SIST EN ISO 7396-1:2016
(Main)Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2016)
Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2016)
This part of ISO 7396 specifies requirements for design, installation, function, performance, testing, commissioning and documentation of pipeline systems used in healthcare facilities for the following:
— oxygen;
— nitrous oxide;
— medical air;
— carbon dioxide;
— oxygen/nitrous oxide mixtures (see Note 1);
— helium/oxygen mixtures;
— (*) oxygen 93;
— gases and gas mixtures classified as medical device, gases delivered to medical devices or intended for medical purposes or gases and gas mixtures for medicinal use not specified above;
— air for driving surgical tools;
— nitrogen for driving surgical tools;
— vacuum.
NOTE 1 Regional or national regulations may prohibit the distribution of oxygen/nitrous oxide mixtures in medical gas pipeline systems.
NOTE 2 Anaesthetic gas scavenging disposal systems are covered in ISO 7396‑2.
This part of ISO 7396 includes requirements for supply systems, pipeline distribution systems, control systems, monitoring and alarm systems and non-interchangeability between components of different gas/vacuum systems.
This part of ISO 7396 specifies safety requirements for pipeline systems used in healthcare facilities, both public and private. It applies to all facilities providing healthcare services regardless of type, size, location or range of services, including, but not limited to:
a) acute care healthcare facilities;
b) internal patient continuing care healthcare facilities;
c) long-term care facilities;
d) community-based providers;
e) ambulatory and external patient care clinics (e.g. day surgery, endoscopy clinics and doctors’ offices).
NOTE 3 This part of ISO 7396 may also be used as reference for pipeline systems for medical gases and vacuum intended to be installed in places other than healthcare facilities.
This part of ISO 7396 applies to the following different types of oxygen supply systems:
— supply systems in which all sources of supply deliver oxygen; in this case the concentration of the
oxygen will be greater than 99%;
— supply systems in which all sources of supply deliver oxygen 93; in this case the concentration of the oxygen may vary between 90% and 96%;
NOTE 4 A mixture of oxygen 93 and oxygen may be delivered by a medical gas supply system. In this case the concentration of the gas can vary between 90% and >99%.
This part of ISO 7396 also applies to:
— extensions of existing pipeline distribution systems;
— modifications of existing pipeline distribution systems;
— modifications or replacement of supply systems or sources of supply.
Oxygen concentrators for domiciliary use are excluded from the scope of this part of ISO 7396.
NOTE 5 Requirements for oxygen concentrators for domiciliary use are specified in ISO 80601‑2-69.
(*) EN 14931 defines additional requirements for hyperbaric application, in particular for flows and pressures of compressed air required to pressurize the hyperbaric chamber and to drive other connected services. Also included are requirements for oxygen and other treatment gases administered to patients.
This part of ISO 7396 does not apply to vacuum systems intended to be used in dentistry.
This part of ISO 7396 does not apply to filling systems for transportable cylinders and transportable
cylinder bundle systems.
Rohrleitungssysteme für medizinische Gase - Teil 1: Rohrleitungssysteme für medizinische Druckgase und Vakuum (ISO/DIS 7396-1:2013)
Dieser Teil von ISO 7396 legt Anforderungen an Auslegung, Installation, Funktion, Leistung, Prüfung Inbetriebnahme und Dokumentation von in Gesundheitseinrichtungen verwendeten Rohrleitungssystemen für folgende Gase fest:
— Sauerstoff;
— Distickstoffoxid (Lachgas);
— medizinische Luft;
— Kohlendioxid;
— Sauerstoff-Distickstoffoxid-Gemische (siehe Anmerkung 1);
— Helium-Sauerstoff-Gemische;
— (*) Sauerstoff 93;
— Gase und Gasgemische, die als Medizinprodukte eingestuft sind, Gase, die Medizinprodukten zugeführt werden oder für medizinische Zwecke vorgesehen sind, oder Gase und Gasgemische für pharmazeutische Verwendungen, die oben nicht festgelegt sind;
— Luft zum Betreiben chirurgischer Werkzeuge;
— Stickstoff zum Betreiben chirurgischer Werkzeuge;
— Vakuum.
ANMERKUNG 1 Regionale oder nationale Bestimmungen können die Verteilung von Sauerstoff-Distickstoffoxid-Gemischen in Rohrleitungssystemen für medizinische Gase untersagen.
