EN ISO 7396-1:2007
(Main)Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2007)
Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2007)
ISO 7396-1:2007 specifies requirements for design, installation, function, performance, documentation, testing and commissioning of pipeline systems for compressed medical gases, gases for driving surgical tools and vacuum in healthcare facilities to ensure continuous delivery of the correct gas and the provision of vacuum from the pipeline system. It includes requirements for supply systems, pipeline distribution systems, control systems, monitoring and alarm systems and non-interchangeability between components of different gas systems.
ISO 7396-1:2007 is applicable to pipeline systems for the following medical gases: oxygen, nitrous oxide, medical air, carbon dioxide, oxygen/nitrous oxide mixtures; to pipeline systems for the following gases: oxygen-enriched air, air for driving surgical tools, nitrogen for driving surgical tools; and to pipeline systems for vacuum.
ISO 7396-1:2007 also applies to extensions of existing pipeline distribution systems, modifications of existing pipeline distribution systems and modifications or replacement of supply systems or sources of supply.
Rohrleitungssysteme für medizinische Gase - Teil 1: Rohrleitungenssyteme für medizinische Druckgase und Vakuum (ISO 7396-1:2007)
Dieser Teil von ISO 7396 legt Anforderungen an Auslegung, Installation, Funktion, Leistung, Dokumentation, Prüfung und Inbetriebnahme von Rohrleitungssystemen für medizinische Druckgase, Gase zum Betreiben chirurgischer Werkzeuge und Vakuum in Gesundheitseinrichtungen fest, um die Beständigkeit der Lieferung des korrekten Gases und die Bereitstellung eines Vakuums durch das Rohrleitungssystem sicherzustellen. Einbezogen sind Anforderungen an Versorgungssysteme, Rohrverteilersysteme, Regel , Überwachungs und Alarmsysteme und die Nichtaustauschbarkeit zwischen Bauteilen unterschiedlicher Gassysteme.
Dieser Teil von ISO 7396 gilt für:
a) Rohrleitungssysteme für folgende medizinische Gase:
Sauerstoff;
Distickstoffoxid (Lachgas);
medizinische Luft;
Kohlendioxid;
Gemische von Sauerstoff und Distickstoffoxid (siehe Anmerkung 1);
b) Rohrleitungssysteme für folgende Gase:
(*) mit Sauerstoff angereicherte Luft;
Luft zum Betreiben chirurgischer Werkzeuge;
Stickstoff zum Betreiben chirurgischer Werkzeuge;
c) Rohrleitungssysteme für Vakuum.
Dieser Teil von ISO 7396 gilt auch für:
Erweiterungen bestehender Rohrverteilersysteme;
Veränderungen bestehender Rohrverteilersysteme;
Veränderungen oder Ersatz von Versorgungssystemen oder Versorgungsquellen.
ANMERKUNG 1 Regionale oder nationale Bestimmungen können die Verteilung von Gemischen von Sauerstoff und Distickstoffoxid in Rohrleitungssystemen für medizinische Gase untersagen.
(*)ANMERKUNG 2 EN 14931 [23] legt zusätzliche oder alternative Anforderungen an die spezifische Verwendung fest, insbesondere Anforderungen an Durchflüsse und Drücke von Druckluft, die erforderlich ist, um die hyperbaren Kammern unter Druck zu setzen und andere damit verbundene Versorgungseinrichtungen zu betreiben, sowie an Durchflüsse und Drücke von Sauerstoff und weiteren Behandlungs¬gasen, die Patienten verabreicht werden.
Systèmes de distribution de gaz médicaux - Partie 1 : Systèmes de distribution de gaz médicaux comprimés et de vide (ISO 7396-1:2007)
L'ISO 7396:2006 spécifie les exigences relatives à la conception, à l'installation, au fonctionnement, aux performances, à la documentation, à l'essai et à la réception des systèmes de distribution de gaz médicaux comprimés, de gaz moteurs pour les instruments chirurgicaux et de vide médical dans les établissements de soins afin que le système de distribution assure une fourniture continue du gaz prévu et du vide médical. Elle comporte des exigences relatives aux systèmes d'alimentation, de distribution, de contrôle, de surveillance et d'alarme, ainsi qu'à l'absence d'interchangeabilité entre les composants de plusieurs systèmes de distribution de gaz.
