ISO 8835-3:1997
(Main)Inhalational anaesthesia systems — Part 3: Anaesthetic gas scavenging systems — Transfer and receiving systems
Inhalational anaesthesia systems — Part 3: Anaesthetic gas scavenging systems — Transfer and receiving systems
Specifies requirements for transfer and receiving systems of active anaesthetic gas scavenging systems (AGSS) intended to reduce the exposure of hospital personnel to anaesthetic gases and vapours.
Systèmes d'anesthésie par inhalation — Partie 3: Systèmes d'évacuation des gaz d'anesthésie — Systèmes de transfert et de réception
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Standards Content (Sample)
;
INTERNATIONAL IS0
STANDARD 88353
First edition
1997-01-15
Inhalational anaesthesia systems -
Part 3:
Anaesthetic gas scavenging systems -
Transfer and receiving systems
SystZrme d ‘anethhsie par inhalation -
Partie 3: Systemes d’kvacuation des gaz d’anesthksie - Syst&mes de
trans fert et de keption
Reference number
IS0 8835-3:1997(E)
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IS0 8835=3:1997(E)
Page
Contents
1
1 Scope .
1
2 Normative references .
2
3 Definitions .
3
. 4 Patient and environmental protection .
4
5 Means of pressure relief. .
4
6 Transfer systems. .
5
7 .
Receiving systems
5
8 Connectors .
6
9 Extract flow .
6
‘IO Electrical requirements .
6
11 Information to be supplied by the manufacturer .
6
12 Marking .
7
................................................................................
13 Identification
Annexes
9
........................................
A Test for pressure rise at inlet to AGSS
11
...................................................................
B Test for induced flow
12
C Test for spillage .
14
D Test for resistance to extract flow .
16
E Bibliography .
0 IS0 1997
All rights reserved. Unless otherwise specified, no part of this publication may be
reproduced or utilized in any form or by any means, electronic or mechanical, including
photocopying and microfilm, without permission in writing from the publisher.
International Organization for Standardization
Case Postale 56 l CH-1211 Geneve 20 l Switzerland
Printed in Switzerland
ii
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IS0 8835=3:1997(E)
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Foreword
IS0 (the lnternatronal Organization for Standardization) is a worldwide fed-
eration of national standards bodies IS0 member bodies). The work of
preparing International Standards is
normally carried out through IS0
technical committees. Each membe body interested in a subject for
which a technical committee has been established has the right to be
represented on that committee. International organizations, governmental
and non-governmentai, rn liaison with ISO, also take part in the work. IS0
collaborates closely with the International Electrotechnical Commission
(I EC) on all matters of electrotechnical standardization.
Draft International Standards adopted by the technical committees are
circulated to the member bodies for voting. Publication as an International
Standard requires approval by at least 75 % of the member bodies casting
a vote.
International Standard IS0 8835-3 was prepared by Technical Committee
lSO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 1,
Breathing attachments and anaesthetic machines.
IS0 8835 consists of the following parts, under the general title
inhala tionai anaes thesla s ys terns:
- Part 7: Anaesthetic workstations and their components - Particular
requirements
- Part 2: Anaesthetic circle breathing systems
- Part 3: Anaesthetic gas scavenging systems - Transfer and
receiving s ys terns
IS0 8835-l will be published as IEC 601-2-13.
NOTE -
Annexes A to D form an integral part of this part of IS0 8835. Annex E is
for information only.
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IS0 8835=3:1997(E)
Introduction
It is recognized that there are many factors affecting conditions within the
operator9 working environment which are outside the controi of manu-
facturers of anaesthetic gas scavenging systems (AGSS). These include
room ventilation, leakage from equipment and the choice of anaesthetic
technique, all of which are variable. Furthermore, the amount of pollutant
taken up by personnel will be affected by other factors, such as the
duration of exposure, their position in relation to any source of pollution,
etc.
This part of IS0 8835 is intended to ensure that, for all practical purposes,
an AGSS will remove essentially all gases delivered to it and thereby
reduce atmospheric pollution to a small fraction of the uncontrolled level.
Atmospheric pollution by anaesthetic gases is the subject of considerable
discussion, and opinions differ as to the limits which should be allowed in
the working environment: recommendations on permissible levels
therefore are not included in this part of IS0 8835 but may be specified in
national standards.
The committee responsible for this part of IS0 8835 has been primarily
concerned with limiting the risks to patients which the transfer and
receiving systems of AGSS can introduce by altering the function of
breathing systems. The wide range of anaesthetic machines, lung
ventilators and related equipment in general use today has been taken into
account.
