SIST EN ISO 10079-1:2016

SLOVENSKI STANDARD
01-februar-2016
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SIST EN ISO 10079-1:2009
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Medical suction equipment - Part 1: Electrically powered suction equipment (ISO 10079-
1:2015)
Medizinische Absauggeräte - Teil 1: Elektrisch betriebene Absauggeräte (ISO 10079-
1:2015)
Appareils d'aspiration médicale - Partie 1: Appareils électriques d'aspiration (ISO 10079-
1:2015)
Ta slovenski standard je istoveten z: EN ISO 10079-1:2015
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 10079-1
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2015
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 10079-1:2009
English Version
Medical suction equipment - Part 1: Electrically powered
suction equipment (ISO 10079-1:2015)
Appareils d'aspiration médicale - Partie 1: Appareils Medizinische Absauggeräte - Teil 1: Elektrisch
électriques d'aspiration (ISO 10079-1:2015) betriebene Absauggeräte (ISO 10079-1:2015)
This European Standard was approved by CEN on 13 May 2015.

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
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10079-1:2015 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered . 4

European foreword
This document (EN ISO 10079-1:2015) 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 May 2016, and conflicting national standards shall be
withdrawn at the latest by November 2018.
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 10079-1:2009.
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(s).
For relationship with EU Directive(s), 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 10079-1:2015 has been approved by CEN as EN ISO 10079-1:2015 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered
This European Standard has been prepared under a Commission’s standardization request M/023
concerning the development of European Standards related to medical devices to provide one voluntary
means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June 1993
concerning medical devices [OJ L 169].
Once this standard is cited in the Official Journal of the European Union under that Directive,
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 corresponding essential requirements
of that Directive and associated EFTA regulations.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Directive 93/42/EEC as amended by 2007/47/EC. This
means that risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’
or ‘removed’, according to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with Essential
Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.
NOTE 3 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 Annex I of
Directive 93/42/EEC [OJ L 169]
Essential Requirements of Clause(s)/sub-clause(s) of this EN Remarks/Notes
Directive 93/42/EEC
7.1 4.4
Third indent only
7.2 5; 7.5 Partly covered
There are no requirements for
packaging.
7.3 6.1.3
First part only
7.6 6.2.3; 6.5; 7.5.1; 7.5.2
8.1 4.2; 5; 7.5.1
8.7 11.3 c)
9.1 6.2; 6.3
First sentence only
9.2 4; 6.1.3 Partly covered
Electrical safety is by ref to
IEC 60601–1 and risk management
by ref to ISO 14971.
Essential Requirements of Clause(s)/sub-clause(s) of this EN Remarks/Notes
Directive 93/42/EEC
10.1 6.4.6 Partly covered.
There are no requirements for the
manufacturer to disclose the
accuracy of the vacuum level
indicator.
10.2 6.4
10.3 11.3 i) Covered for volume measurements
only
12.1 4 Covered by ref to IEC 60601–1
12.1a) 4 Covered by ref to IEC 60601–1
12.2 4 Covered by ref to IEC 60601–1
although suction equipment is not
considered life-support equipment.
12.5 4 Covered by ref to IEC 60601–1 and
thereby to IEC 60601–1–2
12.6 4; 6.5 Covered by ref to IEC 60601–1
12.7.1 6.1.3; 7.4
12.7.2 4 Covered by ref to IEC 60601–1
12.7.3 7.6
12.7.4 4 Covered by ref to IEC 60601–1
12.7.5 4 Covered by ref to IEC 60601–1
12.8.2 7.5.3.2
Second sentence only
12.9 11.3 i); j); k); l); m); n); o); p); q); r)
13.1 11
13.2 11.2
13.3a) 11.3 a)
13.3b) 11.3 b)
13.3c) 11.3 c)
13.3d) 11.3 d)
13.3e) 11.3 e)
13.3 f) 11.3 f)
13.3 k) 11.4 c); q); y)
13.3 l) 11.3 d)
13.3 m) 11.4 i)
13.4 11.4 b)
13.6 a) 11.4 Not covered for the requirement of
ER 13.3b)
13.6 b) 11.4 d); e)
Essential Requirements of Clause(s)/sub-clause(s) of this EN Remarks/Notes
Directive 93/42/EEC
13.6 c) 11.4 d) ;k)
13.6 d) 11.4 d); j); v) Calibration is not covered
13.6 f) 11.4 x)
13.6 h) 11.4 i)
First two paragraphs only
13.6 i) 11.4 j)
13.6 q) 11.4 z)
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
Standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other Union legislation may be applicable to the products falling within the scope of
this standard.
INTERNATIONAL ISO
STANDARD 10079-1
Third edition
2015-11-01
Medical suction equipment —
Part 1:
Electrically powered suction
equipment
Appareils d’aspiration médicale —
Partie 1: Appareils électriques d’aspiration
Reference number
ISO 10079-1:2015(E)
©
ISO 2015
ISO 10079-1:2015(E)
© ISO 2015, Published in Switzerland
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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2015 – All rights reserved

