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 10079-2 (1999): Medical Suction Equipment, Part 2:

Manually Powered Suction Equipment [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/ISO 10079-2 : 1999

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fpfdRlk pw"k.k miLdj
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Indian Standard
MEDICAL SUCTION EQUIPMENT
PART 2 MANUALLY POWERED SUCTION EQUIPMENT

ICS 17.040.10

© BIS 2013
BUREAU OF INDIAN STANDARDS
MANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARG
NEW DELHI 110002

March 2013 Price Group 7

Anaesthetic, Resuscitation and Allied Equipment Sectional Committee, MHD 11

NATIONAL FOREWORD

This Indian Standard (Part 2) which is identical with ISO 10079-2 : 1999 ‘Medical suction equipment
— Part 2: Manually powered suction equipment’ issued by the International Organization for
Standardization (ISO) was adopted by the Bureau of Indian Standards on the recommendation of the
Anaesthetic, Resuscitation and Allied Equipment Sectional Committee and approval of the Medical
Equipment and Hospital Planning Division Council.

Since ISO has published this standard in three parts, only Part 2 and Part 3 adopted as Indian
Standard. The other part of this standard is:

Part 3 Suction equipment powered from a vacuum or pressure source

The text of ISO Standard has been approved as suitable for publication as an Indian Standard without
deviations. Certain conventions are, however, not identical to those used in Indian Standards. Attention
is particularly drawn to the following:
a) Wherever the words ‘International Standard’ appear referring to this standard, they should be
read as ‘Indian Standard’.
b) Comma (,) has been used as a decimal marker while in Indian Standards, the current practice
is to use a point (.) as the decimal marker.

In this adopted standard, reference appear to the following International Standard for which Indian
Standard also exists. The corresponding Indian Standard which is to be substituted in its place is
listed below along with its degree of equivalence for the edition indicated:

International Standard Corresponding Indian Standard Degree of Equivalence

1)
ISO 5356-1 : 1996 Anaesthetic and IS/ISO 5356-1 : 2004 Anaesthetic Technically Equivalent
respiratory equipment — Conical and respiratory equipment — Conical
connectors — Part 1: Cones and connectors: Part 1 Cones and
sockets sockets

The technical committee has reviewed the provisions of the following International Standards referred
in this adopted standard and has decided that they are acceptable for use in conjunction with this
standard:
International Standard Title
ISO 8836 : 1997 Suction catheters for use in the respiratory tract
ISO 10079-1 : 1999 Medical suction equipment — Part 1: Electrically powered suction
equipment — Safety requirements

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, shall be rounded off in accordance
with IS 2 : 1960 ‘Rules for rounding off numerical values (revised)’. The number of significant places
retained in the rounded off value should be the same as that of the specified value in this standard.

1)
Since revised in 2004.
 IS/ISO 10079-2 : 1999

Indian Standard
MEDICAL SUCTION EQUIPMENT
PART 2 MANUALLY POWERED SUCTION EQUIPMENT

1 Scope

This part of ISO 10079 specifies safety and performance requirements for manually powered medical suction
equipment intended for oro-pharyngeal suction. It covers equipment operated by foot or by hand or both (see
Figure 1). Non-electrical suction equipment which may be integrated with electrical equipment is included in the
scope of this part of ISO 10079.

This part of ISO 10079 does not apply to electrically powered suction equipment, whether mains electricity- or
battery-powered, which is dealt with in ISO 10079-1, nor to suction equipment powered from a vacuum or pressure
source which is dealt with in ISO 10079-3, nor to the following:

a) central power supply (by vacuum/compressed air generation), piping systems of vehicles and buildings, and
wall connectors;

b) cathether tubes, drains, curettes and suction tips;

c) syringes;

d) dental suction equipment;

e) waste gas scavenging systems;

f) laboratory suction;

g) autotransfusion systems;

h) passive urinary drainage;

i) closed systems for wound drainage;

j) gravity gastric drainage;

k) orally operated mucous extractors;

l) suction equipment where the collection container is downstream of the vacuum pump;

