Collated - AIIGM ASGT - Riunione 29.09.2015

Template for comments and secretariat observations Date:2015-09-18 Document: FprEN 7396-1 Project:
MB/ Line Clause/ Paragraph/ Type of Comments Proposed change Observations of the
NC1 number Subclause Figure/Table comment2 secretariat
AIIGM Introduction
ed k) safety features of the sources to ensure quality k) …to ensure the quality of gases…
158 of the gases according to specification.
(see resolutions of comments Prague meeting,
October 2014, comment n. US 016)
AIIGM Introduction Where the healthcare facility manufactures the gas

ed
159 on site e.g. for medical air, synthetic air
(manufactured using a proportioning system) or …medical air produced by air compressor systems,
oxygen 93, the healthcare facility is responsible for medical air produced by proportioning systems or
all aspects of the medical gas quality. oxygen 93 produced by oxygen concentrator
systems,
AIIGM 1 ed This part of ISO 7396 does not apply to filling cylinder bundle systems.
001 systems for transportable cylinders and
transportable cylinder bundle systems
ASG Contents, Ed Consistency with definition 3.56 Replace storage vessel(s) with reservoir(s)
150 3.3
AIIGM 3.4 ed …used to fill high pressure storage vessels. ...high-pressure reservoir(s).
031
ASG 3.4 Ed Consistency with definition 3.56 Replace storage vessel(s) with reservoir(s)
032
AIIGM 3.8 ed control system

038
device or set of devices to manage, command,

direct or regulate the behaviour of other device(s)
or system(s) system(s).
1 MB = Member body / NC = National Committee (enter the ISO 3166 two-letter country code, e.g. CN for China; comments from the ISO/CS editing unit are identified by **)
2 Type of comment: ge = general te = technical ed = editorial
Page 1 of 38
ASG 3.9 Ed Use better wording Replace “liquid state” with “liquid phase”
039
AIIGM 3.18 ed gas-specific connector

024
connector with dimensional characteristics which

prevent connections between different gas
services.
Note to Entry: Examples of gas-specific connectors Examples of gas-specific connectors are quick
are quick connectors, screw-threaded connectors, connectors, screw-threaded connectors, diameter-
diameter-indexed safety system (DISS) connectors indexed safety system (DISS) connectors, non-
and non-interchangeable screw-threaded (NIST) interchangeable screw-threaded (NIST) connectors
connectors. and sleeve indexed system (SIS) connectors.
ASG 3.18 Ed Consistency with other clauses Add reference to SIS connectors
025
ASG 3.20 Ed Consistency with official terminology Replace “93/42/EC” with “93/42/EEC”
026
AIIGM 3.31 ed manifold

027
device for connecting the outlet(s) of one or more

cylinders, cylinder bundles or high pressure
Page 2 of 38
storage vessel(s) of the same gas to the pipeline

system. high-pressure reservoir(s)
028
AIIGM 3.32 ed manifold pressure regulator

029
pressure regulator intended to be installed within

sources of supply containing cylinders, cylinder
bundles, or high pressure storage vessel(s). bundles or high-pressure reservoir(s).
030
ASG 3.40 Ed Use better wording Replace “liquid state” with “liquid phase”
033
AIIGM 3.46 ed gas produced by an oxygen concentrator unit gas for medicinal use produced by an oxygen
034 whose concentration is within the limits specified in concentrator whose concentration is within the
the relevant pharmacopeial monograph limits specified in the relevant pharmacopeial
monograph
See resolutions of comments (Prague 2014),

comment n.046 IT)
Page 3 of 38
AIIGM 3.47 ed peak demand

035
maximum forseeable gas flowrate required by a foreseeable

healthcare facility
AIIGM 3.63 ed supply pressure regulator

036
pressure regulator fitted within a source of supply

and intended to regulate the pressure supplied to
the line
pressure regulator(s)
Note to Entry: For a source of supply with

cylinders, cylinder bundles, or high pressure
storage vessel(s), this is referred to as the manifold
pressure regulator. bundles or high-pressure reservoir(s),
ASG 3.63 Ed Consistency with definitions Replace storage vessel(s) with reservoir(s)
037
AIIGM 4.1 (*) ed Safety

040
… Add IEC 60601-1-2 to either the Normative

references or the Bibliography.
National or regional regulations may exist. IEC
60601-1-2 may apply to equipment classified as (see resolutions of comments Prague meeting,
medical devices. October 2014, comment n. US 054)
AIIGM 4.3.2 (*) ed NOTE 1 Criteria for the selection of metallic and Add ISO 11114-1 to Normative references or
041 non-metallic materials are given in ISO 15001, ISO Bibliography.
11114-1 and ISO 11114-2
Add ISO 11114-2 to Normative references or
Page 4 of 38
Bibliography.
ISO 11114-1 and ISO 11114-2.
NOTE 3 Compatibility with oxygen involves both

combustibility and ease of ignition. Materials which
burn in air will burn violently in pure oxygen.
…high concentrations of oxygen.

