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  • AAMI IEC 80601-2-30 : 2009

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    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

    Superseded date:  20-02-2019

    Language(s):  English

    Published date:  01-01-2009

    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 IEC 80601-2-30:2009
    AAMI inclusion to IEC 80601-2-30:2009
    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
    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 compatibility - Requirements and
            tests
    Annexes
    Annex C (informative) - Guide to marking and labeling
                            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

    Abstract - (Show below) - (Hide below)

    Pertains 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 intermittent indirect measurement of the BLOOD PRESSURE without arterial puncture.

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

    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By

    Standards Referenced By This Book - (Show below) - (Hide below)

    AAMI TIR44 : 2012 NON-INVASIVE BLOOD PRESSURE MOTION ARTIFACT - TESTING AND EVALUATION OF NIBP DEVICE PERFORMANCE IN THE PRESENCE OF MOTION ARTIFACT

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

    IEC 60068-2-27:2008 Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
    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 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 60068-2-31:2008 Environmental testing - Part 2-31: Tests - Test Ec: Rough handling shocks, primarily for equipment-type specimens
    IEC 60068-2-64:2008 Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    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"
    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
    ISO 81060-2:2013 Non-invasive sphygmomanometers Part 2: Clinical investigation of automated measurement type
    ISO 9919:2005 Medical electrical equipment Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use
    ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
    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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