EN ISO 10079-4:2021

SLOVENSKI STANDARD
01-december-2021
Medicinska sukcijska (aspiracijska) oprema - 4. del: Splošne zahteve (ISO 10079-
4:2021)
Medical suction equipment - Part 4: General requirements (ISO 10079-4:2021)
Medizinische Absauggeräte - Teil 4: Allgemeine Anforderungen (ISO 10079-4:2021)
Appareils d’aspiration médicale - Partie 4: Exigences générales (ISO 10079-4:2021)
Ta slovenski standard je istoveten z: EN ISO 10079-4:2021
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 10079-4
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2021
EUROPÄISCHE NORM
ICS 11.040.10
English Version
Medical suction equipment - Part 4: General requirements
(ISO 10079-4:2021)
Appareils d'aspiration médicale - Partie 4: Exigences Medizinische Absauggeräte - Teil 4: Allgemeine
générales (ISO 10079-4:2021) Anforderungen (ISO 10079-4:2021)
This European Standard was approved by CEN on 26 July 2021.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10079-4:2021 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 10079-4:2021) has been prepared by Technical Committee ISO/TC 121
"Anaesthetic and respiratory equipment" in collaboration with Technical Committee CEN/TC 215
“Respiratory and anaesthetic equipment” the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by April 2022, and conflicting national standards shall be
withdrawn at the latest by April 2022.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 10079-4:2021 has been approved by CEN as EN ISO 10079-4:2021 without any
modification.
INTERNATIONAL ISO
STANDARD 10079-4
First edition
2021-08
Medical suction equipment —
Part 4:
General requirements
Appareils d’aspiration médicale —
Partie 4: Exigences générales
Reference number
ISO 10079-4:2021(E)
©
ISO 2021
ISO 10079-4:2021(E)
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
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CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved

ISO 10079-4:2021(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements . 4
4.1 Risk management . 4
4.2 Usability . 5
4.3 Clinical studies . 5
4.4 Biophysical or modelling research . 5
4.5 Test methods . 5
5 Materials . 5
5.1 Natural rubber latex . 5
5.2 Cleaning, disinfection and sterilization . 6
6 Design requirements . 6
6.1 General . 6
6.2 Collection containers . 6
6.2.1 Capacity . 6
6.2.2 Strength . 7
6.3 Connections . 7
6.3.1 Tubing connectors . 7
6.3.2 Collection container inlet ports . 7
6.3.3 Collection container exhaust ports . 7
6.4 Suction tubing and intermediate tubing . 8
6.5 Vacuum level indicators . 8
6.6 Environmental conditions for transport and storage . 9
7 Performance requirements .10
7.1 Operating position .10
7.2 Protection devices .10
7.2.1 Contamination protection .10
7.2.2 Overfill protection devices .10
7.2.3 Pressure protection .10
7.3 Noise .11
7.4 Air leakage .11
7.5 Vacuum levels and free air flows.11
7.6 Accuracy .11
7.7 Pharyngeal suction equipment .12
8 Additional/alternative requirements for suction equipment, suction tubing and
intermediate tubing designed for field use or transport use .12
8.1 Physical requirements .12
8.2 Strength .12
8.3 Stability .12
8.4 Environmental conditions during operation .12
8.5 Collection container capacity .13
9 Information supplied by the manufacturer .13
9.1 General .13
9.2 Symbols .14
9.3 Marking .14
9.4 Instructions for use .15
Annex A (informative) Rationale .17
ISO 10079-4:2021(E)
Annex B (normative) Test methods .19
Annex C (informative) Schematic of medical suction equipment .34
Bibliography .35
iv © ISO 2021 – All rights reserved

ISO 10079-4:2021(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member 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-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment
subcommittee SC 8, Suction devices, in collaboration with the European Committee for Standardization
(CEN) Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment, in accordance with the
Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
A list of all parts in the ISO 10079 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
ISO 10079-4:2021(E)
Introduction
[2]
Previously the ISO 10079 series of medical suction equipment standards comprised parts ISO 10079-1,
[3] [4]
ISO 10079-2 and ISO 10079-3 which had many common requirements. It was thought that
combining these common requirements into this new part 4 would prevent the inconsistencies that had
resulted from developing three different parts with common requirements and would make any future
revision/amendment easier to manage.