m) equipment marked as suction unit for permanent tracheostomy;

n) ventouse (obstetric) equipment;

o) neonatal mucous extractors;

p) breast pumps;

q) liposuction;

r) uterine aspiration;

s) thoracic drainage.
1
IS/ISO 10079-2 : 1999

Key
1 Vacuum indicator
2 Filter
3 Collection container
4 Vacuum regulator

NOTE 1 ISO 10079-1 applies to mains electricity- and battery-powered suction equipment. ISO 10079-2 applies to manually
powered suction equipment. ISO 10079-3 applies to suction equipment powered from a vacuum or pressure source.
NOTE 2 Components illustrated are not necessarily required by this part of ISO 10079.
NOTE 3 Suction equipment shown is an example only, and actual systems may consist of other arrangements and
components which are not illustrated.

Figure 1 — Examples of suction equipment

2 Normative references

The following normative documents contain provisions which, through reference in this text, constitute provisions of
this part of ISO 10079. For dated references, subsequent amendments to, or revisions of, any of these publications
do not apply. However, parties to agreements based on this part of ISO 10079 are encouraged to investigate the
possibility of applying the most recent editions of the normative documents indicated below. For undated
references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain
registers of currently valid International Standards.

ISO 5356-1:1996, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets.

ISO 8836:1997, Suction catheters for use in the respiratory tract.

ISO 10079-1:1999, Medical suction equipment — Part 1: Electrically powered suction equipment — Safety
requirements.
2
 IS/ISO 10079-2 : 1999

3 Terms and definitions

For the purposes of this part of ISO 10079, the terms and definitions given in ISO 10079-1 and the following apply.

3.1
manually powered vacuum
manually generated vacuum
generation of vacuum by human effort with a hand or foot or both

3.2
transportable equipment
equipment which is intended to be easily moved from one place to another, whether or not connected to the vacuum
supply, without an appreciable restriction of range

4 Cleaning and sterilization

4.1 The suction equipment shall meet the requirements given in 8.1 to 8.3 after those components which are
subject to contamination and which are intended for re-use have been submitted to 30 cycles of cleaning,
disinfection and/or sterilization as recommended by the manufacturer.

4.2 Any filters installed shall either be of the disposable type or be capable of being cleaned, disinfected and/or
sterilized for re-use in accordance with 4.1.

4.3 Suction equipment incorporating a re-usable collection container assembly shall comply with the requirements
given in 8.1 to 8.3, as appropriate, before and after the collection container assembly has been subjected to 30
cycles of cleaning, disinfection and/or sterilization as recommended by the manufacturer.

4.4 Suction tubing shall either be for single use or be capable of being cleaned, disinfected and/or sterilized as
recommended by the manufacturer.

5 Design requirements
NOTE The constructional requirements may deviate from those detailed in this part of ISO 10079 if the equivalent level of
safety is obtained.

5.1 Connectors

5.1.1 Collection container connectors

The connectors for the suction tubing and the intermediate tubing to the vacuum source shall be designed to
facilitate correct assembly or marked to indicate correct assembly when all parts are mated. Compliance shall be
checked by inspection.

The construction of the connections has frequently been a source of spillover into a vacuum pump. The use of
mechanical fittings so as to ensure correct attachment is highly desirable.

5.1.2 Inside diameter of suction tubing connection

The inside diameter of the suction tubing connection (inlet port) shall be equal to or larger than the inside diameter
of the largest tubing size recommended by the manufacturer.

5.1.3 Exhaust opening

It shall not be possible to connect suction tubing to the exhaust opening.

3
IS/ISO 10079-2 : 1999

5.2 Suction tubing

5.2.1 General

If supplied, suction tubing shall have an inside diameter of not less than 6 mm.

Suction performance may be markedly affected by the length, diameter and degree of collapse of the suction tubing.
When tested in accordance with A.2, the degree of collapse of the suction tubing supplied with the equipment shall
be less than 0,5 throughout its entire length.

5.2.2 Length of suction tubing for foot-operated suction equipment

When the foot-operated vacuum pump is on the floor in the operating position, the length of suction tubing, if
supplied, shall be such that the endpiece can be positioned at least 1,3 m above the floor.