October 2014, comment n. IT 059)
AIIGM 5.1.1 ed a) gas in cylinders, cylinder bundles or high high-pressure reservoir(s);

042 pressure storage vessel(s);
ASG 5.1.1 a) Ed Consistency with definition 3.56 Replace storage vessel(s) with reservoir(s)
043
AIIGM 5.2.5 ed Reserve source(s) of supply

044
first c) all sources of supply are depending upon

the electrical power supply: the connection of the
reserve source of supply to the emergency reserve source(s)
electrical power supply shall be automatic and the
subsequent activation shall be automatic.
second b) the size of the reserve source of supply

such that the system design flow may be supplied
Page 5 of 38
continuously
reserve source(s)
when both the primary and secondary sources of
supply are unavailable; (see resolutions of comments Prague meeting,
d) the location of the reserve source(s) of supply

which should be such as to allow access to and
use of at least the reserve source of supply in case
of fire inside the room(s) housing the primary and
secondary sources of supply reserve source(s)

AIIGM 5.2.7 ed Maintenance supply assembl(ies) assembly

045

October 2014, comment n. IT 095: Keep the title
unchanged and add “each” before “assembly”)
AIIGM 5.2.7.2 ed The manufacturer together with the healthcare

046 facility management shall determine the location of
the maintenance supply assembly. each maintenance supply assembly.
The location of the maintenance supply assembly

should be such as to allow the supply of gas to the
pipeline in case of fire inside the room(s) of the
sources of supply. Risk management procedures each maintenance supply assembly
should consider the need for multiple maintenance
supply assemblies.
Page 6 of 38
The maintenance supply assembly should be

located outside of the area of the supply system
and should allow access by vehicles.
Each maintenance supply assembly.
AIIGM 5.3 ed Supply systems with cylinders, cylinder bundles or high-pressure reservoir(s)
047 bundles, or high pressure storage vessel(s)
048 5.3.1 7 times
5.3.2
5.3.3
AIIGM 5.3.1 ed A supply system with cylinders, cylinder bundles, bundles or high-pressure reservoir(s)
049 or high pressure storage vessel(s) shall comprise:
Except for air and nitrogen for driving surgical

tools, the supply system with cylinders, cylinder
bundles, or high pressure reservoir shall be such
that the system design flow can be supplied with
any two sources of supply out of service. bundles or high-pressure reservoir(s)
AIIGM 5.3.2 ed The primary and secondary sources of supply

050 which alternately supply the pipeline shall each
Page 7 of 38
consist of one bank of cylinders, cylinder bundles,

or high pressure storage vessel(s). When an
exhausted bank of
bundles or high-pressure reservoir(s).
storage vessel(s) is replaced, it shall be possible to
reset the
automatic changeover. Each bank shall have its bundles or high-pressure reservoir(s)
storage vessel(s) connected to a manifold with its
own pressure regulator. Except for air, vent valves
shall be vented outside of the building.
bundles or high-pressure reservoir(s)
AIIGM 5.3.3 ed Except for banks with only one cylinder, cylinder
051 bundle, or high pressure storage vessel, a non-
return valve shall be installed at the manifold end bundles or high-pressure reservoir(s)
of each flexible connection between the cylinder,
cylinder bundles, or high pressure storage
vessel(s) and the manifold.
bundles or high-pressure reservoir(s)
AIIGM 5.4.1 ed a) one cryogenic or non-cryogenic vessel with

052 associated equipment and two banks of cylinders,
or high pressure storage vessel(s); cylinders, cylinder bundles or high-pressure
reservoir(s).
b) two cryogenic or non-cryogenic vessels with
associated equipment and one bank of cylinders
cylinder bundles or high pressure storage
vessel(s);
cylinders, cylinder bundles or high-pressure
reservoir(s).
Page 8 of 38
ASG 5.4.1 a) Ed Consistency with definition 3.56 Replace storage vessel(s) with reservoir(s)
053 5.4.1 b)
ASG 5.4.2 Ed In the field, situations where a brittle material Add the following at the beginning of clause
054 is placed downstream of a vaporizer are very 5.4.2:
rare, as pipelines are made almost Where materials subject to cold embrittlement
exclusively of copper and stainless steel. An are used downstream of the vaporiser
ingress of cryogenic liquid is very rare. system……
AIIGM 5.5.1.1 ed a) a supply system with cylinders, cylinder bundles
055 or high pressure storage vessel(s) as specified in
5.3; high-pressure reservoir(s)
ASG 5.5.1.1 a) Ed Consistency with definition 3.56 Replace storage vessel(s) with reservoir(s)
056
AIIGM 5.5.2.1 (*) ed Regional or national regulations applying to

057 medical air produced by a supply system with air
compressor(s) may exist. Where such regulations
do not exist, medical air shall comply with the
following:
medical air produced by a supply system with air
compressor(s)
---
NOTE 1 Oil can be present as liquid, aerosol and

vapour.
Page 9 of 38
NOTE 2 These values are taken from the

European Pharmacopoeia.
NOTE 2 These values are taken from the European
Pharmacopoeia monograph for “medicinal air”.
AIIGM 5.5.2.5 ed b) a bank of cylinders, cylinder bundles, high cylinders, cylinder bundles or high-pressure
060 pressure storage vessel(s); reservoir(s);
AIIGM 5.5.2.5 NOTE 2 ed a) one compressor unit with one reservoir, one
061 conditioning unit and two banks of cylinders,
cylinder bundles or high pressure storage
vessel(s);
high-pressure reservoir(s)
b) two compressor units with at least two
reservoirs, two conditioning units and one bank of
cylinders, cylinder bundles or high pressure
storage vessel(s);
ASG 5.5.2.5 Ed The first “fitted” is redundant Delete the first “fitted” and amend as follows:
062 Note 4 c) a dew-point sensor with an alarm and
display …..
ASG 5.5.2.5 b) + Ed Consistency with definition 3.56 Replace storage vessel(s) with reservoir(s)
063 Note 2 a)
and b)
AIIGM 5.5.2.6 NOTE 1 ed one compressor unit with one reservoir, one
064 conditioning unit and one bank of cylinders,
Page 10 of 38
cylinder bundles or high pressure reservoir;

AIIGM 5.5.2.12 ed The inlet of the ambient air for compressors shall
058 be located where there is minimal contamination
(e.g. from internal combustion engine exhaust,
vehicle parking, access areas, healthcare facility
waste and disposal systems, vacuum system
exhausts, vents from medical gas pipeline or
anaesthetic gas scavenging systems, ventilation
system discharges, chimney outlets)
… ventilation system discharges, chimney outlets).
Consideration should be given to the potential

effects of prevailing winds on the location of the
intake(s) which should be remote from chimney Consideration should be given to the potential
outlets. effects of prevailing winds on the location of the
intake(s).
which should be remote from chimney outlets.

