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  • BS 5724-2.124(1998) : 1998

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF INFUSION PUMPS AND CONTROLLERS

    Available format(s): 

    Superseded date:  30-06-2015

    Language(s): 

    Published date:  23-11-2012

    Publisher:  British Standards Institution

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

    INTRODUCTION
    SECTION ONE - GENERAL
    1 Scope and object
    2 Terminology and definitions
    3 General requirements
    5 Classification
    6 Identification, marking and documents
    SECTION TWO - ENVIRONMENTAL CONDITIONS
    10 Environmental conditions
    SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
    14 Requirements related to classification
    17 Separation
    19 Continuous leakage currents and patient auxiliary currents
    SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
    21 Mechanical strength
    SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR
    EXCESSIVE RADIATION
    36 Electromagnetic compatibility
    SECTION SIX - PROTECTION AGAINST EXCESSIVE TEMPERATURES AND
    OTHER SAFETY HAZARDS
    44 Overflow, spillage, leakage, humidity, ingress of liquids,
        cleaning, sterilization, disinfection and compatibility
    47 Electrostatic charges
    49 Interruption of the power supply
    SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION
    AGAINST HAZARDOUS OUTPUT
    50 Accuracy of operating data
    51 Protection against hazardous output
    SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS:
    ENVIRONMENTAL TESTS
    SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
    54 General
    56 Components and general assembly
    Annexes
    L References - Publications mentioned in this standard
    AA General guidance and rationale
    ZA Normative references to international publications with
        their corresponding European publications

    Abstract - (Show below) - (Hide below)

    Defines requirement for infusion pumps, infusion controllers, syringe pumps and pumps for ambulatory use as specified in 2.101 and 2.110, for use by medical staff and home patients as prescribed and medically indicated.

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

    Committee CH/62/4
    Development Note Also numbered as BS 5724-2.24(1998). To be read in conjunction with BS EN 60601-1-2 & BS EN 60601-1. Supersedes 90/51556 DC. (11/2005) Superseded by BS EN 60601-2-24 but remains active & will be withdrawn on 14/04/2018. (08/2015)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded

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

    ISO 3744:2010 Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Engineering methods for an essentially free field over a reflecting plane
    IEC 61000-4-4 : 3.0EN+(REDLINE+VERSION) ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-4: TESTING AND MEASUREMENT TECHNIQUES - ELECTRICAL FAST TRANSIENT/BURST IMMUNITY TEST
    IEC 60521:1988 Class 0.5, 1 and 2 alternating-current watthour meters
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    EN 60521:1995/corrigendum Dec. 1997 CLASS 0,5, 1 AND 2 ALTERNATING-CURRENT WATTHOUR METERS
    HD 481.1 : 200S1 ELECTROMAGNETIC COMPATIBILITY FOR INDUSTRIAL-PROCESS MEASUREMENT AND CONTROL EQUIPMENT - GENERAL INTRODUCTION
    ISO 7886-2:1996 Sterile hypodermic syringes for single use Part 2: Syringes for use with power-driven syringe pumps
    EN 60804:2000 Integrating-averaging sound level meters
    EN ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)
    EN 61000-4-3 : 2006 AMD 2 2010 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-3: TESTING AND MEASUREMENT TECHNIQUES - RADIATED, RADIO-FREQUENCY, ELECTROMAGNETIC FIELD IMMUNITY TEST
    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 60801-1:1984 Electromagnetic compatibility for industrial-process measurement and control equipment. Part 1: General introduction
    IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
    EN ISO 3744:2010 Acoustics - Determination of sound power levels and sound energy levels of noise sources using sound pressure - Engineering methods for an essentially free field over a reflecting plane (ISO 3744:2010)
    IEC 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test
    ISO 7864:2016 Sterile hypodermic needles for single use — Requirements and test methods
    ISO 8536-4:2010 Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed
    ISO 3696:1987 Water for analytical laboratory use — Specification and test methods
    EN ISO 3696:1995 Water for analytical laboratory use - Specification and test methods (ISO 3696:1987)
    EN 61000-4-4:2012 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-4: TESTING AND MEASUREMENT TECHNIQUES - ELECTRICAL FAST TRANSIENT/BURST IMMUNITY TEST (IEC 61000-4-4:2012)
    EN 60651:1994/A2:2001 SOUND LEVEL METERS (IEC 60651:1979/A2:2000)
    EN 60529:1991/AC:2016-12 DEGREES OF PROTECTION PROVIDED BY ENCLOSURES (IP CODE) (IEC 60529 EDITION 2.2 CORRIGENDUM 2:2015)
    BS EN 60601-1 : 2006 MEDICAL ELECTRICAL EQUIPMENT PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE
    IEC 60651:1979+AMD1:1993+AMD2:2000 CSV Sound level meters
    IEC 60801-2:1991 Electromagnetic compatibility for industrial-process measurement and control equipment - Part 2: Electrostatic discharge requirements
    EN 60801-2 : 1993 ELECTROMAGNETIC COMPATIBILITY FOR INDUSTRIAL-PROCESS MEASUREMENT AND CONTROL EQUIPMENT - PART 2: ELECTROSTATIC DISCHARGE REQUIREMENTS (IEC 801-2:1991)
    IEC 60804:2000 Integrating-averaging sound level meters
    BS EN 60601-1-2:2015 Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard. Electromagnetic disturbances. Requirements and tests
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