• IEC 60601 is a series of technical standards for the safety and essential performance of medical electrical equipment, published by the International...
    21 KB (2,748 words) - 00:38, 8 April 2023
  • equipment who comply with IEC 60601-1-6 need to also comply by extension to IEC 62366 as part of IEC 60601-1 Edition 3.1. IEC 62366 was initially published...
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    Standard IEC 60601 for home healthcare electro-medical devices defining the requirements for devices used in the home healthcare environment. IEC 60601-1-11...
    60 KB (6,170 words) - 17:17, 26 July 2024
  • documentation contents International Electrotechnical Commission (IEC) List of IEC standards IEC 60601 ISO 14971 ISO 13485 ISO 9001 International Standards for...
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  • edition of IEC 60601-1 and proposals for new requirements IEC 62297 Triggering messages for broadcast applications IEC 62298 Teleweb application IEC 62300...
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  • classified as shown below, per IEC 60601-1:2005, International Standard published by the International Electrotechnical Commission (IEC): The test method does...
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  • EN 50130-4 for alarm systems, EN 50121-4-2 for railway applications or IEC 60601-1-2 for medical equipment. The product, or equipment under test (EUT)...
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  • meet IEC 60950 (Safety of Information Technology Equipment), will usually not comply with the more demanding isolation requirements of IEC 60601-1 (Medical...
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    Rehabilitation: Merck Manual Home Edition". Merckmanuals.com. Retrieved 2012-07-06. IEC 60601-2-10:2012 – Medical electrical equipment – Part 2-10: Particular requirements...
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  • manufacturer's website. For magnetic resonance imaging the limits (described in IEC 60601-2-33) are slightly more complicated: Note: Averaging time of 6 minutes...
    14 KB (1,772 words) - 22:41, 24 July 2024
  • safety), a concept found in the standard for medical electrical equipment IEC 60601-1 A term for negative emotions on the cartoon series Bravest Warriors...
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  • hygiene products. ISO 13485:2016 Certificates meets the requirement of IEC 60601-2-25 : 1993 + A1: 1999 safety of Electrocardiograms. ISO 14971 Good manufacturing...
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  • equipment. Similarly, the specific regulations for medical equipment (MDR and IEC 60601-1-2) also refer to a risk-based approach. The Medical Device Regulation...
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    against: IEC 60601-1 - Safety IEC 60601-2-XX - Performance IEC 60601-1-2 - EMC IEC 60601-1-6 & IEC 62366 - Usability IEC 62304 - Software IEC 62471, 60825-1...
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  • industry to insulate connectors in clinical settings, as specified in IEC 60601-1 (subclause 56.3(c)). The EEG DIN connector has two variations, both...
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  • A concept introduced in the standard for medical electrical equipment IEC 60601-1. Electrical safety standard set forward by standards organizations across...
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    development records before the product is distributed. Further standards are IEC 60601-1 which is for electrical devices (mains-powered as well as battery powered)...
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    field centre The International Electrotechnical Commission (IEC) created the document IEC 60601-2-41 – Particular requirements for the basic safety and essential...
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  • leakage current from the device. Type designations are defined by the IEC 60601 standard. Type B applied parts have a maximum leakage current of 100μA...
    66 KB (8,421 words) - 03:17, 14 August 2024
  • devices. Risk analysis (see risk management) IEC 60601-1 Medical electrical equipment IEC 60601-2-38 IEC 60601-2-52 93/42 EEC Directive medical devices 89/336...
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    those suitable for direct patient contact in accordance with UL 544 and IEC 60601-1. Shock-safe fuseholders have also been integrated into power entry modules...
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  • Committee ITU-T Study Group 16 (Secretary: Simao Campos) Related standards IEC 60601, IEC 61000-3-2, K.127, K.136, K.137 License Freely available Website https://www...
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    specifically designed for medical data collection applications and certified for IEC 60601-1; Launches Terminal Servers for Electrical Utility Substation Market...
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    Device for Connection of Luminaires (category IEC standards)
    the Low Voltage Directive. DCL is only allowed to be installed with ground. "IEC 61995-1", "IEC 61995-2" at International Electrotechnical Commission...
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    Angéiologie. 2005; 57:48-54 Marquage CE 0535. International Standard IEC 60601-2-10 Medical electrical equipment. Particular requirements for the safety...
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    (MDD), European Guideline 93/42 EEC, European Guideline 2007/47 EEC, IEC EN 60601-1, EN 62304, EN 14971 and the machinery directive 2006/42/EC. Medical...
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    Field Parameter Measurements  France (FRA) NF C74-335  Germany (GER) DIN EN 60601-2-5  Bulgaria (BUL) БДС 12.1.001:1979 Охрана на труда. Ултразвук. Общи изисквания...
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  • statistical quality control". IEEE Software. 7 (6): 46. doi:10.1109/52.60601. ISSN 1937-4194. S2CID 538311 – via University of Tennessee – Harlan D....
    39 KB (4,618 words) - 10:23, 13 August 2024