AIIGM 5.5.2.13 ed A supply system with compressors intended to (single-stage pipeline distribution systems cannot
059 supply a single-stage pipeline distribution system have line pressure regulators!)
shall include at least two permanently fitted line
pressure regulators. The design flow of the line pressure regulators
pipeline distribution system shall be supplied with
at least one line pressure regulator isolated for
maintenance.
The instructions for use and maintenance shall line pressure regulators
specify how the permanently fitted l i ne pressure
regulators are intended to operate.
Page 11 of 38
line pressure regulators
AIIGM 5.5.3.1 ed Regional or national regulations applying to

065 synthetic medical air produced by proportioning
unit(s) may exist. Where such regulations do not synthetic medical air
exist, synthetic medical air shall comply with the
following:
medical air produced by proportioning unit(s)
…
NOTE These values are taken from the European

Pharmacopoeia monograph NOTE These values are taken from the European
Pharmacopoeia monograph for “synthetic medicinal
air”.
AIIGM 5.5.3.3 ed a) sources of oxygen and nitrogen, one

066 proportioning unit and two banks of cylinders,
cylinder bundles or high pressure storage vessel(s) high-pressure reservoir(s)
or air compressor units; or
b) sources of oxygen and nitrogen, two

proportioning units and one bank of cylinders,
cylinder bundles or high pressure storage vessel(s)
or air compressor unit; or
c) sources of oxygen and nitrogen, one
proportioning unit, one air compressor unit and one
bank of cylinders cylinder bundles or high pressure
storage vessel(s).
cylinders, cylinder bundles or high-pressure

Page 12 of 38
reservoir(s).
ASG 5.5.3.3 Ed Consistency with definition 3.56 Replace storage vessel(s) with reservoir(s)
067 a), b) and c)
AIIGM 5.5.3.4 ed d) a synthetic medical air reservoir fitted with a medical air
068 pressure-relief valve, a pressure gauge and a
means of purging;
e) an automatic shut-off valve shall be fitted to

prevent synthetic air out of specification (see
5.5.3.1) being delivered at the outlet of the supply
system. medical air
AIIGM 5.5.3.7 ed Means shall be provided to purge the synthetic medical air
069 medical air reservoir.
AIIGM 5.5.3.8 ed Note 1 National or regional regulations concerning NOTE 1

070 the oxygen analyzer may exist
Note 2 Additional monitoring may be required to

show compliance of synthetic medical air with NOTE 2 Additional monitoring may be required to
national or regional regulations. show compliance of medical air produced by
proportioning unit(s) with national or regional
regulations.
AIIGM 5.6.2 ed b) at least one oxygen 93 storage vessel; reservoir;

071
c) a sample port with a shut-off valve immediately
Page 13 of 38
downstream of the oxygen 93 storage vessel;

reservoir;
ASG 5.6.2 Ed Consistency with definition 3.56 Replace storage vessel(s) with reservoir(s)
072 b) and c)
AIIGM 5.6.3 ed Secondary source of supply (see ISO/FDIS amended in Prague meeting)
073
If the secondary source consists of an oxygen

concentrator, it shall include the same components
as the primary source. If the secondary source of cylinders, cylinder bundles or high-pressure
supply consists of only cylinders, cylinder bundles reservoir(s)
or high pressure Oxygen 93 reserviors, the
following requirements apply:
a) the source of supply shall consist of at least one

bank of cylinders, cylinder bundles or high cylinders, cylinder bundles or high-pressure
pressure Oxygen 93 reserviors; reservoir(s)
b) if there is more than one bank of cylinders,

cylinder bundles or high pressure Oxygen 93
reserviors, gas shall be supplied from one bank of cylinders, cylinder bundles or high-pressure
cylinders, cylinder bundles or high pressure reservoir(s)
Oxygen 93 reserviors at a time and on depletion of
one bank switch automatically to another bank or
reservoir.
delete or reservoir
Page 14 of 38
ASG 5.6.3 Ed Use the correct term, i.e. “source of supply” Amend as follows:
074 If the secondary source of supply consists of
an oxygen concentrator, it shall include the
same components as the primary source of
supply.
AIIGM 5.6.4 Reserve source of supply (see ISO/FDIS amended in Prague meeting)
075
If the reserve source consists of an oxygen

concentrator, it shall include the same components
as the secondary source. If the reserve source of cylinders, cylinder bundles or high-pressure
supply consists of only cylinders, cylinder bundles reservoir(s)
or high pressure Oxygen 93 reserviors, the
following requirements apply:
a) the source of supply shall consist of at least one

bank of cylinders, cylinder bundles or high cylinders, cylinder bundles or high-pressure
pressure Oxygen 93 reserviors; reservoir(s)
b) if there is more than one bank of cylinders,

cylinder bundles or high pressure Oxygen 93
reserviors, gas shall be supplied from one bank of cylinders, cylinder bundles or high-pressure
cylinders, cylinder bundles or high pressure reservoir(s)
Oxygen 93 reserviors at a time and on depletion of
one bank switch automatically to another bank or
reservoir.
NOTE This configuration is needed to facilitate

replenishment of the reserve source of supply
without interruption of supply. delete or reservoir
Page 15 of 38
ASG 5.6.4 Ed Use the correct term, i.e. “source of supply” If the reserve source of supply consists of an
076 oxygen concentrator, it shall include the same
components as the secondary source of supply.
AIIGM 5.6.5.1
ed NOTE 1 These valves are taken from the values…. Pharmacopoeia
077 European Pharmacopeia.
NOTE 2 In accordance with the European and US

pharmacopeias, oxygen 93 is oxygen between pharmacopoeias
90% and 96%, the balance of the gas being
predominantly argon and nitrogen.
AIIGM 5.6.5.2 ed Oxygen 93 shall be filtered before the supply