NOTE See also annex C for rationale.

5.3 End-pieces

Suction catheters, if supplied or recommended by the manufacturer, shall comply with ISO 8836.

6 Operational requirements

6.1 Ease of operation

The suction equipment shall be designed to be operated by one person unaided.

6.2 Dismantling and reassembly

Suction equipment intended to be dismantled by the user (for example, for cleaning) shall be designed to facilitate
correct assembly or marked to indicate correct reassembly when all parts are mated. After dismantling, reassembly
and testing in accordance with the manufacturer's instructions, the suction equipment shall meet the requirements
given in 8.1 to 8.3, as appropriate.

6.3 Mechanical shock

After suction equipment intended for field or transport use or both has been drop-tested in accordance with A.3, it
shall meet the requirements given in 8.1 to 8.3, as appropriate.

Field use of suction equipment is intended to cover use in situations outside the health care facility at the site of
accidents or other emergencies. The use of suction equipment in these situations may expose the equipment to
water (including rain), dirt, uneven support, mechanical shock and extremes of temperature.

Transport use of suction equipment is intended to cover situations outside the health care facility such as in
ambulances, cars or airplanes. Use of suction equipment in these situations may expose the equipment to uneven
support, dirt, mechanical shock and a wider range of temperature than normally found in health care facilities.

If the suction equipment can be operated outside its carrying case, it shall meet the requirements given in 8.1 to 8.3,
as appropriate, after the individual parts of the suction equipment have been drop-tested in accordance with A.3 and
reassembled.

6.4 Immersion in water

After suction equipment intended for field use has been dropped in its ready-for-use condition from a height of 1 m
into a water reservoir 1 m ¥ 1 m ¥ 1 m, has been left in the water for 10 s and the water has been expelled for 7 s,
it shall meet the requirements given in 8.1 to 8.3, as appropriate.

NOTE Equipment for field use is likely to experience extreme outdoor conditions and should therefore be designed to
withstand immersion in water and continue to perform satisfactorily.

4
 IS/ISO 10079-2 : 1999

6.5 Stability

Suction equipment operated by foot and intended for field or transport use, or both, shall meet the requirements
given in 8.1 to 8.3, as appropriate, when placed on a surface of 20° (0,35 rad) slope from the horizontal. Other
manually powered suction equipment when operated 10° (0,17 rad) from its normal orientation shall meet the
requirements given in 8.1 to 8.3, as appropriate, in any position except that excluded by the manufacturer as
specified in 11 b).

6.6 Overfill protection devices

6.6.1 For equipment with means to prevent liquids or solids entering the intermediate tubing, the collection
container shall collect not less than 90 % of the stated collection capacity when tested in accordance with A.4.

NOTE Some equipment is designed to continue to pumping when the collection container is full.

6.6.2 Suction shall cease when the overfill protection device operates.

6.7 Vacuum Indicators

6.7.1 Analog displays shall have graduations not less than 2 mm apart, each graduation representing not more
than 5 % of the full-scale value.

6.7.2 Digital displays shall display vacuum at intervals of not greater than 2 % of the full-scale value. The
maximum vacuum for which the equipment is designed shall be marked prominently on the display case or
immediately adjacent to it.

6.7.3 All markings on the vacuum indicator shall be legible to an operator having visual acuity, corrected if
necessary, of at least 1,0, seated or standing 1 m from the vacuum indicator at an illuminance of 215 lx using white
(simulated day-) light.

6.7.4 The full scale of analog vacuum indicators shall be not more than 200 % of the maximum designed negative
pressure of the suction equipment.

6.7.5 Vacuum indicators shall be accurate to within ± 5 % of the full-scale value.

NOTE Movement of a rotary analog vacuum indicator should be anticlockwise for an increase in vacuum.

7 Physical requirements

7.1 Dimensions

Suction equipment intended for field use, including any carrying case or frame, shall pass through a rectangular
opening having dimensions of 600 mm ¥ 300 mm.

