EN ISO 10079-3:2014

SLOVENSKI STANDARD
01-julij-2014
1DGRPHãþD
SIST EN ISO 10079-2:2009
SIST EN ISO 10079-3:2009
0HGLFLQVNDVXNFLMVNDDVSLUDFLMVNDRSUHPDGHO3RGWODþQDDOLWODþQDVXNFLMVND
DVSLUDFLMVNDRSUHPD,62
Medical suction equipment - Part 3: Suction equipment powered from a vacuum or
positive pressure gas source (ISO 10079-3:2014)
Medizinische Absauggeräte - Teil 3: Vakuum- oder druckquellenbetriebene
Absauggeräte (ISO 10079-3:2014)
Appareils d'aspiration médicale - Partie 3: Appareils d'aspiration alimentés par une
source de vide ou de pression (ISO 10079-3:2014)
Ta slovenski standard je istoveten z: EN ISO 10079-3:2014
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.

EUROPEAN STANDARD
EN ISO 10079-3
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2014
ICS 11.040.10 Supersedes EN ISO 10079-3:2009
English Version
Medical suction equipment - Part 3: Suction equipment powered
from a vacuum or positive pressure gas source (ISO 10079-
3:2014)
Appareils d'aspiration médicale - Partie 3: Appareils Medizinische Absauggeräte - Teil 3: Vakuum- oder
d'aspiration alimentés par une source de vide ou de druckquellenbetriebene Absauggeräte (ISO 10079-3:2014)
pression (ISO 10079-3:2014)
This European Standard was approved by CEN on 15 February 2014.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10079-3:2014 E
worldwide for CEN national Members.

Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
Foreword
This document (EN ISO 10079-3:2014) 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 DIN.
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 November 2014, and conflicting national standards shall be withdrawn
at the latest by May 2017.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 10079-3:2009.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive.
For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 10079-3:2014 has been approved by CEN as EN ISO 10079-3:2014 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of
Directive 93/42/EEC.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the normative clauses of
this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the relevant Essential Requirements of that Directive.
NOTE When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC
Essential
Clause(s) / sub-
Requirements (ERs) of Qualifying remarks/notes
clause(s) of this EN
Directive 93/42/EEC
4.1, 4.4, 12 t) 7.1 Partly covered
There are no requirements for materials apart from a
requirement to perform a risk assessment and to
disclose the presence of latex.
As these devices are only for extracting body fluids
toxicity and biological compatibility is not considered
a risk.
4.1, 5, 7.5, 7.5.2, 7.7 7.2
4.1, 4.2, 5 7.3 Only the first part of this ER is covered
7.5.1, 7.5.2 8.1
4.1, 6.3, 6.5 9.1
4.1, 10 9.2 Only covered as far as temperature is concerned
7.4 12.7.1 Only covered as far as stability is concerned
7.6 12.7.3
6.5 12.7.4
11, 12 13.1
11.2 a) 13.3 a)
11.2 b) 13.3 b)
11.2 c) 13.3 c)
11.2 d) 13.3 d)
11.2 e) 13.3 e)
11.2 f) 13.3 f)
12 b) 13.4 Partly covered: disclosure of the intended purpose is
included in the Instructions for use but not the
labelling.
12 13.6a) Covered for the items in 13.3 a), b), c), f), i) and k)
12 b), c), d), f),g), h), j), 13.6 b)
k), o), t), u)
12 k) 13.6 c)
12 b), c), d), h), j), v) 13.6 d)
12 i) 13.6 h) First two paragraphs only
12 d) 13.6 i)
12 z) 13.6 q)
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
INTERNATIONAL ISO
STANDARD 10079-3
Third edition
2014-05-01
Medical suction equipment —
Part 3:
Suction equipment powered from
a vacuum or positive pressure gas
source
Appareils d’aspiration médicale —
Partie 3: Appareils d’aspiration alimentés par une source de vide ou
de pression
Reference number
ISO 10079-3:2014(E)
©
ISO 2014
ISO 10079-3:2014(E)
© ISO 2014
All rights reserved. Unless otherwise specified, 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
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2014 – All rights reserved