The devices for limiting the extent of pressure changes in breathing
systems resulting from the use of AGSS should be as close as possible to,
or within the breathing system.
Protection against sub-atmospheric pressure and induced flow is less
straightforward, experience having shown that any negative pressure at
the patient end of an AGSS can induce a flow of gas from the breathing
system under certain conditions. Such gas loss can be hazardous for
example, by reducing the fresh gas flowrate below the minimum required
by the patient, by altering the composition of the inspired gas mixture, by
affecting the proper functioning of disconnection alarms or other venti-
latory measuring equipment, or by a combination of these factors.
As it is difficult to design the receiving system to prevent it inducing any
flow from the breathing system to the inlet of the AGSS under all
conditions, it has been decided to specify the limits of this flow.
Requirements are included in this part of IS0 8835 for information
concerning induced flow and warning statements, if applicable, to be
supplied by the manufacturer [(see II b)].
Nonactive (passive) AGSS, i.e. those in which the air flow in the disposal
system does not result from a powered device, have been excluded from
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this part of IS0 8835 because they cannot meet the specified safety
requirements under all conditions of use. Proximity gas extraction systems
(i.e. systems not directly connected to the breathing system) are also
excluded from this part of IS0 8835. Therefore this part of IS0 8835 is
restricted to the transfer and receiving systems of active AGSS and to
AGSS in which the receiving system and the disposal system are
integrated.
Examples of typical arrangements of AGSS are shown in figure 1.
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IS0 8835=3:1997(E)
INTERNATIONAL STANDARD @ IS0
Inhalational anaesthesia systems -
Part 3:
Transfer and receiving systems
Anaesthetic gas scavenging systems -
4 Scope
This part of IS0 8835 specifies requirements for transfer and receiving systems of active anaesthetic gas
scavenging systems (AGSS) intended to reduce the exposure of hospital personnel to anaesthetic gases and
vapours. It does not apply to nonactive AGSS (passive AGSS) or to proximity gas extraction systems. This part of
IS0 8835 also specifies requirements for AGSS in which the receiving system is integrated with the disposal
system.
This part of IS0 8835 does not specify requirements for:
a) discrete disposal systems;
b) permanent disposal system installations.
This part of IS0 8835 does not specify connectors for purposes such as the connection of the exhaust outlet of gas
monitors to the AGSS; a specification for such connectors is under consideration.
2 Normative references
The following standards contain provisions which, through reference in this text, constitute provisions of this part
of IS0 8835. At the time of publication, the editions indicated were valid. All standards are subject to revision, and
parties to agreements based on this part of IS0 8835 are encouraged to investigate the possibility of applying the
most recent editions of the standards indicated below. Members of IEC and IS0 maintain registers of currently
valid International Standards.
IS0 5356-l : 1996, Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets.
IS0 5356-2:1987, Anaesthetic and respiratory equipment - Conical connectors - Part 2: Screw-threaded, weight-
bearing connections.
IS0 5359: 1989, Low-pressure flexible connecting assemblies (hose assemblies) for use with medical gas systems.
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IS0 8835=3:1997(E)
1), Inhalational anaesthetic systems - Part 7: Anaes thesia workstations and their components -
IS0 8835-l :-
Particular requirements.
I EC 601-I : 1988, Medical electrical equipment - Part ‘7: General requirements for safety.
Munsell Book of Color?
3 Definitions
For the purposes of this part of IS0 8835, the following definitions apply.
3.1 active anaesthetic gas scavenging system (AGSS): AGSS in which the gas flow in the disposal system
results from a power device.
32 . anaesthetic gas: Gas and/or vapour of a volatile agent used in anaesthesia.
. 3.3 anaesthetic gas scavenging system (AGSS): Complete system which is connected to the exhaust port of a
breathing system or to other equipment for the purpose of conveying expired and/or excess anaesthetic gases to
an appropriate place of discharge.
NOTE - Functionally, a complete system comprises three parts: a transfer system, a receiving system and a disposal
system. These three functionally discrete parts may be either separate or sequentially combined in part or in total. In addition
one or more parts of an AGSS may be sequentially combined with a breathing system, e.g. as in a ventilator, to include the
transfer system, or transfer and receiving systems.
3.4 breathing system: Those gas pathways continuously or intermittently in communication with the patient’s
respiratory tract during any form of ventilation.
NOTES
1) In practice a breathing system usually extends from:
a) the point of supply of a controlled gas mixture, for example the fresh-gas outlet of an anaesthetic machine. In some
situations, particularly in lung ventilators, this point may be inside a piece of equipment and should not be confused
with a connection port fitted elsewhere, for example on the casing of a ventilator.
b) the fresh-gas inlet of a circle system, lung ventilator, T-piece, etc.
c) the fresh-gas inlet of a manually operated resuscitator.