L'ISO 7396:2006 s'applique également aux systèmes de distribution des gaz médicaux suivants (l'oxygène, le monoxyde d'azote, l'air médical, le dioxyde de carbone, les mélanges d'oxygène et de monoxyde d'azote, aux systèmes de distribution des gaz suivants (l'air enrichi en oxygène, l'air moteur des instruments chirurgicaux, l'azote moteur des instruments chirurgicaux et aux systèmes d'alimentation en vide médical.
L'ISO 7396:2006 s'applique également aux extensions des systèmes de distribution installés, aux modifications des systèmes de distribution installés, aux modifications ou au remplacement des systèmes d'alimentation ou des sources d'alimentation.
Sistemi napeljav za medicinske pline - 1. del: Napeljave za stisnjene medicinske pline in podtlak (ISO 7396-1:2007)
Ta del ISO 7396 določa zahteve za načrt, namestitev, delovanje, dokumentacijo, preskušanje in usposobitev za zagon sistemov napeljav za stisnjene medicinske pline, pline za pogon kirurškega orodja in vakuum v zdravstvenih ustanovah, ki iz sistema napeljave zagotavljajo neprekinjeno oskrbo s pravim plinom in dovajanje vakuuma. Vključuje zahteve za sisteme oskrbe, cevovodne distribucijske sisteme, nadzorne sisteme, sisteme za spremljanje in alarm ter neizmenljivost med sestavnimi deli različnih plinskih sistemov. Ta del ISO 7396 velja za: a) sisteme napeljav za naslednje medicinske pline: - kisik; - dušikov oksid; - medicinski zrak; - ogljikov dioksid; - mešanice kisika/dušikovega oksida (glej Opombo 1); b) sisteme napeljav za naslednje pline: - s kisikom obogateni zrak; - zrak za pogon kirurškega orodja; - dušik za pogon kirurškega orodja; c) sisteme napeljav za vakuum. Ta del ISO 7396 velja tudi za: - podaljške obstoječih distribucijskih cevovodnih sistemov; - spremembe obstoječih distribucijskih cevovodnih sistemov; - spremembe ali zamenjavo sistemov oskrbe ali virov oskrbe.
General Information
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2007)Sistemi napeljav za medicinske pline - 1. del: Napeljave za stisnjene medicinske pline in podtlak (ISO 7396-1:2007)Réseaux de distribution de gaz médicaux - Partie 1: Réseaux de distribution de gaz médicaux comprimés et de vide (ISO 7396-1:2007)Rohrleitungssysteme für medizinische Gase - Teil 1: Rohrleitungenssyteme für medizinische Druckgase und Vakuum (ISO 7396-1:2007)Ta slovenski standard je istoveten z:EN ISO 7396-1:2007SIST EN ISO 7396-1:2007en11.040.10Anestezijska, respiratorna in reanimacijska opremaAnaesthetic, respiratory and reanimation equipmentICS:SLOVENSKI
STANDARDSIST EN ISO 7396-1:200701-oktober-2007
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 7396-1April 2007ICS 11.040.10Supersedes EN 737-3:1998
English VersionMedical gas pipeline systems - Part 1: Pipeline systems forcompressed medical gases and vacuum (ISO 7396-1:2007)Réseaux de distribution de gaz médicaux - Partie 1:Réseaux de distribution de gaz médicaux comprimés et devide (ISO 7396-1:2007)Rohrleitungssysteme für medizinische Gase - Teil 1:Rohrleitungenssyteme für medizinische Druckgase undVakuum (ISO 7396-1:2007)This European Standard was approved by CEN on 24 February 2007.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN 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 translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2007 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 7396-1:2007: E
Foreword
This document (EN ISO 7396-1:2007) has been prepared by Technical Committee CEN/TC 215 "Respiratory and anaesthetic equipment", the secretariat of which is held by BSI, in collaboration with Technical Committee ISO/TC 121 "Anaesthetic and respiratory equipment".
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 October 2007, and conflicting national standards shall be withdrawn at the latest by April 2009.
This document supersedes EN 737-3:1998.
This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
3 Annex ZA (informative)
Relationship between this International Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical devices
This International Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide one means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on Medical devices.