ISO 10079-3:2014(E)
Contents Page
Foreword .v
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 investigation . 5
4.4 Biophysical or modelling research . 6
5 Cleaning, disinfection and sterilization . 6
6 Design requirements . 6
6.1 Collection container. 6
6.2 Connections . 7
6.3 Suction tubing . 7
6.4 Vacuum level indicators . 7
6.5 Supply connections . 8
7 Operational requirements . 8
7.1 Ease of operation . 8
7.2 Dismantling and reassembly . 8
7.3 Mechanical shock . 8
7.4 Stability . 9
7.5 Protective devices . 9
7.6 Noise . 9
7.7 Air leakage .10
8 Physical requirements for field and transport use suction equipment .10
8.1 (*)Dimensions .10
8.2 Mass .10
9 Performance requirements for vacuum level and flowrate .11
9.1 High vacuum/high flowrate equipment .11
9.2 Medium vacuum equipment.11
9.3 Low vacuum/low flowrate equipment .11
9.4 Low vacuum/high flowrate equipment .11
9.5 Thoracic drainage equipment for adults .11
9.6 Intermittent vacuum equipment .12
9.7 Vacuum regulators with fixed setting .12
9.8 Vacuum regulators with variable setting .12
9.9 Equipment intended for pharyngeal suction .12
10 (*)Resistance to environment of suction equipment for field and/or transport use .12
10.1 Operating conditions .12
10.2 Storage .12
11 Marking .12
11.1 Use of symbols .12
11.2 Equipment .13
11.3 Equipment or carrying case .14
12 Information to be supplied by the manufacturer .14
Annex A (normative) Test methods .16
Annex B (informative) Rationale statement .27
Annex C (informative) Lumen size and its effect on flowrate .28
ISO 10079-3:2014(E)
Annex D (informative) Schematic of suction equipment .29
Bibliography .30
iv © ISO 2014 – All rights reserved

ISO 10079-3:2014(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 on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 8, Suction devices for hospital and emergency care use.
This third edition cancels and replaces the second edition (ISO 10079-3:1999), which has been technically
revised.
ISO 10079 consists of the following parts, under the general title Medical suction equipment:
— Part 1: Electrically powered suction equipment
— Part 2: Manually powered suction equipment
— Part 3: Suction equipment powered from a vacuum or positive pressure gas source
Annex A forms a normative part of this part of ISO 10079 while Annexes B, C and D are for information
only.
Annex B contains rationale statements for some of the requirements of this part of ISO 10079. The clauses
and subclauses marked with an asterisk (*) after their number have corresponding rationale contained
in Annex B, included to provide additional insight into the reasoning that led to the requirements and
recommendations that have been incorporated in this part of ISO 10079. It is considered that knowledge
of the reasons for the requirements will not only facilitate the proper application of this part of ISO 10079,
but will expedite any subsequent revisions.
INTERNATIONAL STANDARD ISO 10079-3:2014(E)
Medical suction equipment —
Part 3:
Suction equipment powered from a vacuum or positive
pressure gas source
1 Scope
This part of ISO 10079 specifies safety and performance requirements for medical suction equipment
powered from a vacuum or positive pressure gas source generating venturi suction. It applies to
equipment connected to medical gas pipeline systems or cylinders and venturi attachments. Annex D
illustrates the three parts of ISO 10079 by providing a schematic for typical systems.
The equipment can be stand-alone or part of an integrated system.
Additional requirements for suction equipment intended for field and/or transport use are included in
this part of ISO 10079.
This part of ISO 10079 does not apply to the following:
a) central power supply (by vacuum/compressed air generation), piping systems of vehicles and
buildings, and wall connectors;
b) end-piece such as suction catheters, Yankauer sucker and suction tips;
c) syringes;
d) dental suction equipment;
e) anaesthetic gas scavenging systems;
f) laboratory suction;
g) autotransfusion systems;
h) closed systems for wound drainage;
i) mucus extractors, including neonatal mucus extractors;
j) ventouse (obstetric) equipment;
k) breast pumps;
l) liposuction;
m) uterine aspiration;
n) plume evacuation systems.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 10079-3:2014(E)
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 5359, Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases
1)
ISO 7000 , Graphical symbols for use on equipment — Registered symbols
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 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to
be supplied — Part 1: General requirements
ISO 80369 (all parts), Small-bore connectors for liquids and gases in healthcare applications
IEC 60601-1:2005+A1:2012, Medical electrical equipment — Part 1: General requirements for safety
IEC 60601-1-6, Medical electrical equipment — Part 1-6: General requirements for basic safety and essential
performance—Collateral standard: Usability
IEC 61672-1, Electroacoustics — Sound level meters — Part 1: Specifications
IEC 62366, Medical devices — Application of usability engineering to medical devices
EN 1041, Information supplied by the manufacturer of medical devices
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
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 body cavity or wound
3.4
end-piece
that 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
Note 1 to entry: Examples of commonly used end-pieces are a Yankauer sucker and a suction catheter.
3.5
exhaust port
opening through which exhaust gas is discharged
1) The graphical symbol collections of ISO 7000, ISO 7001 and ISO 7010 are also available on the Online Browsing
Platform http://www.iso.org/obp.
2 © ISO 2014 – All rights reserved

