इंटरनेट मानक

Disclosure to Promote the Right To Information

Whereas the Parliament of India has set out to provide a practical regime of right to
information for citizens to secure access to information under the control of public authorities,
in order to promote transparency and accountability in the working of every public authority,
and whereas the attached publication of the Bureau of Indian Standards is of particular interest
to the public, particularly disadvantaged communities and those engaged in the pursuit of
education and knowledge, the attached public safety standard is made available to promote the
timely dissemination of this information in an accurate manner to the public.

“जान1 का अ+धकार, जी1 का अ+धकार” “प0रा1 को छोड न' 5 तरफ”

Mazdoor Kisan Shakti Sangathan Jawaharlal Nehru
“The Right to Information, The Right to Live” “Step Out From the Old to the New”

IS/ISO 7396-2 (2007): Medical Gas Pipeline Systems, Part 2:

Anaesthetic Gas Scavenging Disposal Systems [MHD 11:
Anaesthetic, Resuscitation and Allied Equipment]

“!ान $ एक न' भारत का +नम-ण”

Satyanarayan Gangaram Pitroda
“Invent a New India Using Knowledge”

“!ान एक ऐसा खजाना > जो कभी च0राया नहB जा सकता ह”

है”
ह
Bhartṛhari—Nītiśatakam
“Knowledge is such a treasure which cannot be stolen”
 iS/~SO 7396~2 : 2001

'Indian Standard
MED~CAL GAS P~PEl~NE SYSTEMS
PART 2 ANAESTHET~C GAS SCAVENmNG DISPOSAL SYSTEMS

ICS 11.040.10

© BIS 2009
BUREAU OIF INDIAN STANDARDS
MANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARG
NEW DELHI11 0002
June 2009 Price GJ\oup 13
 tndien Stenderd
MED~CAL GAS P~PEl~N[E SYSTEMS

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 "plpellne" 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.

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

ISO '8835-3:- 1 ), Inhalational anaesthesia systems - Part 3: Transfer and receiving system~ of active
en anaesthetic gas scavenging systems
o
~
az ISO 9170-2, Tenninal units for medical gas pipeline systems- Part 2: Tenninal units for anaesthetIc gas
en scavenging systems
iii
en
o
T
~
1) To be pUbli~hed. (Revision of ISO 8835-3:1997.)

11
isnso 7398-2 : 2007

ISO 1497 1. Medical devices - Application of risk management to medical de vices

ISO 15001 . Anaesthetic and respiratory equipment - Compatibility with oxygen

EN 1041, lntoansiion supplied by the manufacturer with medical devices

EN i 3348, Copper and copper alloys - Seam less, round copp er lube s for medical gases or vacuum

3 Tenu s and definitions

For the purposes of this docu me nt. the following term s and defin itions apply

3.1
AGSS socket
female part or a term inal unit which is Bithe r integral or attached to the base block by a type-speciflc int erface,
and wh ich contains the type-specific connection POint

3.2
AG SS te rmina l un it
Inlet assembly", an AG SS at which the operator mak es connection s and disco nnecnons

3.3
AGSS te rminal unit. bas e blo ck
part ot an AG SS te rm ina l unit whi ch IS att ached to the pipeline dispo sal system

3.4
AGSS ty p~ 1 terminal un it
conne ction !=,oirt between the receiving svst em .me.! thr= dtspo sal system at which an operator ma kes
connection:'> and disconnections

See Figu re 1

3.5
AGSS type iii term in al uni ts
AG SS type 1 termi nal Unit10 be used m h i g!1-flow disposal syste ms

3.6
AGSS typ e 1L term inal un its
AGSS type 1 term inal Uni t to be used in low-flow disp osal systems

3.7
AGSS type 2 terminal un it
conn ection point between th e powe r device or the disposal hose and the remainder of th e dis posal sys tem at
which an operator makes connections and disc onn ectio ns

See Figure 1.

3.8
AGSS type-specific
having characteristics which prevent interc hangeability and thereby allow assig nm ent to one AGSS type only

3.9
AGSS ty pe-s pecific connect ion point
part of the AGSS socke t which is the receptor for an AGSS type -specific probe

2
 isnso 7395-2: 2007

3.'tO
all' compressor system
source of supply with compressor(s) designed to provide medical air and/or air for driving surgical tools and/or
airforAGSS

NOTE Different names or .symbols are used for air for driving surgical tools, such as: Instrument air, surgical air, air
motor, air- 700and air - 800.

3.~1
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 pointof 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. ananaesthetic
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 acceptedby 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 wm be used
at the same time, at flowrates defined in agreement with the management of the healthcare facility
-.
3.16
high-now 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.f1ow 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-fl ow disposal system .
disposai system which is intended to operate witli 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

3
ISIISO 7396-2: 2007

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 fiow 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 /\GSS whrch 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 protecnon 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
 ~S/(SO 13SS-2: 2lilC1

1 o

o
5 6

~ L ____ ~-~~
0 I G!
II 11
~ICfIP . 12
7 ~! 8 I 5 ! mmL
1~1~1 11
I8 I 5 6 I~
1~1~1 13
p! 8 I 6 I
7

I~I~ I ~ 11 14
15
\ 1 }6 ~ }7' 1 18
I

1Qlg] DC! GEl Q[]

19 20 21 22
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 iimit of breathing system or anaesthetic ventilator
3 transferlreceiving system and power device 16 limits of transfer system
4 apparatus such as anaesthetic breathing system and 17 limits of receiving system
inteqral transfer/receiving system 18 limit of disposal system
5 permanent or proprietary connector 1.9 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

5
181180 7396-2 ; :l007

3.31
system design flow
flow calculated from the maximum flow req uireme nt of the healthcare facil ity and corrected by the diversity
factor(s)

3.32
transfer system
part of an AGSS wf1ich transfers expired and/or excess anaesthetic gases from the exhaust port of the breathing
system or other equipm ent to the receiving system

3.33
transfer tube
part of an AGSS whrch transfers expired and/or exc es s anaesthe tic gases from the breat hing system to the
receiving system

4 Gen eral requirements

4.1 Safety

AG S disposal systems shall, when Installed , extended , mod ified, com missioned , operate d and main tained In
accordan ce witn the Instru ctions of the ma nutacturer, present no risks that are not reduced to an acc eptable
level usin g risk managem ent proc edures in accordance with ISO 14971 and whi ch are connected with their
Intended application , In normal condition and in single fault condition .

NOTE 1 A snuatron in which a fault is not detected IS consid ered a normal condition r· au tt condrtro ns/hazardous
situati ons can remam undetected over a penod of lime and as a consequence can lead to an unacceptable ns k. In that
case, a subsequent detected fault condition needs to be considered as a single fault condition SpeCifiC fisk control
measures need to be determined within the ns k rr'dnagerrent precess to deal With such Situations

NOTE 2 Typrcal safety hazards (drsc onhrunty of operalion, incorrect pressure and/or flow, etc.) are hsted In Annex D

4.2 Alternative co nstruction

AGS disposal systems and components, or parts thereof, usmq materials or hav ing forms of construction
different from those detaile d in thrs 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 deg ree of safety is obta ined (I e
compl iance with requiremen ts presumes that risks h;:wf.) been m itigated to acce ptable leve ls) unless objective
evidence to the contrary becomes available.

NOTE 1 Objbc.ll'.;e c vrden ce can be obtained by post-market surveiliance

Evidence of an equivalent degree of safety shall be provided by the manufactu rer.

NOTE 2 Regional or national regulations can require the provision of evidence to the competent authority or a
conformity assessment body e 9 notified body In tile 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 op erating conditions spec ified by the
manufacturer.

NOTE 1 Corrosion resistance includes resistance against the Influence of moisture and the surroundmg materials

Evidence shall be provided by the manufacturer.