ANMERKUNG 2 Entsorgungssysteme von Anästhesiegas-Fortleitungssystemen sind in ISO 7396 2 behandelt.
Dieser Teil von ISO 7396 schließt Anforderungen an Versorgungssysteme, Rohrverteilersysteme, Regel , Überwachungs- und Alarmsysteme und die Nichtaustauschbarkeit zwischen Bauteilen unterschiedlicher Gas-bzw. Vakuumsysteme ein.
Dieser Teil von ISO 7396 legt Sicherheitsanforderungen für in öffentlichen sowie privaten Gesundheits-einrichtungen verwendete Rohrleitungssysteme fest. Die Norm gilt für alle Einrichtungen, die Versorgungs¬leistungen im Bereich der Gesundheitsfürsorge anbieten, unabhängig von der Art, Größe, Lage oder der Breite des Leistungsangebotes, und schließt u. a. folgende ein:
a) Akutversorgungseinrichtungen;
b) interne Patienten-Weiterversorgungseinrichtungen;
c) Langzeit-Pflegeinrichtungen;
d) kommunale Anbieter;
e) ambulante oder externe Patienten-Versorgungseinrichtungen (z. B. Tageschirurgie, Endoskopie-Kliniken und Arztpraxen).
ANMERKUNG 3 Dieser Teil von ISO 7396 kann auch als Referenz für Rohrleitungssysteme für medizinische Gase und Vakuum verwendet werden, die an anderen Bestimmungsorten als Gesundheitseinrichtungen installiert werden sollen.
Dieser Teil von ISO 7396 gilt für die folgenden unterschiedlichen Arten von Sauerstoffversorgungssystemen:
— Versorgungssysteme, in denen alle Versorgungsquellen Sauerstoff bereitstellen; in diesem Fall wird die Sauerstoffkonzentration größer als 99 % sein;
— Versorgungssysteme, in denen alle Versorgungsquellen Sauerstoff 93 bereitstellen; in diesem Fall darf die Sauerstoffkonzentration zwischen 90 % und 96 % variieren.
ANMERKUNG 4 Ein Gemisch aus Sauerstoff 93 und Sauerstoff kann durch ein Versorgungssystem für medizinische Gase bereitstellt werden. In diesem Fall kann die Gaskonzentration zwischen 90 % und >99 % variieren.
Dieser Teil von ISO 7396 gilt auch für:
— Erweiterungen bestehender Rohrverteilersysteme;
— Veränderungen bestehender Rohrverteilersysteme;
— Veränderungen oder Ersatz von Versorgungssystemen oder Versorgungsquellen.
Sauerstoff-Konzentratoren für die häusliche Verwendung sind vom Anwendungsbereich von diesem Teil von ISO 7396 ausgenommen.
ANMERKUNG 5 Anforderungen an Sauerstoff-Konzentratoren für die häusliche Verwendung sind in ISO 80601 2 69 festgelegt.
(*) EN 14931 legt zusätzliche Anforderungen für hyperbare Anwendungen fest, insbesondere an Durchflüsse und Drücke von Druckluft, die erforderlich ist, um die hyperbaren Kammern unter Druck zu setzen und andere damit verbundene Versorgungseinrichtungen zu betreiben. Sie enthält auch Anforderungen für Sauerstoff und weitere Behandlungsgase, die Patienten verabreicht werden.
Dieser Teil von ISO 7396 gilt nicht für Vakuumsysteme, die für die Verwendung in der Zahnmedizin vorgesehen sind.
Dieser Teil von ISO 7396 gilt nicht für Füllsysteme für transportable Druckgasflaschen und transportable Flaschenbündelsysteme.
