BS EN 13976-2-2011 pdf download.Rescue systems Transportation of incubators Part 2 : System requirements.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
EN 1789. Medical vehicles and their equipment — Road ambulances
EN 1865 (all parts). Patient handling equipment used in road ambulances
EN 13718-1, Medical vehicles and their equipment — Air ambulances — Part 1: Requirements for medical devices used in air ambulances
EN 13718-2, Medical vehicles and their equipment — Air ambulances — Part 2: Operational and technical requirements of air ambulances
EN 13976-1 :2011, Rescue systems — Transportation of incubators — Part 1: Interface conditions
EN 60601-1, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005)
EN 60601-1-2, Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral standard: Electromagnetic compatibility — Requirements and tests (IEC 60601-1-2:2007, modified)
EN 60601-2-20, Medical electrical equipment — Part 2-20: Particular requirements for basic safety and essential performance of infant transport incubators (IEC 60601-2-20:2009)
RTCA 00 160, Radio Technical Commission for Aeronautics — Environmental conditions and test procedures for airborne equipment (corresponding to EUROCAE ed-14) /publication available at the RTCA Secretariat. Suite 500. 1425 K Street. N. W. Washington DC, 20005, USA)
RTCA 00 199, Radio Technical Commission for Aeronautics Potential interference to aircraft electronic equipment from devices carried on board fpublication available at the RTCA Secretariat, Suite 500, 1425 K Street, N. W. Washington DC, 20005. USA]
4.1 System combination
Requirements for interfaces are found in part 1 of this standard (EN 13976-1) and basic requirements for transport incubators are described in EN 60601-2-20.
Any medical device which is part of the transport Incubator system shall be designed for use with neonates and infants and for use In transport settings. All of the equipment that is integrated or part of the system shall be tested according to the existing standards relevant to the type of vehicle in which it is to be used Equipment employed as part of transport incubator system shall be specified by the manufacturer as having an intended use in transportation by road and air ambulances and labelled according to the standard.
NOTE Basic requirements for vehicles used as ambulances and medical devices in these vehicles are described in EN 1789 for road ambulances, in EN 13718.1 and EN 13718.2 for air ambulances and in EN 1865 for stretchers.
4.2 Suspension/noise/comfort (shock-absorption)
Ear defenders for the infants shall be used during all transports. Noise from additional equipment shall not exceed 60 dB(A) as set by EN 60601-2-20.
NOTE Vibration and noise can interfere with the general comfort and well-being of infants. Therefore the vibration to which they are exposed should be as low as possible. The transportation of the baby should be at an appropriate speed to ensure the comfort of the baby, High speeds are rarely necessary.
4.3 Temperature conditions
4.3.1 The transport incubator system shall comply with the relevant requirements of EN 60601-2-20 as a minimum standard with regard to controlling the internal temperature.
4.3.2 Where the transport incubator system is to be used at extremes of temperature, additional test data shall be supplied in the accompanying documents. These should include, where relevant, information about operation during exposure up to + 40 °C for 15 mm and —30 °C for 15 mm. The effect of wind chill at intermediate temperatures should be considered.
4.4 Ingress of liquids
All equipment forming part of the transport incubator system shall be drip-proof according to EN 6060 1-2-20.
If the equipment complies with this standard only with an additional accessory or procedure, the manufacturer
shall describe in the accompanying documents how to comply with this standard.
4.5 VIbration
All equipment forming part of the transport incubator system shall comply with EN 1789 or EN 13718-1 and
EN 13718-2.
4.7 EMC
All equipment forming part of the transport incubator system shall comply with EN 60601.1-2 and EN 60601-2-20. Equipment used during air transportation shall comply with RTCA DO 160.
For equipment used for transportation, each user shall carry out mutual compatibility assessments when required to ensure that all medical equipment functions correctly in each mode of transport and with every type of equipment for communication and/or navigation to be used during the transport.
NOTE The manufacturer should indude the requirement for mutual compatibility assessments in the Instructions for use.
4.8 Mass
The mass of the transport incubator system including Its rail parts shall not exceed 140 kg. The requirement for stretchers defined in EN 1865 is 150 kg minimum loading capacity, a margin of 10 kg for the interface is used. The TIS shall be marked with its weight.
NOTE 1 ThIs clause does not apply for cases where the trolley is an integral part of the TIS.
NOTE 2 In all cases the mass should be as low as possible. In cases where the TIS has to be transported in air
ambulances more restrictive weight limits may apply.
4.9 Electricity
The transport incubator system shall be capable of operating on 12 V DC, 24 V DC or, 24VDC and 230 V ACI5O Hz power supplies during transport.
The electrical system shall be designed to prevent the vehicle from draining electrical power from the transport incubator system or Its interface equipment.
4.10 Fixation of component parts
All component parts of the transport Incubator system shall be securely fixed in road ambulances in conformity with EN 1789 and test criteria for the vehicle used or for aircraft as specified by the aviation authorities in accordance with EN 13718-1.
4.11 Modifications
Where a transport incubator system is modified by someone other than the original manufacturer of the transport incubator system, the modifier shall confirm that any additional device is appropriately secured (according to EN 1789, EN 60601-1) and that the fixation of the transport incubator system to the vehicle can still safely carry the extra load (EN 1789 and EN 13718-1 and EN 13718-2).BS EN 13976-2-2011 pdf download.
BS EN 13976-2-2011 pdf download
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