ISO 10079-3:1992
(Main)Medical suction equipment — Part 3: Suction equipment powered from vacuum or pressure source
Medical suction equipment — Part 3: Suction equipment powered from vacuum or pressure source
Appareils d'aspiration médicale — Partie 3: Appareils d'aspiration alimentés par une source de vide ou de pression
General Information
Relations
Standards Content (Sample)
IS0
INTERNATIONAL
STANDARD
10079-3
First edition
1992-l o-1 5
--
Medical suction equipment -
Part 3:
Suction equipment powered from vacuum or
pressure source
Appareils d’aspiration mbdicaux -
Partie 3: Appareils d’aspiration aliment& par une source d/aspiration
(vide) ou de pression
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--- _--
---- -.-
Reference number
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:=----- ----.- I-.--1~- IS0 10079-3: 1992(E)
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IS0 10079-3:1992(E)
Contents
Page
1
......................................................................................... ........
1 Scope
1
2 Normative references . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .-.
.................................................................................. ........ 2
3 Definitions
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
4 Cleaning, disinfection and sterilization
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
5 Design requirements
...... .................................................... 4
6 Operational requirements
7 Physical requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
6
8 Performance requirements for vacuum and flow . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .~~. 7
9 Gas supply
. . . . . . . . . . . . . . . . . . . . . . . . .~. 7
IO Vacuum regulator . . . . . . .
7
II Resistance to environment . .
...................... .................. .............................................. 7
12 Marking
. . . . . . . . . . . . . . . . . . . . . . . . . . 8
13 Information to be supplied by manufacturer
Annex
................................ .......................... 9
A Test methods .
A.1 Test for resistance to implosion, cracking or permanent
9
deformation . . . . ._. . . ., . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
A.2 Test for suction tubing . .*. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*. . . . . . . . . . . . . . . 9
. . . . . . . . . . . . . . 9
A.3 Test for overfill protection and collection capacity
............. ................................................ IO
A.4 Test against spillage
........... .............. IO
A.5 Test for leakage from collection container
....... .......................... IO
A.6 Test for negative pressure protection
12
A.7 Test for positive pressure protection in thoracic drainage .
A.8 Anti-blow-back test in venturi-powered suction systems . . 12
12
A.9 Test of “CF compatible” equipment . .
0 IS0 1992
All rights reserved. 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 Gerkve 20 l Switzerland
Printed in Switzerland
ii
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IS0 10079=3:1992(E)
12
......................................... ......................................
A.10 Drop test
............................... .................................... 13
A.11 Test for vacuum
13
..................... ...........................
A.12 Test for pharyngeal suction
............... 13
A.13 Test for free air flow of low vacuum equipment
13
A.14 Test for thoracic drainage . .
................. 14
A.15 Test for vacuum regulator with a fixed setting
.............. 14
A.16 Test for vacuum regulator with variable setting
..................................... 15
Operating and storage conditions
A.17
. . .
III
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IS0 10079-3:1992(E)
Foreword
IS0 (the International Organization for Standardization) is a worldwide
federation of national standards bodies (IS0 member bodies). The work
of preparing international Standards is normally carried out through IS0
technical committees. Each member body interested itI a subject for
which a technical committee has been established has the right to be
represented on that committee. International organizations, govern-
mental and non-governmental, in liaison with ISO, also take part in the
work. IS0 collaborates closely with the International Electrotechnical
Commission (IEC) 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 lnter-
national Standard requires approval by at least 75 % of the member
bodies casting a vote.
International Standard IS0 10079-3 was prepared by Technical Com-
mittee ISO/TC 121, Anaesthetic and respiratory equipment, Sub-
Committee SC 8, Suction devices for hospital alId errlergency care use.
IS0 10079 consists of the following parts, under the general title Medical
suction equipment:
- Part I: Electrically powered suction equipment - Safety require-
ments
- Part 2: Manually powered suction equipment
- Part 3: Suction equipment powered fi-om vacuum or pressure
source
Annex A forms an integral part of this part of IS0 10079.
iv
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IS0 10079=3:1992(E)
Introduction
This International Standard, which has been prepared under the re-
sponsibility of Sub-Committee 8 of ISO/TC 121, comprises part 3 of the
standard for medical suction equipment, and deals only with suction
equipment powered from a vacuum or pressure source. Part 1 deals
with safety requirements for electrically powered suction equipment,
whereas part 2 deals with manually powered suction equipment.
