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    I.S. EN ISO 81060-1:2012

    Current The latest, up-to-date edition.

    NON-INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE (ISO 81060-1:2007)

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2012

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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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.

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

    Development Note Supersedes I.S. EN 1060-1 and I.S. EN 1060-2. (06/2012)
    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Current

    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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