EN ISO 7396-2:2007

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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ii © ISO 2007 – All rights reserved

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

ISO 7396-2:2007(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 7396-2 was prepared by the European Committee for Standardization (CEN) Technical Committee
CEN/TC 215, Respiratory and anaesthetic equipment, in collaboration with Technical Committee ISO/TC 121,
Anaesthetic and respiratory equipment, Subcommittee SC 6, Medical gas systems, in accordance with the
Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 7396-2:2000), which has been technically
revised.
ISO 7396 consists of the following parts, under the general title Medical gas pipeline systems:
⎯ Part 1: Pipeline systems for compressed medical gases and vacuum
⎯ Part 2: Anaesthetic gas scavenging disposal systems
iv © ISO 2007 – All rights reserved

ISO 7396-2:2007(E)
Introduction
Anaesthetic gas scavenging systems (AGSS) are used to reduce occupational exposure to anaesthetic gases
and vapours.
The anaesthetic gas scavenging system comprises three main parts:
⎯ a transfer system,
⎯ a receiving system, and
⎯ a disposal system.
A schematic diagram of typical anaesthetic gas scavenging systems is shown in Figure 1. Requirements for
receiving systems and transfer systems are specified in ISO 8835-3. Type-specific connections for terminal
units are specified in ISO 9170-2. In this part of ISO 7396, specifications and test procedures are given to
ensure compatibility between the components of the system.
This part of ISO 7396 specifies requirements for pipelines for anaesthetic gas scavenging systems for
anaesthetic gases and vapours. It is intended for use by those persons involved in the design, construction,
inspection and operation of healthcare facilities treating human beings. It is advisable that those persons
involved in the design, manufacture and testing of equipment intended to be connected to pipeline systems
also be aware of the contents of this part of ISO 7396.
Specific components are used for scavenging terminal units and for other connectors which are intended to be
used by the operator. In addition, the system is tested and certified to operate at safe flows and without
leakage. It is also intended to address issues of patient safety.
The objectives of this part of ISO 7396 are to ensure the following:
a) avoidance of cross connections between different pipeline systems;
b) continuity of function of the system;
c) use of suitable materials;
d) cleanliness of components;
e) correct installation;
f) provision of indicating system(s);
g) correct marking of the pipeline system and components;
h) testing, commissioning and certification;
i) correct operational management.
Annex E contains rationale statements for some of the requirements of this part of ISO 7396. It is included to
provide additional insight into the reasoning that led to the requirements and recommendations that have been
incorporated in this part of ISO 7396. The clauses and subclauses marked with (*) after their number have
corresponding rationale contained in Annex E.

INTERNATIONAL STANDARD ISO 7396-2:2007(E)

