• BS EN 60601-2-34:2014

    Current The latest, up-to-date edition.

    Medical electrical equipment Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  31-07-2014

    Publisher:  British Standards Institution

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

    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 of
           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
    202 Electromagnetic compatibility - Requirements
           and tests
    208 General requirements, tests and guidance for
           alarm systems in medical electrical equipment and
           medical electrical systems
    Annexes
    Annex AA (informative) - Particular guidance and rationale
    Annex BB (informative) - Alarm diagrams 208/IEC 60601-1-8:2006
    Bibliography
    Index of defined terms used in this particular standard
    Annex ZA (normative) - Normative references to international
              Publications with their corresponding
              European publications
    Annex ZZ (informative) - Coverage of Essential Requirements
              of EC Directives

    Abstract - (Show below) - (Hide below)

    Defines to BASIC SAFETY and ESSENTIAL PERFORMANCE of INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT.

    Scope - (Show below) - (Hide below)

    IEC 60601-2-34:2011 concerns the basic safety and essential performance of invasive blood pressure monitoring equipment. It amends and supplements IEC 60601-1 (third edition, 2005): Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. The third edition of IEC 60601-2-34 cancels and replaces the second edition published in 2001 and constitutes a technical revision in order to align structurally with the 2005 edition of IEC 60601-1. IEC 60601-2-34 applies to basic safety and essential performance of invasive blood pressure monitoring equipment. It does not apply to catheter tubing, catheter needles, Luer locks, taps and tap tables connected. It does not apply to non-invasive blood pressure monitoring equipment.

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

    Committee CH/62/4
    Development Note Supersedes 99/562553 DC. To be read in conjunction with BS EN 60601-1. (10/2005) Supersedes BS 5724-2.34(1995) and 91/54806 DC. (03/2006) 2001 Edition remains current and will be withdrawn on 27/06/2017. Supersedes 09/30169318 DC. (07/2014)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Superseded By
    Supersedes

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

    EN 60601-2-49:2015 Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
    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
    EN 60601-2-27:2014 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
    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
    EN 60601-1-2:2015 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
    IEC 80601-2-30:2009+AMD1:2013 CSV Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
    IEC 60601-2-27:2011 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    IEC 60601-2-49:2011 Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
    EN 60601-1-8:2007/A11:2017 MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS (IEC 60601-1-8:2006/A1:2012)
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