This document contains those requirements that are common to electrically, manually and gas-powered
medical suction equipment.
vi © ISO 2021 – All rights reserved

INTERNATIONAL STANDARD ISO 10079-4:2021(E)
Medical suction equipment —
Part 4:
General requirements
1 Scope
This document specifies general requirements for medical suction equipment that are common to all
parts of the ISO 10079 series.
This document is not applicable to the following:
a) end-pieces such as suction catheters, drains, curettes, Yankauer suckers and suction tips;
b) syringes;
c) dental suction equipment;
d) anaesthetic gas scavenging systems;
e) laboratory suction;
f) autotransfusion systems;
g) mucus extractors including neonatal mucus extractors;
h) suction equipment where the collection container is downstream of the vacuum pump;
i) ventouse (obstetric) equipment;
j) suction equipment marked for endoscopic use only; and
k) plume evacuation systems.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 3744, Acoustics — Determination of sound power levels and sound energy levels of noise sources using
sound pressure — Engineering methods for an essentially free field over a reflecting plane
ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
ISO 7000, Graphical symbols for use on equipment — Registered symbols
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 20417, Medical devices — Information to be provided by the manufacturer
ISO 10079-4:2021(E)
ISO 80369-2, Small-bore connectors for liquids and gases in healthcare applications — Part 2: Connectors
for respiratory applications
ISO 80369-3, Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors
for enteral applications
ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications — Part 6: Connectors
for neuraxial applications
ISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications—Part 7 Connectors for
intravascular or hypodermic applications
IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, Medical electrical equipment — Part 1: General requirements
for safety
IEC 61672-1, Electroacoustics - Sound level meters — Part 1: Specifications
IEC 80369-5, Small-bore connectors for liquids and gases in healthcare applications—Part 5 Connectors
limb cuff inflation applications
EN 15986, Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices
containing phthalates
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply:
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
collection container
container in which liquids and solid particles are collected
3.2
collection container assembly
collection container and its closure with connectors for suction
3.3
drainage
removal of liquid, solid particles or gas from a body cavity or wound
3.4
end-piece
part of the suction equipment applied to the patient which begins at the site where material is drawn in
and ends at the first detachable connection
EXAMPLE Commonly used end-pieces include Yankauer suckers and suction catheters.
[1]
[Source: ISO 4135:2001, 8.2.7]
3.5
exhaust port
opening through which exhaust gas is discharged
3.6
field use
use of suction equipment in situations outside of a healthcare facility or home environment
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ISO 10079-4:2021(E)
3.7
filter
device for retention of particulate matter
3.8
free air flow
rate of unrestricted flow of air through a designated inlet
3.9
high flow
free air flow ≥ 20 l/min
3.10
high vacuum
vacuum level of 60 kPa or stronger (absolute pressure 0 to 40 kPa)
3.11
inlet port
opening through which liquid, solid particles or gas enters
3.12
intermediate tubing
tubing between the collection container and the vacuum source
3.13
intermittent vacuum
suction in which the negative pressure applied to the end-piece is automatically and periodically
returned to atmospheric pressure
3.14
low flow
free air flow < 20 l/min
3.15
low vacuum
vacuum level of 20 kPa or weaker (absolute pressure 80 kPa to 100 kPa)
3.16
medium vacuum
vacuum level between 20 kPa and 60 kPa (absolute pressure 40 kPa to 80 kPa)
3.17
overfill protection device
device to prevent liquid or solid particles from entering the intermediate tubing
3.18
single fault condition
condition in which a single means for reducing a risk is defective or a single abnormal condition is
present
Note 1 to entry: Maintenance of equipment is considered a normal condition.
[SOURCE: IEC 60601:2005+AMD1: 2012+ AMD 2:2020, 3.116 modified by removing ME equipment.]