NOTE2 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 EconomicArea (EEJI,), upon request

6
4.3.2 If copper pipes are used, they shall comply with the requirements given in EN 1~346.

Evidence shall be provided by the manufacturer.

NOTE 1 Regional or national regulations can require the provision of evidence to the competent authority of a
conformity assessment body, e.g. notifiedbody in the European EconomicArea (EEA), uponreq.uest.

NOTE2 The requirement in 4.3.2 a;;ows 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
carefullyevaluated' for their durability following exposure to volatile anaesthetic agents. •

4.3.4 All components of the system, other than copper pipes, wh ich come in contact with anaesthetic
gases and vapours shall be cleaned in accordance with ISO 15001.

Evidence shall be provided by the .rnanutacturer.

NOTE Regional' or national regulations can require the provision of evidence to the' competent authority or a
conformity assessment body, e.q, notified body in the European EconomicArea (EEA), upon request.

4.3.5 If lubricants are used, they shall be compatible with anaesthetic gases and vapours at the operating
condhions specified by the manufacturer.

Evidence shall be provided by the manufacturer.

NOTE Req 'onal or national regulations can require the provision of evidence to tl1e competent authority or -a
conformity assessment body, e.g. notified body in the European EconomicArea (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 singlefault 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 dedica ted vacuum pumps .

The AGS disposal system shall be such that the system design flow can be supplied with anyone source of
supply for air or anyone 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 sole ly 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 1te~minal

unit(s), dri~eri'bY com'pres~ed'
air from a su~ply
.system for air and a pipetlne qistribution system comp lying with Isq 7396-1 , provided with a means of
adjusting the flow from the receiVing system thmugh the type 1 terminal unit to meet the requirements
specified in 8.1.1 and 8.1.2 [see Figure 2 a)];

7
ISIISO 7396-2 : 2007

b) an exhaust ejector for each AGSS type 2 term inal unit, driven by compressed air from a supply system for
air and a pipeline distribution system complying with ISO 7396-1, prov ided 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 numbe r of term inal units in use [see
Figure 2 c)].

NOl L Such means can be located either within the pipeline and/or in combinationwith the terminal unites).

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 authonty or a
conform ity assessment body, e.g notified body III the European Economic Area (EEA). upon request.

5.5 Power devices consisting of fa ns, blowers or dedica ted vacuum pum ps shall not be located In the same
room as gas and non-cryogen ic 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, contam ination with oil, grease, and increased oxygen and nitrous
oxide concentrations.

6 Indicating systems

Means shail be provided to mdicate 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 movementof the pipelines.

8
 8 --t>---i !----I> 9 8--t>---1 ~--I>9

4 1 5
4 1
7 7
a) b)

8
4
r 6

® " 9

8--i>----\ 2
4
8--0----\

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 o~ discharge

Figure 2 - Typ ical examples of power devices

8 Disposal system characteristics and test methods for pressure and vlow

8.1 Requ irements'

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) shail not exceed 50 IImin 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 I/min, and shall not
be lower than 25 I/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 Ilmin (see also ISO 8~35-3:-, 10.1). .

9
IS11S0 7396-2 : 2007

8.1.2 Req uirements fo r th e AGS dis po s al sys tem with type 1H term i nal unit s

The flowrate through each type 1H term inal unit or, if not prov ided , at the interface point upst ream of the
power dev ice (see Figure 1) shall not exceed 80 I/min when the resist ance to flow which is provided to
simula te the resistance of the receiving system , is such as to produce a pressure drop of 1 kPa at 801lmln ,
and shall not be lower than 50 Ilmin when the resistance to flow, which is provide d, is such as to produce a
pressure drop of 2 kPa at 50 I/min (see also ISO 8835-3'- ,10.2).

8.1.3 Requirements for the AGS disp os al syste m w ith ty pe 2 te rmina l uli its

With a flowrate of 50 l/min through the socket of each AGSS type 2 termi nal unit, th e pressure drop shall not
exceed 7,5 kPa

8.2 Test method s for p ress u r e an d fIO\.L';

8.2.1 General

8.2.1.1 All means for adjusting pressure and flow shall be adjusted to control the flow at each term inal
uni t. Each termina l unit on the system shall be tested as follows:

a) with only the term .nat u rut under test in use;

b) for systems With more than one termi nal un it. With all terminal units in use wh ich are required to provi de
the system desrqn flow at the specified diversity factor.

8.2.1. 2 Testing shall be carried out using amb ient air.

8.2.1 .3 The reso lution and accuracy of ali measuring devices used for testing shall be appropriate for the
values to be mea sured All measuring devices used for certification shall be calib rated at appropriate interv als.

8.2,2 Test methods for flow in dis p osa l systems fitted w ith typ e 1L term ina l u nits

8.2.2 .1 Test devi ces

In order to Simulate the resistance to flow of a rece iving system comp lying With ISO 8835- 3 , calib rated test
devi ces Which are fitted wit h type 1L probes and which produce a pre ssure drop of 1 kPa at a flowra te of
50 IImin (test device 1/50 ) an d 2 kPa at a tlo wrate of 25 i/rnin (test dev ice 2/25) shall be used

NOTE A IYPICd l test devi ce IS shown in FigUrA 3

8.2 .2.2 Procedure

8.2 .2.2.1 Activate the power dev ice on the AG S disposal system to be tested

8.2.2 .2.2 A test device Iuted with type 1L probe wluch produces a pressure drop of 1 kPa at 50 I/min shall
be inserted into each type 1L terminal unit in turn with all the other terminal unit s close d. The flowrat e on the
test device at each ternuna l Unit shall be reco rde d.

8.2.2 .2.3 A test deVICE; fitted wittl type 1L probe which pro duces a pressu re drop of ? kPa at 25 Ilmln shall
be inserted Into each type 1L term inal Unit in turn with all the other term inal un its closed . The flowrate on the
test device at each terminal unit shall be recorded

8.2.2.2.4 Type 1L prob es which produce a pressure drop of i kPa at 50 Ilm ln shall be inserted into each of
several type 1L termina l units up to the syst em design flow of the AGS disposal syst em with all the other
term inal uni ts closed A test devi ce with type 1L prob e which produ ces a pressu re drop of 2 kPa at 25 I/mln
shall be inserted into each term inal unit in turn . The fiowrat e at each term inal unit when this test device is
connect ed sha ll be recorded .

10
 tsnso 7395-2: 2007

r-----
I
I
I
1

4
P 3

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 sarriesefflnq of the
means of pressure and flow adjustment. The . results shall be recorded on a form such as F:orm C.7.1 (see
Annex C). . -

8.2.3 Test methods for flow in disposal systems fitted wi th 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
I/min (test device 1/80) and 2 kPa at a flowrate of 50 I/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 ~e tested.

8.2.3.2.~ A test device fitted with type 1H probe; which produces a pressure drop of l' kPa at 80 IImin, shall
be inserted into each type 1H terminal unit in turn with all'the other terminal units closed. The f lowrate on the
test device at each terminal unit shall be recorded.

11
ISIISO 7396-2 : 2007

8.2.3.2.3 A test device fitted with type 1H probe. which produces a pressure drop of 2 kPa at 50 I/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 te rminal unit shall be recorded

8.2.3.2.4 Type 1H probes, which produce a pressure drop of 1 kPa at 80 I/min. shall be inserted into each
of several type 1H term inal units up to the system design flow of the AGS disposal system with all the other
terminal units closed. A test device with type 1H probe. which produces a pressure drop of 2 kPa at 50 ilmin,
shall be inserted into each term inal unit in turn . The flowrate at each terminal unit when this test device is
connected shall be recorded .

8.2.3.2.5 The tests in 8.2 3 2.2. 8 2.3 2.3 and 8.2.3 2.4 shall be carried out at the same setting of the
means of pressu re and flow adjustment. The results shall be recorded on a form such as Form C.7.2 (see
Anne x C).