Systèmes de distribution de gaz médicaux - Partie 1: Systèmes de distribution de gaz médicaux comprimés et de vide (ISO 7396-1:2016)
ISO 7396-1:2016 spécifie les exigences relatives à la conception, à l'installation, au fonctionnement, aux performances, aux essais, à la réception et à la documentation des systèmes de distribution utilisés dans les établissements de soins pour les gaz suivants:
- l'oxygène;
- le protoxyde d'azote;
- l'air médical;
- le dioxyde de carbone;
- les mélanges d'oxygène et de protoxyde d'azote (voir Note 1);
- les mélanges d'hélium et d'oxygène;
- (*) l'oxygène 93;
- les gaz et les mélanges de gaz classés en tant que dispositif médical, les gaz fournis à des dispositifs médicaux ou ceux destinés à des usages médicaux ou les gaz et les mélanges de gaz destinés à un usage médical non spécifié ci-dessus;
- l'air moteur pour les instruments chirurgicaux;
- l'azote moteur pour les instruments chirurgicaux;
- le vide.
NOTE 1 Les réglementations locales ou nationales peuvent interdire la distribution des mélanges oxygène/protoxyde d'azote par les systèmes de distribution de gaz médicaux.
NOTE 2 Les systèmes d'évacuation de gaz d'anesthésie non réutilisables sont traités dans l'ISO 7396‑2.
ISO 7396-1:2016 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/de vide.
ISO 7396-1:2016 spécifie des exigences de sécurité applicables aux systèmes de distribution utilisés dans les établissements de soins publics et privés. Elle s'applique à tous les établissements fournissant des services de soins de santé indépendamment du type, de la taille, de la localisation ou de la gamme de services, comprenant, sans s'y limiter:
a) les établissements de soins intensifs;
b) les établissements de soins continus de patients internes;
c) les établissements de soins de longue durée;
d) les prestataires communautaires;
e) les unités de soins ambulatoires et les cliniques de soins de patients externes (par exemple, chirurgie ambulatoire, cliniques d'endoscopie et cabinets médicaux).
NOTE 3 La présente partie de l'ISO 7396 peut également être utilisée en tant que référence pour les systèmes de distribution de gaz médicaux et de vide destinés à être installés ailleurs que dans des établissements de soins.
ISO 7396-1:2016 s'applique aux différents types de systèmes d'alimentation en oxygène suivants:
- les systèmes d'alimentation dans lesquels toutes les sources d'alimentation fournissent de l'oxygène; dans ce cas, la concentration du gaz sera supérieure à 99 %;
- les systèmes d'alimentation dans lesquels toutes les sources d'alimentation fournissent de l'oxygène 93; dans ce cas, la concentration du gaz peut varier entre 90 % et 96 %.
NOTE 4 Un mélange d'oxygène 93 et d'oxygène peut être distribué par un système d'alimentation en gaz médicaux. Dans ce cas, la concentration du gaz peut varier entre 90 % et > 99 %.
ISO 7396-1:2016 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.
Les concentrateurs d'oxygène destinés à un usage à domicile n'entrent pas dans le domaine d'application de la présente partie de l'ISO 7396.
NOTE 5 Les exigences applicables aux concentrateurs d'oxygène destinés à un usage
Sistemi napeljav za medicinske pline - 1. del: Sistemi napeljav za stisnjene medicinske pline in podtlak (ISO 7396-1:2016)
Ta del standarda ISO 7396 določa zahteve za zasnovo, namestitev, delovanje, zmogljivost, preskušanje, zagon in dokumentacijo sistemov napeljav, ki se uporabljajo v zdravstvenih ustanovah za naslednje:
– kisik;
– dušikov oksid;
– medicinski zrak;
– ogljikov dioksid;
– mešanica kisika/dušikovega oksida (glej opombo 1);
– mešanica helija/kisika;
– (*) kisik 93;
– plini in plinske zmesi, klasificirane kot medicinski pripomoček, plini, ki se dovajajo v medicinske pripomočke ali se uporabljajo za zdravstvene namene, ter plini in plinske zmesi za medicinsko uporabo, ki ni navedena zgoraj;
– zrak za pogon kirurških instrumentov;
– dušik za pogon kirurških instrumentov;
– podtlak.
OPOMBA 1: Regionalni ali nacionalni predpisi morda prepovedujejo distribucijo mešanic kisika/dušikovega oksida v sistemih napeljav za medicinske pline.
OPOMBA 2: Sisteme za odstranjevanje anestezijskih plinov in hlapov obravnava standard ISO 7396 2.
Ta del standarda ISO 7396 vključuje zahteve za sisteme oskrbe, distribucijske sisteme napeljav, krmilne sisteme, nadzorne in alarmne sisteme ter nezmožnost zamenljivosti med komponentami različnih sistemov za pline/podtlak.