3.19
suction
application of vacuum to remove liquid, solid particles or gas
3.20
suction tubing
tubing for conduction of liquid, solid particles or gas between the end-piece and the collection container
ISO 10079-4:2021(E)
3.21
thoracic drainage
drainage of liquid and gas from the thoracic cavity by application of suction to the thoracic cavity of the
patient
3.22
transport use
use during patient transport outside of a healthcare facility
EXAMPLE ambulance or aeroplane.
3.23
vacuum level
pressure less than atmospheric pressure
3.24
vacuum level indicator
device for displaying the vacuum level
3.25
vacuum regulator
device for controlling the applied vacuum level
3.26
vacuum source
component or device for generating a vacuum
4 General requirements
4.1 Risk management
4.1.1 An established risk management process, (e.g. ISO 14971), shall be applied to the design of the
suction equipment. The risk management process shall include the following elements:
— risk analysis;
— risk evaluation;
— risk control; and
— production and post-production information.
Check conformance by inspection of the risk management file.
4.1.2 Suction equipment shall, when transported, stored, installed, operated in normal use and
maintained according to the instructions for use, present no risks that are not reduced to an acceptable
level using risk management procedures in accordance with ISO 14971 and which are associated with
their intended application in normal and in single fault condition.
NOTE A situation in which a fault is not detected is considered a normal condition. Fault conditions/
hazardous situations might remain undetected over a period of time and as a consequence, might lead to an
unacceptable risk. In that case, a subsequent detected fault condition is considered a single fault condition. Specific
risk control measures to deal with such situations can be determined within the risk management process.
Check conformance by inspection of the risk management file.
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ISO 10079-4:2021(E)
4.1.3 Where requirements refer to freedom from unacceptable risk, the acceptability or unacceptability
of this risk shall be determined by the manufacturer in accordance with their policy for determining
acceptable risk.
Check conformance by inspection of the risk management file.
4.2 Usability
The manufacturer shall apply a usability engineering process to assess and mitigate any risks caused
[5]
by usability problems associated with correct use (i.e. normal use) and use errors (e.g. IEC 60601-1-6
[8]
and IEC 62366-1 ).
Check conformance by inspection of the usability engineering file.
4.3 Clinical studies
Where appropriate, clinical studies shall be performed under the conditions for which performance
is claimed and documented in the risk management file. The clinical studies shall comply with the
requirements of ISO 14155.
NOTE Clinical data can be sourced from the following:
— clinical investigation(s) of the device concerned;
— clinical investigation(s) or other studies reported in the scientific literature of a similar device for
which equivalence to the device in question can be demonstrated; or
— published and/or unpublished reports on other clinical experience of either the device in question
or a similar device for which equivalence to the device in question can be demonstrated.
Check conformance by inspection of the risk management and technical files.
4.4 Biophysical or modelling research
Where appropriate, validated biophysical or modelling research shall be performed under the
conditions for which performance is claimed and documented in the risk management file.
NOTE Biophysical or modelling research is the application of validated physical methods and theories to
biological problems. Examples include the use of a combination of models (i.e. mathematical, computer, physical,
cell and tissue culture, and animal) in a complementary and interactive manner to simulate the performance of
medical devices.
Check conformance by inspection of the technical file.
4.5 Test methods
Manufacturers can use type tests different from those detailed within this document if an equivalent
degree of safety is obtained. Alternative test methods shall be validated against the test methods
specified in Annex B.
5 Materials
5.1 Natural rubber latex
If any components of the suction equipment incorporate natural rubber latex, the manufacturer
shall provide a specific justification for using this substance in their technical file. See also 9.3 g) for
additional marking requirements.
Check conformance by inspection of the technical file.
ISO 10079-4:2021(E)
5.2 Cleaning, disinfection and sterilization
5.2.1 Parts of the suction equipment which can be subject to contamination shall either be for single
use or capable of being cleaned and disinfected or sterilized as appropriate.
Check conformance by inspection of the technical file.
5.2.2 Parts of the suction equipment intended for re-use shall meet the requirements of Clause 7, as
appropriate, after those components have been subjected to 30 cycles of cleaning and disinfection or
sterilization as recommended by the manufacturer [see 9.4 g)].
Check conformance by the tests given in Annex B.