8.2.4 Test method for pressure in disposal systems fitted with type 2 terminal units

8.2.4 .1 Test devices

Test devices fitted with a type 2 probe and providing flowrates up to 50 11m in shall be used.

8.2.4.2 Procedure

8.2.4.2.1 Activate the power device

8.2.4.2.2 The probe of the test device shall be Inserted into each terminal unit in turn with ali the other
term inal units closed The flowra te shall be adjusted to (50 :i: 5) I/min . The pressure shall be recorded at the
inlet to the terminal Unit

8.2.4.2.3 If indrvidua: piping to each terminal Unit is not provided . test devices shall be inserted into each of
severa l terminal units up to the system design now of the AGS disposal system with all the other terminal Units
closed Each flowrate shall be adjusted to (50 -t 5) IImin. The pressure at the inlet to each terminal unit shall
be recorded .

8.2.4 .2.4 The results shall be recorded on a form such as Form C 7 3 (see Annex C) .

8.3 Means to prevent backflow

For disposal systems With exhaust ejectors driven by compressed air, means shall be provided to prevent
backflow of waste anaesthetic gases and vapours through terminal uruts

NOTE 1 nrs can be achieved by, for exampl e. mdivrdual piping or non-return valves.

9 Terminal units

Terminal units shall comply With ISO 9170-2.

10 Marking and colour coding

10.1 Marking

10.1.1 Pipe lines 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 10m and adjacent to terminal units.

10.1.2 Connecting assemblies and disposal hoses shaii be marked "AG SS" or national equ ivalent

12
 £5/[5 0 7396-2: 2007

10.1.3 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.

10.2 Colo ur coding

10.2.1 If colour coding is used, it shall be red magenta or in acco rdance with the national standard.

NOTE An example of red magenta is 3050-R40B, in accordance with SS 01 91 02.

10.2.2 If colour coding is used, it shall be durable.

10.3 Test for durability

The test for durability of markings. and colour coding is given in 12.4.10.

11 Pipe line installation

11.1 Pipelines and electrical services shall be either:

a) run in separate compart rr.ents; or

b) separated by more than 50 mm.

NOTE Regional or national regulations which apply to electrical installations in buildings can exist.

11.2 Metallic pipelines, if applicable, shall be bonded to an earth terminal as near as possible to the point at
which the pipeline enters the building. Pipelines shall not be used for earthing the electrical equipment

NOTE: 1 Regional or nationat regulations which apply to electrical installations in buildings can exist.

NOTE 2 Regional or national requlatons, which apply to conti:luity of earthing across all joints within the same building
and to electrical isolation of different buildinqs from each o~her, can exist. .

11.3 Pipelines shali be protected from physical damage, for example damage which might be sustained from
the movement of portable equipment such as trolleys, stretchers and trucks, in corridors and in other locations.

11.4 Unprotected pipelines contalninq gas under positive pressure shall not be installed in areas of special
hazard. If installation of pipelines in such a location is unavoidable, the pipeline shall be protected by an
enc.osure which will prevent the liberation of gases within the room should leai<s occur in the pipeline installed
in the area.

NOTE 1 Ar. area where flammable materials are stored is an example of an area of special hazard.

NOTE 2 Regional or national regulations which apply to building requirements and fire prevention can exist.

11.5 If pipet nes are placed underground they shall be placed in tunnels or ducts. The tunnel or duct shall be
en provided with adequate drainage to prevent the accumulation of water. If pipelines are placed in the same
o
o
C'I tunnel, trench or duct with fuel pipelines, steam lines or other services, they shall be separated by more than
i3 50 mm. Ducts in which pipelines are installed shall be ventilated.
·z
en
ffi If plpel'nes for an AGS disposal system are placed in a tunnel or duct along with other services or with
en
o pipelines for other fluids or gases, the potential hazard arising from this situation shall be assessed using risk
J management procedures ir. accordance with ISO 14971. The risk assessment shall.take into account that a
leak which is not detected (e.g. by an alarm or other means such as periodic inspection recommended by the

13
ISII80 7396·2; : 2001

manufacturer} snall be considered a normal condition and not a ~i ngle fault condition . Th e route of pipe s
placed underg roun d sho uld be indicated at th e site by appropriate m ean s, e.g. by co nti nuous maridng tape
above the pipeline at approximately one-hall tile depth of burial

11.6 Pipelines shall not be installed in eleva tor shafts.

11.1 Damage due to contact with corrosive materials shall be mlnlrnrsed, 6.g. by the us e of lmpe rmeable
non-me tallic materi als app lied to the outer surface of the pipe in the area where the con tact ca n occur.

'I i .S All owances shall be made for expansion and contracncn of pipelines.

11.9 If condensation is likely to occur in the pipelines, means sllall be pro vided to rem ove co ndensation from
the syste m.

11.1 0 Pipehnss shall be supported at lotervals to prevent sagging or distort ion Rec om m ended Intervals for
rigid metallic pipes are given Ifl T able 1.

11.11 The sunoorts &hall ensu re that rho plpeli'i8 cannot be displaced acci dent ally.

The supports shall either be of corr osion-res istan t ma terial, or shall be treated to preve nt corro ston Means
shall be provided to pre vent etectrolytic corro sion .

Where pipe lines crOBS ele ctric cables, the pipes shall be support ed adjacent to the cables

Pipelines shall not be used as support for, nor ~hal! they be supported by. other pipeltnes or conduits.

i i . i 2 Except for mecharucat JOints used for certai n components , all metall ic pipeline jom ts shall be brazed or
welded. Til e methods used for brazing or weldi ng shall permit the jo mts to m aintai n th eir m ech anical
characteristics up to an ambient temperature of 600 CC. Filler me tals for braz ing sh all be nominally cadm ium-
free (less than 0,025 % mass fraction cadmiu m)

NOTE Mechanical JOInts (e.g flanged or threaded connections) can be used to connect components such as shut-off
valves, terminal units, pressure regulato rs, controls and monitonng and alarm sensors to the pipeline.

11.13 The exhaust from the disposal system shall be piped to the outside or into the exh aust conduit of a non-
recirculatmg ventilation sys tem and shall be provided with a means to prevent the ing ress. of insects, debris
and precip itatio n

The locatio n of the exha ust outlet shall be rem ote from the air Intake for med ical air co mp ressor system s, air
intakes, doors , windows or oth er openings in buildings.

Considera tion should be given to the po tential effects of prevailing winds when considering the location of the
exhaust outlet.

14
If the exhaust outlet is accessible to personnel, a \wming against the inhalation of noxious gas shall be affixed
at the point of discharge.

Tests after completion of installation shall be carried out, documented and certified by the manufacturer.

NOTE Regional or national regulations requiring the manufacturer to have an approved quality system can exist

An example of a procedure for testing and commissioning is given in Annex B.

12.2.1 Testing shall be carried out with ambient air.

12.2.2 Before any testing is carried out, every terminal unit in a system under test shall be labelled to lndicate
that the system is under test and shall not be used.

12.2.3 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 ~ertification shall be calibrated at appropriate intervals.

12.3 Tests, lnspectlons and checks

The following tests, inspections and checks shall be carried out before use of the system:

a) inspection and tests for leakage;

b) lnspectlon for marking and support intervals of the pipelir:te system;

c) check of mechanical function and cleanliness of the terminal units;

d) test for cross connection;

e) tests for function of power devices;

f) tests for pressure and flow at the terminal units;

g) check of the indicating system;

h) check of the AGS disposal system exhaust;

i) check of identification and labelling of the terminal units.