NOTE 1 Suction equipment is often combined with resuscitation equipment which may make it impossible to define the mass
or dimensions for suction equipment alone. In these circumstances this subclause may not apply, but the mass and dimensions
of all equipment intended for field use should be as small as possible.

NOTE 2 See also annex A.

7.2 Mass

The mass of suction equipment intended for field use, complete with its carrying case or frame and accessories,
shall not exceed 6 kg.

7.3 Collection container

7.3.1 The inlet of the collection container shall have an inside diameter of not less than 6 mm and not less than the
maximum inside diameter of the suction tubing recommended by the manufacturer. The inlet shall not be
compatible with any conical connector specified in ISO 5356-1.

5
IS/ISO 10079-2 : 1999

7.3.2 For suction equipment which is intended to continue operating when the collection container is full and is
intended for field use, the volume of the collection container shall be not less than 200 ml. For suction equipment
intended for field use, the usable volume of the collection container shall be not less than 300 ml. For all other
suction equipment, including suction equipment intended for transport use, the usable volume of the collection
container shall be not less than 500 ml.

7.3.3 For suction equipment not intended for field use, one or more collection containers recommended by the
manufacturer shall be used. The collection container shall be sufficiently transparent to clearly show the level of the
content in normal use. The collection container shall be marked with its usable volume, expressed in millilitres. For
collection containers having a capacity of 500 ml or greater, an approximate indication of the volume of the contents
shall be given by graduations. The intervals of the graduations should be not less than 50 ml and not more than
250 ml.

7.3.4 The collection container shall not implode, crack or permanently deform when tested in accordance with A.5.
Following this test, the suction equipment shall meet the requirements of 6.6.1, 6.6.2, 8.1, 8.2 and 8.3, as
appropriate.

8 Performance requirements for vacuum and flowrate

NOTE See also annex C for rationale.

8.1 Vacuum

When tested in accordance with A.6, suction equipment shall develop a vacuum of at least 40 kPa below
atmospheric pressure within 10 s.

8.2 Flowrate

When tested in accordance with A.7, suction equipment shall evacuate 200 ml of simulated vomitus in not more
than 10 s.

8.3 Free air flow

When tested in accordance with A.8, the peak free air flow shall be at least 0,33 l/s (20 l/min).

8.4 Packaging

Packaging shall meet the requirements of 7.1 and 7.2. After due regard to equipment protection, the packaging
should be such that the equipment is easily portable and also easily removable in a ready-for-use state.

9 Resistance to environment

9.1 Operating conditions

When tested in accordance with A.9.2.3 and A.9.2.4, suction equipment intended for field and/or transport use shall
meet the requirements given in 8.1 to 8.4.

9.2 Storage

When tested in accordance with A.9.2.1 and A.9.2.2, suction equipment intended for field and/or transport use shall
meet the requirements given in 8.1 to 8.4.

6
 IS/ISO 10079-2 : 1999

10 Marking

The following information shall be permanently and legibly marked on the suction equipment:

a) for equipment not intended for field and/or transport use, either the words "high vacuum", "medium vacuum" or
"pharyngeal suction" or the maximum vacuum and flowrate that can be developed;

b) the name and/or trademark of the manufacturer or supplier;

c) a model number or other identification of the equipment;

d) words indicating “exhaust” on the exhaust opening, if a single opening is provided;

e) the inlet connection to the collection container, unless misconnection is prevented by a design feature.

11 Information to be supplied by manufacturer

The manufacturer shall provide a manual or manuals of operating and maintenance instructions.