Medical gas pipeline systems —
Part 2:
Anaesthetic gas scavenging disposal systems
1 Scope
This part of ISO 7396 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.
NOTE In this part of ISO 7396, the term “pipeline” refers exclusively to pipelines that are part of a dedicated
anaesthetic gas scavenging system (AGSS).
This part of ISO 7396 is applicable only to those disposal systems intended to be connected via AGSS
terminal units conforming to ISO 9170-2 and to AGSS receiving systems conforming to ISO 8835-3.
This part of ISO 7396 also applies to:
⎯ extensions of existing AGSS disposal systems;
⎯ modifications of existing AGSS disposal systems;
⎯ modifications or replacement of power devices.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 5359, Low-pressure hose assemblies for use with medical gases
ISO 7396-1:2007, Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases
and vacuum
1)
ISO 8835-3:— , Inhalational anaesthesia systems — Part 3: Transfer and receiving systems of active
anaesthetic gas scavenging systems
ISO 9170-2, Terminal units for medical gas pipeline systems — Part 2: Terminal units for anaesthetic gas
scavenging systems
1) To be published. (Revision of ISO 8835-3:1997.)
ISO 7396-2:2007(E)
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 15001, Anaesthetic and respiratory equipment — Compatibility with oxygen
EN 1041, Information supplied by the manufacturer with medical devices
EN 13348, Copper and copper alloys — Seamless, round copper tubes for medical gases or vacuum
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
AGSS socket
female part of a terminal unit which is either integral or attached to the base block by a type-specific interface,
and which contains the type-specific connection point
3.2
AGSS terminal unit
inlet assembly in an AGSS at which the operator makes connections and disconnections
3.3
AGSS terminal unit base block
part of an AGSS terminal unit which is attached to the pipeline disposal system
3.4
AGSS type 1 terminal unit
connection point between the receiving system and the disposal system at which an operator makes
connections and disconnections
See Figure 1.
3.5
AGSS type 1H terminal units
AGSS type 1 terminal unit to be used in high-flow disposal systems
3.6
AGSS type 1L terminal units
AGSS type 1 terminal unit to be used in low-flow disposal systems
3.7
AGSS type 2 terminal unit
connection point between the power device or the disposal hose and the remainder of the disposal system at
which an operator makes connections and disconnections
See Figure 1.
3.8
AGSS type-specific
having characteristics which prevent interchangeability and thereby allow assignment to one AGSS type only
3.9
AGSS type-specific connection point
part of the AGSS socket which is the receptor for an AGSS type-specific probe
2 © ISO 2007 – All rights reserved

ISO 7396-2:2007(E)
3.10
air compressor system
source of supply with compressor(s) designed to provide medical air and/or air for driving surgical tools and/or
air for AGSS
NOTE Different names or symbols are used for air for driving surgical tools, such as: instrument air, surgical air, air
motor, air - 700 and air - 800.
3.11
anaesthetic gas scavenging system
AGSS
complete system which is connected to the exhaust port(s) of a breathing system or other equipment for the
purpose of conveying expired and/or excess anaesthetic gases and vapours to an appropriate point of discharge
NOTE Functionally, an AGSS comprises three different parts: a transfer system, a receiving system and a disposal
system. These three functionally discrete parts can be either separate or sequentially combined in part or in total. In
addition, one or more parts of an AGSS can be combined with a breathing system or other equipment (e.g. an anaesthetic
ventilator) to include the transfer system, or transfer and receiving systems.
3.12
commissioning
proof of function to verify that the agreed specification is met and is accepted by the user or his representative
3.13
disposal hose
part of an AGSS which transfers expired and/or excess anaesthetic gases and vapours from the power device
to the probe of an AGSS type 2 terminal unit
3.14
disposal system
means by which the expired and/or excess anaesthetic gases and vapours are conveyed from the receiving
system to an appropriate point of discharge
NOTE A point of discharge can be, for example, the exterior of a building or a non-recirculating extract ventilation
system.
3.15
diversity factor
factor which represents the maximum proportion of terminal units in a defined clinical area which will be used
at the same time, at flowrates defined in agreement with the management of the healthcare facility
3.16
high-flow disposal system
disposal system which is intended to operate with a high-flow transfer and receiving system complying with
ISO 8835-3
3.17
high-flow transfer and receiving system
transfer and receiving system complying with ISO 8835-3 which connects through an AGSS type 1H terminal
unit as specified in ISO 9170-2 to a high-flow disposal system complying with this part of ISO 7396
3.18
low-flow disposal system
disposal system which is intended to operate with a low-flow transfer and receiving system complying with
ISO 8835-3
3.19
low-flow transfer and receiving system
transfer and receiving system complying with ISO 8835-3 which connects through an AGSS type 1L terminal
unit as specified in ISO 9170-2 to a low-flow disposal system complying with this part of ISO 7396
ISO 7396-2:2007(E)
3.20
manufacturer
natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device
before it is placed on the market under his own name, regardless of whether these operations are carried out
by that person himself or on his behalf by a third party
3.21
maximum operating pressure
maximum pressure at which a terminal unit is designed to operate
NOTE Operating pressure for a type 1 terminal unit is negative and for a type 2 terminal unit it is positive.
3.22
maximum test pressure
maximum pressure to which a terminal unit is designed to be subjected during pipeline pressure testing
3.23
non-return valve
valve which permits flow in one direction only
3.24
power device
part of an AGS disposal system that provides flow and pressure for scavenging
3.25
probe
non-interchangeable male component designed for acceptance by, and retention in, a socket
3.26
quick connector
pair of type-specific components which can be easily and rapidly joined together by a single action of one or both
hands without the use of tools
3.27
receiving hose
part of an AGSS which transfers expired and/or excess anaesthetic gases and vapours from the receiving system
to the disposal system
3.28
receiving system
part of an AGSS which provides an interface between the transfer system and the disposal system
3.29
shut-off valve
valve which prevents flow in both directions when closed
3.30
single fault condition
condition in which a single means for protection against a safety hazard in equipment is defective or a single
external abnormal condition is present
NOTE Maintenance of equipment is considered a normal condition.
4 © ISO 2007 – All rights reserved

ISO 7396-2:2007(E)
Key
1 apparatus such as anaesthetic breathing system or 11 permanent connection
anaesthetic ventilator and integral transfer/receiving
12 point of discharge
system and power device
13 flexible hose or pendant
2 apparatus such as anaesthetic breathing system or 14 disposal hose
anaesthetic ventilator
15 limit of breathing system or anaesthetic ventilator
3 transfer/receiving system and power device 16 limits of transfer system
4 apparatus such as anaesthetic breathing system and 17 limits of receiving system
integral transfer/receiving system
18 limit of disposal system
5 permanent or proprietary connector 19 proprietary connection (functionally specific)
6 receiving hose 20 30 mm conical connection
7 breathing system or anaesthetic ventilator 21 type 1 terminal unit probe/socket
8 transfer tube 22 type 2 terminal unit probe/socket
9 receiving system
10 power device
NOTE 1 Type 1 terminal unit probe/socket is for negative pressure. Type 2 terminal unit probe/socket is for positive
pressure.
NOTE 2 The limit between the receiving system and the disposal system as shown does not necessarily coincide with
an actual physical limit such as a wall. In the arrangement shown, a terminal unit on a wall would be located on the inlet to
the power device.
Figure 1 — Schematic diagram of typical AGSS connections
ISO 7396-2:2007(E)
3.31
system design flow
flow calculated from the maximum flow requirement of the healthcare facility and corrected by the diversity
factor(s)
3.32
transfer system
part of an AGSS which transfers expired and/or excess anaesthetic gases from the exhaust port of the breathing
system or other equipment to the receiving system
3.33
transfer tube
part of an AGSS which transfers expired and/or excess anaesthetic gases from the breathing system to the
receiving system
4 General requirements
4.1 Safety
AGS disposal systems shall, when installed, extended, modified, commissioned, operated and maintained in
accordance with the instructions of the manufacturer, present no risks that are not reduced to an acceptable
level using risk management procedures in accordance with ISO 14971 and which are connected with their
intended application, in normal condition and in single fault condition.
NOTE 1 A situation in which a fault is not detected is considered a normal condition. Fault conditions/hazardous
situations can remain undetected over a period of time and as a consequence can lead to an unacceptable risk. In that
case, a subsequent detected fault condition needs to be considered as a single fault condition. Specific risk control
measures need to be determined within the risk management process to deal with such situations.
NOTE 2 Typical safety hazards (discontinuity of operation, incorrect pressure and/or flow, etc.) are listed in Annex D.
4.2 Alternative construction
AGS disposal systems and components, or parts thereof, using materials or having forms of construction
different from those detailed in this part of ISO 7396, shall be presumed to be in compliance with the safety
objectives of this part of ISO 7396 if it can be demonstrated that an equivalent degree of safety is obtained (i.e.
compliance with requirements presumes that risks have been mitigated to acceptable levels) unless objective
evidence to the contrary becomes available.
NOTE 1 Objective evidence can be obtained by post-market surveillance.
Evidence of an equivalent degree of safety shall be provided by the manufacturer.
NOTE 2 Regional or national regulations can require the provision of evidence to the competent authority or a
conformity assessment body, e.g. notified body in the European Economic Area (EEA), upon request.
4.3 Materials
4.3.1 The materials used for pipelines and other components of the disposal system shall be corrosion-
resistant and compatible with anaesthetic gases and vapours under the operating conditions specified by the
manufacturer.
NOTE 1 Corrosion resistance includes resistance against the influence of moisture and the surrounding materials.
Evidence shall be provided by the manufacturer.
NOTE 2 Regional or national requirements can require the provision of evidence to the competent authority or a
conformity assessment body, e.g. notified body in the European Economic Area (EEA), upon request.
6 © ISO 2007 – All rights reserved

ISO 7396-2:2007(E)
4.3.2 If copper pipes are used, they shall comply with the requirements given in EN 13348.
Evidence shall be provided by the manufacturer.
NOTE 1 Regional or national regulations can require the provision of evidence to the competent authority or a
conformity assessment body, e.g. notified body in the European Economic Area (EEA), upon request.
NOTE 2 The requirement in 4.3.2 allows the use of the same stock of copper pipes as is used for the installation of
pipeline systems for compressed medical gases and vacuum in accordance with ISO 7396-1.
4.3.3 The potential hazards arising from the use of non-metallic pipes and components shall be taken into
account, using risk management procedures in accordance with ISO 14971.
NOTE Experience shows that non-metallic pipes and their junctions used in AGS disposal systems need to be
carefully evaluated for their durability following exposure to volatile anaesthetic agents.
4.3.4 All components of the system, other than copper pipes, which come in contact with anaesthetic
gases and vapours shall be cleaned in accordance with ISO 15001.
Evidence shall be provided by the manufacturer.
NOTE Regional or national regulations can require the provision of evidence to the competent authority or a
conformity assessment body, e.g. notified body in the European Economic Area (EEA), upon request.
4.3.5 If lubricants are used, they shall be compatible with anaesthetic gases and vapours at the operating
conditions specified by the manufacturer.
Evidence shall be provided by the manufacturer.
NOTE Regional or national regulations can require the provision of evidence to the competent authority or a
conformity assessment body, e.g. notified body in the European Economic Area (EEA), upon request.
4.3.6 Precautions shall be taken to maintain the cleanliness of components during transportation, storage
and installation.
4.4 Continuity of operation
The AGS disposal system shall be designed so to achieve continuity of operation in normal condition and in
single fault condition.
NOTE Loss of mains electrical power is a single fault condition. A fault in control equipment is a single fault condition.
In order to achieve these objectives, the AGS disposal system shall comprise at least two sources of supply of
air to drive exhaust ejectors or at least two fans, blowers or dedicated vacuum pumps.
The AGS disposal system shall be such that the system design flow can be supplied with any one source of
supply for air or any one fan, blower or dedicated vacuum pump out of service.
Means shall be provided so that each power device can be isolated for maintenance or repair.
5 Power device
5.1 The power device shall be used solely to power the AGS disposal system.
5.2 The power device shall be one of the following:
a) an exhaust ejector, for one or more AGSS type 1 terminal unit(s), driven by compressed air from a supply
system for air and a pipeline distribution system complying with ISO 7396-1, provided with a means of
adjusting the flow from the receiving system through the type 1 terminal unit to meet the requirements
specified in 8.1.1 and 8.1.2 [see Figure 2 a)];
ISO 7396-2:2007(E)
b) an exhaust ejector for each AGSS type 2 terminal unit, driven by compressed air from a supply system for
air and a pipeline distribution system complying with ISO 7396-1, provided with a means of adjusting the
flow from the receiving system to meet the requirements specified in 8.1.3 [see Figure 2 b)];
NOTE 1 Due to the high air flow required by the AGS disposal system, it is advisable to use a supply system with
compressor(s) or proportioning units.
c) at least two fans, blowers or dedicated vacuum pumps.
NOTE 2 National and regional regulations concerning noise within medical environment levels can exist.
NOTE 3 See Annex A for guidelines for power devices consisting of fans, blowers or dedicated vacuum pumps.
If dedicated vacuum pumps are installed as power device(s), they shall be compatible with oxygen and the
anaesthetic gases and vapours.
(*) A vacuum supply system in accordance with ISO 7396-1 shall not be used as AGSS power device.
5.3 Means shall be provided to adjust pressure and flow in the disposal system to meet the requirements
given in 8.1.1 and 8.1.2 for type 1 terminal units, regardless of the number of terminal units in use [see
Figure 2 c)].
NOTE Such means can be located either within the pipeline and/or in combination with the terminal unit(s).
5.4 Means for adjusting the pressure and flow shall be arranged so that they can be maintained without
interruption of operation.
Evidence shall be provided by the manufacturer.
NOTE Regional or national regulations can require the provision of evidence to the competent authority or a
conformity assessment body, e.g. notified body in the European Economic Area (EEA), upon request.
5.5 Power devices consisting of fans, blowers or dedicated vacuum pumps shall not be located in the same
room as gas and non-cryogenic liquid cylinder supply systems.
5.6 The locations of power devices complying with this part of ISO 7396 and supply systems complying with
ISO 7396-1 shall be decided by risk management process in accordance with ISO 14971 in order to minimize
the risk arising from hazards such as fire, contamination with oil, grease, and increased oxygen and nitrous
oxide concentrations.
6 Indicating systems
Means shall be provided to indicate to the operator that the AGS disposal system is operating.
7 Pipelines, connecting assemblies and disposal hoses
7.1 If connecting assemblies or disposal hoses are readily accessible to the operator, their connectors shall
be type-specific. The dimensions of the connectors shall be different from those specified in ISO 5359.
7.2 If flexible connecting assemblies or disposal hoses are used between components of the disposal
system and they are not readily accessible to the operator without significant disassembly of fixed
components or not normally replaced during their lifetime, the connectors of the assembly need not be type-
specific. The dimensions of the connectors shall be different from those specified in ISO 5359.
NOTE Examples of such connecting assemblies are those in hinged-arm booms, tracks and ceiling pendants, and
those used for isolation of vibration, building movement and relative movement of the pipelines.
8 © ISO 2007 – All rights reserved