12.4 Requi rements for tests, lnspections and checks listed in 12.3

12.4.1 :nslOectlon and leakage

12.4.1.1 Pipelines downstream of the power device shall be Visually inspected for the integrity of all
connections.

12.4.1.2 Pipelines between a type 1 terminal unit and a power device shall be tested at a pressure of
70 kPa ± 10 %. The pressure drop in these sections , after a test period of 15 min with the terminal units
blanked off, shall be less than 10 kPa. .

15
ISIISO 7396 u2:
li}01

12.4.2 Marking and support intervals of the pipeline system

The marking of the pipeline system shall meet the requirements of 10 1. The colour coding of the pipeline
system, jf used, shall meet the requirements of 10 2. The support intervals shall meet the requirements of
~ 1.10.

12.4.3 Mechanical function and cleanliness of the terminal units

It shall be demonstrated for each terminal unit that the appropriate probe can be inserted, captured and
released. All terminal units shall be inspected for the absence of Visible particulate matter.

12.4.4 Cross connection

There shall be no cross connection to any other pipeline system

12.4.5 Function of power devices

All power devices shall operate In accordance with the manufacturer's manuals and specifications.

12.4.6 Pressure !1!1d flow at the terminal units

It shall be demonstrated that the flow al each AGSS type 1L terminal unit IS In accordance with 8,1 1.

It shall be demonstrated that thE' flow at earn AGSS type 1H terrmnat unit IS In accordance With 8 1 2

It shall be demonstrated that the pressure drop at each AGSS type 2 terminal uiut IS in accordance with 8 1 3

12.4.i Indicating system

The indicating system shall comply With Clause 6

12.4.8 AGS disposal system exhaust

The exhaust from the disposal system shall comply with 11 13.

12.4.9 Identification and labelling of the terminal units

On satisfactory completion of the tests, inspections and checks descnbed in 12.41 to 12.4.8, the construction
labels indicating that the system IS under lest shall be removed At the same time, the correct identification and
labelling (marking and. if used, colour coding) of each terminal unit shall be checked.

12.4.10 Test for durability of markings and colour coding

Rub markings and colour coding by hand, Without undue pressure, first for 15 s With a cloth rag soaked With
distilled water, then for 15 s with a cloth rag soaked With ethanol and then for 15 s with a cloth rag soaked with
isopropanol. Carry out this test at ambient temperature The markings shall remain legible.

12.5 Certification of the system

Before an AGS disposal system is used, it shall be certified in writing to the healthcare tacuity that all tests,
Inspections and checks given in 12.3 have been satisfactorily carried out and all the requirements of 12.4
have been met. The results of tests showing details of the areas tested should be part of the permanent
record of the healthcare facility.

NOTE Typical forms for this purpose are given in Annex C.

16
The system manufacturer shall certify that all drawings and manuals, as required in Clause 13, have been
supplied to the owher or client.

12.6 Extensions or modifications

When extensions or modifications are made to the system, the appropriate tests, inspections and checks in
12.3 shall be carried out before the system is returned to service.

13 ~ n fo rm ati o n to be s upplied roy the marmfacturell'

13.1 General
The information to be provided by the manufacturer shall be in accordance with EN 1041 or equivalent
national standards. . . '

13.2 Instructi ons for use .

13.2.1 The manufacturer of the complete system or the manufacturer(s) of each component of the AGS
disposal system (l.e. powe r device, terminal units and pipeline system) shall provide the healthcare facility
with instructions for use.

NOTE1 The power ' device. terminal units and pipeline system can be supplied by one or several different
manufacturers.

NOTE2 Regional or national regulations which apply to manufacturers of medical devices can exist.

13.2.2 The instructions for use snail contain the following:

the name or trade name and address of thernanutacturer;

year of manufacture and, where appropriate, the lifetime of the system and its components, any specIal
storage and/or handling conditions:

any special operating instructions;

any warnings and/or precautions to be taken . in particular the danger of fire or explosion due to the use of
oil and grease in oxygen-enriched atmospheres or the use of flammable anaesthetic agents;

batch or serial number;

a technical specification including the performance of the system, and how to connect and disconnect
detachable parts and accessories;

a description of the indicating system;

the position in normal condition (l.e, open or closed) of all shut-off valves , if fitted;

instructions for recommended periodic checks of function of the system;

instructions for recommended maintenance tasks and their frequency, and a list of recommended spare
parts, if applicable; .

adequate information regarding which anaesthetic gases and vapours the system is designed to be used
with;

11
ISIISO 739 6-2 . ..:i01

instructions for the disposal of comp C','1ents or consurnaoles (e 9 oil used in compressors an d vacuu m
pumps)

13.2.3 The instruction for use given in 13.2 2 shall take into account the possibility that sev eral diffelent
organisations are involvec in oper ation, use and maintenance.

13.3 Operational management tntormat ion

13.3.1 The manufacturerts) of each com ponent of the AGS disposal system (i e. power device, termi nal units
and pipeline system) shall provide ope rational manaqernent information to U1G he althcare facility to en able it to
draft its Operationa l management docu ment.

13.3.2 The system manu facturerts) shall provide instructions to the hedltt1care facil ity for recom mended
maintenance tasks and their frequency, and a lis! of rec omrneoded soare c srts

NOTE Informative guidelines for the preparation of the Uper"J1 !oI181 "l<Jila:;,wmer.l document are q.ven in Annex G of
ISO 7396-1 :'007, lnformahve quroetines fO! (,6r-111 19 out :3 CiS!: 'nani19(;!l:3nt procedure are given 111 Annex D

13.4 "As-instil lied" drawings

13.4.1 A separat e set ot "as-Installed" mechanical drawings WlliC'!> S llOW the actua l locations of the pipelines ,
the diameters of the pipeunes shut-off valves and ali othe r components shall be maintained durinq
construct-on, and shall be brought up to dote as ch anq es are mad e Ihese drawing>. $ r l"l ll -nclude detail s
whic h will enable buned or con cea led pipelines to be located

13.4.2 A corr.plote set of "as-mstalled' drawings of the pip eune SyW3fl1 as spec rfted In 13.4 1 shall be
presented tc H) t !lc-,'l!thlare tacillty of the pipeline system. fer mcfusion as part of the pe rmanent record of me
PIfJeiine 5 y ~; t !.. ~1

13 5 Elec tri cal d iagrams

f] ectrlcn: dlarJI at-i s for the components supplied shall be provided by tile system manufacturer to the
hE'c:.lthC.l fe faciilly

18
 ~S/~SO 1396-2: 2~a1

AlUlJll'ilra~ fA
(informative)

GOJlhdleUBIJ'llSS VOl(' [O,?wer dlra'iECeS cOU1lsfisQuli1l~ ofF fFaJli1ls~ lbJ~owelrs

or <dledDca~e<dl 'ia<ClUHUJIl'Il'Il ~ll.DmlfJs

.4:-1 Services containing combustible gases or liquids should not be permitted within the power device area.

A.2 All electrical fittings in power device rooms should be located infixed positions to minimize the risk of
physical damage.

A.3 Fire fighting equipment should be provided within the power device area.

NOTE Regional or' national regulationswhich apply to fire protection can exist.

' A.4 The power device area should be well ventilated to the open air. Ducting for such ventilation should not
be connected to ducting servicing any other building. .

A.S· The doors or gate should be capable of being locked. An emergency exit should be provided which
should be free from obstructions at all times. It should be possible to open .any door from the inside without a
key at all times. All doors should open outwards. '

A.6 Power device rooms should:

a) comply with local building codes;

b) have a warning notice "NO SMOKING", or similar, clearly displayed on both sides of each door or gate.

A. 7 Clauses A.1 to A.6 apply to power devices which are centrally located. Power devices that are not
centrally located and mayor may.not be connected to a pipeline system should be installed and serviced in
accordance with the instructions supplied by the manufacturer.