This International Standard has been prepared in response to a need for
a safety and performance standard for suction systems. Suction is used
to clear the airway and remove unwanted material from body cavities.
Suction is also used to assist drainage and decompress body cavities.
Suction and vacuum systems are used widely both in health care facili-
ties such as hospitals, for domiciliary care of patients who are nursed
at home, and in emergency situations both outside hospitals in field
conditions and during transport in ambulances.
As far as possible, this International Standard has been written specify-
ing performance requirements corresponding with those needed for ef-
fective and safe treatment of the patient.
Some devices specified in this standard are intended to be operated in
conjunction with a pipeline complying with IS0 7396.
.
Annex A gives test methods to be used to verify compliance with the
requirements given in this part of IS0 10079.
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INTERNATIONAL STANDARD
IS0 10079=3:1992(E)
Medical suction equipment -
Part 3:
Suction equipment powered from vacuum or pressure source
k) orally operated mucous extractors;
1 Scope
I) suction equipment where the collection container
is downstream of the vacuum pump;
This part of IS0 10079 specifies safety and perform-
ance requirements for medical suction equipment
m) equipment marked as suction unit for permanent
powered from a vacuum or pressure source (see
tracheostomy;
figure I). In particular it applies to connections for
pipelines and venturi attachments. n) ventouse (obstetric) equipment;
Suction equipment, e.g. electronic timing, controlled 0) neonatal mucous extractors;
by electrical means, may also need to comply with
IEC 601-1:1988.
p) breast pumps;
This part of IS0 10079 does not apply to electrically q) liposuction;
powered suction equipment, whether mains elec-
tricity or battery-powered, which is dealt with in r) uterine aspiration.
IS0 10079-1, nor to manually powered suction
equipment which is dealt with in IS0 10079-2, nor to
2 Normative references
the following:
a) central power supply (by vacuum/compressed The following standards contain provisions which,
air generation), piping systems of vehicles and through reference in this text, constitute provisions
buildings, and wall connectors; of this part of IS0 10079. At the time of publication,
the editions indicated were valid. All standards are
b) catheter tubes, drains, curettes and suction tips; subject to revision, and parties to agreements based
on this part of IS0 10079 are encouraged to investi-
gate the possibility of applying the most recent edi-
c) syringes;
tions of the standards indicated below. Members of
IEC and IS0 maintain registers of currently valid In-
d) dental suction equipment;
ternational Standards.
e) waste gas scavenging systems;
IS0 407:1991, Small medical gas cylinders - Pin-
index yoke-type valve connections.
f) laboratory suction;
IS0 5356-l :I 987, Anaesthetic and respiratory equip-
g) autotransfusion systems;
ment - Conical connectors - Part I: Cones and
sockets.
h) passive urinary drainage;
IS0 5359:1989, Low-pressure flexible connecting as-
i) closed systems for wound drainage;
semblies {hose assemblies) for use with medical gas
systems.
j) gravity gastric drainage;
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IS0 10079=3:1992(E)
IEC 601-1:1988, Medical electrical equipment - Part
3.2 drainage: Removal of fluids from a body cavity
I: General requirements for safety.
or wound, assisted by vacuum.
3 Definitions 3.3 end piece: That part of the suction equipment
applied to the patient. The end piece starts at the
For the purposes of this part of IS0 10079, the fol- site where material is drawn in and ends at the first
detachable connection.
lowing definitions apply.
3.1 collection container: Container in which liquids
3.4 exhaust opening: Port or ports through which
or solid particles are collected.
exhaust is discharged.
Applicable standard:
Power source Vacuum Filter
Collection
lndlca tor
container
Mains
eLectricity
Electrically powered
suctlon equipment
(IS0 10079-I)
Battery
Manually powered
suction equlpment
Manual
(IS0 10079-Z)
Compressed
gas SUPPLY
Sue tion equipment
powered from a vacuum
or pressure source
(IS0 10079-3)
Vacuum
pipeline
NOTES
1 IS0 10079-l applies to mains electricity and battery-powered suction equipment.
IS0 10079-2 applies to manually powered suction equipment. This part of IS0 10079 applies to suction equipment powered
from a vacuum or pressure source.