6 Design requirements
6.1 General
6.1.1 Suction equipment classified as medical electrical equipment, as defined in 3.63 of
IEC 60601-1:2005+AMD1:2012 +AMD2: 2020 shall meet the r elevant requirements of IEC 60601-1.
NOTE This applies not only to electrically powered suction equipment but also to suction equipment with
electrical components e.g. timers, indicators etc.
Check conformance by inspection of the technical file.
6.1.2 Suction equipment intended to be dismantled by the user (e.g. for cleaning) shall be designed to
facilitate correct assembly or marked to indicate correct reassembly.
Check conformance by inspection of the technical file.
6.1.3 Suction equipment shall meet the requirements of Clause 7, as appropriate, after dismantling and
reassembly in accordance with the manufacturer’s instructions.
Check conformance by the tests given in Annex B after the suction equipment has been reassembled.
6.1.4 Suction equipment shall be designed to be operated by one person, unaided.
Check conformance by functional testing.
6.1.5 Means shall be provided to prevent foam passing from the collection container into the vacuum
source.
NOTE This does not apply to suction equipment designed to continue to operate when the collection container
is full. [See 8.5 b)].
Check conformance by the tests given in B.2.3.
6.2 Collection containers
6.2.1 Capacity
Collection containers shall:
a) clearly show the level of contents, and
b) have a usable volume ≥ 500 ml.
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ISO 10079-4:2021(E)
NOTE 1 See A.2 for rationale.
NOTE 2 Transparent or translucent collection containers allow a qualitative assessment of the contents.
NOTE 3 See Clause 8 for additional/alternative requirements for the capacity of collection containers for
suction equipment for field use or transport use.
Check conformance by the tests given in B.2.
6.2.2 Strength
Collection containers shall not implode, crack or permanently deform and shall meet the requirements
of Clause 7, as appropriate, after being subjected to a pressure of either 120 % of the manufacturer’s
recommended maximum vacuum level or 95 kPa below atmospheric, whichever is the stronger vacuum
level, for 5 min.
Reusable collection containers shall be tested after 30 cycles of cleaning and disinfection or sterilization
as recommended by the manufacturer [see 9.4 g)].
Check conformance by the tests given in B.3.
6.3 Connections
6.3.1 Tubing connectors
Connectors for suction tubing and intermediate tubing shall:
a) be designed to facilitate correct assembly or clearly marked to indicate correct assembly when all
parts are mated and
b) have an inside diameter equal to or larger than the inside diameter of the largest suction tubing or
intermediate tubing size specified by the manufacturer [see 9.4 n)].
NOTE Incorrect connections have frequently been a cause of spill over into the vacuum source and a loss of
suction.
Check conformance by functional testing and inspection.
6.3.2 Collection container inlet ports
Collection container inlet ports shall:
a) not be compatible with any of the conical connectors specified in ISO 5356-1 or any of the small-
bore connectors specified in ISO 80369-2, ISO 80369-3, IEC 80369-5, ISO 80369-6, ISO 80369-7 and
b) have an inside diameter ≥ 6 mm.
Check conformance by functional testing.
6.3.3 Collection container exhaust ports
It shall not be possible to connect suction tubing or intermediate tubing to collection container exhaust
ports.
Check conformance by functional testing.
ISO 10079-4:2021(E)
6.4 Suction tubing and intermediate tubing
6.4.1 Suction tubing and intermediate tubing shall have:
a) an inside diameter ≥ 6 mm and
b) a degree of collapse ≤ 0,5 throughout its entire length.
NOTE 1 See A.3 for rationale.
NOTE 2 Special surgical procedures such as liposuction and suction curettage often use large-bore suction
tubing and intermediate tubing and connectors.
Check conformance by functional testing and the test given in B.4
6.4.2 Suction tubing shall have a length ≥ 1,3 m.
NOTE 1 See A.4 for rationale.
NOTE 2 This requirement does not apply to suction tubing designed for use with hand-operated suction
equipment.
Check conformance by functional testing.
6.4.3 Suction tubing and connectors, in their ready-to-use state after any preparation for use
recommended by the manufacturer, shall be evaluated for biological safety according to ISO 10993-1.
Check conformance by inspection of the technical file.