19
ISIISO 7396··2 . 2007

Annex B
(informative)

Example of procedure for testing and commissioning

8.1 General

This test procedure is given as an example of how the specifications of Clause 12 can be verified so that the
system may be commissioned and certified . Other procedures may be devised which validly test these
specifications in this procedure the gillen sequence of tests is Important and should be followed . The general
requirements 01 '1/ .3 snoulo be followed .

When the .esuus of a test do not meet the pass criteria , remedial work sha ll be carried out and previous te st s
repeated as necessary

Typical forms for cerufication of the system me given in Annex C A summary of typical tests required wh ich
lists the spe cification. proc ed ure rind form fo: eac h test is giv en in f-orm C. i .

8.2 Inspection and tes ts for leakage

8 .2.1 Inspection

Visually inspect the exhaust pi peline system for the mteqnty (;f ali' connections

8 .2.2 Tests for leakage

8.2 .2.1 General cond itions

Isolate thp rower device from the pipeline Open ail shut-o ff valves (if fitted) and blank off all type 1 terminal units
If necessary, remove all means of adjusting the flow and clan-; t1l'?:r r.onnecll011 pOints

8 .2.2.2 Example of procedure

Connect a suitable pressure-measuring device to thp system ur,d21 lest Fill thp system With clean , Oil-free, ury
comp ressed gas ell J pressure of 70 kPa .: 10 %1 Record 11'1('- pressure dnd. .1ftel a perrod of 15 min, record the
pressure again The pressure drop shall not exceed 10 kPa

NOl E. There IS nco allowance for temperature Variation In thiS {"'5i

8.2 .2.3 Test results

Record the results on a form such as Form C 2

B.3 Ins pection for marking and sup port interva !s of t he p ipeline syste m

8 .3.1 Exa mp le of procedure

VIsually inspect that marking has been correctly placed on the pipeline system, especially adjacent to
T-connections and where the pipeline system passes through walls or partitions. Check tha t marKing complies
with 10.1 and colour coding, if used, complies wit h 10.2. Check that the support Intervals comply with 11 10.

20
 isnso 7396-2: 21007

8.3.2 Test results

Record the results on a form such as Form C.3.

B.4, Check of rnechanlcal fu nctl on and! lnspectlon for c leanliness of the terminal
unlts .

B.4.1 lEJl:amlOle of procedure

8.4.1.1 Inspect the test probes to ensure that they conform to ISO 9170~2. Insert a test probe into each
terminal unit in turn. Check that the probe can be inserted, captured and released.

8.4.1.2 Check each term inal unit for the absence of visible particulate matter.

8.4.2 Test results

Record the results on a form such as Form C.4.

18.5 Test for cross connection

8.5.1 IExampie of procedure

Test the pipeline system of the AGS disposal system for cross connection to any other medical gas or vacuum
pipeline system. With all power devices switched off and with pressure in all other medical gas or vacuum pipeline
systems, check at all AGSS terminal units that there is no positive or negative pressure.

8.5.2 Test results

Record the results on a form such as Form C.5.

8.5 Tests for fun ction of power devices

8.6.1 EJl:ample of procedure

Test all power devices for operation in accordance with the manufacturer's manua ls and specifications.

8.6.2 Test results

Record the results on a form such as Form C.6.

8.7 Test for pressure and flow at the term inal units

8.7.1 EJl:ample of procedures

Procedures for testing for flow at the type 1L terminal units are given in 8.2.2.

Procedures for testing for flow at the type 1H terminal units are given in 8.2.3.

Procedures for testing for pressure at the type 2 terminal units are given in 8.2.4.

21
ISIISO 7396-2. lOO?

8 ,7'.2 Test results

Record the results on forms sucb as Forms C 71, C '1 2 and C,7.3

8.8 Check of the indicating systp.m

8.8.1 Example of procedure

Check functioning of the means provided W Indicate to the opera.or trial tI,e power device is Of'''t;r~:ltirlg

8.8.2 Test results

Record the results on a fnrrr SL,ci, as Fn"!1 C e

8.9 Check of the AGS dlsposat system exhaust

8.9.1 Example of procedure

IS piped (:lJilc;, to the uut:;,dA or Int:: the exhaust conduu 01 a non-rectrcutatrnp vent.latron system,

B.9.2 Test results

B 10 Cheek of idtwtif!cation and IBhclii n'1 of the terminal units

Remove the COI'S"'uc"li(m lorJ!"j on eacn terrnn 1~11 urut whrch indrca'es that the system IS 'lot :n b':': 'J;;(~a UU II J)!
remove these 1:~Delf; unless ali preceding tests (,,"JE! been completed saustactonly ,01 !i'1'~' :,:,\rne i:rr:l' d',"'_I' if" ;'),;
correct Idendflc8t'of1 and latJ<J!I!r(l marking and...; used ::c,!our cod.....CJ) of each terr;:'('a ':'W
'

8.10.2 Test results

Record the results rJn ~' 'c:em such as F0rt11 C 10

22
 ISIISO 7'396-2: 2007

A nnex C
(informative)

Typical fo rm s f or certif ic ation of AG S d is pos al systems

Tile form s !JI\f'.:H1 in this annex are to be completed dur ing testing and comm issioning of AGS disposal system s
::1 2cco r d;)nce witt' Annex B

23
fSItSO 7396-2: 2007

Form C.1 - Summary of tests

Healthcare facHity Area identification _

This is to certify that the following tests and procedures have been carried out satisfactorily on the anaesthetic
gas scavenging disposal system at healthcare facility.

(Sheet ...... of ........ sheets)

Form Desc rip tion of tests and procedures

Test
required
I Procedure Specification
Date of
completion
of tests and
procedures
Yesl No

C.1 Summary of tests

C.2 Leakage 8 .2 12.4.1

--
f- - '-
Marking and support intervals of the pipeline
C.3 B.3 12.4.2
system
-
Mechanical function
C.4 B.4 12.4.3
and cleanliness of Ihe terminal units
--- - - - - --
C.5 Cross connection 18 .5 12.4.4
- - ---
C.6 Function of power devices 8 .6 ~~.5 --
C.7 Pressure and flow at the terminal units B.7
C.7.1 - for type 1L terminal units 8.2.2 12.4.6

C.7.2 - for type 1H terminal units 8.2.3

C: I .3 - for type 2 terminal units 8.2.4

..-
C.8 Indicating system 8.8 12.4.7
-- -._--
C.9 AGS disposal system exhaust 8.9 12.4.8
--
Identification and labelling
C.tO : 8 .10 12.4.9
of the terminal units I, ...l. •

Manufactu rer's Representative

Position, _ _ _ __ Signature _

Date --'- Name

Autho rized Person

Position _ ________ Signature _

Date _ _ __ Name _

24
 181150 7396-2: 2001

Form C.2 -Inspections and tests for leakage

Healthca.a facility _ Area identification

(Sheet ...... of ........ sheets)

This is to certify that the pipeline system was inspected and tested for leakage. At a test pressure of 70 kPa
the pressure drop after 15 min was I<Pa (maximum permitted is 10 kPa).

Measunng instrument(s) used

Manufacturer's Representative

Position . . _ _ _ _ _ Signature

Date _ _ _ _ _ Name

Authorized Person

Posmon Signature

Da~ Name

25
 isnso 7396-2: 2007

Form ~.3 - Inspection for marking and support intervals of the plpellne system

Healthcare facility .....:.. Area identification _

(Sheet of sheets)
This is to certify that the pipeline system was inspected for marking and support intervals. The marking and, if;
used, colour coding have been tested for durability.

Manufacturer's Representative
Position Signature _

Date Name _

Authorized Person

Position Signature ....,- _

Date Name _

26
 ISIISO 7396-2: 2007

form C.4 - - Check of mechanic al function and cl eanliness o f th e termi nal units

Healthcare facility_ _. . _ Area identi fication

(Sheet ...... of ........ sheets)

Thrs is certify that all terminal units were checked for mechanical function and inspected for cleanliness .