Ta del standarda ISO 7396 določa varnostne zahteve za sisteme napeljav, ki se uporabljajo v zdravstvenih ustanovah, tako javnih kot zasebnih. Uporablja se za vse ustanove, ki nudijo zdravstvene storitve, ne glede na vrsto, velikost, lokacijo ali obseg storitev, ki med drugim vključujejo tudi:
– zdravstvene ustanove za akutno oskrbo;
– zdravstvene ustanove za stalno oskrbo notranjih pacientov;
– ustanove za dolgotrajno oskrbo;
– ponudnike oskrbe v skupnosti;
– ambulantne in zunajbolnišnične klinike (npr. dnevna kirurgija, endoskopske klinike in zdravniške ordinacije).
OPOMBA 3: Ta del standarda ISO 7396 se lahko uporablja tudi kot referenca za sisteme napeljav za medicinske pline in podtlak, ki so namenjeni za namestitev v ustanovah, ki niso zdravstvene.
Ta del standarda ISO 7396 se uporablja za naslednje različne vrste sistemov za oskrbo s kisikom:
– sistemi napeljav, pri katerih vsi viri dovajajo kisik; v tem primeru je koncentracija
kisika večja od 99 %;
– sistemi napeljav, pri katerih vsi viri dovajajo kisik 93; v tem primeru je koncentracija kisika med 90 in 96 %;
OPOMBA 4: Mešanico kisika 93 in kisika lahko dovaja sistem za oskrbo z medicinskimi plini. V tem primeru je koncentracija plina med 90 in >99 %.
Ta del standarda ISO 7396 se uporablja tudi za:
– razširitve obstoječih distribucijskih sistemov napeljav;
– spremembe obstoječih distribucijskih sistemov napeljav;
– spremembe in zamenjave sistemov ali virov oskrbe.
Naprave za koncentriranje kisika za uporabo na domu niso zajete v tem delu standarda ISO 7396.
OPOMBA 5: Zahteve za naprave za koncentriranje kisika za uporabo na domu so določene v standardu ISO 80601 2-69.
(*) Standard EN 14931 opredeljuje dodatne zahteve za hiperbarično uporabo, zlasti za pretoke in tlake stisnjenega zraka, potrebnega za ustvarjanje nadtlaka v hiperbarični komori in za izvajanje ostalih povezanih storitev. Vključene so tudi zahteve za kisik in druge pline za zdravljenje, ki jih prejema pacient.
Ta del standarda ISO 7396 se ne uporablja za podtlačne sisteme, ki so namenjeni uporabi v zobozdravstvu.
Ta del standarda ISO 7396 se ne uporablja za polnilne sisteme za premične jeklenke in
sisteme sklopov premičnih jeklenk.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 7396-1:2016
01-julij-2016
1DGRPHãþD
SIST EN ISO 7396-1:2007
SIST EN ISO 7396-1:2007/A1:2010
SIST EN ISO 7396-1:2007/A2:2010
SIST EN ISO 7396-1:2007/A3:2013
Sistemi napeljav za medicinske pline - 1. del: Sistemi napeljav za stisnjene
medicinske pline in podtlak (ISO 7396-1:2016)
Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases
and vacuum (ISO 7396-1:2016)
Rohrleitungssysteme für medizinische Gase - Teil 1: Rohrleitungssysteme für
medizinische Druckgase und Vakuum (ISO/DIS 7396-1:2013)
Systèmes de distribution de gaz médicaux - Partie 1: Systèmes de distribution de gaz
médicaux comprimés et de vide (ISO 7396-1:2016)
Ta slovenski standard je istoveten z: EN ISO 7396-1:2016
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 7396-1:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 7396-1:2016
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SIST EN ISO 7396-1:2016
EN ISO 7396-1
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2016
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 7396-1:2007
English Version
Medical gas pipeline systems - Part 1: Pipeline systems for
compressed medical gases and vacuum (ISO 7396-1:2016)
Systèmes de distribution de gaz médicaux - Partie 1: Rohrleitungssysteme für medizinische Gase - Teil 1:
Systèmes de distribution de gaz médicaux comprimés Rohrleitungssysteme für medizinische Druckgase und
et de vide (ISO 7396-1:2016) Vakuum (ISO 7396-1:2016)
This European Standard was approved by CEN on 7 November 2015.