ISO 10079-3:2014(E)
3.6
field use
use of suction equipment in situations outside of the health care facility at the site of accidents or other
emergencies
3.7
filter
device for retention of particulate matter
3.8
free air flowrate
rate of unrestricted flow of air through a designated inlet
3.9
high flowrate
free air flowrate of 20 l/min or more
3.10
high vacuum
vacuum level of 60 kPa or more below atmospheric pressure
3.11
inlet port
opening through which liquids, solid particles or gas enter
3.12
intermediate tubing
tubing between the collection container and the vacuum source
3.13
intermittent vacuum
type of suction in which the negative pressure applied to the end piece is automatically and periodically
returned to atmospheric pressure
3.14
low flowrate
free air flowrate less than 20 l/min
3.15
low vacuum
vacuum level of not more than 20 kPa below atmospheric pressure
3.16
medical gas pipeline system
complete system which comprises a supply system, a monitoring and alarm system and a distribution
system with terminal units at the points where medical gases or vacuum are required
[SOURCE: ISO 7396-1:2007, definition 3.29]
3.17
medium vacuum
vacuum level of more than 20 kPa but less than 60 kPa below atmospheric pressure
3.18
outlet port
opening through which gas exits from the collection container
3.19
overfill protection device
device intended to prevent liquid or solid particles from entering the intermediate tubing
ISO 10079-3:2014(E)
3.20
single fault condition
condition in which a single means for protection against a safety hazard in equipment is defective or a
single external abnormal condition is present
Note 1 to entry: Maintenance of equipment is considered a normal condition.
3.21
suction
application of vacuum to remove liquid, solid particles or gas
3.22
suction tubing
tubing for conduction of liquid, solid particles or gas between the end-piece and the collection container
3.23
thoracic drainage
drainage of liquids and gas from the thoracic cavity by application of suction to the thoracic cavity of
the patient
Note 1 to entry: For the purposes of this part of ISO 10079, all thoracic drainage is considered to be active.
3.24
transport use
use during patient transport outside of a health care facility (e.g. in an ambulance or airplane)
3.25
vacuum level
pressure less than atmospheric pressure
Note 1 to entry: In this part of ISO 10079, vacuum level is expressed as a difference from atmospheric pressure.
3.26
vacuum level indicator
device for displaying the vacuum level
3.27
vacuum source
component of device for generating vacuum
3.28
vacuum regulator
device for controlling the applied vacuum level
4 General requirements
Suction equipment with components controlled by electrical means, e.g. electronic timing, shall meet
the relevant requirements of IEC 60601-1:2005+A1:2012.
4.1 Risk management
4.1.1 This part of ISO 10079 specifies requirements that are generally applicable to risks associated
with suction equipment powered from a vacuum or positive gas source. An established risk management
process shall be applied to the design of the device. The risk management process shall include the
following elements:
— risk analysis;
— risk evaluation;
4 © ISO 2014 – All rights reserved