The manual(s) shall include the following information:

a) a warning that the suction equipment should only be used by persons who have received adequate instructions
in its use;

b) instructions on how to make the suction equipment operational in all intended modes of operation, and any
limitations on the use of the equipment;

c) instructions that the user should carry out the manufacturer's recommended test procedure after dismantling
and reassembly of the equipment;

d) a specification detailing the following:

1) operating environment limits,

2) storage environment limits;

e) instructions for the dismantling and reassembly of components, if applicable (see 6.2), including an illustration
of the component parts in their correct relationship;

f) recommended methods of cleaning, disinfection and/or sterilization of the suction equipment and its
components (see clause 4) after any contamination by body fluids or vomitus;

g) suction equipment function test(s) which may be performed by the user prior to use;

h) a list of parts that can be replaced by the user, including part numbers;

i) recommendations for maintenance, including a recommendation for frequency of approved or factory service;

j) fault-finding and correction procedures;

k) the date of publication and/or revision of the manual;

l) size and type of tubing and connection to the collection container, including any maximum length, if applicable;

m) method of emptying the collection container and operation after overflow has occurred;

n) name and address of the manufacturer and/or supplier;

o) the operational suitability of the suction equipment (see clause 6).

7
IS/ISO 10079-2 : 1999

Annex A
(normative)

Test methods

A.1 General
The apparatus and test methods specified in this annex are not intended to exclude the use of other measuring
devices or methods which yield results of an accuracy equal to or greater than those specified. In case of dispute,
the methods given in this part of ISO 10079 shall be the reference methods.

A.2 Test for suction tubing collapse

At 20 °C to 25 °C, uncoil the suction tubing to its full length and plug one end to prevent any air flow through it.
Attach a vacuum source to the other end of the tubing and adjust the level of vacuum to the maximum, if a
maximum is specified by the manufacturer. If there is no disclosed maximum, conduct the test at 60 kPa below
atmospheric pressure. Hold this vacuum for 5 min. Calculate the degree of collapse A by measuring the outside
diameter of the suction tubing along its length with calipers, as illustrated in Figure A.1. Repeat the test while the
tube is loosely coiled around a 100 mm diameter cylinder.
NOTE Narrow grooves may be cut in the cylinder to aid caliper measurement.

Degree of collapse, A:

ODinitial − OD test
A=
IDinitial

Pass A < 0,5

Fail A > 0,5

Figure A.1 — Apparatus for flexible suction tubing tests

8
 IS/ISO 10079-2 : 1999

A.3 Drop test

Drop the suction equipment from a height of 1 m onto a concrete floor in the worst-case mode. Test the suction
equipment for compliance with the requirements given in 8.1 to 8.3, as appropriate.

A.4 Test for overfill protection and collection capacity

Connect the overfill protection device in accordance with the manufacturer's instructions. Set the suction equipment
to maximum free air flowrate. Suck water at room temperature into the collection container until the shut-off
mechanism of the overfill protection device is activated. Note the water level. Remove the suction tubing from water
to allow free air flow. Run the equipment for a further 2 min. Measure the volume of water which has passed the
shut-off mechanism. Measure the volume collected in the collection container at the time the overfill protection
device is activated.

For re-usable suction equipment, carry out the test after the equipment has been subjected to 30 cycles of cleaning,
disinfection and/or sterilization as recommended by the manufacturer.

A.5 Test for resistance to implosion, cracking or permanent deformation

Place the collection container and the filter assembly (if present) or the complete suction equipment (if the
equipment has an integrated collection container) in a protective enclosure, i.e. box or bag, at 20 °C to 25 °C. If an
in-line filter is used or recommended, attach the filter for the test. Attach a vacuum source to the collection container
opening. Evacuate the collection container and accessories (if present) under test to 120 % of the manufacturer's
recommended maximum vacuum or to a vacuum not exceeding 95 kPa below atmospheric pressure, whichever is
the lesser vacuum. Hold the vacuum for 5 min, and then release. Repeat the procedure once.

CAUTION — This test can be hazardous. Proper care should be taken to protect personnel from possible
flying debris.

For re-usable collection containers or re-usable filter assemblies, perform the test after 30 cycles of cleaning,
disinfection and/or sterilization as recommended by the manufacturer.

NOTE In some suction equipment, the collection container is integrated with the suction equipment.

Check by visual inspection for implosion, cracking or permanent deformation of the collection container or the filter
assembly.

A suitable test apparatus is shown in Figure A.2.

