SIST EN 13976-2:2004
(Main)Rescue systems - Transportation of incubators - Part 2: System requirements
Rescue systems - Transportation of incubators - Part 2: System requirements
This standard specifies the requirements for an incubator transport system including the interactions between the vehicle and the incubator and the associated equipment, needed for care and treatment of noenates, used in emergency or planned transport. It also specifies the particular requirements needed to ensure proper function of equipment during transportation (e.g. monitors, respirators, infusion pumps, ECLS-systems, gas supply) and to provide safe transporation for infants and operators.
Rettungssysteme - Inkubatortransport - Teil 2: Anforderungen an Transportsysteme
Diese Europäische Norm legt die Anforderungen an ein Inkubatortransportsystem einschließlich der Wechselbeziehungen zwischen dem Fahrzeug und dem Inkubator sowie der dazugehörigen Ausrüstung fest, die bei Notfall- oder geplanten Transporten für die Pflege und Behandlung von Säuglingen erforderlich ist.
Sie legt auch die besonderen Anforderungen fest, die zur Sicherstellung der einwandfreien Funktion der Ausrüstung (z. B. Überwachungsgeräte, Beatmungsgeräte, Infusionspumpen, Systeme zur extrakorporalen Lungenunterstützung (ECLS), Versorgung mit Gasen) während des Transports und für einen sicheren Transport von Säuglingen und Personal gestellt werden müssen.
In dieser Norm ist auch festgelegt, dass die Ausrüstungen oder Systeme nicht störend in die Funktionen des Fahrzeugs eingreifen dürfen.
In dieser Norm sind keine Anforderungen an die Fahrzeuge, Geräte oder Inkubatoren selbst festgelegt, diese Anforderungen finden sich in anderen Normen. Transportinkubatoren sind jedoch normalerweise mit anderen Geräten verbunden und bilden ein "Inkubatortransportsystem".
Systémes de sauvetage - Transport d'incubateurs - Partie 2: Exigences relatives au systéme
La présente Norme européenne spécifie les exigences s'appliquant aux systemes d'incubateurs de transport, y compris aux interactions entre le véhicule, l'incubateur et les équipements associés, utilisés pour les soins aux nourrissons dans le cadre d'un transport d'urgence ou non.
Elle spécifie également les exigences particulieres nécessaires pour garantir un bon fonctionnement des équipements pendant le transport (par exemple : moniteurs, respirateurs, pompes de perfusion, systemes d'assistance respiratoire extracorporels, alimentation en gaz) et assurer la sécurité du nourrisson et du personnel soignant pendant le transport.
La présente Norme européenne stipule également que les équipements ou systemes ne doivent pas interférer avec les fonctions du véhicule ou de l'engin a moteur assurant le transport.
La présente Norme européenne ne prescrit pas d'exigences relatives aux véhicules, dispositifs ou incubateurs en tant que tels; ces exigences sont formulées dans d'autres normes. Cependant, les incubateurs de transport sont normalement combinés avec d'autres équipements, pour former un «systeme d'incubateur de transport».
Reševalni sistemi – Prevoz inkubatorjev – 2. del: Zahteve za sistem
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 13976-2:2004
01-februar-2004
Reševalni sistemi – Prevoz inkubatorjev – 2. del: Zahteve za sistem
Rescue systems - Transportation of incubators - Part 2: System requirements
Rettungssysteme - Inkubatortransport - Teil 2: Anforderungen an Transportsysteme
Systémes de sauvetage - Transport d'incubateurs - Partie 2: Exigences relatives au
systéme
Ta slovenski standard je istoveten z: EN 13976-2:2003
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
11.160 3UYDSRPRþ First aid
SIST EN 13976-2:2004 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 13976-2:2004
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SIST EN 13976-2:2004
EUROPEAN STANDARD
EN 13976-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2003
ICS 11.040.10; 11.160
English version
Rescue systems - Transportation of incubators - Part 2: System
requirements
Systémes de sauvetage - Transport d'incubateurs - Partie Rettungssysteme - Inkubatortransport - Teil 2:
2: Exigences relatives au systéme Anforderungen an Transportsysteme
This European Standard was approved by CEN on 3 November 2003.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2003 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 13976-2:2003 E
worldwide for CEN national Members.
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SIST EN 13976-2:2004
EN 13976-2:2003 (E)
Contents
page
Foreword.3
Introduction .4
1 Scope .5
2 Normative references .5
3 Terms and definitions.7
4 Requirements .7
4.1 System combination.7
4.2 Suspension/noise/comfort (shock-absorption).7
4.3 Temperature conditions .7
4.4 Ingress of liquids .7
4.5 Humidity.7
4.6 Protection against electrical shock .7
4.7 Pressure.8
4.8 Vibration.8
4.9 Mechanical integrity .8
4.10 Fire prevention .8
4.11 EMC .8
Annex A (normative) Medical devices used in conjunction with transport incubators.9
A.1 General.9
A.2 Monitors.9
A.3 Respirators and respiration devices.10
A.4 Devices for injection and infusion .11
A.5 Devices for diagnosis and treatment.11
A.6 Bandaging and nursing.11
A.7 Drugs.12
Annex B (informative) Staffing and ergonomics .13
B.1 General.13
B.2 Responsibility.13
B.3 Competence.13
B.4 Records.13
B.5 Space.14
B.6 Safety .14
B.7 Communication.14
B.8 Ergonomics .14
B.9 Insurance .14
Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other
provisions of EU Directives. .15
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SIST EN 13976-2:2004
EN 13976-2:2003 (E)
Foreword
This document (EN 13976-2:2003) has been prepared by Technical Committee CEN /TC 239, "Rescue systems",
the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an identical text or
by endorsement, at the latest by June 2004, and conflicting national standards shall be withdrawn at the latest by
June 2004.
