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  • IEC 80601-2-30:2018

    Current The latest, up-to-date edition.

    Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s):  English - French

    Published date:  22-03-2018

    Publisher:  International Electrotechnical Committee

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    Table of Contents - (Show below) - (Hide below)

    FOREWORD
    INTRODUCTION
    201.1 Scope, object and related standards
    201.2 Normative references
    201.3 Terms and definitions
    201.4 General requirements
    201.5 General requirements for testing ME EQUIPMENT
    201.6 Classification of ME EQUIPMENT and ME SYSTEMS
    201.7 ME EQUIPMENT identification, marking and
            documents
    201.8 Protection against electrical HAZARDS from ME
            EQUIPMENT
    201.9 Protection against mechanical HAZARDS of ME
            EQUIPMENT and ME SYSTEMS
    201.10 Protection against unwanted and excessive
            radiation HAZARDS
    201.11 Protection against excessive temperatures
            and other HAZARDS
    201.12 Accuracy of controls and instruments and
            protection against hazardous outputs
    201.13 HAZARDOUS SITUATIONS and fault conditions
            for ME EQUIPMENT
    201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
            (PEMS)
    201.15 Construction of ME EQUIPMENT
    201.16 ME SYSTEMS
    201.17 Electromagnetic compatibility of ME EQUIPMENT
            and ME SYSTEMS
    201.101 Requirements for CUFFS
    201.102 Connection tubing and CUFF connectors
    201.103 Unauthorized access
    201.104 Maximum inflating time
    201.105 Automatic cycling modes
    201.106 Clinical accuracy
    202 Electromagnetic disturbances - Requirements and
            tests
    206 Usability
    210 Requirements for the development of physiologic
            closed-loop controllers
    211 Requirements for medical electrical equipment
            and medical electrical systems used in the
            home healthcare environment
    212 Requirements for medical electrical equipment
            and medical electrical systems intended for
            use in the emergency medical services environment
    Annexes
    Annex C (informative) - Guide to marking and labelling
            requirements for ME EQUIPMENT and
            ME SYSTEMS
    Annex AA (informative) - Particular guidance and rationale
    Annex BB (informative) - Environmental aspects
    Annex CC (informative) - Reference to the ESSENTIAL PRINCIPLES
    Bibliography
    Index of defined terms

    Abstract - (Show below) - (Hide below)

    IEC 80601-2-30:2018 is also available as IEC 80601-2-30:2018 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.

    IEC 80601-2-30:2018 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. 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. 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 201.11 and 201.105.3.3, as well as 7.2.13 and 8.4.1 of IEC 60601-1:2005. This second edition cancels and replaces the first edition published in 2009 and Amendment 1:2013. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:
    a) alignment with IEC 60601-1:2005/AMD1:2012 and IEC 60601-1-8:2006/AMD1:2012 , and with IEC 60601-1-2:2014 and IEC 60601-1-11:2015;
    b) referencing IEC 60601-1-10:2007 and IEC 60601-1-12;
    c) changing an operator-accessible cuff-sphygmomanometer connector from not compatible with the ISO 594 series to compatible with the ISO 80369 series;
    d) added additional requirements for public self-use sphygmomanometers;
    e) added a list of primary operating functions.

    General Product Information - (Show below) - (Hide below)

    Committee TC 62/SC 62D
    Development Note Supersedes IEC 60601-2-30. (01/2009) Stability Date: 2022. (03/2018)
    Document Type Standard
    Publisher International Electrotechnical Committee
    Status Current
    Supersedes

    Standards Referencing This Book - (Show below) - (Hide below)

    IEC 60068-2-27:2008 Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO 81060-1:2007 Non-invasive sphygmomanometers — Part 1: Requirements and test methods for non-automated measurement type
    IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
    IEC 60721-3-7:1995+AMD1:1996 CSV Classification of environmental conditions - Part 3-7: Classification of groups of environmental parameters and their severities - Portable and non-stationary use
    ISO 16142-1:2016 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
    IEC 60601-1-10:2007+AMD1:2013 CSV Medical electrical equipment - Part 1-10: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers
    IEC 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
    IEC 60068-2-64:2008 Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance
    ISO 21647:2004 Medical electrical equipment Particular requirements for the basic safety and essential performance of respiratory gas monitors
    IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
    IEC 60601-2-2:2017 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
    CR 13825:2000 Luer connectors - A report to CEN chef from the CEN forum task group "Luer fittings"
    IEC 60601-1-3:2008+AMD1:2013 CSV Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
    ISO 81060-2:2013 Non-invasive sphygmomanometers Part 2: Clinical investigation of automated measurement type
    ISO 80369-1:2010 Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements
    ISO 9919:2005 Medical electrical equipment Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use
    IEC TR 60721-4-7:2001+AMD1:2003 CSV Classification of environmental conditions - Part 4-7: Guidance for the correlation and transformation of environmental condition classes of IEC 60721-3 to the environmental tests of IEC 60068 - Portable and non-stationary use
    ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
    IEC 60601-1-9:2007+AMD1:2013 CSV Medical electrical equipment - Part 1-9: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
    ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
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