078 source shutoff valve to maintain the particulate
contamination below the level provided by Table 2, shut-off
class 2 of ISO 8573-1:2010 (see 5.5.2.2)
(see 5.5.2.2).
AIIGM 5.6.5.3 ed If periodic change of the filter element(s) is not

079 scheduled, then means shall be provided to verify
the status of filter elements filter elements.
AIIGM 5.6.7 ed Oxygen 93 storage vessels 5.6.7 Oxygen 93 reservoir(s)

080
Each oxygen 93 storage vessel or group of oxygen Each oxygen 93 reservoir or group of oxygen 93
93 storage vessels shall: reservoir(s)
d) be arranged so that each vessel can be reservoir

maintained separately.
NOTE An oxygen 93 storage vessel may be

supplied by more than one oxygen concentrator. oxygen 93 reservoir
Page 16 of 38
ASG Contents, Ed Consistency with definition 3.56 Replace storage vessel(s) with reservoir(s)
151 5.6.7
ASG 5.6.7 Ed Consistency with definition 3.56 Replace storage vessel(s) with reservoir(s)
081 3 times
ASG 5.6.7 Ed Consistency with definition 3.56 Replace storage vessel with reservoir
082 Note
ASG 5.6.7 d) Ed Consistency with definition 3.56 Replace vessel with reservoir
083
AIIGM 5.6.8.3 ed The oxygen analyzer and automatic isolating valve oxygen 93 reservoir
084 on the oxygen storage reservoir shall be located
upstream of the oxygen storage reservoir. oxygen 93 reservoir
ASG 5.6.8.3 Second Ed Use the correct term Replace “oxygen storage reservoir” with “oxygen
085 sentence 93 reservoir”
2 times
AIIGM 5.6.8.7 ed A supply system with oxygen concentrators shall

086 include means for calibrating the analyzing
Page 17 of 38
system(s) by reference to mixture(s) of known

composition
known composition.
AIIGM 5.6.9 ed Local filling of permanently attached high pressure oxygen 93 high-pressure reservoir(s), acting as
087 oxygen 93 reservoir(s), acting as reserve reserve source of supply.
reservoirs.
Caution must be taken in filling high pressure

oxygen reservoirs as the practice has inherent oxygen 93 high-pressure reservoir(s)
risks of fire
due to the high oxidising capacity of materials,

which at ambient pressure are fully compatible with
oxygen, but at higher pressures can easily ignite
and burn in pure oxygen. These risks may be
mitigated by following relevant standards. can easily ignite and burn easily in high
concentrations of oxygen.
ASG 5.6.9 First line Ed Use the correct term Replace “oxygen reservoirs” with “oxygen 93
088 reservoirs”
Third line “pure” is redundant
Delete the word “pure”
AIIGM 5.6.9.1 ed a) Means shall be provided to ensure that the filling reserve high-pressure reservoir(s)
089 of high pressure reservoirs does not affect delivery
of oxygen 93 to the pipeline distribution system. (see resolutions of comments Prague meeting,
October 2014, comment n. DE 188)
Page 18 of 38
AIIGM 5.6.9.2 ed The following safety measures shall be provided 5.6.9.2 The following safety measures shall be
090 implemented:
a) means (e.g. a non-return valve) to ensure that
there is no back flow to the oxygen concentrator (see ISO 14971 for terminology, the measures are
supply system. “implemented”, not “provided”)
b) appropriate barrier(s) to protect personnel;
c) In order to ensure safety of patients in the event in

of temperature build-up, the high pressure booster
compressor shall have a temperature sensor on booster compressor
each compression stage, it may give rise to an
alarm for high temperature thresholds
recommended by the manufacturer of the
compressor, and it may stop the compressor;
d) The following operating alarms shall be

provided, set to activate at thresholds as defined booster compressor
by the manufacturer:
booster compressor
—an enclosure temperature sensor;
the
—an output gas temperature sensor;
—a power sensor;
—a high pressure sensor.
In the event of actuation of any of these alarms,

the compressor unit shall be automatically stopped
in order to
avoid contamination of the reserve source of

supply.
booster compressor
e) A means shall be provided to purge the high
Page 19 of 38
pressure oxygen 93 reservoir.
oxygen 93 high-pressure reservoir(s).
ASG 5.6.9.2 c) Ed Use better wording Replace ,” it may give rise to” with “to activate”
091
ASG 5.6.9.2 d) Ed Use the correct term Replace “compressor” with “high pressure
092 Last booster compressor”
sentence
ASG 5.7.3 Ed Consistency with the notes in 7.2.2, 7.2.3 and Use the following text:
094 7.2.4
NOTE
System design flow is calculated in accordance

with appropriate diversity factors. Examples of
diversity factors are given in HTM 02 [34], [35], FD
S 90-155 [33] and AS 2896-1998 [23].
ASG 5.7.12 Ed Use better wording Replace “sustained” with “supplied”

