. These cover a wide array of safety specifications such as insulation, mechanical hazards, temperature, radiation, ergonomic, risk assessment process, pollution mitigation, and many others. This paper focuses on insulation
  • Bye, bye bacteria
    from the Radiation Safety Academy, Gaithersburg, Md. "Basically a high voltage is applied to a filament, usually tungsten,
  • Medical Device Link .
    Medical Device & Diagnostic Industry writer and editor for the Laser Institute of America, a professional society that fosters laser applications and safety, describes the differences between U.S. and European standards for medical laser products. What is the status of the FDA laser radiation
  • Medical Device Link .
    ), with Amendments 1 (1991-11) and 2 (1995-03). Technology-related safety requirements addressing medical systems, electromagnetic compatibility (EMC), x-ray radiation, and programmable systems are covered by supplementary standards. A further group of standards covers device-specific safety
  • Combination Products: Navigating Two FDA Quality Systems
    and effect analysis (FMEA) methods are required during scale-up and validation. These tools help establish critical risk factors that could create safety and quality issues during manufacturing. They can be an integral part of a PAT program whereby the decision to reject or salvage a valuable raw
  • Medical Device Link .
    , hazards from chemical substances, effects of radiation, liberated gases, explosion, and implosion. This article discusses various safety factors that IVD manufacturers should consider when designing their electrical equipment to make sure that these
  • Medical Device Link .
    and precision tolerances. Processing methods include flaring, forming, convoluting, corrugating, and cuffing. The heat-shrink tubing is available in shrink ratios from 1.25:1 to 4:1 and can withstand all common methods of sterilization, including autoclave, radiation, and EtO. In moves to increase safety
  • Medical Device Link . Materials Characterization as an Integral Part of Global Biocompatibility
    of more radiation-sterilizable and environmentally safe grades. Polymers for medical devices must be safe and mechanically appropriate. Photo: NAMSA Along with its increased demand for medical-grade plastics, the device industry has intensified its awareness of the need to ensure the safety

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