Manufacturer's Represen tative

Position Signat ure

Date - - - ----_._ .. _----- Name

Authorized Pers on

Posrnon _ .. ._. _ _ SignatlJlE? . _

Date " .__ . _. _._ •. _ Name

27
fiS/~SO 7395~2: 2007

Form C.,S - Test for cross connection

Healthcare facility Area identification _

(Sheet of sheets)
This is to certify that the pipeline system was tested for cross connection to any other pipeline system.

Measuri.nginstrument(s) used _

Manufacturer's Representative

Position _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Signature _

Date Name . .....,...._

Authorizedl Person

Position Signature -"- _

Date Nanie _

28 '
 181150 7396-2: 2007

Form e.G - Tests for function of power devices

Healthcare facility•. _ Area ident'fication

(Sheet of sheets)
This is to certify that all power devices have been tested in accordance with the manufacturer's manuals and
specitications.

Measuring instrument(s} used

Manufacturer's Representative

Position SlgnatLlre

Date _ Name

Authorized Person

Posit ron ________________ Signature

Date _ _ _ _ _ _~ Name

29
 rom C.7.1 - Tests ro r ff10w fo r AGSS type "eL ieL"mll'la! amISs
Healthcare facility , Area identification _

(Sheet of sheets)
This is to certify that the AGS$ type 1L terminal units were tested in accordance with 8.2.2 with test device 1/50,
(pressure drop 1 kPa, maximum flowrate 50 "min) and with test device 2/25 (pressure drop 2 kPa, minimum
flowrate 25 IImin).

I
One tenn lnal unit In use ... termin al units In use a I
I

Flow rate measured Flowrate measured!

Tennlnall..mit Room Terminal unit Room
number number Test device lest device number number Test device Test device
1150 2/25 1150 2/25

-
,~
a
-
Numberto correspond 10 system design now of the AGS system.
-
Measuring instrument(s) used _

lllianufactu rer' s Represe ntative

Posit ion Signature ~ _

Date Name _

Authorized Perso n

Position Signature _

Date Name _

'. . .
..

30
 IS/ISO 1396-2: 2007

Form C.7.2 - Tests for flow for AGSS type 1H terminal units

Healthcare facility_ _ Area identification ----_.-----------

(Sheet of sheets)
Itus IS to certify that the AGSS type 1H terminal units were tested in accordance with 8.2.3 with test device
1180, (pressure drop 1 kPa, maximum flowrate 801/min) and with test device 2/50 (pressure drop 2 kPa,
minimum flowrste 50 I/min).

-==== _.one terminal unit in use ~ ... terminal units in -u:e a

T..,m;t:U~abl~Ur.l1itll n~.OmObr;I~.·-TF!owrate measured Terminal unit I

f
Room Ftowrate measured
I
1-
.... ""

."
'" '"
II
Test devi ce Test device
1180
- --t
I 2150
number

'
number Test device Test device
1/80
~:
2150 I
i

~=:~==r=--~=t-.==-:-~:--~-==~~==t~--==;=4
I
,a
l\-
~ !
._-.~
~==l
Numberto conespond 10system de~ign flow of the AGS $yslflm _ _.... ~ .I
...._..J

r'J!easunng mstr ument. s) used _. _

Manufacturer's Representative

Positron ,_ Signature , .. _

Dale Name

Authorized Person

Position _ _ _ _ _ Signature

D~t',; Name
--_. ---- -------,

31
 Fol11l'l C.7.3 -Tests 11'011' pressure for AGSS type 2 terminal 1II11 Its

Aealthcare facility Area identification _

(Sheet of sheets)
This is to certify that the type 2 terminal units were tested in accordance with 8.2.4 (test fJowrate 501{min,
maximum pressure drop 7,5 kPa).

pressur:--~rmii1aiun'i~··
One tell11linal unit in use terminal units in lise a
Termlnal unit I Pressure
Room number Room number I
number measured number I measw'edl

----~._ ~- --------t------·-f--------··f--------j---------ll

a Numberto correspond to system design flow of the AGSsystem,

Measuring lnstrumentts) used

Manufactllrer's Representative

Position Signature _--..., _

Date _________________ Name -"- _

Authorized! Person

Position Signature _

Date Name _

32
 ISIISO 7396-2: 2007

Form C.8 - Check of the indicating system

Healthcare facility _ Area identification

(Sheet of sheets)
This is to certify that the indicating system has been checked for proper operation.

Manufacturer's Representative

Position Signature

Date Name

Authorized Person

Position Signature

Date Name

33
Healthcare facility Area identification _

(Sheet of sheets)
This is to certify that the AGS disposal, system exhaust has been checked.

Manufacturer's Relflreseniaiive

Position _..,...,........,.._:........,.----------- Signature _

Date - - - - - - - - - - Name _

Authorized Person

Position ._ _- - - - - - - - - - - - - Signature _

Date _...,..----.,. Name -=-- _

 ISIISO 7396~2: 2007

Form C.10 - Check of identification and labelling of the terminal units

Healthcare facility _ Area identification

(Sheet of sheets)
This IS to certrfy that all ter minal units have been checked for identification and labell ing (marking and, if used,
colour codin g), and labels indicating that the system is not to be used have been removed.

Manufact ur er'S Representative

Position _ _ _ _ _ _ _ _ _.__ Signature

Dale _ . Nam e
- - - - -- ---

Authorized Person

Position _ _ _ _ ____ _ __ _ _ _ Signature

Date Name

35
rsnso 7396-2: 2007

All'Illi1le:K ID
(informative)

IR[$~ mallllalgemeU1lft clhlec/Jdosfr

0.1 General
Risk manag-ement should be carried out in accordance with ISO 14971.

This annex gives the recommended risk management procedure and checklist used to identify the root causes
and the hazardous situations (l.e. causes of harm) related to defined safety objectives and appropriate risk
control measures for the AGS disposal system.

The risk management procedure and the risk control checklist should be used by both the manufacturer (M) of
the AGS disposal system and the healthcare facility (H) representative(s) during:

design, installation, commissioning and operation of new AGS disposal systems;

ong'olng operation and monitoring of existing AGS disposal systems.

D.2 Risk: management procedure

When manag ing t he risks associated with the AGSS, it is first necessary to complete a risk assessment of the
overa ll system . .

Having assessed the risks (Le. the combination of severity and probability of occurrence of the harm), the
design should endeavour to mitigate the risks by using procedures in the order of priorlty;

a) inherently safe design;

b) protecti ve measures in the medical device itself or in the manufacturing p,i'0cess;

c) information for safety.

D.3 Risk management checklist

Tables D.1 and D.2 give a list of typical safety objectives, root causes, hazardous situations and appropriate
risk control measures to mitigate the risk to acceptable levels, and identify the organizations responsible for :
action .'