Key
1 Vacuum source
2 Vacuum indicator
3 Protective enclosure
4 Closed to atmosphere
5 Equipment under test

Figure A.2 — Apparatus for testing resistance to implosion, cracking or permanent deformation
9
IS/ISO 10079-2 : 1999

A.6 Test for vacuum

Set up the suction equipment with the collection container in place, and fit a vacuum indicator to the container inlet,
thus totally occluding the tubing. For hand- or foot-operated suction equipment, operate the equipment at a
frequency not exceeding 2 Hz. Record the reading of the vacuum indicator after 10 s.

A.7 Test for pharyngeal suction

A.7.1 Test material and apparatus

A.7.1.1 Simulated vomitus

Prepare the simulated vomitus by dissolving 10 g of food grade xanthan gum in 1 l of distilled water and adding
100 g of 1 mm diameter glass beads having a specific gravity of approximately 2,55.

NOTE 0,1 % (mass fraction) benzoic acid may be added as a preservative.

A.7.1.2 Graduated cylinder

Use a graduated cylinder, having a capacity of at least 300 ml with graduations no more than 50 ml apart.

A.7.2 Procedure

Agitate the simulated vomitus to disperse the glass beads by capping and inverting the glass cylinder at least 10
times immediately before testing. Pour 250 ml at ambient temperature into the graduated cylinder. Attach the
suction tubing to the suction equipment and operate the equipment with the level of the simulated vomitus at the
same horizontal level as the top of the collection container. Place the suction tubing into the graduated cylinder and
record the time taken to evacuate 200 ml of the simulated vomitus.

A.8 Test for free air flow

Connect a flowrate-measuring device with a response time of not more than 100 ms, an accuracy of at least 0,05 l/s
over the range 0,1 l/s to 0,5 l/s and a resistance of not more than 2 Pa/l/s (such as a pneumotachograph) in series
with a chamber having a volume of (100 ± 10) ml. Attach the suction equipment in a gas-tight manner to the 100 ml
chamber. (See Figure A.3 for a typical test set-up.) Operate the suction equipment according to the manufacturer's
instructions and record the flowrate.

Key
1 Flow-measuring device
2 Connecting piece, inside
diameter 10 mm to 20 mm and
less than 100 mm length
3 100 ml chamber
4 Connecting tubing, inside
diameter 10 mm, length 1,3 m,
or suction tubing as
recommended by the
manufacturer
5 Equipment under test

Figure A.3 — Apparatus for testing free air flow

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 IS/ISO 10079-2 : 1999

A.9 Operating and storage conditions

A.9.1 General

Following completion of each of the procedures in A.9.2.1, A.9.2.2, A.9.2.3 and A.9.2.4, test the suction equipment
for compliance with the requirements given in 8.1, 8.2 or 8.3, as appropriate.

A.9.2 Procedure

A.9.2.1 High temperature operation

Place the suction equipment in an environmental chamber, maintained at a temperature of (50 ± 2) ∞C and with a
relative humidity of at least 95 %, for at least seven days. At the end of this period, remove the suction equipment
from the chamber and allow it to stand at a temperature of between 18 ∞C and 22 ∞C and at 40 % to 70 % relative
humidity. Within 5 min, start operating and testing the suction equipment.

A.9.2.2 Low temperature operation

Place the suction equipment in an environmental chamber, maintained at a temperature of (−18 ± 2) ∞C for 4 h or
until the test system stabilizes. At the end of this period, remove the suction equipment from the chamber and allow
it to stand at a temperature of between 18 ∞C and 22 ∞C and a relative humidity of between 40 % and 70 %. Within
5 min, start operating and testing the suction equipment.

A.9.2.3 High temperature storage

Place the suction equipment in an environmental chamber, maintained at a temperature of (60 ± 5) ∞C and at 40 %
to 70 % relative humidity, for a period of not less than 4 h or until the test system stabilizes. At the end of this period,
remove the suction equipment from the chamber and allow it to stand at a temperature of between 18 ∞C and 22 ∞C
and at 40 % to 70 % relative humidity for 4 h. At the end of this period, operate and test the suction equipment.