ISO 10079-3:2014(E)
— risk control;
— production and post-production information.
EXAMPLE ISO 14971.
Check compliance by inspection of the risk management file.
4.1.2 Suction equipment powered from a vacuum or positive pressure gas source shall, when
transported, stored, installed, operated in normal use and maintained according to the instructions of
the manufacturer, 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 needs to be considered as a single fault condition. Specific
risk control measures need to be determined within the risk management process to deal with such situations.
Check compliance by inspection of the risk management file.
4.1.3 Where requirements of this part of ISO 10079 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 compliance by inspection of the risk management file.
4.1.4 The manufacturer may use type tests different from those detailed within this part of ISO 10079,
if an equivalent degree of safety is obtained. Alternative test methods shall be validated against the test
methods specified in Annex A of this part of ISO 10079.
Check compliance by inspection of the technical file.
4.2 Usability
The manufacturer shall address, in accordance with IEC 60601-1-6 and IEC 62366, the usability
engineering process, and the risk resulting from poor usability.
Check compliance by inspection of the usability engineering file.
4.3 Clinical investigation
Where appropriate, clinical investigation shall be performed under the conditions for which performance
is claimed and documented in the risk management file. The clinical investigation shall comply with the
requirements of ISO 14155.
NOTE Clinical data may be sourced from:
— clinical investigation(s) of the device concerned, or
— 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 compliance by inspection of the risk management file.
ISO 10079-3:2014(E)
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.
Check compliance by inspection of the technical file.
5 Cleaning, disinfection and sterilization
Parts of the suction equipment which may be subject to contamination shall either be for single use
or capable of being cleaned and disinfected or sterilized as appropriate. This includes filters, suction
tubing and collection containers.
Parts intended for re-use shall meet the requirements of Clauses 7 and 9, as appropriate, after
those components have been submitted to 30 cycles of cleaning and disinfection or sterilization as
recommended by the manufacturer.
Check compliance by functional testing.
6 Design requirements
6.1 Collection container
6.1.1 General
The collection container shall clearly show the level of contents in normal use.
Check compliance by inspection.
6.1.2 Container capacity and usable volume
6.1.2.1(*) For suction equipment intended for field use with overfill protection, the usable volume
of the collection container shall be not less than 300 ml.
6.1.2.2(*) For suction equipment intended for field use and which is intended to continue operating
when the collection container is full, the volume of the collection container shall be not less than 200 ml.
Check compliance by functional testing and inspection.
6.1.2.3 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 and the container shall be fitted
with overflow protection.
Check compliance by inspection and the tests given in A.2.
6.1.3 Container strength
The collection container shall not implode, crack or permanently deform and shall meet the requirements
of Clauses 7 and 9, 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 less, for 5 min.
Containers intended for re-use shall be tested after 30 cycles of cleaning and disinfection or sterilization
as recommended by the manufacturer.
Check compliance by the tests given in A.3.
6 © ISO 2014 – All rights reserved

ISO 10079-3:2014(E)
6.2 Connections
6.2.1 Tubing connectors for collection containers
The connectors for the suction tubing and the intermediate tubing shall be designed to facilitate correct
assembly or clearly marked to indicate correct assembly when all parts are mated.
Check compliance by functional testing and inspection.
NOTE Incorrect connections have frequently been a cause of spill over into the vacuum source and a loss of
suction.
6.2.2 Inlet port
The inside diameter of the suction tubing connector (inlet port of the collection container) shall be at
least 6mm and 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 as specified by the manufacturer.
The inlet shall not be compatible with any conical connector specified in ISO 5356-1 or small-bore
connectors specified in ISO 80369 (all parts).
Check compliance by functional testing and inspection.
NOTE Because of the risk of misconnection, the internal diameter of the inlet port of the collection container
should not be greater than 14 mm.
6.2.3 Exhaust port
It shall not be possible to connect suction tubing to the exhaust port.
Check compliance by functional testing
6.3 Suction tubing
6.3.1 Suction tubing shall have an inside diameter of not less than 6 mm.
The degree of collapse of the suction tubing shall be less than 0,5 throughout its entire length.
Check compliance by the tests given in A.4 using the tubing specified by the manufacturer of the suction
equipment.
6.3.2(*) Suction tubing if supplied or recommended by the manufacturer shall have a minimum
length of 1,3 m.
NOTE Suction performance may be markedly affected by the length and diameter of the tubing between the
collection container and end-piece, See Annex C.
6.4 Vacuum level indicators
Suction equipment with an operator-adjustable vacuum regulator, shall have a means of indicating the
vacuum level below atmospheric pressure at the patient end when attached to a suction catheter or
drainage tube.
6.4.1 The full scale of analog vacuum level indicators shall be not more than 200 % of the maximum
vacuum level below atmospheric pressure as specified by the manufacturer.
6.4.2 Analog displays shall have graduations not less than 2 mm apart, each graduation representing
not more than 5 % of the full-scale value.
ISO 10079-3:2014(E)
NOTE Movement of a rotary analog vacuum level indicator should be anticlockwise for an increase in vacuum
level.
6.4.3 Digital displays shall display vacuum level below atmospheric pressure at intervals of not greater
than 5 % of the full-scale value.
6.4.4 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.
6.4.5 Vacuum level indicators on suction equipment except as specified in 6.4.4 shall be accurate to
within ± 5 % of the full-scale value.
6.4.6 Low vacuum equipment shall be fitted with a vacuum level indicator between the vacuum source
and collection container.
Check compliance by inspection and functional testing.
6.5 Supply connections
Suction equipment powered by gas or vacuum shall:
— if connected directly to the terminal unit of a medical gas pipeline system, be fitted with a probe
complying with the relevant national standard;
— if connected remotely to the terminal unit of a medical gas pipeline system or the outlet of a regulator
via a low-pressure hose assembly, the hose assembly shall comply with ISO 5359.
Check compliance by inspection.
NOTE Medical gas pipeline systems complying with ISO 7396-1 supply vacuum level of 60 kPa (absolute
pressure) at a flowrate of 25 l/min. Vacuum level of 60 kPa (absolute pressure) is the same as 40 kPa below
atmospheric.
7 Operational requirements
7.1 Ease of operation
The suction equipment shall be designed to be operated by one person unaided.
Check compliance by functional testing.
7.2 Dismantling and reassembly
Suction equipment intended to be dismantled by the user (e.g. for cleaning) shall be designed to facilitate
correct reassembly or marked to indicate correct reassembly. After dismantling and reassembling, in
accordance with the manufacturer’s instructions, the suction equipment shall meet the requirements of
Clause 9 as appropriate.
7.3 Mechanical shock
Suction equipment intended for field and/or transport use shall meet the requirements of Clause 9 after
being dropped from a height of 1 m onto a concrete floor in the worst-case mode.
If the suction equipment can be operated outside its carrying case, individual parts of the suction
equipment shall be drop-tested as above and reassembled. The reassembled suction equipment shall
meet the requirements given in Clause 9, as appropriate.
Check compliance by the tests given in A.5.
8 © ISO 2014 – All rights reserved

