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  • Abstract:
    This particular standard is written at a time when technical evolution of medical robots is in rapid progress and the scientific foundation of safe use is still being expanded. This International Standard is the result of work that began in ISO/TC 184/SC 2/WG 7 in October 2006 on personal care ROBOTS, to address an emerging type of medical robot that was used outside of an industrial environment. That group was working on a new standard, ISO 13482, which was published as an International Standard (IS) in 2014. While initially focused on non-medical applications, WG 7 recognized that work was needed on medical devices utilizing robotic technology. In October 2009, ISO/TC 184/SC 2 established a WG 7, Study Group (SG) on Medical care robots, comprised of experts from Canada, France, Germany, Japan, Korea, Romania, Switzerland, UK and USA.
  • Document number:
    DIN EN IEC 80601-2-78; VDE 0750-2-78
  • Issuing date:
    2021-05-01
  • Document type:
    Norm
  • Title:
    Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation (IEC 80601-2-78:2019); German version EN IEC 80601-2-78:2020
  • Replaces:
    DIN EN 80601-2-78(2018-06)
  • Author:
    German Commission for Electrical, Electronic and Information Technologies of DIN and VDE
  • Search term:
    Assistance systems; Definitions; Design; Electric appliances; Electrical appliances; Electrical engineering; Electrical medical equipment; Electrical safety; Electromedicine; Health impairment; Impairment damage; Marking; Medical electronics; Medical equipment; Medical sciences; Medical technology; Protection against electric shocks; Rehabilitation; Safety; Safety requirements; Specification (approval); Supports; Testing; Treatment
  • Application areas:
    03.44 Handhabungssysteme, Roboter; 09.05 Medizinische Geräte und Instrumente
  • Hazards:
    AB Terminologische Festlegungen in Normen mit Arbeitsschutzbezug; DA Mechanische Gefährdungen im Allgemeinen; EA Elektrische Gefährdungen im Allgemeinen; GF Optische Strahlungen (infrarote Strahlung, ultraviolette Strahlung, Laserstrahlungen); GI Ionisierende Strahlungen (Röntgenstrahlungen, radioaktive Strahlung / Alpha-, Beta- und Gamma-Strahlung); GL Kontakt mit heißen oder kalten Medien (Oberflächen, Umgebungen); KE Belastungen durch Funktionsstörungen an Arbeitsmitteln (Ausfall, Bruch, fehlerhafte Montage, Softwarefehler, Störung der Energieversorgung)
  • ICS:
    11.040.60 Therapy equipment
  • Price:
    143,69 EUR
  • Cross references:
    IEC 60601-1-2 (2014-02)<S>; IEC 60601-1-6 (2010-01)<S>; IEC 60601-1-6 AMD 1 (2013-10)<S>; IEC 60601-1-8 (2006-10)<S>; IEC 60601-1-10 (2007-11)<S>; IEC 60601-1-11 (2015-01)<S>; IEC 62366-1 (2015-02)<S>; ISO 14971 (2007-03){historisch}<S>; ISO 22523 (2006-10)<S>; IEC 60601-1-8 AMD 1 (2012-11)<S>; IEC 60601-1-10 AMD 1 (2013-11)<S>; DIN EN 60601-1 (2013-12); DIN EN 60601-1 Beiblatt 2 (2009-09); DIN EN 60601-1-1 (2002-08); DIN EN 60601-1-9 (2021-05); DIN EN 60601-1-12 (2016-01); DIN EN 60601-2-1 (2016-08); DIN EN 60601-2-2 Beiblatt 1 (2014-02); DIN EN 60601-2-3 (2017-10); DIN EN 60601-2-5 (2016-08); DIN EN 60601-2-6 (2017-10); DIN EN 60601-2-8 (2016-08); DIN EN 60601-2-10 (2017-09); DIN EN 60601-2-11 (2016-04); DIN EN 60601-2-17 (2016-03); DIN EN 60601-2-18 (2016-10); DIN EN 60601-2-19 (2017-09); DIN EN 60601-2-21 (2017-09); DIN EN 60601-2-22 (2015-08); DIN EN 60601-2-22 Beiblatt 1 (2007-10); DIN EN 60601-2-23 (2016-08); DIN EN 60601-2-24 (2016-04); DIN EN 60601-2-25 (2016-08); DIN EN 60601-2-26 (2016-02); DIN EN 60601-2-27 (2015-04); DIN EN 60601-2-29 (2009-06); DIN EN 60601-2-33 (2017-11); DIN EN 60601-2-34 (2015-01); DIN EN 60601-2-36 (2015-11); DIN EN 60601-2-37 (2016-11); DIN EN 60601-2-40 (2019-04); DIN EN 60601-2-41 (2016-02); DIN EN 60601-2-43 (2020-12); DIN EN 60601-2-44 (2017-03); DIN EN 60601-2-45 (2017-01); DIN EN 60601-2-47 (2016-02); DIN EN 60601-2-50 (2017-09); DIN EN 60601-2-52 (2016-04); DIN EN 60601-2-54 (2020-03); DIN EN 60601-2-57 (2011-11); DIN EN 60601-2-62 (2016-04); DIN EN 60601-2-63 (2020-09); DIN EN 60601-2-64 (2018-01); DIN EN 60601-2-65 (2021-01); DIN EN 60601-2-68 (2020-04); DIN EN 61924-2 (2013-09); DIN EN 61924-2 Berichtigung 1 (2014-03); DIN EN ISO 9999 (2017-03); DIN EN ISO 10218-1 (2012-01); DIN EN ISO 10535 (2007-04); DIN EN ISO 11064-7 (2006-08); DIN EN ISO 11064-7 Berichtigung 1 (2006-10); DIN EN ISO 13482 (2014-11); DIN EN ISO 14971 (2020-07); DIN EN ISO 15223-1 (2017-04); DIN EN ISO 22523 (2007-04); IEC Guide 109 (2012-06); IEC 60601-1 (2005-12); IEC 60601-1-9 (2007-07); IEC 60601-2-33 (2010-03); IEC/TR 60601-4-1 (2017-05); IEC/TR 62366-2 (2016-04); ISO 7176-1 (2014-10); ISO 7176-2 (2017-10); ISO 7176-3 (2012-12); ISO 7176-4 (2008-10); ISO 7176-5 (2008-06); ISO 7176-6 (2018-06); ISO 7176-7 (1998-05); ISO 7176-8 (2014-12); ISO 7176-9 (2009-11); ISO 7176-10 (2008-11); ISO 7176-11 (2012-12); ISO 7176-13 (1989-08); ISO 7176-14 (2008-02); ISO 7176-15 (1996-11); ISO 7176-19 (2008-07); ISO 7176-19 AMD 1 (2015-11); ISO 7176-21 (2009-04); ISO 7176-22 (2014-09); ISO 7176-25 (2013-07); ISO 7176-26 (2007-04); ISO 7176-28 (2012-10); ISO 7176-30 (2018-12); ISO 9999 (2016-10); ISO 10218-1 (2011-07); ISO 11064-7 (2006-04); ISO 13482 (2014-02); DIN EN 60601-1-2 (2022-01); DIN EN 60601-1-3 (2021-10); DIN EN 60601-1-6 (2021-11); DIN EN 60601-1-8 (2021-12); DIN EN 60601-1-8 (2021-12); DIN EN 60601-1-9 (2021-05); DIN EN 60601-1-10 (2021-11); DIN EN 60601-1-11 (2021-12); DIN EN 60601-2-4 (2021-09); DIN EN IEC 60601-2-20 (2021-08); DIN EN IEC 60601-2-31 (2021-07); DIN EN 62366-1 (2021-08); IEC 61924-2 (2021-02); ISO 16840-10 (2021-06); ISO 8373 (2021-11); ISO 10535 (2021-10)
  • Identical with:
    EN IEC 80601-2-78(2020-04)<IDT>; IEC 80601-2-78(2019-07)<IDT>
  • Update flag:
    Unchanged