093
Page 20 of 38
AIIGM 5.8.1 ed a) in the same room as equipment with electrically

095 driven motors, (e.g. air compressors, vacuum
pumps, water pumps). motors
An exception may be made for equipment e.g.

fans, blowers directly ventilating the enclosure and
for locations open to the outside without risk of
confinement
b) in the same room as equipment with open confinement;

flames (e.g. boilers, gas water heaters).
AIIGM 5.8.2 (*) ed The ambient temperature in rooms for supply for supply systems in rooms
096 systems shall be maintained in the range of 10°C
to 40°C.
AIIGM 6.1 ed The control panel, the monitoring, and the alarm monitoring
097 system shall be designed in accordance with IEC
60601-1-8.
AIIGM 6.2.2 ed c) the indicator panel(s) for the emergency clinical

098 alarm signals specified in 6.5 shall be installed in
the clinical and critical areas. An additional panel critical care areas.
indicating the area monitored may be installed
near the area shut-off valve;
Page 21 of 38
AIIGM 6.4 ed NOTE 5 ppm V/V is the value specified in the The monograph in the European Pharmacopoeia is
099 European Pharmacopeia Medical Air monograph. called “Medicinal air”
0.001%
European Pharmacopoeia Medicinal Air monograph
Additional operating alarms may be required by

regional or national regulations e.g. for air supplied oxygen 93 supplied from a concentrator system.
by a compressor system or oxygen supplied from a
concentrator.
k) malfunctioning of a supply system for oxygen 93;

k) malfunctioning of a supply system for oxygen October 2014, comment n. IT 236 and FR 234)
93;
k) malfunctioning of a supply system with an

oxygen concentrator;
l) malfunctioning of a supply system with an

oxygen concentrator;
ASG 6.4 After g) Ed Use the correct term Replace “oxygen” with “oxygen 93”
100
ASG 6.4 Ed One of the two items is redundant Keep k) and delete l) or keep l) and delete k)
101 k) and l)
Page 22 of 38
AIIGM 6.6 (*) ed d ) temperature of any air compressor exceeding d ) temperature of any air compressor exceeding
102 the threshold defined by the manufacturer. the threshold defined by the manufacturer;
f) for systems supplied from oxygen concentrator f) for systems supplied from oxygen concentrator
supply units, an oxygen concentration below 90%. supply units, an oxygen concentration below 90%;
AIIGM 7.2.2 NOTE 2 ed NOTE 2 The following factors will contribute to the These requirements are applicable also to single
103 pressure change: performance of l i n e pressure stage distribution systems; delete “line”
regulators, pressure drop in the pipeline
downstream of the line pressure regulator and performance of pressure regulators
pressure drop across the terminal unit.
pressure regulator
AIIGM 7.2.3 NOTE 2 ed NOTE 2 The following factors will contribute to the These requirements are applicable also to single
104 pressure change: performance of l i n e pressure stage distribution systems; delete “line”
regulators, pressure drop in the pipeline
downstream of the line pressure regulator and performance of pressure regulators
pressure drop across the terminal unit.
pressure regulator
ASG 7.3.1 Ed Use better wording Add “requirements” before “shall be met”
105
7.3.1 d) Delete “it” and add “the low pressure flexible
connection” at the beginning of the sentence
AIIGM 7.4.1 (*) ed The instructions for use and maintenance shall
106 specify how the two permanently fitted pressure
regulators are intended to operate. line pressure regulators
Page 23 of 38
ASG 8.1.6 Ed This valve is a main shut-off valve (see e.g. Replace “An inlet shut-off valve” with “A main
107 item 2 in Figures A.23, A.24 and A.25 shut-off valve”
AIIGM 8.3.1 ed All terminal units in the pipeline system other than
108 those provided only for emergency, system test
purposes or maintenance of components (e.g. line
pressure regulators) shall be on the patient side of
an area shut-off valve (upstream for vacuum).
delete (upstream for vacuum) (“Patient side” is

clear)
AIIGM 8.3.4 ed For pressure gases: For compressed gases:

110
AIIGM 8.3.10 ed No area shut-off valve shall be fitted downstream 8.3.10 No area shut-off valve shall be fitted
109 of the sensor activating the emergency pressure downstream of the sensor activating the emergency
alarm. pressure alarm.
Already said in 8.3.9, delete 8.3.10

AIIGM 10.1.2 ed NOTE ISO 5359 2008 does not include marking or oxygen 93.
002 colour coding for Oxygen 93.
b) use letters not less than 6 mm high;
Page 24 of 38
c) be applied with the gas name and/or symbol

along the longitudinal axis of the pipeline; and
gas/vacuum
ASG 10.1.2 a) Ed In ISO 5359:2014 DAM1 and in ISO Delete the note.
003 Note 18082:2014 DAM1 marking for oxygen 93 is
defined.
AIIGM 10.2 ed NOTE 1 ISO 5359 2008 does not include marking oxygen 93.
004 or colour coding for Oxygen 93.
ASG 10.2 Ed Colour coding is not defined in ISO Amend the note as follows:
005 Note 1 5359:2014 DAM1 and in ISO 18082:2014
DAM1 NOTE 1 ISO 5359:2014 DAM 1 does not include
colour coding for Oxygen 93
AIIGM 11.1.2 ed Pipeline components which ar e l i abl e t o come Pipeline components which ar e l i abl e t o come in
007 in contact with the actual gas shall meet the contact with the actual gas shall meet the
cleanliness requirements of EN 13348 and ISO cleanliness requirements of EN 13348 or ISO
15001 and be supplied protected from 15001, as applicable (see 4.3.6 e 4.3.7) , and be
contamination prior to, and during, installation. supplied protected from contamination prior to, and
during, installation.
(EN 13348 is applicable only to pipes, ISO 15001 is

applicable only to components other than pipes,
see 4.3.6 e 4.3.7)
ASG 11.1.5 Ed Evidence shall be provided Add the following:

