NF EN ISO 7396-1
Medical gas pipeline systems - Part 1 : pipelines for compressed medical gases and vacuum
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.
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.
Le présent document est destiné à compléter la série de normes européennes sur le sujet. Il spécifie les exigences de conception et d'installation des réseaux de distribution de gaz médicaux (à simple ou à double détente), réseau de vide (aspiration) compris. Il donne également les modalités de réception.
<p>ISO 7396-1:2016 specifies requirements for design, installation, function, performance, testing, commissioning and documentation of pipeline systems used in healthcare facilities for the following:</p> <p>- oxygen;</p> <p>- nitrous oxide;</p> <p>- medical air;</p> <p>- carbon dioxide;</p> <p>- oxygen/nitrous oxide mixtures (see Note 1);</p> <p>- helium/oxygen mixtures;</p> <p>- (*) oxygen 93;</p> <p>- 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;</p> <p>- air for driving surgical tools;</p> <p>- nitrogen for driving surgical tools;</p> <p>- vacuum.</p> <p>NOTE 1 Regional or national regulations may prohibit the distribution of oxygen/nitrous oxide mixtures in medical gas pipeline systems.</p> <p>NOTE 2 Anaesthetic gas scavenging disposal systems are covered in ISO 7396‑2.</p> <p>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.</p> <p>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:</p> <p>a) acute care healthcare facilities;</p> <p>b) internal patient continuing care healthcare facilities;</p> <p>c) long-term care facilities;</p> <p>d) community-based providers;</p> <p>e) ambulatory and external patient care clinics (e.g. day surgery, endoscopy clinics and doctors' offices).</p> <p>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.</p> <p>ISO 7396-1:2016 applies to the following different types of oxygen supply systems:</p> <p>- supply systems in which all sources of supply deliver oxygen; in this case the concentration of the oxygen will be greater than 99%;</p> <p>- 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%;</p> <p>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%.</p> <p>ISO 7396-1:2016 also applies to:</p> <p>- extensions of existing pipeline distribution systems;</p> <p>- modifications of existing pipeline distribution systems;</p> <p>- modifications or replacement of supply systems or sources of supply.</p> <p>Oxygen concentrators for domiciliary use are excluded from the scope of this part of ISO 7396.</p> <p>NOTE 5 Requirements for oxygen concentrators for domiciliary use are specified in ISO 80601‑2-69.</p> <p>(*) 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.</p> <p>ISO 7396-1:2016 does not apply to vacuum systems intended to be used in dentistry.</p> <p>ISO 7396-1:2016 does not apply to filling systems for transportable cylinders and transportable cylinder bundle systems.</p>
- Avant-proposv
- Introductionvi
-
1 Domaine d'application1
-
2 Références normatives2
-
3 Termes et définitions2
-
4 Exigences générales7
-
4.1 Sécurité7
-
4.2 Autre construction8
-
4.3 Matériaux8
-
4.4 Conception du système10
-
5 Systèmes d'alimentation10
-
5.1 Composants du système10
-
5.2 Exigences générales11
-
5.3 Systèmes d'alimentation par bouteilles ou par cadres de bouteilles13
-
5.4 Systèmes d'alimentation par récipients cryogéniques ou non cryogéniques mobiles ou fixes14
-
5.5 Systèmes d'alimentation en air14
-
5.6 Systèmes d'alimentation équipés de concentrateur(s) d'oxygène19
-
5.7 Systèmes d'alimentation en vide médical19
-
5.8 Emplacement des systèmes d'alimentation20
-
5.9 Emplacement des groupes de bouteilles20
-
5.10 Emplacement des récipients cryogéniques fixes20
-
6 Systèmes de surveillance et systèmes d'alarme20
-
6.1 Généralités20
-
6.2 Exigences relatives à l'installation21
-
6.3 Signaux de surveillance et signaux d'alarme21
-
6.4 Dispositions relatives aux alarmes de contrôle de fonctionnement23
-
6.5 Dispositions relatives aux alarmes d'urgence médicale23
-
6.6 Dispositions relatives aux alarmes de contrôle de fonctionnement d'urgence24
-
7 Systèmes de distribution24
-
7.1 Résistance mécanique24
-
7.2 Pression de service24
-
7.3 Flexibles et raccords à basse pression26
-
7.4 Système de distribution à deux niveaux de pression26
-
8 Vannes de sectionnement26
-
8.1 Généralités26
-
8.2 Vannes de sectionnement d'exploitation27
-
8.3 Vannes de sectionnement de zone28
-
9 Prises murales, raccords spécifiques au gaz, gaines techniques médicales, détendeurs et manomètres29
-
10 Marquage et code couleur29
-
10.1 Marquage29
-
10.2 Code couleur30
-
11 Installation des canalisations30
-
11.1 Généralités30
-
11.2 Supports de canalisation31
-
11.3 Raccords des canalisations32
-
11.4 Extensions et modifications des systèmes de distribution de gaz médicaux existants32
-
12 Essais, réception et certification33
-
12.1 Généralités33
-
12.2 Exigences générales pour les essais33
-
12.3 Contrôles et vérifications avant obturation33
-
12.4 Essais, contrôles et modes opératoires avant utilisation du système33
-
12.5 Exigences relatives aux contrôles et aux vérifications avant obturation34
-
12.6 Exigences relatives aux essais, contrôles et modes opératoires avant utilisation du système34
-
12.7 Certification des systèmes40
-
13 Informations à fournir par le fabricant41
-
13.1 Généralités41
-
13.2 Instructions d'utilisation41
-
13.3 Informations relatives à la gestion opérationnelle42
-
13.4 Plans en conformité avec l'installation42
-
13.5 Schémas électriques42
- Annexe A (informative) Représentations schématiques des systèmes d'alimentation et des systèmes de distribution de zones types43
- Annexe B (informative) Lignes directrices relatives à l'emplacement des groupes de bouteilles, des zones de stockage des bouteilles et des récipients fixes de liquides cryogénique et non cryogénique66
- Annexe C (informative) Exemple de mode opératoire pour les essais et la réception67
- Annexe D (informative) Formulaires types pour la certification des systèmes de distribution de gaz médicaux80
- Annexe E (informative) Relation entre la température et la pression111
- Annexe F (informative) Liste de vérification pour la gestion des risques113
- Annexe G (informative) Gestion opérationnelle127
- Annexe H (informative) Justification147
- Bibliographie149
The Requirements department helps you quickly locate within the normative text:
- mandatory clauses to satisfy,
- non-essential but useful clauses to know, such as permissions and recommendations.
The identification of these types of clauses is based on the document “ISO / IEC Directives, Part 2 - Principles and rules of structure and drafting of ISO documents ”as well as on a constantly enriched list of verbal forms.
With Requirements, quickly access the main part of the normative text!
COBAZ is the simple and effective solution to meet the normative needs related to your activity, in France and abroad.
Available by subscription, CObaz is THE modular solution to compose according to your needs today and tomorrow. Quickly discover CObaz!
Request your free, no-obligation live demo
I discover COBAZ