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  • Abstract:
    Replacement: This part of the 80601 International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of AUTOMATED SPHYGMOMANOMETERS, hereafter referred to as ME EQUIPMENT, which by means of an inflatable CUFF, are used for non-continuous indirect estimation of the BLOOD PRESSURE without arterial puncture. NOTE 1 Equipment that performs indirect DETERMINATION of the BLOOD PRESSURE without arterial puncture does not directly measure the BLOOD PRESSURE. It only estimates the BLOOD PRESSURE. This document specifies requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE for this ME EQUIPMENT and its ACCESSORIES, including the requirements for the accuracy of a DETERMINATION. This document covers automatic electrically-powered ME EQUIPMENT used for the intermittent, indirect estimation of the BLOOD PRESSURE without arterial puncture, including BLOOD PRESSURE monitors for the HOME HEALTHCARE ENVIRONMENT. Requirements for indirect estimation of the BLOOD PRESSURE without arterial puncture ME EQUIPMENT with an electrically-powered PRESSURE TRANSDUCER and/or displays used in conjunction with a stethoscope or other manual methods for determining BLOOD PRESSURE (NON-AUTOMATED SPHYGMOMANOMETERS) are specified in document ISO 81060-1 [2]. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 201 and 2005.3.3, as well as 7.2.13 and 8.4.1 of IEC 60601-1:2005. NOTE 2 See also 4.2 of IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012. 20 Object Replacement: The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for an AUTOMATED SPHYGMOMANOMETER as defined in 2001.
  • Document number:
    IEC 80601-2-30
  • Issuing date:
  • Document type:
  • Title:
    Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
  • Replaces:
    IEC 62D/1548/FDIS(2017-11); IEC 80601-2-30(2009-01); IEC 80601-2-30 Corrigendum 1(2010-01); IEC 80601-2-30 AMD 1(2013-07); IEC 80601-2-30 Edition 1.1(2013-07)
  • Author:
    IEC/SC 62D Electromedical equipment
  • Search term:
    Automatic; Blood pressure; Blood pressure meter; Control instruments; Cyclic; Definitions; Determinations; Efficiency; Electric appliances; Electrical engineering; Electrical hazards; Electrical safety; Electromedicine; Features; Mechanical hazards; Medical equipment; Medical sciences; Medical technology; Minimum requirements; Non-invasive; Protection against electric shocks; Safety; Safety engineering; Safety requirements; Specification (approval); Sphygmography; Sphygmomanometers; Surveillance (approval); Testing
  • Application areas:
    09.05 Medizinische Geräte und Instrumente
  • Hazards:
    AB Terminologische Festlegungen in Normen mit Arbeitsschutzbezug; AD Folgen von Belastungen und Gefährdungen (z. B. Ermüden, Ersticken, Ertrinken); BB Mikroorganismen (Viren, Bakterien, Parasiten u. Ä.); EA Elektrische Gefährdungen im Allgemeinen; EB Berühren spannungsführender oder leitfähiger Teile; GF Optische Strahlungen (infrarote Strahlung, ultraviolette Strahlung, Laserstrahlungen); HB Klima (Temperatur, Feuchtigkeit, Luftströmung, Luftzusammensetzung u. Ä.)
  • ICS:
    11.040.01 Medical equipment in general; 11.040.55 Diagnostic equipment
  • Price:
    290,00 EUR
  • Cross references:
    IEC 60068-2-27 (2008-02)<S>; IEC 60068-2-64 (2008-04)<S>; IEC 60601-1 (2005-12)<S>; IEC 60601-1 AMD 1 (2012-07)<S>; IEC 60601-1-2 (2014-02)<S>; IEC 60601-1-6 (2010-01)<S>; IEC 60601-1-6 AMD 1 (2013-10)<S>; IEC 60601-1-10 (2007-11)<S>; IEC 60601-1-11 (2015-01)<S>; IEC 60601-1-12 (2014-06)<S>; IEC 60601-2-2 (2017-03)<S>; IEC 62366-1 (2015-02)<S>; IEC 80369-5 (2016-03)<S>; ISO 80369-1 (2018-11)<S>; ISO 81060-2 (2013-05){historisch}<S>
  • Cited in:
    DIN EN IEC 80601-2-30 (2020-03); DIN EN ISO 81060-2 (2020-03)<STARR>; DIN EN ISO 81060-2 (2020-12)<STARR>; DIN EN ISO 81060-3 (2023-06)<STARR>; 18/30377771 DC (2018-07-09){historisch}; EN ISO 81060-2 (2019-11)<STARR>; EN ISO 81060-3 (2023-01)<STARR>; ISO 81060-2 (2018-11)<STARR>; ISO 81060-3 (2022-12)<STARR>; ISO/TS 81060-5 (2020-02)<STARR>; GOST ISO 81060-2 (2021)
  • Identical with:
    DIN EN IEC 80601-2-30(2020-03)<IDT>; ANSI/AAMI/IEC 80601-2-30(2018)<IDT>; AS 80601.2.30(2018)<MOD>; ABNT NBR IEC 80601-2-30(2021-12-08)<IDT>; BS EN IEC 80601-2-30(2019-07-03)<IDT>; NF C74-388(2019-05-24)<IDT>; IEC 80601-2-30(2018-03)<IDT>; CSA C22.2 No. 80601-2-30(2019-09-01)<IDT>; OVE EN IEC 80601-2-30(2020-04-01)<IDT>; UNE-EN IEC 80601-2-30(2019-07-01)<IDT>; TS EN IEC 80601-2-30(2019-09-30)<IDT>
  • Update flag: