ISO 7396-2:2000
(Main)Medical gas pipeline systems — Part 2: Anaesthetic gas scavenging disposal systems
Medical gas pipeline systems — Part 2: Anaesthetic gas scavenging disposal systems
Réseaux de distribution de gaz médicaux — Partie 2: Systèmes d'évacuation de gaz d'anesthésie non réutilisables
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Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 7396-2
First edition
2000-11-15
Medical gas pipeline systems —
Part 2:
Anaesthetic gas scavenging disposal
systems
Réseaux de distribution de gaz médicaux —
Partie 2: Systèmes d'évacuation de gaz d'anesthésie non réutilisables
Reference number
ISO 7396-2:2000(E)
©
ISO 2000
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ISO 7396-2:2000(E)
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ISO 7396-2:2000(E)
Contents
Foreword.iv
Introduction.v
1 Scope .1
2 Normative references .1
3 Terms and definitions .2
4 General requirements.6
5 Power device.6
6 Indicating systems.8
7 Pipelines, connecting assemblies and disposal hoses.8
8 Disposal system characteristics.8
9 Terminal units .11
10 Marking .11
11 Pipeline installation .11
12 Testing, commissioning and certification.12
13 Information to be supplied by the manufacturer.15
Annex A (informative) Guidelines for power devices.16
Annex B (informative) Example of procedure for testing and commissioning.17
Annex C (informative) Typical forms for use in testing and commissioning of AGS disposal systems
in accordance with annex B .21
Annex D (informative) Recommended minimum requirements for the organization of maintenance.33
Annex E (informative) Rationale .35
Bibliography.36
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ISO 7396-2:2000(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 3.
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 part of ISO 7396 may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
International Standard ISO 7396-2 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory
equipment, Subcommittee SC 6, Medical gas systems.
ISO 7396 consists of the following parts, under the general title Medical gas pipeline systems:
� Part 1: Pipelines for compressed medical gases and vacuum
� Part 2: Anaesthetic gas scavenging disposal systems.
Annexes A to E of this part of ISO 7396 are for information only.
NOTE Throughout this part of ISO 7396, a clause for which a rationale is provided in annex B is indicated by a boldface
capital R.
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ISO 7396-2:2000(E)
Introduction
This part of ISO 7396 specifies requirements for anaesthetic gas scavenging (AGS) disposal systems.
The anaesthetic gas scavenging system (AGSS) 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.
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INTERNATIONAL STANDARD ISO 7396-2:2000(E)
Medical gas pipeline systems —
Part 2:
Anaesthetic gas scavenging disposal systems
1 Scope
This part of ISO 7396 specifies requirements for the installation, function, performance, documentation, testing and
commissioning of anaesthetic gas scavenging disposal systems to ensure patient and operator safety. It includes
requirements for the power device, pipeline system, performance and for non-interchangeability between key
components.
This part of ISO 7396 specifies:
a) the compatibility between and safe performance of the disposal system and the other components of the
AGSS by design, installation and commissioning;
b) the use of appropriate materials;
c) the testing for correct installation of the completed system to ensure achievement of the performance intended
by the manufacturer;
d) the marking of pipeline and components.
NOTE In this part of ISO 7396, the term “pipeline” refers exclusively to pipelines that are part of a dedicated anaesthetic
gas scavenging system.
This part of ISO 7396 is applicable only to those disposal systems which are intended to be connected via AGSS
terminal units which comply with ISO 9170-2 to receiving systems which comply with ISO 8835-3.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of
this part of ISO 7936. For dated references, subsequent amendments to, or revisions of, any of these publications
do not apply. However, parties to agreements based on this part of ISO 7936 are encouraged to investigate the
possibility of applying the most recent editions of the normative documents indicated below. For undated
references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain
registers of currently valid International Standards.
ISO 5359, Low-pressure hose assemblies for use with medical gases.
ISO 7396-1, Medical gas pipeline systems — Part 1: Pipelines for compressed medical gases and vacuum.
ISO 8835-3:1997, Inhalational anaesthesia systems — Part 3: Anaesthetic gas scavenging systems — Transfer
and receiving systems.
ISO 9170-2, Terminal units for medical gas pipeline systems — Part 2: Terminal units for anaesthetic gas
scavenging systems.
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ISO 7396-2:2000(E)
ISO 14971, Medical devices — Application of risk management to medical devices.
ISO 15001, Anaesthetic and respiratory equipment — Compatibility with oxygen.
3 Terms and definitions
For the purposes of this part of ISO 7936, the following terms and definitions apply.
3.1
AGSS socket
that 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 AGS system at which the operator makes connections and disconnections
3.3
AGSS terminal unit base block
that 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 disposal system at which an operator makes connections and
disconnections
3.5
AGSS type 1L terminal unit
terminal unit to be used in low-flow disposal systems
3.6
AGSS type 1H terminal unit
terminal unit to be used in high-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
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
that part of the AGSS socket which is the receptor for an AGSS type-specific probe
3.10
air compressor system
source of supply with compressor(s) designed to provide air for breathing and/or air for driving surgical tools
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 to an appropriate place of discharge
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ISO 7396-2:2000(E)
NOTE Functionally, an AGSS comprises three different parts: a transfer system, a receiving system and a disposal system.
These three functionally discrete parts may be either separate or sequentially combined in part or in total. In addition, one or
more parts of an AGSS may be combined with a breathing system or other equipment .
3.12
commissioning
proof of function to verify that an agreed specification is met and is accepted by the user or the representative of the
user
3.13
design capacity
total flow of an AGS disposal system taking into account the diversity factor, i.e. the number of AGSS terminal units
which may be in use at the same time
3.14
disposal hose
that part of an AGSS which transfers expired and/or excess gases from the power device to the probe of an AGSS
type 2 terminal unit
3.15
disposal system
means by which the expired and/or excess anaesthetic gases are conveyed from the receiving system to an
appropriate place of discharge
NOTE A place of discharge may be, for example, the exterior of a building or a non-recirculating extract ventilation system.
3.16
high-flow disposal system
disposal system that generates extract flows not lower than 75 l/min from transfer and receiving systems complying
with ISO 8835-3
3.17
low-flow disposal system
disposal system that generates extract flows not more than 50 l/min from transfer and receiving systems complying
with ISO 8835-3
3.18
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
3.19
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.
3.20
maximum test pressure
maximum pressure to which a terminal unit is designed to be subjected during pipeline pressure testing
3.21
non-return valve
valve which permits flow in one direction only
3.22
placing on the market
making available for the first time, in return for payment or free of charge, a device other than a device intended for
clinical investigation, with a view to distribution and/or use
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ISO 7396-2:2000(E)
3.23
power device
that part of a disposal system of an AGSS which provides the gas flow for scavenging
3.24
probe
non-interchangeable male component designed for acceptance by, and retention in, a socket
3.25
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
3.26
receiving hose
that part of an AGSS which transfers expired and/or excess gases from the receiving system to the disposal system
3.27
receiving system
that part of an AGSS which provides an interface between the transfer system and the disposal system
3.28
shut-off valve, isolating valve
manual or automatic valve which prevents flow in both directions when closed
3.29
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
3.30
terminal unit check valve
valve which remains closed until opened by insertion of an appropriate probe and which then permits flow in either
direction
3.31
transfer system
that part of an AGSS which transfers expired and/or excess anaesthetic gases from the exhaust port of the breathing
system to the receiving system
3.32
transfer tube
that part of an AGSS which transfers expired and/or excess gases from the breathing system to the receiving system
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ISO 7396-2:2000(E)
Key
1 Apparatus including breathing system and integral transfer/receiving system 12 Discharge
and power device
13 Flexible hose or pendant
2 Apparatus including breathing system
14 Disposal hose
3 Transfer/receiving system and power device
15 Limit of breathing system
4 Apparatus including breathing system and integral transfer/receiving system
16 Limit of transfer system
5 Permanent or proprietary connector
17 Limit of receiving system
6 Receiving hose
18 Limit of disposal system
7 Breathing system or anaesthetic ventilator
19 Proprietary connection (functionally
8 Transfer tube specific)
9 Receiving system 20 30 mm conical connection
10 Power device 21 Type 1 terminal unit probe/socket
11 Permanent connection 22 Type 2 terminal unit probe/socket
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 may not coincide with an actual physical
limit such as a wall.
Figure 1 — Schematic diagram of typical AGSS connections
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ISO 7396-2:2000(E)
4 General requirements
4.1 Safety
AGS disposal systems shall, when installed, commissioned, operated in normal use and maintained according to
the instructions of the manufacturer, cause no safety hazard which could be foreseen using risk analysis
procedures in accordance with ISO 14971 and which is connected with their intended application, in normal
condition and in single fault condition.
4.2 R Alternative construction
AGS disposal system installations and components or parts thereof, using materials or having forms of construction
different from those detailed in this part of ISO 7396, shall be accepted if it can be demonstrated that an equivalent
degree of safety is obtained.
Such evidence shall be provided by the manufacturer.
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.
Evidence shall be provided by the manufacturer.
4.3.2 R If copper pipes are used, they shall comply with the requirements for copper tubing for pipelines given
in ISO 7396-1.
NOTE 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.
Evidence shall be provided by the manufacturer.
4.3.3 R All components of the system which come in contact with anaesthetic gases and vapours shall be
cleaned in accordance with ISO 15001.
4.3.4 R If lubricants are used, they shall be compatible with anaesthetic gases and vapours at the operating
conditions.
Evidence shall be provided by the manufacturer.
4.3.5 All precautions shall be taken to maintain cleanliness during transportation, storage and installation.
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 each type 1 terminal unit, driven by compressed air from an air compressor system and
a pipeline 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 a) or b); see Figure 2a);
b) an exhaust ejector for each type 2 terminal unit, driven by compressed air from an air compressor system and
a pipeline 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 c); see Figure 2b);
c) one or more fans, blowers or dedicated vacuum pumps, provided with means of adjusting and controlling the
vacuum level in the pipeline system and therefore the flow through each type 1 terminal unit within the limits
specified in 8.1 a) or b), regardless of the number of terminal units in use; see Figure 2 c).
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ISO 7396-2:2000(E)
Key
1 Compressed-air-driven power device 6 Ambient air
2 Vacuum pump/fan/blower power device 7 Compressed medical air
3 Flow regulating valve 8 Receiving system
4 Type 1 terminal unit 9 Discharge
5Type2terminalunit
Figure 2 — Typical examples of power devices
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ISO 7396-2:2000(E)
6 Indicating systems
Means shall be provided to indicate to the operator that the power device is operating.
7 Pipelines, connecting assemblies and disposal hoses
7.1 If the connecting assemblies or disposal hoses are readily accessible to the operator, the connecting
assembly or the disposal hoses shall be type-specific and the dimensions of its connectors shall not comply with
ISO 5359.
NOTE Examples of assemblies and hoses readily accessible to the operator are those in a ceiling flexible pendant or a
rigid ceiling column with access panels.
7.2 If the connecting assemblies or disposal hoses are not readily accessible to the operator without significant
disassembly of fixed equipment, the connectors of the assembly need not be type-specific.
NOTE Examples of assemblies and hoses not readily accessible to the operator are those in hinged-arm booms, tracks
and pendants.
7.3 If the connecting assemblies are not normally replaced during their life, the assembly need not be type-
specific.
NOTE Examples of such assemblies are those used for isolation of vibration, building movement and relative movement of
the pipelines.
7.4 Means shall be provided to prevent backflow of waste gas to terminal units.
NOTE This may be achieved by, for example, individual piping or non-return valves.
8 Disposal system characteristics
8.1 Requirements
The characteristics of the AGS disposal system shall be as follows.
a) 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 is such as to produce a pressure drop of 2 kPa at 25 l/min (see
also ISO 8835-3:1997, subclause 9.3). The results shall be recorded on a form such as Form C.6/1 (see
annex C).
The test method for compliance is given in 8.2.
b) The flowrate through each type 1H terminal unit or, if not provided, at the interface point upstream of the power
�5
device (see Figure 1) shall be ( 75 ) l/min when the resistance of the receiving system is such as to produce
0
a pressure drop of 2 kPa at 75 l/min (see also ISO 8835-3:1997, subclause 9.4). The results shall be recorded
on Form C.6/1 (see annex C).
The test method for compliance is given in 8.2.
c) With a flowrate of 50 l/min through the socket of each type 2 terminal unit, if provided, the pressure drop shall
not exceed 7,5 kPa.
The test method for compliance is given in 8.2. The results shall be recorded on a form such as Form C.6/2 (see
annex C).
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ISO 7396-2:2000(E)
8.2 Test method for flowrate and pressure drop
8.2.1 General
8.2.1.1 All flow control valves (if fitted) shall be adjusted for the purpose of controlling 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 specified to operate at the
same time.
8.2.1.2 Testing shall be performed using ambient air.
8.2.1.3 The resolution of all pressure measuring devices shall be at most 10 % of the specified values to be
measured.
8.2.2 Test methods for disposal systems fitted with type 1 terminal units
8.2.2.1 Test devices
8.2.2.1.1 In order to simulate the resistance to flow of a low-flow receiving system complying with ISO 8835-3,
test devices which are fitted with type 1L probes and 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. Typical test devices are
shown inFigure3.
8.2.2.1.2 In order to simulate the resistance to flow of a high-flow receiving system complying with ISO 8835-3, a
test device which is fitted with a type 1H probe and produces a pressure drop of 2 kPa at a flowrate of 75 l/min (test
device 2/75) shall be used. Typical test devices are shown in Figure 3.
8.2.2.2 Procedure
8.2.2.2.1 If the test devices are not precalibrated, the flowrate and the pressure drop of each test device shall
be checked to make sure that they are in accordance with the specified values (1 kPa at 50 l/min and 2 kPa at
25 l/min or 2 kPa at 75 l/min) when connected to a suitable source of suction.
8.2.2.2.2 The power device on the AGS disposal system to be tested shall be activated.
8.2.2.2.3 The test device fitted with type 1L probe which produces 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.
8.2.2.2.4 The test device fittedwithtype1L probe whichproduces2kPaat 25 l/min shallbeinserted intoeach
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.
8.2.2.2.5 Test devices fitted with type 1L probes which produce 1 kPa at 50 l/min shall be inserted into each of
several type 1L terminal units up to the design capacity of the AGS low-flow disposal system with all the other
terminal units closed. The flowrate on each test device shall be recorded at the same time.
8.2.2.2.6 A test device fitted with type 1L probes which produce 2 kPa at 25 l/min shall be inserted into each of
several type 1L terminal units up to the design capacity of the AGS low-flow disposal system with all the other
terminal units closed. The flowrate on each test device shall be recorded at the same time.
8.2.2.2.7 The test device fitted with a type 1H probe which produces 2 kPa at 75 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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ISO 7396-2:2000(E)
Key
1 Type 1 probe 3 Fixed orifice
2 Flowmeter 4 Pressure measuring device (for calibration only)
Figure 3 — Typical test device for AGS disposal system characteristics (with type 1 terminal units)
8.2.2.2.8 Test devices fitted with type 1H probe which produce 2 kPa at 75 l/min shall be inserted into each of
several type 1H terminal units up to the design capacity of the AGS high-flow disposal system with all other
terminal units closed. The flowrate on each test device shall be recorded at the same time. Each flowrate shall be
�5
( 75 ) l/min. The results shall be recorded on a form such as Form C.6/1 (see annex C).
0
8.2.3 Test method for disposal systems fitted with type 2 terminal units
8.2.3.1 Test devices
Test devices fitted with a type 2 probe and providing flowrates up to 50 l/min shall be used.
8.2.3.2 Procedure
8.2.3.2.1 The power device on the AGS disposal system to be tested shall be activated.
8.2.3.2.2 The test device shall be inserted into each terminal unit in turn with all the other terminal units closed.
The flowrate shall be adjusted to (50� 5) l/min. The pressure shall be recorded at the inlet to the terminal unit.
8.2.3.2.3 A test device shall be inserted into each of several terminal units up to the design capacity of the AGS
disposal system with all the other terminal units closed. Each flowrate shall be adjusted to (50� 5) l/min. The
pressure at the inlet to each terminal unit shall be recorded. The results shall be recorded on a form such as Form
C.6/2 (see annex C).
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ISO 7396-2:2000(E)
9 Terminal units
Terminal units shall comply with ISO 9170-2.
10 Marking
10.1 Pipelines shall be marked “AGSS” or national equivalent and shall have arrows denoting the direction of flow
adjacent to valves, if fitted, at junctions and changes of direction, before and after walls and partitions, etc. at
intervals of no more than 10 m and adjacent to terminal units.
10.2 Connecting assemblies and disposal hoses shall be marked “AGSS” or national equivalent.
10.3 Marking shall be:
a) durable;
b) with letters not less than 6 mm high for the pipelines and not less than 2,5 mm high for connecting assemblies
and disposal hoses.
10.4 If colour coding is used, it shall be red magenta or in accordance with the national standard.
NOTE An example of red magenta is 3050-R40B in accordance with SS 01 91 02.
10.5 Colour coding shall be durable.
10.6 The test for durability of marking and colour coding is given in 12.4.10.
11 Pipeline installation
11.1 Pipelines and electrical services shall be either
a) run in separate compartments; or
b) separated by more than 50 mm.
11.2 The pipelines, if metallic, shall be bonded to an earth terminal as near as possible to the point at which the
pipeline enters the building. The pipelines shall not be used for earthing the electrical equipment. The relevant
parts of national regulations for electrical installations in buildings shall apply.
11.3 Pipelines shall be protected from physical damage.
EXAMPLES Damage which might be sustained from the mov
...
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