EN ISO 7396-2:2007

Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007)

ISO 7396-2:2007 specifies requirements for the design, installation, function, performance, documentation, testing and commissioning of anaesthetic gas scavenging disposal systems, to ensure patient safety and to minimize exposure of the operator and other persons to anaesthetic gases and vapours. It includes requirements for the power device, pipeline system, performance, non-interchangeability between key components and avoidance of cross connections between anaesthetic gas scavenging (AGS) disposal systems and medical gas and vacuum pipeline systems.
ISO 7396-2:2007 is applicable only to those disposal systems intended to be connected via AGSS terminal units compliant with ISO 9170-2 to AGSS receiving systems compliant with ISO 8835-3.
ISO 7396-2:2007 also applies to:
extensions of existing AGSS disposal systems;modifications of existing AGSS disposal systems;modifications or replacement of power devices.

Rohrleitungssysteme für medizinische Gase - Teil 2: Entsorgungssysteme von Anästhesiegas-Fortleitungssystemen (ISO 7396-2:2007)

Dieser Teil von ISO ISO 7396 legt Anforderungen an das Design, die Installation, die Funktion, die Leistung, die Dokumentation, die Prüfung und die Inbetriebnahme von Entsorgungssystemen eines Anästhesiegas- Fortleitungssystems fest, um die Sicherheit des Patienten sicherzustellen und das Ausgesetztsein des Anwenders und weiterer Personen gegenüber Anästhesiegasen und -dämpfen auf ein Mindestmaß herabzusetzen. Er enthält Anforderungen an die Antriebseinrichtung, das Rohrleitungssystem, die Leistung und die Nichtaustauschbarkeit von Schlüsselkomponenten und an das Vermeiden von Querverbindungen zwischen Anästhesiegas-(AGF-)Entsorgungssystemen und Rohrleitungssystemen für medizinische Gase und Vakuum.
ANMERKUNG   In diesem Teil von ISO ISO 7396 bezieht sich der Begriff Rohrleitung ausschließlich auf Rohrleitungen, die Teil eines besonders dafür vorgesehenen Anästhesiegas-Fortleitungssystems (AGSF) sind.
Dieser Teil von ISOISO  7396 gilt nur für solche Entsorgungssysteme, die dafür vorgesehen sind, über AGFS-Entnahmestellen nach ISOISO  9170 9170 2 und an Aufnahmesysteme nach ISOISO  8835  3 angeschlossen zu werden.
Dieser Teil von ISO ISO 7396 gilt auch für:
a)   Erweiterungen vorhandener AGF-Entsorgungssysteme;
b)   Änderungen vorhandener AGF-Entsorgungssysteme;
c)   Änderungen oder Ersatz von Antriebseinrichtungen.

Systèmes de distribution de gaz médicaux - Partie 2: Systèmes d'évacuation de gaz d'anesthésie non réutilisables (ISO 7396-2:2007)

L'ISO 7396-2:2007 spécifie les exigences relatives à la conception, à l'installation, au fonctionnement, aux performances, à la documentation, aux essais et à la mise en service des systèmes d'évacuation de gaz d'anesthésie afin de garantir la sécurité du patient et de réduire à sa valeur minimale l'exposition de l'opérateur et d'autres personnes aux vapeurs et aux gaz d'anesthésie. Elle inclut des exigences relatives à la source d'alimentation, au réseau de distribution, aux performances, à la non interchangeabilité entre les composants clés ainsi qu'aux mesures prises pour éviter toute interversion entre les systèmes d'évacuation de gaz d'anesthésie et les réseaux de distribution de vide et de gaz médicaux.
L'ISO 7396-2:2007 s'applique uniquement aux systèmes d'évacuation qui sont destinés à être raccordés via des prises murales de systèmes d'évacuation de gaz d'anesthésie conformes à l'ISO 9170‑2 à des systèmes de réception de systèmes d'évacuation de gaz d'anesthésie conformes à l'ISO 8835-3.
La présente partie de l'ISO 7396 s'applique également
aux extensions des systèmes d'évacuation de gaz d'anesthésie existants,
aux modifications des systèmes d'évacuation de gaz d'anesthésie existants,
aux modifications ou au remplacement des sources d'alimentation.

Sistemi napeljav za medicinske pline - 2. del: Sistemi za odstranjevanje anestezijskih plinov in hlapov (ISO 7396-2:2007)

General Information

• Status: Published
• Publication Date: 31-Mar-2007
• Withdrawal Date: 29-Apr-2009
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215/WG 3 - Medical gas supply systems
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 01-Apr-2007
• Due Date: 06-Jan-2008
• Completion Date: 01-Apr-2007
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 7396-2:2007 - Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007)

Relations

• Replaces: EN 737-2:1998 - Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems - Basic requirements
• Effective Date: 22-Dec-2008
• Replaces: EN 737-2:1998/A1:1999 - Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems - Basic requirements
• Effective Date: 22-Dec-2008
• Replaces: EN 737-2:1998/AC:2000 - Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems - Basic requirements
• Effective Date: 22-Dec-2008

Standards Content (Sample)