Once this standard is cited in the Official Journal of the European Communities under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZA 1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA 1— Correspondence between this International Standard and Directive 93/42/EEC, Medical devices
Clause(s)/Sub-clause(s) of this International Standard Essential Requirements (ERs) of EU Directive 93/42/EEC Qualifying remarks/Notes 4 1, 2, 7.1, 7.3
4.3.2 9.3
4.3.3 7.1
4.3.4 9.2, 9.3, 12.7.1
4.3.5 9.3
4.3.6 7.1, 9.3, 12.7.1
4.3.7 7.2, 7.6
4.3.8 7.2, 7.6
4.3.9 9.2
5.5.2.12 3, 9.2
4.4.1 2, 3
4.4.2 1, 2, 3, 4
5.1 to 5.2.7 1, 2, 3, 4, 7.6, 12.8.1, 12.8.2
5.2.8 3
5.3.1 to 5.3.4 2, 3, 7.6
5.3.5 7, 12.7.1
5.3.6 7, 12.7.1
5.3.7 7.1, 9.3
5.3.8 7.1
5.4 3
5.5.1 3, 12.8
5.5.2.1 to 5.5.2.10 3, 7.2, 12.8
5.5.2.11 7.6
5.5.2.13 12.7.2
5.5.3 3, 7.2, 7.6, 12.8
5.6 3, 7.2, 7.6, 9.3, 12.8
Clause(s)/Sub-clause(s) of this International Standard Essential Requirements (ERs) of EU Directive 93/42/EEC Qualifying remarks/Notes 5.7.1 to 5.7.7 3, 8.1, 12.8.1
5.7.8 to 5.7.9 7,6, 8.1
5.7.10 12.7.2
5.8 to 5.10 2, 3
6 1, 2, 3, 4, 12.3, 12.8.1, 12.8.2, 12.9
7 1, 2, 3
7.1 9.3, 12.7.1
7.2.1 to 7.2.4 2, 3
7.2.5 9.2
7.2.6 9.2
7.3 2, 3, 4
7.4 2, 3, 12.8
8 1, 2
9 9.1, 12.7.4, 13.6 c)
9.3 9.2, 12.5, 12.6
10 13.2
11 1, 2, 3, 4, 9
11.1.3 12.6
12.1 to 12.4 1, 2, 3
12.5.1 9.3, 12.7.1, 9.2
12.5.2 7.5, 9.3, 12.7.1, 9.2
12.6.1 7.5, 12.7.1
12.6.2 to 12.6.9 2, 3, 7.5, 12.8
12.6.10 7.2
12.6.11 7.2
12.6.12 7.2
12.6.13 7.2
12.6.14 7.2
12.6.15 to 12.6.16 12.7.4, 12.8.1
13 4, 13.1, 13.3, 13.6 c), 13.6 d), 13.6 e), 13.6 k), 13.6 l), 13.6 m), 13.6 n)
WARNING: Other requirements and other EU Directives may be applicable to the products falling within the scope of this standard.
Reference numberISO 7396-1:2007(E)© ISO 2007
INTERNATIONAL STANDARD ISO7396-1Second edition2007-04-01Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum Réseaux de distribution de gaz médicaux — Partie 1: Réseaux de distribution de gaz médicaux comprimés et de vide
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ISO 7396-1:2007(E) © ISO 2007 – All rights reserved iiiContents Page Foreword.v Introduction.vi 1 Scope.1 2 Normative references.2 3 Terms and definitions.2 4 General requirements.7 4.1 (*) Safety.7 4.2 (*) Alternative construction.7 4.3 Materials.8 4.4 System design.9 5 Supply systems.10 5.1 System components.10 5.2 General requirements.10 5.3 Supply systems with cylinders or cylinder bundles.12 5.4 Supply systems with mobile or stationary cryogenic or non-cryogenic vessels.13 5.5 Supply systems for air.13 5.6 Supply systems with oxygen concentrator(s).17 5.7 Supply systems for vacuum.18 5.8 Location of supply systems.18 5.9 Location of cylinder manifolds.19 5.10 Location of stationary cryogenic vessels.19 6 Monitoring and alarm systems.19 6.1 General.19 6.2 Installation requirements.19 6.3 Monitoring and alarm signals.20 6.4 Provision of operating alarms.21 6.5 Provision of emergency clinical alarms.22 6.6 (*) Provision of emergency operating alarms.22 7 Pipeline distribution systems.22 7.1 Mechanical resistance.22 7.2 Distribution pressure.22 7.3 Low-pressure hose assemblies and low-pressure flexible connections.23 7.4 Double-stage pipeline distribution systems.24 8 Shut-off valves.24 8.1 General.24 8.2 Service shut-off valves.25 8.3 Area shut-off valves.25 9 Terminal units, gas-specific connectors, medical supply units, pressure regulators and pressure gauges.26 10 Marking and colour coding.27 10.1 Marking.27 10.2 Colour coding.27 11 Pipeline installation.27 11.1 General.27 11.2 Pipeline supports.28 11.3 Pipeline joints.29
ISO 7396-1:2
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