36
 Table 0.1 - Risk managem ent checklist - Systems with blowers, fans or vacuum pumps
,....--------,.---------,------- ---,--_. I Responsible
Safety objective Root cause Hazardous siti ation
organizations

1) Continuity of
operation

H+V1

H
,
H
L ---'-----------
[c) H+M

I
d) Failure of indIcat ing ) to ensure continu ty of electrical supply ~ H..:.M
means

ystern H
Iy to ensure continuity of electrical H

electrical supply H
-_..
electrical supply H
--
nt addresses Issues of electrical supply H
-
Procedure to ensure that ali comp onents are restored to an operating H
condition following restoration of normal power supply
 Tflble D.1 (continj.Jed)

Safety objective Root cause Hazardous situation Risk control measures

f) Component failure
I - - - - - - + - -- - - - - - - i
,
Potential loss of flow with Review and identification of critical compo nents
failure of critical I-- - - - - - - - - ------1,--- -- - -- - ,
Specinc preventive ma inte~ance for critical components
components -- ---- ,------+---~----___t
Specification for the critical components from approved suppliers
Indicating means routinely checked to ensure that the power device is
opera ting in accorda nce with the manufacturer's specifications
--- - - - -i--- - - - - - - -1
Adequate spares/redundancy forcritical components : H
,Operational management document addresses issues of critical ~f---------­
H
component failure

Ignition of components Ensure that AGS disposal system is used only with anaesthet ic gases and H
vapours as specified by the manufacturer
f------,-----+-----------j----- -
g) Failure of the Potential failure of Operat ional management document addresses issues of critical H
maintenan ce system components and component failure
subsequent failure-of
power device
2) Syslem a} Incorrect Inadequate flow Design validation in accordance with Clause 12 M
performance design/specification of - - - - -,
components and Commission ing checks following installation H+M
1 - -- - - - - - - - - - - - - -- - - - - - - - - - - f - -- - - ----I
pipeline systems Provide usage informat ion H
- --- - - -
Opera tional management document addresses period ic checks of usage H
1 - - - - - - - - - - - 1 - - - --
Ignition of components Selection of components to ensure they are compatible with anaesthetic M
gases and vapours as specified by the manufacturer
-~ -- ---- - - -- - + - - ---------1
Operat ional management document to ensure that all replacement parts .H+M
used are compa tible with anaesthetic gases and vapours
. - - - - - - -- - - - - - -t-- --- - - - - -I
b) Ir.adequate corrosion Failure of Correct design/protection of pipelines/components M
protection of pipelines/components. i - - - - - - - - - - - -- - - - - - - - -- - -- - - -- - --
plpellnes/cornponents Operational management document addresses periodic inspection and
L.eakages. maintenance of pipelines

L..- - ' -_ _ ~
Collapse of supports
___''__ '__ . -JL -'
 Table 0.1 (continued)
--
Safety objective Root cause Hazardous situation I- Risk control measures =psponSlbl.
organizations
I
i
--_..
'c) Back!low of gases : incorrect 'low to the I Correct deSign of the AGS drsposal system to prevent backflow of M
I receivinq system : anaesthetic gases and vapour s into type 2 terminal units I
1------------ i
t
: Ccrnrrussicrunq checks to demonstrate performance of any means to H+M
I i prevent backflow
1-·_--------11- --------'---
d) Cross connections t Posrt.ve pressure In AGS : Correct design of AGS dispos al system to prevent cross connections M
I between medical gas : disposal system
I pipelines
r-, , , , --------
! Cornmissicninq of AGS dispos al system to demonstrate no cross H+M
!
i
or vacuum pipeline
systems and AGS I connections
f--·-------
I disposal system I Operational management doc ument addresses avoidance of cross H
I r connections when system is rn odified/extended
: I - I -
3) System ' a) Incorrect operation or : loss or reduction of flow i Define respons.bilitres for all a ssociated staff/users of the AGS disposal H
operation I
I maintenance of the I
i Failure of components
: system
! AGS disposal system ~ ._---------
' :Training for all associated staff'/use-s of the AGS disposal system H+M

II I Operational management doc ument to specify the need to assess

I competency of all associated s tafflusers of the AGS disposal system and
H

.....- I
.....l. .--l.. I
t
specify the retraining requirem ents. Recording of training
.

-0en0
0
..."
W
(!)
CD
I
i\)

Nt
(..o.l
co 0
....,
Q
 Table 0.2 - Risk management checklist - Systems with exhaust ejector(s) driven by compressed air
ResponslblCll
Safety objective Root cause Hazardous situation Risk control measures
organl~tlons
-
1) Continuity of a) Blockage/partial Loss or reduction' of flow Flow tests at every terminal unit before use M
operation blockage of the
pipeline
b) Failure of the power Loss or reduction of flow Preventive maintenance program set up for each power device H
device
Operational procedures established for emergency situations to ensure
H
continuity of scavenging
Routine testing of each terminal unit to ensure it is operating in
H
accordance with the manufacturer's specifications
Operational management document to address failure of power device H
c) Loss of the AGS Loss or reduction of flow Provide alarm systems for compressed air M+H
disposal system
compressed air or Routine testing of the alarm systems for compressed air H
variation of its
pressure rate/f1owrate Routine testing of the indicating means H
Check capacity of the AGS disposal system compressed air supply M+H
system
Routine ·testing ofeach terminal unit to ensure it is operating in ' H
accordance with the manufacturer's specifications
.. Operational management 'document addresses issues of AGS disposal H
system compressed air supply system failure
d) Loss of the AGS Loss or reduction of flow Procedure to ensure that all components are restored to an operating H
disposal system condition following reestablishment of the compressed air supply
compressed air or
variation of its Operational procedures established for emergency situations to ensure
continuity of flow to the patient H
pressure rate/f1owrate
e) Poor power device Mechanical damaqe to Adequate physical protection from mechanical damage H+M
location/housing the power device leading
to loss of flow
 Table 0.2 (continued)
.
Safety objective Root cause T Hazardous situation Risk control measures
.
-~ Re~~onSible
organizations
f) Failure of indicating Abnormal condition of Routine testing of the indicating system H
means the power device not
detected
g) Failure of AGS I Loss or reduction of the Routine testing of the alarm systems for compressed air H
disposal system ' AGS disposal system
compress ed air alarm compressed air pressure
system not detected
-
h) Compone nt failure I Potential loss or variation Review and identification of critical components M
Iof flow with failure of
critical components Specific preventive maintenance for critical components H+M
-
! Specification for the critical components from approved suppliers M
I
Routine testing of each terminal unit ::0 ensure it is operating in H
accordance with the manufacturer's specificatlons
Adequate spares/redundancy for critical components H

Ii Operational management document addresses issues of critical

Icomponent failure
H

Ii) Compone nt failure 1'90"'00 of o~mpooeo', ISelection of dedicated vacuum pumps (If fitted) which are compatible with
oxygen and anaesthetic gases and vapours
M

~,,,uceo,
Ensure that AGS disposal system is .ised only with anaesthetic gases H
and vapours as specified by the manufacturer
the - - k e n t i a l failure of Operational management document addresses issues of critical H
nee system i components and component failure
L L"o'eoo I;SeqJel;t failure of
power device
I

-en
Cii
0
.....,
W
<0
en
I
N

-
0/:»
N
(;;)
Q

"""
 Table 0.2 (continued)
I
Responsible
-en
fJ).

0
Safety objective Root cause Hazardous situation Risk control measures I organizations ~
(..)
ee
2) System a) Incorrect Inadequate flow Design validation in accordance with Clause 12 M en
I
performance design/specification of I--~ - - -. - - - - I\)
components and Commissioning checks following installation H+M
---_._-----1--~---- ---1 N
pipeline systems 0
Provide usage information M+H 0
- - ---- ----------- - ""-!
Operational management document addresses periodic Inspection and H
maintenance of pipelines
f-- - --------l----
---------
Ignition of components
-~---.-
Selection of components to ensure they are co~patible with anaesthetic
gases and vapours as specified by the manufacturer
t
'
M

Operational managem;nt document to ensure that all replacement- ~+M

t------ +- -+u_s_ed are compatible with anaes~et~c gas.es and vapours _ I -~
b) Inadequate corrosion Failure of Correct design/protection of pipelines/components I M
protection of pipelines/components. - -
pipelines/components Leakages. Collapse of Operational management document addresses periodic inspection or H
supports maintenance of pipelines
I---'--~-- ---~-+------'------f------ ------'-----------------t-------'-----1
c) Backflow of gases Incorrect supply to the Correct design of the AGS disposal system to prevent back feeding of M
patient waste gases into type 1 and type 2 terminal units
- --.------------------I---~ ~------f