Annex A is normative and annex B is informative.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal,
Slovakia, Spain, Sweden, Switzerland and the United Kingdom.
3
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SIST EN 13976-2:2004
EN 13976-2:2003 (E)
Introduction
This European standard gives the requirements for a transport incubator system that will ensure its
interchangeability as well as its safe and effective function in different vehicles or crafts. Such systems are
essential in allowing the uninterrupted care of patients. Requirements for interface conditions are given in part 1
(EN 13976-1).
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SIST EN 13976-2:2004
EN 13976-2:2003 (E)
1 Scope
This European Standard specifies the requirements for a transport incubator system including the interactions
between the vehicle or craft and the incubator and the associated equipment, needed for care and treatment of
infants, used in emergency or planned transport.
It also 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 standard also stipulates that the equipment or systems shall not interfere with the functions of the vehicle or
craft providing transportation.
This 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”.
2 Normative references
This European Standard incorporates by dated or undated reference, provisions from other publications. These
normative references are cited at the appropriate places in the text and the publications are listed hereafter. For
dated references, subsequent amendments to or revisions of any of these publications apply to this European
Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the
publication referred to applies (including amendments).
EN 455-1, Medical gloves for single use — Part 1: Requirements and testing for freedom from holes.
EN 455-2, Medical gloves for single use — Part 2: Requirements and testing for physical properties.
EN 455-3, Medical gloves for single use — Part 3: Requirements and testing for biological evaluation.
EN 794-1, Lung ventilators — Part 1: Particular requirements for critical care ventilators.
EN 794-3, Lung ventilators — Part 3: Particular requirements for emergency and transport ventilators.
EN 864, Medical electrical equipment — Capnometers for use with humans – Particular requirements.
EN 865, Pulse oximeters — Particular requirements.
EN 1060-1, Non-invasive sphygmomanometers — Part 1: General requirements.
EN 1060-2, Non-invasive sphygmomanometers — Part 2: Supplementary requirements for mechanical
sphygmomanometers.
EN 1281-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets.
EN 1281-2, Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-
bearing connectors.
EN 1615, Enteral feeding catheters and enteral giving sets for single use and their connectors - Design and testing
EN 1617, Sterile drainage catheters and accessory devices for single use.
EN 1618, Catheters other than intravascular catheters — Test methods for common properties.
EN 1707, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Lock
fittings.
EN 1733, Suction catheters for use in the respiratory tract.
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SIST EN 13976-2:2004
EN 13976-2:2003 (E)
EN 1782, Tracheal tubes and connectors.
EN 1789:1999, Medical vehicles and their equipment — Road ambulances.
EN 1819, Laryngoscopes for tracheal intubation — Particular requirements.
EN 1865, Specifications for stretchers and other patient handling equipment used in road ambulances.
EN 12342, Breathing tubes intended for use with anaesthetic apparatus and ventilators.
EN 13718-1, Air, water and difficult terrain ambulances — Part 1: Medical device interface
requirements for the continuity of patient care.
EN 13718-2, Air, water and difficult terrain ambulances — Part 2: Operational and technical requirements for
continuity of patient care.
EN 13976-1, Rescue systems — Transportation of incubators — Part 1: Interface conditions.
EN 60601-1:1990, Medical electrical equipment — Part 1: General requirements for safety (IEC 60601-1:1988).
EN 60601-1-2, Medical electrical equipment — Part 1-2: General requirements for safety. Collateral standard:
Electromagnetic compatibility — Requirements and tests (IEC 60601-1-2:2001).
EN 60601-2-20:1996, Medical electrical equipment — Part 2: Particular requirements for safety of transport
incubators (IEC 60601-2-20:1990).
EN 60601-2-24, Medical electrical equipment — Part 2: Particular requirements for the safety of infusion pumps
and controllers (IEC 60601-2-24:1998).
EN 60601-2-30, Medical electrical equipment — Part 2-30: Particular requirements for the safety, including
essential performance, of automatic cycling non-invasive blood pressure monitoring equipment (IEC 60601-2-
30:1999).
EN ISO 6009, Hypodermic needles for single use — Colour coding for identification (ISO 6009:1992).
EN ISO 7864, Sterile hypodermic needles for single use (ISO 7864:1993).
EN ISO 7886-1, Sterile hypodermic syringes for single use — Part 1: Syringes fo
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