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  • Abstract:
    This part 2-101 of the IEC 61010 series applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes.
  • Document number:
    DIN EN 61010-2-101; VDE 0411-2-101
  • Issuing date:
    2017-10-01
  • Document type:
    Norm
  • Title:
    Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment (IEC 61010-2-101:2015); German version EN 61010-2-101:2017
  • Replaces:
    DIN EN 61010-2-101(2003-09); DIN EN 61010-2-101(2013-01)
  • Author:
    German Commission for Electrical, Electronic and Information Technologies of DIN and VDE
  • Search term:
    Biological hazards; Control devices; Control equipment; Definitions; Diagnosis; Diagnostic equipment; Electric appliances; Electrical engineering; Hazards; In vitro; Laboratory apparatus; Laboratory medicine; Laboratory ware; Measuring instruments; Medical equipment; Protective measures; Risk analysis; Safety; Safety requirements; Specification (approval); Testing
  • Application areas:
    09.05 Medizinische Geräte und Instrumente
  • Hazards:
    AB Terminologische Festlegungen in Normen mit Arbeitsschutzbezug; CG Gefährdungsart: giftig; DA Mechanische Gefährdungen im Allgemeinen; EA Elektrische Gefährdungen im Allgemeinen
  • ICS:
    11.100.10 In vitro diagnostic test systems
  • Price:
    55,66 EUR
  • Cross references:
    ISO 18113-5 (2009-12)<G>; ISO 13857 (2019-10)<G>; ISO 14971 (2019-12)<G>; DIN EN 60073 (2003-05); DIN EN 61010-1 (2020-03); DIN EN IEC 61010-2-081 (2022-07); DIN EN ISO 13857 (2020-04); DIN EN ISO 14971 (2022-04); IEC 61010-2-101 (2018-10); EUV 2017/746 (2017-04-05)
  • Cited in:
    DIN 1946-4 (2018-06); DIN 1946-4 (2018-09); DIN EN 50562 (2018-04); DIN EN IEC 60335-2-110 (2022-08); DIN EN IEC 60519-1 (2020-12); DIN EN 60601-1 (2022-11); DIN EN IEC 61010-2-030 (2022-11); DIN EN IEC 61010-2-081 (2022-07); DIN EN IEC 61010-2-202 (2022-06); DIN EN IEC 61326-1 (2022-11); DIN EN IEC 61340-6-1 (2019-08); DIN EN 62446-1 (2019-04); DIN EN 62586-1 (2018-07); DIN EN 62974-1 (2018-07); DIN EN 82304-1 (2018-04); DIN EN ISO 23553-1 (2022-08); DIN EN ISO 27427 (2020-02); DIN VDE 0680-6 (2021-08); VDI 4068 Blatt 4 (2018-06)<GLEITEND>
  • Identical with:
    EN 61010-2-101(2017-02)<IDT>; IEC 61010-2-101(2015-01)<IDT>
  • Update flag:
    Unchanged