2 Components illustrated are not necessarily required by this International Standard.
3 Suction equipment shown are only examples, and actual systems may consist of other arrangements and components
not illustrated in the figure.
Figure 1 - Schematic drawing illustrating suction equipment
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IS0 10079=3:1992(E)
3.5 filter: Device for separation of particulate mat- 3.24 vacuum indicator: Device for displaying the
ter. level of vacuum.
3.6 free air flow: Unrestricted flow of air through a 3.25 vacuum
pump: Powered device for generating
nominated inlet. vacuum.
3.7 high flow: Suction with a free air flow of 3.26 vacuum regulator: Device for controlling the
20 I/min. or greater. maximum vacuum applied to the patient.
3.8 high vacuum: Vacuum of at least - 60 kPaQ.
3.27 vacuum source: Means of generating vacuum.
The source may be integral with the suction equip-
3.9 inlet: Part of a component through which fluids
ment or be separate from the suction equipment.
and/or solids enter.
4 Cleaning, disinfection and sterilization
3.10 intermediate tubing: Tubing between the col-
lection container and the vacuum source.
4.1 Any filters installed shall either be of the
3.11 intermittent suction: Suction where the nega-
single-use type or be capable of being cleaned, dis-
tive pressure applied to the end piece is automati-
infected and/or sterilized for re-use.
cally and periodically returned to atmospheric
pressure.
4.2 Equipment with filters intended for re-use shall
comply with the requirements specified in 8.1 to 8.7,
3,12 low flow: Suction with a free air flow of less
as appropriate, after the filters have been subjected
than 20 l/min.
to 30 cycles of sterilization as recommended by the
manufacturer.
3.13 low vacuum: Vacuum not more than
- 20 kPa.
4.3 Suction tubing shall either be for single use or
3.14 medium vacuum: Vacuum less than - 60 kPa be capable of being cleaned, disinfected and/or
and greater than - 20 kPa. sterilized as recommended by the manufacturer.
3.15 outlet: Part of a component throuyh which flu-
L
4.4 Suction equipment incorporating a re-usable
ids and/or solids exit.
collection container assembly shall comply with the
requirements given in 8.1 to 8.7, as appropriate, be-
3.16 overfill protection: Prevention of liquid or solid
fore and after the collection container has been
particles entering the intermediate tubing.
subjected to 30 cycles of cleaning, disinfection
and/or sterilization as recommended by the manu-
3.17 overfill protection container assembly: Col-
facturer.
lection container and its closure.
overfill protection device: Any device intended
3.18 5 Design requirements
to prevent liquid or solid particles entering the
intermediate tubing.
5.1 Collection container
3.19 suction: Application of vacuum to remove flu-
51.1 The inlet of the collection container shall have
ids and/or solid particles.
an inside diameter of not less than 6 mm and not
less than the maximum inside diameter of the
3.20 suction equipment: Single self-contained unit
suction tubing recommended by the manufacturer.
or combination of units which generates or controls
The inlet shall not be compatible with any conical
suction.
connector specified in IS0 5356-l.
3.21 suction tubing: Tubing for conduction of fluids
from the end piece to the collection container. 5.1.2 For suction equipment which is intended to
continue operating when the collection container is
full and intended for field use, the volume of the
3.22 thoracic drainage: Drainage to the thoracic
collection container shall be not less than 200 ml.
cavity of the patient.
For all other suction equipment, including suction
equipment intended for field and/or transport use,
3.23 vacuum: Pressure less than atmospheric
the usable volume of the collection container shall
pressure, normally expressed as a difference from
be not less than 500 ml.
atmospheric pressure.
--
1) 1 kPa z= 7,500 63 mmHg or 4,014 629 in H,O or 10,197 16 cm H,O or IO hPa
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IS0 10079=3:1992(E)
NOTE 1 “Field use” of suction equipment is intended to
6 Operational requirements
cover use in situations outside of the health care facility
at the site of accidents or other emergencies. The use of
6.1 Overfill protection
suction equipment in these situations may expose the
equipment to water including rain, dirt, uneven support,
mechanical shock and extremes of temperature. “Trans-
6.1.1 An overfill protection device shall be provided
port use” of suction equipment is intended to cover situ-
to prevent liquids entering the suction equipment.
ations outside of the health care facility such as in
Suction shall cease when the overfill protection de-
ambulances, cars or aeroplanes. Use of suction equip-
vice operates. When tested in accordance with A.3,
ment in these situations may expose the equipment to
not more than 5 ml of liquid shall pass downstream
uneven support, dirt, mechanical shock and a wider range
of the overfill protection device.
of temperature than normally found in health care facili-
ties.