ISO 7396-2:2007(E)
a) b)
c)
Key
1 compressed-air-driven power device
2 vacuum pump/fan/blower power device
3 means to adjust pressure and flow
4 type 1 terminal unit
5 type 2 terminal unit
6 ambient air
7 compressed air
8 receiving system
9 point of discharge
Figure 2 — Typical examples of power devices
8 Disposal system characteristics and test methods for pressure and flow
8.1 Requirements
8.1.1 Requirements for the AGS disposal system with type 1L terminal units
The flowrate through each type 1L terminal unit or, if not provided, at the interface point upstream of the power
device (see Figure 1) shall not exceed 50 l/min when the resistance to flow, which is provided to simulate the
resistance of the receiving system, is such as to produce a pressure drop of 1 kPa at 50 l/min, and shall not
be lower than 25 l/min when the resistance to flow, which is provided to simulate the resistance of the
receiving system, is such as to produce a pressure drop of 2 kPa at 25 l/min (see also ISO 8835-3:—, 10.1).
ISO 7396-2:2007(E)
8.1.2 Requirements for the AGS disposal system with type 1H terminal units
The flowrate through each type 1H terminal unit or, if not provided, at the interface point upstream of the
power device (see Figure 1) shall not exceed 80 l/min when the resistance to flow, which is provided to
simulate the resistance of the receiving system, is such as to produce a pressure drop of 1 kPa at 80 l/min,
and shall not be lower than 50 l/min when the resistance to flow, which is provided, is such as to produce a
pressure drop of 2 kPa at 50 l/min (see also ISO 8835-3:—, 10.2).
8.1.3 Requirements for the AGS disposal system with type 2 terminal units
With a flowrate of 50 l/min through the socket of each AGSS type 2 terminal unit, the pressure drop shall not
exceed 7,5 kPa.
8.2 Test methods for pressure and flow
8.2.1 General
8.2.1.1 All means for adjusting pressure and flow shall be adjusted to control the flow at each terminal
unit. Each terminal unit on the system shall be tested as follows:
a) with only the terminal unit under test in use;
b) for systems with more than one terminal unit, with all terminal units in use which are required to provide
the system design flow at the specified diversity factor.
8.2.1.2 Testing shall be carried out using ambient air.
8.2.1.3 The resolution and accuracy of all measuring devices used for testing shall be appropriate for the
values to be measured. All measuring devices used for certification shall be calibrated at appropriate intervals.
8.2.2 Test methods for flow in disposal systems fitted with type 1L terminal units
8.2.2.1 Test devices
In order to simulate the resistance to flow of a receiving system complying with ISO 8835-3, calibrated test
devices which are fitted with type 1L probes and which produce a pressure drop of 1 kPa at a flowrate of
50 l/min (test device 1/50) and 2 kPa at a flowrate of 25 l/min (test device 2/25) shall be used.
NOTE A typical test device is shown in Figure 3.
8.2.2.2 Procedure
8.2.2.2.1 Activate the power device on the AGS disposal system to be tested.
8.2.2.2.2 A test device fitted with type 1L probe which produces a pressure drop of 1 kPa at 50 l/min shall
be inserted into each type 1L terminal unit in turn with all the other terminal units closed. The flowrate on the
test device at each terminal unit shall be recorded.
8.2.2.2.3 A test device fitted with type 1L probe which produces a pressure drop of 2 kPa at 25 l/min shall
be inserted into each type 1L terminal unit in turn with all the other terminal units closed. The flowrate on the
test device at each terminal unit shall be recorded.
8.2.2.2.4 Type 1L probes which produce a pressure drop of 1 kPa at 50 l/min shall be inserted into each of
several type 1L terminal units up to the system design flow of the AGS disposal system with all the other
terminal units closed. A test device with type 1L probe which produces a pressure drop of 2 kPa at 25 l/min
shall be inserted into each terminal unit in turn. The flowrate at each terminal unit when this test device is
connected shall be recorded.
10 © ISO 2007 – All rights reserved