SLOVENSKI STANDARD
01-oktober-2007
1DGRPHãþD
SIST EN 737-2:2000
SIST EN 737-2:2000/A1:2000
SIST EN 737-2:2000/AC:2002
Sistemi napeljav za medicinske pline - 2. del: Sistemi za odstranjevanje
anestezijskih plinov in hlapov (ISO 7396-2:2007)
Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems
(ISO 7396-2:2007)
Rohrleitungssysteme für medizinische Gase - Teil 2: Entsorgungssysteme von
Anästhesiegas-Fortleitungssystemen (ISO 7396-2:2007)
Réseaux de distribution de gaz médicaux - Partie 2: Réseaux d'évacuation de gaz
d'anesthésie non réutilisables (ISO 7396-2:2007)
Ta slovenski standard je istoveten z: EN ISO 7396-2:2007
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 7396-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2007
ICS 11.040.10 Supersedes EN 737-2:1998
English Version
Medical gas pipeline systems - Part 2: Anaesthetic gas
scavenging disposal systems (ISO 7396-2:2007)
Réseaux de distribution de gaz médicaux - Partie 2: Rohrleitungssysteme für medizinische Gase - Teil 2:
Réseaux d'évacuation de gaz d'anesthésie non réutilisables Entsorgungssysteme von Anästhesiegas-
(ISO 7396-2:2007) Fortleitungssystemen (ISO 7396-2:2007)
This European Standard was approved by CEN on 15 March 2007.
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 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 Management Centre has the same status as the
official 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 STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2007 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7396-2:2007: E
worldwide for CEN national Members.

Foreword
This document (EN ISO 7396-2:2007) 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 737-2:1998.

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.
Annex ZA
(informative)
Relationship between this International Standard and the Essential
Requirements of EU Directive 93/42/EC 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 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
Clause(s)/Sub-clause(s) of Essential Requirements (ERs) of EU Qualifying
this International Standard Directive 93/42/EEC remarks/Notes
4.1 1
4.2 2
4.3 2
4.3.1 4, 7.1, 7.3, 9.2, 9.3
4.3.2 4, 7.1, 7.3, 9.2, 9.3
4.3.3 2
4.3.4 4, 7.1, 9.3
4.3.5 4, 7.1, 7.3, 9.3
4.3.6 5
5.1 1, 2, 3
5.2 3, 9.3, 12.8.2
5.3 3, 4
5.4 3, 4
5.5 9.2, 9.3
9.2, 9.3
5.6
6 2, 12.2, 12.3
7 1, 2
7.1 2
7.2 2
8.1 1, 3, 9.1, 12.8.2
8.2 1, 3, 9.1, 12.8.2
9 9.1, 12.7.4
10 13.2
11 1, 2, 3
11.1 2
9.2
11.2
11.3 – 11.11 2, 9.2, 12.7.1
Clause(s)/Sub-clause(s) of Essential Requirements (ERs) of EU Qualifying
this International Standard Directive 93/42/EEC remarks/Notes
11.12 4, 7.2, 7.5
11.13 7.2, 7.5, 7.6
12 1, 2, 3
12.4.1 7.2, 7.5
12.4.2 9.2, 12.6, 12.7.1, 13.2
12.4.3 9.1, 12.7.4
12.4.4 2, 3, 9.2
12.4.5 3, 12.8.2
12.4.6 3
12.4.7 2, 12.2, 12.3
12.4.8 4, 7.2, 7.5, 7.6
12.4.9 9.1, 12.7.4
13 9.1, 13.1, 13.3 a), 13.3 i), 13.3 j), 13.6 a),
13.6 c), 13.6 d)
WARNING: Other requirements and other EU Directives may be applicable to the products
falling within the scope of this standard.

INTERNATIONAL ISO
STANDARD 7396-2
Second edition
2007-04-01
Medical gas pipeline systems —
Part 2:
Anaesthetic gas scavenging disposal
systems
Réseaux de distribution de gaz médicaux —
Partie 2: Réseaux d'évacuation de gaz d'anesthésie non réutilisables

Reference number
ISO 7396-2:2007(E)
©
ISO 2007
ISO 7396-2:2007(E)
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ISO 7396-2:2007(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references. 1
3 Terms and definitions. 2
4 General requirements. 6
4.1 Safety. 6
4.2 Alternative construction . 6
4.3 Materials. 6
4.4 Continuity of operation . 7
5 Power device. 7
6 Indicating systems. 8
7 Pipelines, connecting assemblies and disposal hoses. 8
8 Disposal system characteristics and test methods for pressure and flow . 9
8.1 Requirements. 9
8.2 Test methods for pressure and flow. 10
8.3 Means to prevent backflow. 12
9 Terminal units . 12
10 Marking and colour coding. 12
10.1 Marking. 12
10.2 Colour coding. 13
10.3 Test for durability. 13
11 Pipeline installation. 13
12 Testing, commissioning and certification. 15
12.1 General. 15
12.2 General requirements for tests . 15
12.3 Tests, inspections and checks. 15
12.4 Requirements for tests, inspections and checks listed in 12.3 . 15
12.5 Certification of the system. 16
12.6 Extensions or modifications. 17
13 Information to be supplied by the manufacturer. 17
13.1 General. 17
13.2 Instructions for use . 17
13.3 Operational management information. 18
13.4 “As-installed” drawings . 18
13.5 Electrical diagrams. 18
Annex A (informative) Guidelines for power devices consisting of fans, blowers or dedicated
vacuum pumps. 19
Annex B (informative) Example of procedure for testing and commissioning. 20
Annex C (informative) Typical forms for certification of AGS disposal systems. 23
Annex D (informative) Risk management checklist. 36
Annex E (informative) Rationale . 44
Bibliography . 45

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