008 Documented evidence of compliance shall be
provided by the manufacturer and considered as
Page 25 of 38
part of the test records.
or, at least:
Evidence shall be provided by the manufacturer.
ASG 11.1.12 Ed Use better wording Replace “Allowance shall be made for expansion
006 and contraction of pipelines” with
“During installation means shall be provided to allow

expansion and contraction of pipelines”
AIIGM 11.4.10 ed The test gas on the modification shall be purged

009 downstream in order to prevent backflow
contamination of the existing pipeline before the
valve specified in 11.4.3 is opened
opened.
AIIGM 12.2 ed General requirements for tests

010
In this standard, requirements for flow rate and

volume for the gas delivered are expressed at NTP
(Normal Temperature and Pressure) Pressure).
AIIGM 12.4 ed n) test of the quality of oxygen 93 produced by oxygen 93 produced by supply systems with
011 oxygen concentrator unit(s) (see 12.6.14); oxygen concentrator(s)

Page 26 of 38
ASG 12.4 After p) Ed Consistency with clause 12.6.17 Add the following new dash item:
012
q) verification of restart after power supply failure

(see 12.6.17)
AIIGM 12.6.1 ed d) combined test for leakage and mechanical d) combined test for leakage and mechanical
013 integrity of vacuum pipeline systems. integrity of vacuum pipeline systems (see 12.6.1.7).
AIIGM 12.6.3 Test for cross-connection Consistency with 3.17:

018
It shall be proved that there are no cross- It shall be proved that there are no cross-
connections between pipelines for different gases connections between pipelines for different gas
or vacuum. services or vacuum services.
AIIGM 12.6.5.1 ed If a NIST or DISS connector… If a NIST, DISS or SIS connector…

019
ASG 12.6.5.1 Second Ed SIS connectors should also be referred to Add mention of SIS connectors as in the title
020 sentence
AIIGM 12.6.6 ed It shall be shown using tests or verification of

021 calculation or other suitable methods that whilst
the system is delivering the system design flow,
the requirements given in Table 2, 7.2.2, 7.2.3 and
7.2.4 are met at selected terminal units.
7.2.1, Table 2,
Page 27 of 38
AIIGM 12.6.11 ed NOTE 1 The test methods are given in the relevant Pharmacopoeia
014 Pharmacopeia monographs.
AIIGM 12.6.13 ed NOTE 1 The test methods are given in the relevant Pharmacopoeia
015 Pharmacopeia monographs. Alternative methods
of analysis may be used.
AIIGM 12.6.14 ed NOTE 1 The test methods are given in the relevant pharmacopoeia
016 pharmacopeia monographs. Alternative methods
of anaysis may be used. analysis
AIIGM 12.6.16 ed NOTE 2 National or Regional regulations regional

017 permitting other sampling criteria can exist.
AIIGM 13.3.2 ed the minimum and maximum oxygen  the minimum and maximum oxygen
022 concentrations delivered by the oxygen concentrations delivered by the
concentrator unit(s) at the system design flow compressor unit, proportioning unit and
under the ambient conditions specified by the oxygen concentrator unit at the system
healthcare facility; design flow under the ambient conditions
specified by the healthcare facility;
starting procedure of the oxygen concentrator  starting procedure of the compressor unit,
unit(s) if applicable; proportioning unit and oxygen
concentrator unit if applicable
starting time of the oxygen concentrator unit(s) if  starting time of the compressor unit,
applicable. proportioning unit and oxygen
concentrator unit if applicable