6.4.4 Suction tubing and intermediate tubing shall be made of materials suitable for their intended use
and the environmental conditions that they can be subjected to during transport, storage or when in use
(see 8.4).
Check conformance by inspection of the technical file.
6.4.5 Suction tubing shall be manufactured to reduce, to a minimum, the risks posed by substances
leaching from the materials.
NOTE Attention is drawn to substances which are carcinogenic, mutagenic or toxic to reproduction.
Check conformance by inspection of the risk management file.
6.4.6 Manufacturers of suction tubing intended for the treatment of children or pregnant or nursing
women and made of materials that incorporate phthalates, which are classified as carcinogenic,
mutagenic or toxic to reproduction, shall provide a specific justification for the use of these substances in
their risk management file. [See also 9.3 h) for additional marking and instructions for use requirements].
Check conformance by inspection of the risk management file.
6.5 Vacuum level indicators
6.5.1 Suction equipment with an operator-adjustable vacuum regulator shall indicate the vacuum level
at the inlet side of the vacuum regulator (see Figure C.1).
Check conformance by inspection.
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ISO 10079-4:2021(E)
6.5.2 The full scale of analogue vacuum level indicators shall be ≤ 200 % of the maximum vacuum level
specified by the manufacturer (see 9.3 l).
Check conformance by inspection.
6.5.3 Analog displays shall have graduations ≥ 2 mm apart with each graduation representing ≤ 5 % of
the full-scale value.
Check conformance by inspection.
6.5.4 Digital displays shall indicate the vacuum level at intervals ≤ 5 % of the full-scale value.
Check conformance by inspection.
6.5.5 Movement of rotary analogue vacuum level indicators should be anti-clockwise for an increase in
vacuum level.
6.5.6 Vacuum level indicators on suction equipment intended for thoracic drainage shall be accurate to
within ± 5 % of the full-scale value in the middle three-fifths of the operating range.
Check conformance by inspection of the technical file.
6.5.7 Vacuum level indicators, except as specified in 6.5.6, shall be accurate to within ± 5 % of the full-
scale value.
Check conformance by inspection of the technical file.
6.5.8 Vacuum level indicators, on low vacuum suction equipment, shall be fitted between the vacuum
source and the collection container.
Check conformance by inspection.
6.6 Environmental conditions for transport and storage
6.6.1 The manufacturer shall specify, in the instructions for use, the environmental conditions that
the suction equipment can withstand whilst in its protective transport packaging without affecting its
performance when operated at ambient conditions [see 9.4 j)].
Check conformance by inspection of the instructions for use.
6.6.2 If the instructions for use state a more restricted range of environmental conditions of transport
and storage than those specified in 6.6.3, they shall be justified in the risk management file.
Check conformance by inspection of the risk management file.
6.6.3 Unless otherwise indicated in the instructions for use, suction equipment, suction tubing and
intermediate tubing shall withstand, whilst in their protective transport packaging, the following
environmental conditions.
a) Temperatures from – 40 °C to + 70 °C;
b) Relative humidity from 15 % to 90 % non-condensing and
c) Atmospheric pressures from 620 hPa to 1060 hPa.
Check conformance by the tests given in Annex B.
ISO 10079-4:2021(E)
7 Performance requirements
7.1 Operating position
Suction equipment shall operate, within the manufacturer’s specifications, when in its normal operating
position and placed on a sloping surface (10 ± 1)° from the horizontal.
Check conformance by inspection of the technical file.
NOTE See Clause 8 for additional/alternative requirements for suction equipment for field use and transport
use.
7.2 Protection devices
7.2.1 Contamination protection
Means shall be provided to prevent contamination of the vacuum source (e.g. a microbial filter).
NOTE This does not apply to suction equipment designed to continue to operate when the collection container
is full.
Check conformance by inspection.
7.2.2 Overfill protection devices
7.2.2.1 Overfill protection devices shall not activate until at least 90 % of the indicated maximum
capacity of the collection container has been reached.
Check conformance by the tests given in B.2.
7.2.2.2 When an overfill protection device is activated, suction shall cease and prevent >5 ml of fluid
from passing downstream of the overfill protection device within 2 min.