A.9.2.4 Low temperature storage

Place the suction equipment in an environmental chamber, maintained at a temperature of (−40 ± 5) ∞C for a period
of at least 4 h or until the test system stabilizes. At the end of this period, remove the suction equipment from the
chamber and allow it to stand at a temperature of between 18 ∞C and 22 ∞C for 4 h. At the end of this period,
operate and test the suction equipment.

11
IS/ISO 10079-2 : 1999

Annex B
(informative)

Table of typical ranges of volume for collection containers for specific uses

NOTE If more specific or multiple uses are intended, the most appropriate volume may differ from the range suggested.
Local experience may also justify deviations from the suggested range of volumes.

Table B.1

Use Range of volume

litres

Surgical suction 1,5 to 4

Adult or infant oral nasal tracheal suction 0,7 to 1,5
Gastric drainage 1 to 2
Wound drainage 0,5 to 1
Adult pleural or mediastinal drainage 1 to 2
Paediatric pleural or mediastinal drainage 0,25 to 1
Field and transport use 0,2 to 1,5a
a Applies to suction equipment with pump-through capability.

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 IS/ISO 10079-2 : 1999

Annex C
(informative)

Rationale statement

Remarks made in this annex apply to the relevant clauses and subclauses in the main body of this part of
ISO 10079; the numbering is, therefore, not consecutive.

5.2.2 Length of suction tubing for foot-operated suction equipment

1,3 m will allow the suction equipment to be operated on the floor when being used on a patient who is on a bed or
trolley.

7.2 Dimensions

These dimensions applied to equipment intended for use outside the hospital will allow the application of suction
through a narrow opening such as a car window or under other adverse conditions.

8 Performance requirements for vacuum and flowrate

The requirement for the suction equipment for flowrate is based on the volume of an average adult's oro-pharynx,
and this would allow the minimum interruption to ventilation to establish a patent airway; the American Heart
Association recommends 7 s as the longest interruption to basic cardiopulmonary resuscitation. The requirement for
vacuum is not considered superfluous, as a high vacuum could be needed to clear the suction tube of any larger
particles. The level of 300 mmHg is as recommended by the American Heart Association; however they do not
specify flowrate for portable suction equipment, only that it should be adequate for pharyngeal suction. For this
reason, it was decided to introduce a "vomit" performance test which included reasonably viscous and particulate
material.

A.9 Operating and storage conditions

The conditions specified for operating and storage conditions have been aligned with ISO 8382. Resuscitators
intended for use with humans.

13
Bureau of Indian Standards

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Enquiries relating to copyright be addressed to the Director (Publications), BIS.

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 along with 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.: MHD 11 (0107).

Amendments Issued Since Publication

______________________________________________________________________________________
Amendment No. Date of Issue Text Affected
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
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Manak Bhavan, 9 Bahadur Shah Zafar Marg, New Delhi 110002
Telephones: 2323 0131, 2323 3375, 2323 9402 Website: www.bis.org.in

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Regional Offices: Telephones

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Central : Manak Bhavan, 9 Bahadur Shah Zafar Marg 2323 7617
NEW DELHI 110002 3841

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Eastern : 1/14, C.I.T. Scheme VII M, V.I.P. Road, Kankurgachi 8499, 2337 8561
KOLKATA 700054 2337 8626, 2337 9120

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Northern : SCO 335-336, Sector 34-A, CHANDIGARH 160022 3843
260 9285

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Southern : C.I.T. Campus, IV Cross Road, CHENNAI 600113 1216, 2254 1442
2254 2519, 2254 2315
Western : Manakalaya, E9 MIDC, Marol, Andheri (East) 9295, 2832 7858
MUMBAI 400093 2832 7891, 2832 7892

Branches: AHMEDABAD. BANGALORE. BHOPAL. BHUBANESHWAR. COIMBATORE. DEHRADUN.

FARIDABAD. GHAZIABAD. GUWAHATI. HYDERABAD. JAIPUR. KANPUR. LUCKNOW.
NAGPUR. PARWANOO. PATNA. PUNE. RAJKOT. THIRUVANATHAPURAM. VISAKHAPATNAM.
Published by BIS, New Delhi