Commissioning checks to demonstrate performance of any means to H+M

prevent backflow
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _.1... --'
 Table 0.2 (continued)

Responsible
Safety objective Root cause Hazardous situation Risk control measures
organizations
- I

I
Cross connections M
between medical gas j--
or vacuum pipeline i H+M
systems and AGS
disposal system
\ H I

Power device
contamination Irorn
- ~-Mj
demonstrate absence of
visible particulate
matter
I
-

~-
incorrect pressure of pressed air pressure
AGS disposal system M+H--
compressed air demonstrate the means of
accordance with the

- -- +-- --
sses periodic inspection and H
trol/regulation
-
3) System Incorrect operation or ff/users of the AGS disposal H
operation maintenance of the
AGSS -------
, AGS disposal system H+M

Clfy the need to assess H

the AGS disposal system and
ording of tminlng
I
I
---- ....{
b) Incompatibility of the Impossibility of use or -d to be connected to AGS I H
AGS system with other incorrect usn
medical devices I H

c) Incorrect operation or Loss or redvcbor of flow 1Define responsibilities for all associated st,,fflusers of the AGS disposal H
maintenance of the system
Failure of cornpo-ients
AGS disposal system
Training for all associated staff/users of the AGS disposal system H+M

Operational management document to spe dfy the need to assess H

competency of ali associated staft/users Of the AGS disposal system and
-,-- ..l- ..l- . _
II specify the retraining requirements. ~:.~~ing of training
GMGIPN-109 BIS/ND/2009-300 Copies
 Ana esthetic, Resuscit ation and Allied Equ ipment Se ctional Committ ee, M H R 11

NATIONAL FOR EWORD

This Indian Standa rd (Pa rt 2) which is ide ntica l with ISO 73 96-2 : 2007 'Medical gas pipeline systems _.
Part 2: An aesth etic gas scavenging di spo sal systems ' is s ued by t he Interna tio na l Organiz ation for
Standardizat ion (ISO) was adopted by the Burea u of Indian Standar ds on t he recommendation of the
Anaesthetic, Resuscitation and Allied Equipment Sec tional Co mmittee an d approval of the Medical Equipme nt
and Hospital Planning Division Council.

Anaesth etic ga s scave ngmg systems (AGSS) are used to reduce occ upa tional exposure to ana esthetic
gase s and vapours.

The anaesthetic gas scavenging system comp rises three rnam parts :
a trans fer system,
a rece iving sys tem, and
a disposal syster I I.

A schematic diagram of typical anaes thet ic gus scavenq inq sys tems is shown in Fig . 1. Requirements for
recervinq sy stems and trans fer systems nrc specnied In ISO 8835-3 : 2007 'Inhalatio n ana esthesia systems
- - Part 3: Transfer and receiving systems of act ive anae sthetic gas scavengi ng systems '. Type-spec ific
connections for terminal uruts are specified In ISO 9170-2 : 2008 'Terminal units for medical gas pipeline
systems - Part 2:Termina l units for anaes the tic ga s scavenging systems' . Specification an d test procedu res
are given in this part to ensure compatibility betwe en the co mpone nts of the sy ste m .

.Th is standar d spec ifies requ irem ents for prpeh nes for an aes thet ic gas scave nging sys tems for anaesthetic
gases and vapours . It IS int en ded for us e by thos e pe rsons involved rn the desiqn, const ruction , Inspection
and operation of hea lthcare facilities treatrnq human bemgs . ii is ad visab le tha t those persons Invo lved In
the des ign, ma nufacture and tes ting of equipme nt intended to be co nnected to pipeline sys tems shou ld also
be aware of the contents of this standard .

Specific components are used for scavenging terminal units and for ot he r connectors which are mten ded to
be used by the operato r. In addition, the sys tem is tested and certified to opera te at safe flows and without
leak3ge. It is also Intende d to add ress Issues at pauen t safel y.

The objec tives of thrs stand aro are to ens ure th e tol low inq.
a) Avo ida nce of c ross connections between di ffere nt pipeli ne sys tems,
b) Continuity of function of the system,
c) Use of SUitable matenals,
d) Ceanl iness of components,
e) Correct ins ta llation.
f) Provision of indicating system(s),
g) Correct marking of th e pipeline sy ste m and components,
h) Testing, commissioning and certific atio n, and
j) Correct ope rational manage me nt.

This sta ndard is published III two parts. T he other part of this series IS:

Part 1 Pipeline sys tems for compressed medical gases and vacuum

The text of ISO Sta nda rd has been approved as suitable for pub hcation as an InJ ICln Standard wi thout

(Continued un third co ver)

\ CL1n;/f1U<3d from second cover)

deviations Certain conventions are, however. not identical to those used in Indian Standards. Attention is
particularly drawn to the tollowmq.

a) Wnerever the words lnternauonal Standard' appear reternnq to thrs standard, they should be read as
'Indian Standar'd'

b) Comma (.) has been used as a decimal marker 111 the International Standard while in indian Standards,
the current practice is to use a oornt (.) as the decimal marker.

In tlus adopted standard. reference appears to certain International Standards for which indian Standards
also exist. The corresponding Indian Standards which are to be substituted ill their places are listed below
along With their degree of equivalence tor tile edition mdicated:

ltnernetionet Standard Corresponding Indian Standard Degree of Equivalence

ISO 7396-1 : 2007 Medica! qas IS,ISO 7396-1 ,2007 Medical gas Identical
pipeline systems -- Part 1: Pipeline pipeline systems: Part i Pipe hne
systems for compressed medical systems for compressed medical
gases and vacuum gases and vacuum

ISO 1!.JUOl : 2003 Anaesthetic 8nd IS/!SO 15001 : 2003 Anaesthetic and do
respiratory equiprnent - Compatibility respiratory equipment --- Compatibility
with oxyger I with oxygen

The technical comrnutee responsible for the preparation of tlus standard has reviewed the provisions of the
tollowrnq International Standards and has decided that they are acceptable for use in conjunction with this
standard:

International Standard Title

ISO 5359: 2008 Low-pressure hose assemblies for use with medical gases

ISO 8835-3 : 2007 lnhalational anaestnesia systems -- Part :3: Transfer and receiving systems of
active anaesthetic gas scavenging systems

ISO 9170-2 : 2008 Terrmnal units for rncdrcal gas pipeline systems -- Part 2: Terrninalunits for
anaesthetic gas scavenging systems

ISO 14971 : 2007 Medical devices - Application of risk management to medical devices

EN 1041 : 2008 Inlorrnauon supphed by the rnanutacturer With medical devices

EN 13348: 2008 Copper and copper alloys - Seamless, round copper tubes for medical gases
or vacuum

For the purpose of deciding whether a particular requirement of this standard IS complied with, the final
value, observed or calculated expressing the result of a test or analysis, shall be rounded off in accordance
with IS 2: 1960 'Rules for rounding off numencal values (revlsec!)'. The number of significant places retained
in the rounded off value should be the same as that of the specified value in this standard,
Bureau of Ind ian Standards
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harmonious development of the activities of standardization, marking and quality ce rt!fication of
goods and attending to connected matters in the country.

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Review of Indian Standards

Amendments are issued to standards as the need arises on the basis of comments. Standards are
also reviewed periodically; a standard alongwith amendments is reaffirmed when such review indicates
that no changes are needed; if the review indicates that changes are needed, it is taken up for revision,
Users of Indian Standards should ascertain that they are in possession of the latest amendments or
edition by referring to the latest issue Of 'BIS Catalogue' and 'Standards: Monthly Additions '.

This Indian' Standard has been developed from Doc NO.:,MHR 11 (041).

Amendments Issued Since Pub lication

Amend No. Date of Issue Text Affected

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