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  • EN 13976-2:2011

    View superseded by
    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Rescue systems - Transportation of incubators - Part 2: System requirements

    Available format(s): 

    Superseded date:  25-06-2019

    Language(s): 

    Published date:  18-05-2011

    Publisher:  Comite Europeen de Normalisation

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements
    Annex A (informative) - Ergonomics
    Annex ZA (informative) - Relationship between this
             European Standard and the Essential
             Requirements of EU Directive 93/42/EEC
             on medical devices
    Bibliography

    Abstract - (Show below) - (Hide below)

    This European Standard specifies the requirements for a transport incubator system needed for care and treatment of infants, used in emergency or planned transport.It specifies the particular requirements needed to ensure the proper function of equipment during transportation (e.g. monitors, respirators, infusion pumps, extra corporeal lung support- (ECLS-) systems, gas supply) and to provide safe transportation for infants and operators.This European Standard also stipulates that the equipment or systems shall not interfere with the functions of the ambulance providing transportation.This European Standard does not give requirements for the vehicles, crafts, devices or incubators as such, these requirements are found in other standards. However, transport incubators are normally combined with other equipment to form a transport incubator system.

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

    Committee CEN/TC 239
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Superseded
    Superseded By

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

    I.S. EN 1865-5:2012 PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 5: STRETCHER SUPPORT
    BS EN 13718-1:2014 Medical vehicles and their equipment. Air ambulances Requirements for medical devices used in air ambulances
    EN 13718-2:2015 Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances
    BS EN 13976-1:2011 Rescue systems. Transportation of incubators Interface conditions
    12/30266576 DC : 0 BS EN 13718-2 - MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS OF AIR AMBULANCES
    13/30276231 DC : 0 BS EN 13718-1 - MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES
    06/30106983 DC : 0 EN 13718-1 - MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS OF MEDICAL DEVICES USED IN AIR AMBULANCES
    EN 13976-1:2011 Rescue systems - Transportation of incubators - Part 1: Interface conditions
    UNI EN 13718-1 : 2014 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES
    BS EN 1865-5:2012 Patient handling equipment used in road ambulances Stretcher support
    09/30205924 DC : 0 BS EN 13976-1 - RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS
    UNI EN 1865-5 : 2012 PATIENT HANDLING EQUIPMENT USED IN ROAD AMBULANCES - PART 5: STRETCHER SUPPORT
    UNE-EN 13976-1:2011 Rescue systems - Transportation of incubators - Part 1: Interface conditions
    DIN EN 13718-2:2015-05 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES
    DIN EN 13718-1:2014-12 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES
    UNE-EN 13718-2:2015 Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances
    16/30333928 DC : 0 BS EN 13976-1 - RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS
    UNI EN 13976-1 : 2011 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS
    EN 13718-1:2014 Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
    I.S. EN 13718-1:2014 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 1: REQUIREMENTS FOR MEDICAL DEVICES USED IN AIR AMBULANCES
    BS EN 13718-2:2015 Medical vehicles and their equipment. Air ambulances Operational and technical requirements for air ambulances
    I.S. EN 13718-2:2015 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES
    I.S. EN 13718-2:2015+A1:2020 MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES
    DIN EN 13976-1 E : 2011 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS
    EN 1865-5:2012 Patient handling equipment used in road ambulances - Part 5: Stretcher support
    DIN EN 1865-5:2012-09 Patient handling equipment used in road ambulances - Part 5: Stretcher support
    DIN EN 13976-1:2016-03 (Draft) RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS
    I.S. EN 13976-1:2011 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS
    DIN EN 13976-1:2011-08 RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 1: INTERFACE CONDITIONS