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 CEN-CENELEC 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 CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7396-1:2016 E
worldwide for CEN national Members.
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SIST EN ISO 7396-1:2016
EN ISO 7396-1:2016 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical devices . 4
2
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SIST EN ISO 7396-1:2016
EN ISO 7396-1:2016 (E)
European foreword
This document (EN ISO 7396-1:2016) has been prepared by Technical Committee
ISO/TC 121 “Anaesthetic and respiratory equipment” in collaboration with Technical Committee
CEN/TC 215 “Respiratory and anaesthetic equipment”, the secretariat of which is held by BSI.
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 September 2016, and conflicting national standards
shall be withdrawn at the latest by March 2019.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
This document supersedes EN ISO 7396-1:2007.
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,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 7396-1:2016 has been approved by CEN as EN ISO 7396-1:2016 without any
modification.
3
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SIST EN ISO 7396-1:2016
EN ISO 7396-1:2016 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical devices
This European 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 Union 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 European Standard and Directive 93/42/EEC,
Medical devices
Clause(s)/Sub-clause(s) of Essential Requirements (ERs) of Qualifying remarks/Notes
EU Directive 93/42/EEC
this European Standard
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 9.2
4.4.1 2, 3
4.4.2 1, 2, 3, 4
5.1 to 5.2.9 1, 2, 3, 4, 7.6, 12.8.1, 12.8.2
5.3.1 to 5.3.3 2, 3, 7.6
5.3.4 7, 12.7.1
5.3.5 7, 12.7.1
5.3.6 7.1, 9.3
5.3.7 2, 3
5.4 3
5.5.1 3, 12.8
5.5.2.1 to 5.5.2.11 3, 7.2, 12.8
5.5.2.12 7.6
5.5.2.13 3, 9.2
5.5.2.14 12.7.2
5.5.2.15 3, 7.2
5.5.3 3, 7.2, 7.6, 12.8
4
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SIST EN ISO 7396-1:2016
EN ISO 7396-1:2016 (E)
5.6 2, 3, 7.2, 7.3, 7.6, 9.3, 12.8
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
5.7.11 7.2
5.7.12 3, 7.2, 7.6
5.7.13 3, 9.3
5.7.14 3, 9.3
5.7.15 3, 12.8
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
11.1.5 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),
13.6 q)
WARNING: Other requirements and other EU Directives may be applicable to the products falling
within the scope of this standard.
5
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SIST EN ISO 7396-1:2016
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SIST EN ISO 7396-1:2016
INTERNATIONAL ISO
STANDARD 7396-1
Third edition
2016-02-15
Medical gas pipeline systems —
Part 1:
Pipeline systems for compressed
medical gases and vacuum
Systèmes de distribution de gaz médicaux —
Partie 1: Systèmes de distribution de gaz médicaux comprimés et de
vide
Reference number
ISO 7396-1:2016(E)
©
ISO 2016
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SIST EN ISO 7396-1:2016
ISO 7396-1:2016(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
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ii © ISO 2016 – All rights reserved
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SIST EN ISO 7396-1:2016
ISO 7396-1:2016(E)
Contents Page
Foreword .vi
Introduction .vii
1 (*) Scope . 1
2 Normative references . 2
3 Terms and definitions . 3
4 General requirements . 9
4.1 (*) Safety . 9
4.2 (*) Alternative construction .10
4.3 Materials .10
4.4 System design.12
4.4.1 General.12
4.4.2 Extensions and modifications of existing pipeline systems .12
5 Supply systems .13
5.1 System components .13
5.2 General requirements .13
5.2.1 Capacity and storage .13
5.2.2 Continuity of supply .13
5.2.3 Primary source of supply.14
5.2.4 Secondary source of supply .14
5.2.5 Reserve source(s) of supply .14
5.2.6 Means of pressure relief .15
5.2.7 Maintenance supply assembly .15
5.2.8 Pressure regulators .16
5.2.9 (*)Ozone Sterilizers .16
5.3 Supply systems with cylinders, cylinder bundles or high-pressure reservoir(s) .16