ISO 7396-2:2007(E)
Key
1 type 1 probe
2 flowmeter
3 fixed orifice
4 pressure measuring device (for calibration only)
Figure 3 — Typical test device for AGS disposal system characteristics (with type 1 terminal units)

8.2.2.2.5 The tests in 8.2.2.2.2, 8.2.2.2.3 and 8.2.2.2.4 shall be carried out at the same setting of the
means of pressure and flow adjustment. The results shall be recorded on a form such as Form C.7.1 (see
Annex C).
8.2.3 Test methods for flow in disposal systems fitted with type 1H terminal units
8.2.3.1 Test devices
In order to simulate the resistance to flow of a receiving system complying with ISO 8835-3, calibrated test
devices which are fitted with type 1H probes and which produce a pressure drop of 1 kPa at a flowrate of 80
l/min (test device 1/80) and 2 kPa at a flowrate of 50 l/min (test device 2/50) shall be used.
NOTE A typical test device is shown in Figure 3.
8.2.3.2 Procedure
8.2.3.2.1 Activate the power device on the AGS disposal system to be tested.
8.2.3.2.2 A test device fitted with type 1H probe, which produces a pressure drop of 1 kPa at 80 l/min, shall
be inserted into each type 1H terminal unit in turn with all the other terminal units closed. The flowrate on the
test device at each terminal unit shall be recorded.
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