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  • AAMI ISO 81060-1:2007(R2013)

    Current The latest, up-to-date edition.

    NON INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  26-06-2013

    Publisher:  Association for the Advancement of Medical Instrumentation

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

    Glossary of equivalent standards
    Committee representation
    Background of AAMI Adoption of ISO 81060-1:2007
    AAMI inclusion to ISO 81060-1:2007
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Identification and marking
       4.1 Units of measurement
       4.2 Legibility of markings
       4.3 Durability of markings
       4.4 Marking of non-automated sphygmomanometer
       4.5 Usability of reading
       4.6 Marking of the cuff
       4.7 Marking of the non-automated sphygmomanometer
            packaging
    5 General requirements for testing non-automated
       sphygmomanometers
       5.1 Type tests
       5.2 Representative sample
       5.3 Environmental conditions
       5.4 Repairs and modifications
       5.5 Humidity preconditioning treatment
    6 General requirements
       6.1 General
       6.2 Electrical safety
       6.3 Mechanical safety
       6.4 Mechanical strength
    7 Requirements
       7.1 Pressure indicating means
       7.2 Pneumatic system
       7.3 Tamper proofing or unauthorized access
       7.4 Dynamic response in normal use
       8 Additional requirements for non-automated
         sphygmomanometer with mercury manometer
       8.1 Internal diameter of the tube containing mercury
       8.2 Portable non-automated sphygmomanometer
       8.3 Prevention of mercury spillage during transport
       8.4 Prevention of mercury spillage in normal use
       8.5 Quality of the mercury
    9 Non-automated sphygmomanometers with aneroid manometer
       9.1 Scale mark at zero
       9.2 Zero
       9.3 Hysteresis error
       9.4 Construction and materials
    10 Cleaning, sterilization and disinfection
       10.1 Reusable non-automated sphygmomanometer and parts
       10.2 Non-automated sphygmomanometer and parts requiring
            processing before use
       10.3 Non-automated sphygmomanometer and parts delivered
            sterile
    11 Biocompatibility
    12 Information supplied by the manufacturer
       12.1 Accompanying document
       12.2 Instructions for use
       12.3 Technical description
    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

    Abstract - (Show below) - (Hide below)

    Describes the requirements for non-automated sphygmomanometers, as defined in 3.11, 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)

    Committee WG 07
    Document Type Test Method
    Product Note Reconfirmed 2013
    Publisher Association for the Advancement of Medical Instrumentation
    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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