2) The breathing system usually extends to the point at which the gas mixture escapes to atmosphere or to a gas scavenging
system, for example from an APL valve, the open end of a T-piece, etc.
3) The exact arrangement of any system and the method of use influences and may affect the composition of a gas mixture.
Gas pathways exclusively concerned with gas scavenging systems are not regarded as a part of breathing system.
4)
5) It is not possible to eliminate all ambiguity in defining the term “breathing system”. When this term is used in any standard
or document, or other scientific publication, in which it could affect the precise interpretation thereof, the limits and
configuration of any “breathing system” referred to therein should be clearly defined.
system: Th at part of an AGS means of which the expired a excess anaesthetic gases are
3.5 disposal nd/or
s bY
conveyed from a receiving system to a point of di scharge.
NOTE - The disposal system contains a power device which may either form part of a permanent disposal system
installation or be installed within the operator’s working environment, either as a discrete device or integrated with the
receiving system.
3.6 extract flow: Flow of gas from the transfer and receiving systems of an AGSS at the entry to the disposal
system.
1) To be published.
2) Available from Munsell Color, 2441 N. Calvert Street, Baltimore, MD, 21218 USA.
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receiving
3.7 high-flow disposal system: Disposal system which, when connected to a high-flow transfer and
to gene flowrate of 75 I/min.
system complying with this part of IS0 8835, is able rate an extract of
3.8 induced flow: Flow at the inlet of the transfer system which is caused by the subatmospheric pressure
generated in the AGSS.
Disposal system which, whe n connected to a low-flow transfer and receiv ing
3.9 low-flow disposal system:
in.
system complying with this part of IS0 8835, is able to generate extract flowrates of not mo .e than 5 0 I/m
ct flowrate: Highest flowrate of gas at the entry
3.10 maximum extra to the disposal system which can be
accommodated without exceeding th e specified limitations for ind uced flow.
flowrate: Lowest flowrate of gas at the entry to the disposal system which ensures that
3.11 m inimum extract
is not exceeded.
the speci fied limit of spilla ge to atmosphere
ment that is connected by means of a permanent connection
3 . I2 non-operator-detachable equipment: Equip
of a tool.
or a connection that can be detached only by the use
3.13 power device: That part of the disposal system of an active AGSS which generates the extract flow.
‘t of an AGSS which transfers expired and/or excess gases from the receiving
3.14 receiving hose: That par
system to the disposal system.
3.15 receiving system: That part of AGSS which provides an interface between a transfer system and a disposal
system.
3.16 spillage: Volume of expired and/or excess anaesthetic gas which cannot be a ccom modated by the AGSS
over a period.
specified
3.17 transfer tube: That part of the AGSS transfer system which transfers gases from the breathing system to
the receiving system.
3.18 transfer system: That part of an AGSS which transfers expired and/or excess anaesthetic gases from the
exhaust port of a breathing system to a receiving system.
4 Patient and environmental protection
4.1 Normal operating conditions
4.1.1 Pressure
When tested by the method described in annex A, with continuous flowrates of 30 I/min and 75 I/min of air into the
inlet of the AGSS, the pressure rise at this inlet shall not exceed 50 Pa (0,5 cmH20) and 350 Pa (3,5 cmH20)
respectively. This requirement shall also be met when there is no extract flow at the outlet of the receiving system
(e.g. when th e power device is inoperative or disconnected from the receiving system).
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4.12 induced flow
The effect of operating the AGSS at the maximum extract flow specified for the transfer and receiving systems
shall be such that, when tested by the method described in annex B, the induced flowrate at the inlet to the AGSS
shall not exceed 50 mI/min.
4.1.3 Spillage
When tested by the method described in annex C, the spillage to atmosphere shall not exceed 100 mI/min.
4.2 Single fault condition
42.1 Pressure
The pressure rise at the inlet of the AGSS shall not exceed I,5 kPa (15 cmH20) when the procedure described in
4.1 .I is repeated at a flowrate of 75 I/min, having introduced single faults one at a time.
NOTE - An example of a single fault is occlusion of the transfer tubing.
4.2.2 Induced flow
The induced flowrate at the inlet to the AGSS shall not exceed 500 mI/min when the procedure described in 4.1.2 is
repeated, having introduced single faults one at a time.
NOTE - An example of a single fault is occlusion of any air-entrainment inlet.
4.2.3 Spillage
Under single fault condition, gases may be spilled into the atmosphere at a rate in excess of 100 mI/min.
4.3 Materials
All components of the AGSS shall be made of materials that are compa
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