Protective me ans shoul d also be provided to prevent
foam pass ing downstre am into t he vacuum source.
51.3 For suction equipment not intended for field
NOTE 4 An overfill protection device be an integral
may
use, one or more collection containers rec-
part of the suction equipment.
ommended by the manufacturer and either for
single-use or of a re-usable type, shall be used. For
6.1.2 If the overfill protection device is integral with
all collection containers, the contents shall be
the collection container, when tested in accordance
clearly visible in the position of normal use. The
with A.3, it shall not activate until at least 90 % of
collection container shall be marked with its usable
the stated capacity of the collection container has
volume, expressed in millilitres. For collection con-
been reached.
tainers having a capacity of 500 ml or greater, ap-
proximate indication of the volume of the contents
6.2 Spillage
shall be given by graduations at intervals of not less
than 50 ml and not more than 250 ml.
After testing in accordance with A.4, the suction
equipment shall meet the requirements specified in
8.1 to 8.7, as appropriate.
5.1.4 The collection container shall not implode,
crack or permanently deform when tested in ac-
6.3 Air leakage
cordance with A.I. Following this test, the suction
equipment shall meet the requirements of 6.1, 6.3
and 8.1 to 8.7, as appropriate.
6.3.1 Collection containers for general use
6.3.1.1 When tested in accordance with A.5.1, for
51.5 The connectors for the suction tubing and the
single-use containers, the maximum leakage into
intermediate tubing to the vacuum source shall be the collection container assembly shall not exceed
designed to facilitate correct assembly or marked to 200 ml/min if the collection container is intended for
indicate correct assembly when all parts are mated. use with suction equipment having a free air flow of
Compliance shall be checked by inspection. more than I I/min. The pressure increase shall be
less than 3,3 kPa t V in 10 s where I/ is the total
NOTE 2 The design of the connectors should impede
volume, in litres, of the collection container.
Incorrect connections have been
wrongful connections.
frequently a cause of spili-over into a vacuum source.
6.3.1.2 A re-usable collection container assembly
shall meet the requirements given in 6.3.1.1, before
and after being subjected to 30 cycles of cleaning,
disinfection and/or sterilization as recommended by
5.2 Suction tubing
the manufacturer.
6.3.2 Collection containers for thoracic drainage
5.2.1 When tested in accordance with A.2, suction
tubing supplied with the equipment shall retain at
6.3.2.1 When tested in accordance with A.5.2, no
least 50 % (0,5) of its inside diameter throughout its
more than three bubbles shall be observed in 10 s.
length.
NOTE 5 Three bubbles in 10 s approximates to a
leakage of 4 ml/min.
6.3.2.2 Re-usable collection container assemblies
shall meet the requirement given in 6.3.2.1 before
and after being subjected to 30 cycles of cleaning
NOTE 3 Suction performance may be markedly affected
and/or sterilization as recommended by the manu-
by the length and diameter of the tubing between the
facturer.
coliection container and the end piece.
4
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IS0 10079-3:1992(E)
NOTE 6 These tests are intended to ensure satisfactory
electrical resistance (impedance) of greater than
overall performance of the vacuum system when parts
10 MKI.
are supplied by different manufacturers.
6.6 Vacuum indicators
6.4 Exhaust air
It shall not be possible to connect suction tubing to
6.6.1 Suction equipment having vacuum regulators
any exhaust opening.
with a variable control shall have a vacuum indi-
cator displaying the vacuum on the patient side of
the vacuum regulator.
6.5 Protective devices
6.5.1 Positive and negative pressure protection
6.6.2 Analogue displays shall have graduations not
less than 2 mm apart, each graduation representing
6.5.1.1 If a device intended to limit the maximum not more than 5 % of the full scale value.
level of vacuum is fitted, when tested in accordance
wi,th A-6, the output of the suction equipment shall
6.6.3 Digital displays shall display vacuum at in-
not deviate from the vacuum limit by more than
tervals of not greater than 2 % of the full scale
+ 4 kPa.