NOTE This does not apply to suction equipment designed to continue to operate when the collection container
is full [see 8.5 b)].
Check conformance by the tests given in B.2.
7.2.3 Pressure protection
7.2.3.1 Negative pressure protection
If a means to limit the maximum vacuum level is fitted the vacuum shall not exceed the maximum
vacuum level by more than 10 %.
Check conformance by functional testing.
7.2.3.2 Positive pressure protection
Thoracic drainage suction equipment shall not develop a positive pressure of more than 1 kPa at the
patient inlet with a free air flow of 10 l/min.
Check conformance by the tests given in B.5.
7.2.3.3 Protection against reverse flow
Means shall be provided which prevents fluid flowing back to the patient due to the pressure differential
between the equipment and the patient.
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ISO 10079-4:2021(E)
Check conformance by inspection of the technical file.
7.3 Noise
The maximum A-weighted sound pressure level (steady or peak value) shall:
a) for low vacuum/low flow and thoracic drainage suction equipment be <60 dB(A) and
b) for all other suction equipment, be <70 dB(A).
Check conformance by the test given in B.6.
7.4 Air leakage
Leakage into the collection container assembly shall:
a) for general use suction equipment, be <1 kPa pressure drop and
b) for thoracic drainage suction equipment, be <4 ml/min flow.
Collection container assemblies intended for re-use shall be tested after 30 cycles of cleaning and
disinfection or sterilization as recommended by the manufacturer, [see 9.4 g)].
Check conformance by the tests given in B.7, as appropriate.
7.5 Vacuum levels and free air flows
Suction equipment shall develop the vacuum level and free air flow within the time limits given in Table 1,
for the equipment’s stated category, at the maximum indicated vacuum level setting.
Check conformance by the tests given in B.8 and B.9 as appropriate.
Table 1 — Vacuum levels and free air flows
Category Vacuum level (kPa) Free air flow (l/min) Maximum time allowable to
reach vacuum level and free
air flow
High vacuum/high flow ≥ 60 ≥ 20 l/min 10 s
Medium vacuum 20 to 60 ≥ 20 l/min 10 s
Low vacuum/low flow < 20 < 20 l/min 10 s
Low vacuum/high flow < 20 ≥ 20 l/min 10 s
Thoracic drainage for adults < 10 > 15 l/min 5 s
NOTE See A.5 for rationale.
7.6 Accuracy
7.6.1 The accuracy of the cycling frequency of intermittent vacuum equipment shall be within ± 10 %
of the specified fixed frequency [(see 9.3 p)] or the mid-range setting, if adjustable.
Check conformance by the test given in B.11.
7.6.2 The accuracy of the vacuum levels shall be within ± 10 % of the set or fixed vacuum level at zero
flow.
Check conformance by the tests given in B.12 and B.13 as appropriate.
ISO 10079-4:2021(E)
7.7 Pharyngeal suction equipment
Suction equipment intended for pharyngeal suction shall evacuate ≥ 200 ml of simulated vomitus in not
more than 10 s.
Check conformance by the test given in B.14.
8 Additional/alternative requirements for suction equipment, suction tubing
and intermediate tubing designed for field use or transport use
8.1 Physical requirements
8.1.1 Suction equipment intended for field use or transport use, including any carrying case or frame,
shall pass through a (600 × 300) mm opening.
NOTE See A.6 for rationale.
Check conformance by functional testing.
8.1.2 Suction equipment intended for field use or transport use, complete with its carrying case or
frame and accessories, shall not exceed a mass of 6 kg.
NOTE Suction equipment is often combined with resuscitation equipment which can make it impossible to
define the dimensions or the mass for the suction equipment alone. In these circumstances, 8.1.2 might not apply
but all equipment intended for field use or transport use should be as small and as lightweight as possible.
Check conformance by functional testing.
8.2 Strength
8.2.1 Suction equipment intended for field use or transport use shall meet the requirements of Clause 7
after being dropped from a height of 1 m onto a concrete floor in the worst-case orientation.
Check conformance by functional testing.
8.2.2 If the suction equipment is designed to be operated outside of its carrying case,
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