5.4 Supply systems with cryogenic or non-cryogenic vessels .16
5.5 Supply systems for air .17
5.5.1 General requirements .17
5.5.2 Supply systems with air compressor(s) .18
5.5.3 Supply systems with proportioning unit(s) .21
5.6 Supply systems with oxygen concentrator(s) .23
5.6.1 General requirements .23
5.6.2 Primary source of supply.23
5.6.3 Secondary source of supply .23
5.6.4 Reserve source of supply .24
5.6.5 Specifications for oxygen 93 .24
5.6.6 Oxygen concentrator unit . .25
5.6.7 Oxygen 93 reservoirs .25
5.6.8 Oxygen analysers .25
5.6.9 Local filling of permanently attached high-pressure reservoir(s), acting as
reserve source of supply .26
5.7 Supply systems for vacuum .27
5.8 Location of supply systems .28
5.9 Location of cylinder manifolds .28
5.10 Location of stationary cryogenic vessels .29
6 Monitoring and alarm systems .29
6.1 General .29
6.2 Installation requirements .29
6.3 Monitoring and alarm signals .30
6.3.1 General.30
6.3.2 Auditory signals .30
6.3.3 Visual signals .30
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SIST EN ISO 7396-1:2016
ISO 7396-1:2016(E)
6.3.4 Emergency and operating alarm characteristics .30
6.3.5 Information signals .31
6.3.6 Remote alarm extensions .31
6.4 Provision of operating alarms .31
6.5 Provision of emergency clinical alarms .32
6.6 (*) Provision of emergency operating alarms .32
7 Pipeline distribution systems .33
7.1 Mechanical resistance .33
7.2 Distribution pressure .33
7.3 Low-pressure hose assemblies and low-pressure flexible connections .34
7.4 Double-stage pipeline distribution systems .35
8 Shut-off valves .35
8.1 General .35
8.2 Service shut-off valves .36
8.3 Area shut-off valves .36
9 Terminal units, gas-specific connectors, medical supply units, pressure regulators
and pressure gauges .38
10 Marking and colour coding .38
10.1 Marking .38
10.2 Colour coding .38
11 Pipeline installation .39
11.1 General .39
11.2 Pipeline supports .40
11.3 Pipeline joints .40
11.4 Extensions and modifications of existing pipeline systems .41
12 Testing and commissioning .41
12.1 General .41
12.2 General requirements for tests .42
12.3 Inspections and checks before concealment .42
12.4 Tests, checks and procedures before use of the system .42
12.5 Requirements for inspections and checks before concealment .43
12.5.1 Inspection of marking and pipeline supports.43
12.5.2 Check for compliance with design specifications .43
12.6 Requirements for tests, checks and procedures before use of the system .43
12.6.1 General.43
12.6.2 (*) Tests of area shut-off valves for leakage and closure and checks for
correct zoning and correct identification .45
12.6.3 Test for cross-connection .45
12.6.4 Test for obstruction and flow .46
12.6.5 Checks of terminal units and NIST, DISS or SIS connectors for mechanical
function, gas specificity and identification .47
12.6.6 Tests or checks of system performance .47
12.6.7 (*) Tests of pressure-relief valves .47
12.6.8 Tests of all sources of supply .48
12.6.9 Tests of monitoring and alarm systems .48
12.6.10 Test for particulate contamination of pipeline distribution systems .48
12.6.11 Tests of the quality of medical air produced by supply systems with
air compressor(s) . .49
12.6.12 Tests of the quality of air for driving surgical tools produced by supply
systems with air compressor(s) .49
12.6.13 Tests of the quality of medical air produced by supply systems with
proportioning unit(s) . .49
12.6.14 Tests of the quality of oxygen 93 produced by supply systems with
oxygen concentrator(s) .49
12.6.15 Filling with specific gas .49
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SIST EN ISO 7396-1:2016
ISO 7396-1:2016(E)
12.6.16 Tests of gas identity .49
12.6.17 Verification of restart after power supply failure .50
12.7 Statement of compliance to this part of ISO 7396 .50
13 Information to be supplied by the manufacturer .50
13.1 General .50
13.2 Instructions for installation .50
13.3 Instructions for use .50
13.4 Operational management information .51
13.5 “As-installed” drawings .52
13.6 Electrical diagrams .52
Annex A (informative) Schematic representations of typical supply systems and are
...
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