-
value. The maximum vacuum for which the equip-
ment is designed shall be marked prominently on
a positive pressure relief
In vacuum regulators,
the display case or immediately adjacent to it.
valve should be included to prevent positive press-
ure build up at the patient when misconnected to a
positive pressure source.
6.6.4 All low vacuum equipment shall be fitted with
a vacuum indicator which shall be installed between
6.5.1.2 When tested in accordance with A.7,
the vacuum source and collection container to indi-
thoracic drainage systems shall not develop a
cate the vacuum applied to the suction tubing.
pressure in excess of 1 kPa at the patient inlet.
6.6.5 The full scale of analogue vacuum indicators
6.5.2 Filter assembly
shall be not more than 200 % of the maximum de-
signed negative pressure of the suction equipment.
6.5.2.1 Any part of a filter assembly which is re-
usable, shall be capable of being cleaned, disin-
6.6.6 Vacuum indicators on suction equipment, ex-
fected and/or steri I ized according to the
cept as specified in 6.6.7, shall be accurate to within
manufacturer’s instructions, and shall then meet the
+ 5 % of the full scale value.
requirements of 6.1 and 8.1 to 8.7, as appropriate. -
Air leaving the collection container should pass
6.6.7 Vacuum indicators on suction equipment in-
through a microbiological filter before entering the
tended for thoracic drainage shall be accurate to
suction equipment.
within $- 5 % of the full scale value in the middle
three-fifths of the indicator range.
6.5.2.2 The filter assembly shall not implode, crack
or permanently deform when tested in accordance
with A.I.
6.6.8 All markings on the vacuum indicator shall
be legible to an operator having visual acuity, cor-
rected if necessary, of at least l,O, seated or stand-
6.5.3 Anti-blow-back in suction equipment powered
ing 1 m from the vacuum indicator at an illuminance
by venturi device
of 215 Ix.
6.5.3.1 In venturi-powered suction systems, the de-
Movement of a rotary analogue vacuum indicator
vice shall not produce a positive pressure of more
should be COUI ter-clockwise for an increase in vac-
than 1 kPa in the vacuum line under any single fault
uum.
condition.
6.5.3.2 When tested in accordance with A.8, a
6.7 Dismant I ing and reassembly
positive pressure of greater than 1 kPa shall not be
developed by occlusion of the venturi outlet(s).
Suction equipment intended to be dismantled by the
user (for example, for cleaning) shall be designed
so as to minimize incorrect reassembly when all
6.5.4 Electrical protection
parts are mated. After dismantling and reassembly,
When tested in accordance with A.9, suc,tion equip- the suction equipment shall meet the requirements
ment marked as “CF compatible” shall have an specified in 6.1, 6.3 and 8.1 to 8.7, as appropriate.
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IS0 10079=3:1992(E)
6.8 Mechanical shock
8 Performance requirements for vacuum
and flow
After suction equipment intended for field or trans-
port use or both has been dropped in accordance
8.1 General
with A.lO, it shall meet the requirements specified
in 6.1, 6.3 and 8.1 to 8.7, as appropriate.
Suction equipment intended for use with piped vac-
If the suction equipment can be operated outside of
uum or installed venturi systems and which does not
it shall meet the requirements
its carrying case, itself generate vacuum, shall meet the requirements
specified in 6.1 and 8.1 to 8.7, as appropriate, after
of 8.2 to 8.7, as appropriate, when a vacuum of
the individual parts of the suction equipment, ex-
- 95 kPa is applied.
cluding the cylinder and regulator, have been
dropped in accordance with A.10 and reassembled.
8.2 High vacuum high flow equipment
When tested in accordance with A.ll, suction
6.9 Immersion in water equipment marked “high vacuum high flow” shall
develop a vacuum of at least - 60 kPa within 10 s.
After suction equipment intended for field use has
been dropped in its ready-for-use condition from a
83 . Medium vacuum equipment
height of 1 m into a water reservoir
1 m x 1 m x 1 m, has been left in the water for 10 s
When tested in accordance with A.ll, suction
and the water has been expelled for 7 s, it shall
equipment marked medium vacuum shall develop a
meet the requirements specified in 6.1 and 8.1 to
vacuum of less than - 60 kPa but greater than
8.7, as appropriate.
- 20 kPa.