ISO 10079-3:2014(E)
7.4 Stability
Suction equipment intended for field and/or transport use shall meet the requirements given in Clause 9,
as appropriate, when placed on a surface of (20 ± 2)° slope from the horizontal.
Suction equipment not intended for field use and/or transport use shall meet the requirements of
Clause 9, as appropriate, when placed in any position on a surface of (10 ± 1)° slope from the horizontal,
unless excluded by the manufacturer.
Check compliance by functional testing.
7.5 Protective devices
7.5.1 Contamination protection
There shall be a means to prevent contamination of the vacuum source e.g. a microbial filter.
Check compliance by inspection.
7.5.2 Overfill protection devices
When an overfill protection device is activated suction shall cease and no more than 5 ml of fluid shall
pass downstream of the overfill protection device.
If the overfill protection device is integral with the collection container, it shall not activate until at least
90 % of the stated capacity of the collection container has been reached.
Means to prevent foam passing downstream into the vacuum source shall be provided.
Check compliance by the tests given in A.2.1.
7.5.3 Pressure protection
7.5.3.1 Negative pressure protection
If a device to limit the maximum vacuum level is fitted, the vacuum shall not exceed the set vacuum level
by more than 10 %.
Check compliance by functional testing.
7.5.3.2 Positive pressure protection
Thoracic drainage systems shall not develop a pressure in excess of 1 kPa.
Check compliance by the tests given in A.6.
A venturi-powered suction device shall not produce a positive pressure at the patient end of more than
1 kPa under normal or single fault condition.
Check compliance by the tests given in A.7.
7.6 Noise
7.6.1 Low vacuum/low flowrate equipment
In normal use the maximum A-weighted sound pressure level (peak or steady value) of low vacuum/low
flowrate equipment, including equipment for thoracic drainage, shall not exceed 60 dB.
Check compliance by the test given in A.8.
ISO 10079-3:2014(E)
7.6.2 Suction equipment other than that specified in 7.6.1
In normal use, the maximum A-weighted sound pressure level (steady or peak value) of suction equipment
other than low vacuum/low flowrate equipment shall not exceed 70 dB.
Check compliance by the test given in A.8.
7.7 Air leakage
7.7.1 Collection containers for general use
The maximum leakage into the collection container assembly shall not exceed 200 ml/min. If the
collection container is intended for use with suction equipment having a free air flowrate of more than
1 l/min, the pressure increase shall be less than 3,3 kPa/V in 10 s, where V is the total volume of the
collection container in litres.
Collection containers intended for re-use shall be tested after 30 cycles of cleaning and disinfection or
sterilization as recommended by the manufacturer.
Check compliance by the tests given in A.9.1.
7.7.2 Collection containers for thoracic drainage
The maximum leakage shall be no more than three bubbles in 10 s.
Collection containers intended for re-use shall be tested after 30 cycles of cleaning and disinfection or
sterilization as recommended by the manufacturer.
Check compliance by the tests given in A.9.2.
8 Physical requirements for field and transport use suction equipment
8.1 (*)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 Suction equipment is often combined with resuscitation equipment which may make it impossible to
define the 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.
Check compliance by functional testing.
8.2 Mass
The mass of suction equipment intended for field use, complete with its carrying case or frame and
accessories, shall not exceed 6 kg.
NOTE Suction equipment is often combined with resuscitation equipment, which may make it impossible
to define a mass for suction equipment alone. In these circumstances this item may not apply, but all equipment
intended for field use should be as lightweight a
...