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  • BS EN ISO 81060-1:2012

    Current The latest, up-to-date edition.

    Non-invasive sphygmomanometers Requirements and test methods for non-automated measurement type

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  31-07-2012

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Identification and marking
    5 General requirements for testing non-automated
       sphygmomanometers
    6 General requirements
    7 Requirements
    8 Additional requirements for non-automated sphygmomanometer
       with mercury manometer
    9 Non-automated sphygmomanometers with aneroid manometer
    10 Cleaning, sterilization and disinfection
    11 Biocompatibility
    12 Information supplied by the manufacturer
    Annex A (informative) - Rationale and guidance
    Annex B (informative) - Advice regarding non-automated
            sphygmomanometers with a mercury manometer
    Annex C (informative) - Environmental aspects
    Annex D (informative) - Reference to the essential principals
    Annex E (informative) - Terminology - Alphabetized index of
            defined terms
    Bibliography
    Annex ZA (informative) - Relationship between this European
             Standard and the Essential Requirements of EU
             Directive 93/42/EEC on medical devices

    Abstract - (Show below) - (Hide below)

    Describes requirements for non-automated sphygmomanometers, and their accessories, which, by means of inflatable cuffs, are used for the non-invasive blood pressure measurement by operator observation.

    Scope - (Show below) - (Hide below)

    ISO 81060-1:2007 specifies requirements for non-automated sphygmomanometers and their accessories, which, by means of inflatable cuffs, are used for the non-invasive blood pressure measurement by operator observation. ISO 81060-1:2007 specifies requirements for the safety and essential performance, including effectiveness and labelling, for non-automated sphygmomanometers and their accessories, including test methods to determine the accuracy of non-invasive blood pressure measurement. ISO 81060-1:2007 covers non-invasive blood pressure measurement devices with a pressure-sensing element and display used in conjunction with means of detecting blood flow.

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

    Committee CH/205/10
    Development Note Renumbers & supersedes BS ISO 81060-1. 2012 version incorporates corrigendum to BS ISO 81060-1. Supersedes 06/30137313 DC, BS EN 1060-1, BS EN 1060-2 & 11/30251468 DC. (07/2012)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

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

    ISO 7010:2011 Graphical symbols Safety colours and safety signs Registered safety signs
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    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 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
    IEC 60601-2-30:1999 Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment
    IEC 60601-2-34:2011 Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
    ISO 21647:2004 Medical electrical equipment Particular requirements for the basic safety and essential performance of respiratory gas monitors
    CR 13825:2000 Luer connectors - A report to CEN chef from the CEN forum task group "Luer fittings"
    ISO/TR 16142:2006 Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
    IEC 60721-3-0:1984+AMD1:1987 CSV Classification of environmental conditions - Part 3: Classification of groups of environmental parameters and their severities - Introduction
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    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 14971:2007 Medical devices Application of risk management to medical devices
    ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    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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