ASG 13.3.2 Ed Use better wording Add the article before all dash items, if
Page 28 of 38
023 required
ASG Annex A Sentence Ed The figures are 26, from A.1 to A.26 Replace A.44 with A.26, 2 times
111 before Replace A.25 with A.26
Table A.1
and title of
Table A.1
ASG Annex A Table A.1 Ed All figures are identified as e.g. A.1, A.15, etc. Use the same method of identification of the
112 In the first column they are referred to as e.g. figures all through the document, A.1 or A1
A1, A15 etc.
ASG Annex A Table A.1 Ed Vacuum is not medical , is vacuum only ! Delete “medical” before “vacuum”
113 Draw. Ref.
2 times
A22
ASG Annex A Figures Ed The titles of the figures shall be as the titles See the proposed change for each figure
114 given in Table A.1. The titles in Table A.1 are
correct (except for vacuum). Amend the titles
of some figures as proposed below.
ASG Annex A Figure A.1 Ed Typing error Delete “and” between “manifold” and
115 title “systems”
ASG Annex A Figure A.4 Ed The cryogenic storage vessel systems are Make “system” plural after “cryogenic storage
116 title two. vessel”
Page 29 of 38
ASG Annex A Figure A.5 Ed The supply system is for medical air Use the titles given in table A.1
117 title
ASG Annex A Figure A.6 Ed The supply system is for medical air. Use the titles given in table A.1.
118 title Reservoir should be plural “reservoirs”
ASG Annex A Figure A.7 Ed Reservoir should be plural “reservoirs” Use the titles given in table A.1.
119 title
ASG Annex A Figure A.8 Ed Consistency with table A.1 Delete the brackets for “optional”
120 title
ASG Annex A Figure A.9 Ed The title is not complete Use the titles given in table A.1.
121 title
ASG Annex A Figure A.10 Ed The title is not complete Use the title given in table A.1.
122 title
ASG Annex A Figure A.11 Ed Amend the content of box I Change “medical air reservoir” into “air for
123 title tools reservoir” or simply “air reservoir”
Page 30 of 38
ASG Annex A Figure A.12 Ed Amend the content of boxes I Change “medical air reservoir” into “air for
124 title tools reservoir” or simply “air reservoir” 2
times
ASG Annex A Figure A.13 Ed Amend the content of boxes I Change “medical air reservoir” into “air for
125 title tools reservoir” or simply “air reservoir” 2
times
ASG Annex A Figure A.16 Ed The last “systems” should be singular Use the titles given in table A.1.
126 title “system”
ASG Annex A Table A.2 Ed Consistency with the content of the boxes in Delete “Medical gas”
127 Item A the Figures concerned
ASG Annex A Table A.2 Ed Consistency with the content of the boxes in Delete “Medical gas” and “cylinder bindles”
128 Item B the Figures concerned
ASG Annex A Table A.2 Ed Consistency with the content of the boxes in Delete “Medical gas”
129 Item D the Figures concerned
ASG Annex A Table A.2 Ed Consistency with the content of the boxes in Delete “Cryogenic storage vessel”
130 Item E the Figures concerned
Page 31 of 38
ASG Annex A Table A.2 Ed Consistency with the content of the boxes in Delete all items in brackets
131 Item H the Figures concerned
ASG Annex A Table A.2 Ed Consistency with the content of the boxes in Delete “Synthetic medical air” and change
132 Item K the Figures concerned “analysis system” with “analyser”
ASG Annex A Table A.2 Ed Consistency with the content of the boxes in Delete all items in brackets
133 Item N the Figures concerned
ASG Annex A Table A.2 Ed Consistency with the content of the boxes in Change “reserve supply source” with “reserve
134 Item BB the Figures concerned source of supply”
ASG Annex A Table A.2 Ed Only the first letter shall be capital Change Pressure Switch into Pressure switch
135 Item 12
ASG C.3.3.2 For Method Ed Vacuum is not medical, is vacuum only ! Delete “medical” before “vacuum”
147 2
d)
ASG C.3.3.2 For Method Ed Vacuum is not medical, is vacuum only ! Delete “medical” before “vacuum”
148 3 2 times
c) The pressure should be expressed in kPa Add the vacuum level in kPa
with the corresponding value in psi in
Page 32 of 38
and brackets.
d) The vacuum level should be expressed in Add the vacuum level in kPa
kPa with the corresponding value in “inHg” in
brackets.
AGSS is outside the scope of this Standard. Delete reference to AGSS

2 times
ASG C.3.4.4 Ed The test conditions should be better specified Amend as follows:
149
…..for driving surgical tools with exhaust to

atmosphere does not exceed the value given
in Table 4.
ASG C.3.14.2.2 Ed Use the correct term Add “concentration” to the title
142
ASG C.3.14.2.4 Ed Use the correct term Replace “contamination” with

143 “concentration”
ASG C.3.14.2.6 New clause Ed Consistency with clause 5.6.5.1 f) Add the following new clause:
144
C.3.14.2.6 Nitrous gases NO/NO2 concentration
Using appropriate test devices at the sample

port, verify that the nitrous gases NO/NO2
Page 33 of 38
concentration does not exceed the level specified

in 5.6.5.1 f)
ASG C.3.14.2.7 New clause Ed Consistency with clause 5.6.5.1 g) Add the following new clause :
145
C.3.14.2.7 Sulphur dioxide concentration
Using appropriate test devices at the sample

port, verify that the sulphur dioxide
concentration does not exceed the level
specified in 5.6.5.1 g)
ASG C.3.17 New clause Ed Consistency with clauses 12.4 q) and 12.6.17 Add the following new clause:
146 C.3.17 Verification of restart of after
power supply failure (see 12.6.17)
Documented evidence of compliance
with 12.6.17 shall be considered as part of
the test records
ASG Annex D Form D.1.2 Ed Consistency with clauses 12.4 q), 12.6.17 and Add a line referring to 12.6.17 and C.3.17.
136 C.3.17 Amend the title of Form D.1.2 by adding
12.6.17
A dedicated form is not needed.
ASG Annex D Form D.10 Ed Consistency with other clauses Add reference to SIS connectors in the second
137 column and in the title
AIIGM H 7.2.1 ed With a ventilator equipped with more than one

152 different gas input port, even very small leakages
Page 34 of 38
from one of the gas systems to the other can

cause considerable build up of contamination in a
medical gas pipeline system over extended
periods during which little flow is withdrawn
during which little flow is withdrawn.
AIIGM H.1.1, H.1.2 ed Oxygen concentrators may be used for supplying H.1
153 oxygen 93 to a medical gas pipeline system as a
substitute for medical oxygen. As oxygen 93 is not
covered by a Pharmacopoeia monograph in all
territories, regional or national regulations might
prevent its use as a replacement for medical oxygen
oxygen.
oxygen
AIIGM H.5.2.2.1 ed This situation has already been recognized for the
154 supply systems for air and nitrogen for driving
surgical tool: three sources of supply are not tools
necessary; two are sufficient (see 5.5.2.5).
AIIGM H.5.5.2.1, ed A monograph on medical air has been published There are two different monographs on medical air
155 5.5.2.2 and by the European Pharmacopoeia Commission in the European Pharmacopoeia: “medicinal air”
5.5.2.4 (EPC) [36] and “synthetic “medicinal air”
A monograph on “medicinal air” has been published

by the European Pharmacopoeia Commission
(EPC) [36]
AIIGM H.5.5.2.15 ed A fixed high pressure reservior connected to a An high-pressure reservoir