8.4 Pharyngeal suction equipment
6.10 Stability
The equipment shall produce a minimum free air
Suction equipment intended for field or transport
flow of 20 I/min. When tested in accordance with
use or both shall meet the requirements specified in
A-12, suction equipment intended for pharyngeal
6.1 and 8.1 to 8.7, as appropriate, when operated
suction shall evacuate 200 ml of simulated vomitus
20” (0,35 rad) from its normal orientation.
in less than 10 s. When tested in accordance with
A.ll, the equipment shall develop a vacuum of at
least - 40 kPa within 10 s.
7 Physical requirements
8.5 Low vacuum low flow equipment
When tested in accordance with A-13, suction
equipment marked “low vacuum low flow” shall
7.1 Dimensions
produce a continuous free air flow of less than
20 I/min and a vacuum of not more than - 20 kPa.
Suction equipment is often combined with resusci-
tation equipment which may make it impossible to
define a mass or dimensions for suction equipment
86 . Low vacuum high flow equipment
alone. In these circumstances, this clause may not
apply but the mass and dimensions of all equipment
When tested in accordance with A.13, suction re-
intended for field use should be as small as poss-
“low vacuum high flow” shall
quirement marked
ible.
produce a free air flow of not less than 20 I/min and
a vacuum of not more than - 20 kPa.
Suction equipment intended for field use, including
any carrying case or frame, shall pass through a
8.7 Thoracic drainage equipment
rectangular opening having dimensions of
600 mm x 300 mm.
When tested in accordance with A.14, suction
equipment marked “thoracic drainage” shall pro-
duce a free air flow of not less than 15 I/min at the
7.2 Mass
inlet of the collection container, and the level of
vacuum developed shall not exceed - 7 kPa.
The mass of suction equipment intended for field
use, complete with its carrying case or frame and
NOTE 7 In some situations, e.g. broncho pleural fistula,
accessories, shall not exceed 6 kg. higher flows such as 25 I/min may be required.
6
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IS0 10079-3:1992(E)
quirements specified in 6.1, 6.3 and 8.1 to 8.7, as
9 Gas supply
appropriate.
NOTE 8 Suction equipment may be driven from fixed
power sources such as piped vacuum or gas, or may be
11.2 Storage
driven by a local power source such as a cylinder.
When tested in accordance with A.17.2.3 and
9.1 Gas supply pressure A.17.2.4, as appropriate, suction equipment intended
for field or transport use or both shall meet the re-
If it is intended that gas-powered suction equipment quirements specified in 6.1, 6.3 and 8.1 to 8.7, as
is to be connected to a separate gas source by the appropriate.
user, the suction equipment shall meet the require-
ments specified in 8.1 to 8.7, as appropriate, when
12 Marking
connected to a gas supply either at pressures be-
tween 270 kPa and 550 kPa or at such pressure as
12.1 Equipment
recommended by the manufacturer.
The fol lowing i nformation sha
Testing shall be performed by connecting the II be perman ently and
legibly marked on the suction equi
suction equipment to an external gas source which pment:
is capable of varying through the range of pressures
a) the na me a nd/or trade-mark of the manufacturer
from 270 kPa to 550 kPa, and testing the perform-
or sup plier;
ance of the suction equipment at source pressures
of 270 kPa to 550 kPa or the recommended pressure
model number or other identification of the
to the requirements of 8.1 to 8.7, as appropriate.
w a
uipment;
eq
9.2 Separate gas connections
c) for gas-powered suction equipment which can be
detached from the power source, the rec-
If it is intended that the suction equipment supply
ommended range of gas supply pressures
hose is to be connected to the gas source by the
through which the suction equipment will oper-
user, the connector to the gas source shall be either
ate;
a DISS or NIST gas-specific connector as specified
in IS0 5359, as appropriate, or be another gas-
39
) word s ind icating “exhaust on the exhaust
specific connector.
e opening is provi ded;
open ing, if a sing1
10 Vacuum regulator ) for suction equipment intended for wound drain-
age or thoracic drainage, words indicating
NOTE 9 If fitted, a vacuum regulator may be of a fixed
wound drainage or thoracic drainage, as appro-
setting or have a variable control.
priate;
f) the inlet connection to the collection container,
10.1 Vacuum regulators with fixed setting
unless mis-connection is prevented by a design
feature.
When tested in accordance with A.15, the vacuum
indicated shall not deviate by more than + 10 %
-
from the fixed setting.
12.2 Equipment on carrying case
NOTE 10 Al
...
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