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

    EN 794-1:1997+A2:2009 Lung ventilators - Part 1: Particular requirements for critical care ventilators
    EN 60601-2-20:2009/A1:2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-20: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT TRANSPORT INCUBATORS (IEC 60601-2-20:2009/A1:2016)
    ISO 8836:2014 Suction catheters for use in the respiratory tract
    EN 455-1:2000 MEDICAL GLOVES FOR SINGLE USE - PART 1: REQUIREMENTS AND TESTING FOR FREEDOM FROM HOLES
    EN 12342:1998+A1:2009 Breathing tubes intended for use with anaesthetic apparatus and ventilators
    ISO 7376:2009 Anaesthetic and respiratory equipment Laryngoscopes for tracheal intubation
    EN 60601-2-24:2015 Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
    EN 1060-2:1995+A1:2009 Non-invasive sphygmomanometers - Part 2: Supplementary requirements for mechanical sphygmomanometers
    EN ISO 8836:2014 Suction catheters for use in the respiratory tract (ISO 8836:2014)
    EN ISO 7886-2 : 1997 STERILE HYPODERMIC SYRINGES FOR SINGLE USE - SYRINGES FOR USE WITH POWER-DRIVEN SYRINGE PUMPS
    EN 1618 : 1997 CATHETERS OTHER THAN INTRAVASCULAR CATHETERS - TEST METHODS FOR COMMON PROPERTIES
    EN 1060-1:1995+A2:2009 Non-invasive sphygmomanometers - Part 1: General requirements
    ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin
    EN 1782:1998+A1:2009 Tracheal tubes and connectors
    EN 13718-1:2014 Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
    EN ISO 5356-1:2015 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2015)
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    EN ISO 7376:2009 Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2009)
    ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
    EN ISO 10079-2:2014 Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2014)
    EN 794-3:1998+A2:2009 Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators
    IEC 60601-2-20:2009+AMD1:2016 CSV Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transportincubators
    RTCA DO 199 VOL II : 1988 Potential Interference to Aircraft Electronic Equipment from Devices Carried Aboard (Vol II)
    EN 455-3:2015 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
    ISO 7886-2:1996 Sterile hypodermic syringes for single use Part 2: Syringes for use with power-driven syringe pumps
    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
    EN ISO 10555-3:2013 Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous catheters (ISO 10555-3:2013)
    EN ISO 6009:2016 Hypodermic needles for single use - Colour coding for identification (ISO 6009:2016)
    ISO 5356-2:2012 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
    ISO 10079-1:2015 Medical suction equipment Part 1: Electrically powered suction equipment
    EN ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)
    EN 864 : 1996 MEDICAL ELECTRICAL EQUIPMENT - CAPNOMETERS FOR USE WITH HUMANS - PARTICULAR REQUIREMENTS
    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
    ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
    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
    ISO 8185:2007 Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems
    EN ISO 21647:2009 Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 21647:2004, including Cor 1:2005)
    EN 60601-2-30:2000 Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment
    ISO 10079-2:2014 Medical suction equipment Part 2: Manually powered suction equipment
    IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
    EN ISO 10555-5:2013 Intravascular catheters - Sterile and single-use catheters - Part 5: Over-needle peripheral catheters (ISO 10555-5:2013)
    EN ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016)
    ISO 7864:2016 Sterile hypodermic needles for single use — Requirements and test methods
    RTCA DO 199 VOL I : 1988 Potential Interference to Aircraft Electronic Equipment from Devices Carried Aboard (Vol I)
    EN ISO 5356-2:2012 Anaesthetic and respiratory equipment - Conical connectors - Part 2: Screw-threaded weight-bearing connectors (ISO 5356-2:2012)
    ISO 10555-3:2013 Intravascular catheters — Sterile and single-use catheters — Part 3: Central venous catheters
    ISO 9919:2005 Medical electrical equipment Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use
    ISO 10555-1:2013 Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements
    EN 455-2:2015 Medical gloves for single use - Part 2: Requirements and testing for physical properties
    IEC 60601-2-24:2012 Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
    EN 1615 : 2000 ENTERAL FEEDING CATHETERS AND ENTERAL GIVING SETS FOR SINGLE USE AND THEIR CONNECTORS - DESIGN AND TESTING
    EN 1789:2007+A2:2014 Medical vehicles and their equipment - Road ambulances
    EN 60529:1991/AC:2016-12 DEGREES OF PROTECTION PROVIDED BY ENCLOSURES (IP CODE) (IEC 60529 EDITION 2.2 CORRIGENDUM 2:2015)
    EN 13976-1:2011 Rescue systems - Transportation of incubators - Part 1: Interface conditions
    EN ISO 8185:2009 Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007)
    ISO 6009:2016 Hypodermic needles for single use Colour coding for identification
    EN 1707 : 1996 CONICAL FITTINGS WITH A 6 % (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - LOCK FITTINGS
    ISO 10555-5:2013 Intravascular catheters — Sterile and single-use catheters — Part 5: Over-needle peripheral catheters
    EN ISO 9919:2009 Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use (ISO 9919:2005)
    EN 1617 : 1997 STERILE DRAINAGE CATHETERS AND ACCESSORY DEVICES FOR SINGLE USE
    EN 13718-2:2015 Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances
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