156 permanently installed compressor is normally not
subjected to any ingression of impurities and the
Page 35 of 38
connectors and tubing are permanently installed

and controlled. The risk is thereby reduced and the
reservoir may therefore be refilled on site.
Repeated refilling of the high pressure reservoir

may result in accumulation of impurities. Periodic
emptying of the high pressure reservoir should be high-pressure reservoir
planned.
high-pressure reservoir
AIIGM H.6.6 ed The subcommittee heard persuasive arguments for (See H.5.5.2.7)
157 both locations.
There are persuasive arguments for both locations.
ASG Annex I Table I.1 Ed Use better wording Replace N/a with “Non applicable”
138
AIIGM Annex J ed a) from 90% to about 100% when oxygen is used cylinders, cylinder bundles or high-pressure
139 in cylinders, high pressure reservoir(s) or cryogenic reservoir(s)
vessels within the secondary and the reserve
sources of supply.
b) from 90% to 96% when only oxygen 93% is

used (this occurs for example when a filling system
associated with the oxygen concentrator is used to
fill high pressure reservoirs fitted within the
secondary and reserve source of supply with high-pressure reservoir(s)/cylinders/cylinder

oxygen 93%); bundles (see ISO/FDIS Prague meeting)
AIIGM Annex J ed - consideration about potential risk arising if non- if gas-specific connectors
140 interchangable connectors for oxygen and oxygen
Page 36 of 38
93 are used. (e.g. incompatibility between portable

oxygen cylinders equipped with integrated (See resolutions of comments Prague meeting,
pressure reducers and transport ventilators or with October 2014, comment n. US 425)
equipment held for disaster response)
AIIGM K.1 ed Where the medical gases are manufactured on

160 site, the healthcare facility is responsible for the
safety, quality and efficacy of the medical gases medical gases manufactured.
manufactured
AIIGM K.2.1 ed - synthetic medical air manufactured using a synthetic medical air is not defined
161 proportioning system;
- synthetic medical air manufactured using a
proportioning system
ASG K.4.2 Second last Ed Use better wording Amend as follows:

162 item ensure that the manufacturing ……
AIIGM Annex L ed Bibliography [36] Monograph on Medicinal Air, European

141 Pharmacopoeia Commission, 2005
[36] Monograph on Medical Air, European
Pharmacopoeia Commission, 2005
[37] Monograph on Synthetic Medicinal Air,

European Pharmacopoeia Commission, 2005
[37] Monograph on Synthetic Air, European
Pharmacopoeia Commission, 2005
Page 37 of 38
Page 38 of 38

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Template for comments and secretariat observations Date:2015-09-18 Document: FprEN 7396-1 Project:

AIIGM Introduction Where the healthcare facility manufactures the gas

AIIGM 3.8 ed control system

device or set of devices to manage, command,

AIIGM 3.18 ed gas-specific connector

connector with dimensional characteristics which

AIIGM 3.31 ed manifold

device for connecting the outlet(s) of one or more

storage vessel(s) of the same gas to the pipeline

AIIGM 3.32 ed manifold pressure regulator

pressure regulator intended to be installed within

See resolutions of comments (Prague 2014),

AIIGM 3.47 ed peak demand

maximum forseeable gas flowrate required by a foreseeable

AIIGM 3.63 ed supply pressure regulator

pressure regulator fitted within a source of supply

Note to Entry: For a source of supply with

AIIGM 4.1 (*) ed Safety

… Add IEC 60601-1-2 to either the Normative

ISO 11114-1 and ISO 11114-2.

NOTE 3 Compatibility with oxygen involves both

(see resolutions of comments Prague meeting,

AIIGM 5.1.1 ed a) gas in cylinders, cylinder bundles or high high-pressure reservoir(s);

AIIGM 5.2.5 ed Reserve source(s) of supply

first c) all sources of supply are depending upon

second b) the size of the reserve source of supply

d) the location of the reserve source(s) of supply

(see resolutions of comments Prague meeting,

AIIGM 5.2.7 ed Maintenance supply assembl(ies) assembly

(see resolutions of comments Prague meeting,

AIIGM 5.2.7.2 ed The manufacturer together with the healthcare

The location of the maintenance supply assembly

The maintenance supply assembly should be

Each maintenance supply assembly.

Except for air and nitrogen for driving surgical

AIIGM 5.3.2 ed The primary and secondary sources of supply

consist of one bank of cylinders, cylinder bundles,

bundles or high-pressure reservoir(s)

bundles or high-pressure reservoir(s)

AIIGM 5.4.1 ed a) one cryogenic or non-cryogenic vessel with

AIIGM 5.5.2.1 (*) ed Regional or national regulations applying to

NOTE 1 Oil can be present as liquid, aerosol and

NOTE 2 These values are taken from the

cylinder bundles or high pressure reservoir;

… ventilation system discharges, chimney outlets).

Consideration should be given to the potential

which should be remote from chimney outlets.

(see resolutions of comments Prague meeting,

line pressure regulators

AIIGM 5.5.3.1 ed Regional or national regulations applying to

NOTE These values are taken from the European

AIIGM 5.5.3.3 ed a) sources of oxygen and nitrogen, one

b) sources of oxygen and nitrogen, two

cylinders, cylinder bundles or high-pressure

e) an automatic shut-off valve shall be fitted to

AIIGM 5.5.3.8 ed Note 1 National or regional regulations concerning NOTE 1

Note 2 Additional monitoring may be required to