ISO 10079-1:2015(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 . 5
4.5 Test methods . 5
5 Cleaning, disinfection and sterilization . 5
6 Design requirements . 6
6.1 Collection container. 6
6.1.1 General. 6
6.1.2 Container capacity . 6
6.1.3 Container strength . 6
6.2 Connections . 6
6.2.1 Tubing connectors for collection containers . 6
6.2.2 Inlet port . 7
6.2.3 Exhaust port. 7
6.3 Suction tubing . 7
6.4 Vacuum level indicators . 7
6.5 Spillage on electrical suction equipment . 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 . 8
7.5 Protective devices . 9
7.5.1 Contamination protection . 9
7.5.2 Overfill protection devices . 9
7.5.3 Pressure protection . 9
7.6 Noise . 9
7.6.1 Low vacuum/low flowrate equipment . 9
7.6.2 Suction equipment other than that specified in 7.6.1 . 9
7.7 Air leakage .10
7.7.1 Collection containers for general use .10
7.7.2 Collection containers for thoracic drainage .10
8 Physical requirements for suction equipment for field use .10
8.1 (*) Dimensions .10
8.2 Mass .10
9 Performance requirements for vacuum level and flowrate .10
9.1 High vacuum/high flowrate equipment .10
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 .11
9.7 Vacuum regulators with fixed setting .11
9.8 Vacuum regulators with variable setting .12
9.9 Equipment intended for pharyngeal suction .12
ISO 10079-1:2015(E)
9.10 Battery powered transportable suction equipment .12
9.11 Interruption of the power supply .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 Information to be supplied by the manufacturer (labelling and instructions for use) .13
11.1 Information supplied by the manufacturer shall comply with EN 1041. .13
11.3 Labelling of equipment .13
11.4 Instructions for use .14
Annex A (normative) Test methods .16
Annex B (informative) Rationale statement .27
Annex C (informative) Lumen size and its effect on flowrate .28
Annex D (informative) Schematic of suction equipment .29
Bibliography .30
iv © ISO 2015 – All rights reserved

ISO 10079-1:2015(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 10079-1:1999), 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 Annex B, Annex C, and Annex 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 (*) at the beginning of the paragraph 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 into 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.
Annex D illustrates the three parts of ISO 10079 by providing a schematic for typical systems.
INTERNATIONAL STANDARD ISO 10079-1:2015(E)
Medical suction equipment —
Part 1:
Electrically powered suction equipment
1 Scope
This part of ISO 10079 specifies safety and performance requirements for electrically powered medical
and surgical suction equipment. It applies to equipment used in health care facilities such as hospitals,
for domiciliary care of patients and for field and transport use.
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-pieces such as suction catheters, drains, curettes, Yankauer suckers and suction tips;
c) syringes;
d) dental suction equipment;
e) anaesthetic gas scavenging systems;
f) laboratory suction;
g) autotransfusion systems;
h) mucus extractors including neonatal mucus extractors;
i) suction equipment where the collection container is downstream of the vacuum pump;
j) ventouse (obstetric) equipment;
k) suction equipment marked for endoscopic use only;
l) 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 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
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

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.
ISO 10079-1:2015(E)
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 60529, Degrees of protection provided by enclosures (IP Code)
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 60601-1-11:2010, Medical electrical equipment — Part 1-11: General requirements for basic safety and
essential performance — Collateral Standard: Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment
IEC 60601-1-12:2014, Medical electrical equipment — Part 1-12: General requirements for basic safety and
essential performance — Collateral Standard: Requirements for medical electrical equipment and medical
electrical systems intended for use in the emergency medical services environment
IEC/TR 60878, Graphical symbols for electrical equipment in medical practice
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
drainage
removal of liquid, solid particles or gas from a body cavity or wound
3.3
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
Note 1 to entry: Examples of commonly used end-pieces are a Yankauer sucker and a suction catheter.
3.4
exhaust port
opening through which exhaust gas is discharged
3.5
field use
use of suction equipment in situations outside of the health care facility and home environment
3.6
filter
device for retention of particulate matter
3.7
free air flowrate
rate of unrestricted flow of air through a designated inlet
2 © ISO 2015 – All rights reserved

ISO 10079-1:2015(E)
3.8
high flowrate
free air flowrate (3.7) of 20 l/min or more
3.9
high vacuum
vacuum level (3.23) of 60 kPa or more
3.10
inlet port
opening through which liquid, solid particles or gas enter
3.11
intermediate tubing
tubing between the collection container (3.1) and the vacuum source (3.26)
3.12
intermittent vacuum
type of suction (3.19) in which the negative pressure applied to the end-piece (3.3) is automatically and
periodically returned to atmospheric pressure
3.13
low flowrate
free air flowrate (3.7) less than 20 l/min
3.14
low vacuum
vacuum level (3.23) of not more than 20 kPa
3.15
medium vacuum
vacuum level (3.23) of more than 20 kPa, but less than 60 kPa
3.16
outlet port
opening through which gas exits from the collection container (3.1)
3.17
overfill protection device
device intended to prevent liquid or solid particles from entering the intermediate tubing (3.11)
3.18
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.
3.19
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 (3.3) and the collection
container (3.1)
ISO 10079-1:2015(E)
3.21
thoracic drainage
drainage (3.2) of liquid and gas from the thoracic cavity by application of suction (3.19) 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.
3.22
transport use
use during patient transport outside of a health care facility (e.g. in an ambulance or airplane)
3.23
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.
3.24
vacuum level indicator
device for displaying the vacuum level (3.23)
3.25
vacuum regulator
device for controlling the applied vacuum level (3.23)
3.26
vacuum source
component of device for generating vacuum
4 General requirements
Electrically powered medical suction equipment 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 electrically powered medical suction equipment. 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;
— risk control;
— production and post-production information.
EXAMPLE ISO 14971.
Check compliance by inspection of the risk management file.
4.1.2 Electrically powered suction equipment 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.
4 © ISO 2015 – All rights reserved

ISO 10079-1:2015(E)
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 to deal with such situations need to be determined within the risk management process.
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.
4.2 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 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;
— 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 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.
Check compliance by inspection of the technical file.
4.5 Test methods
The manufacturer can 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.
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.
ISO 10079-1:2015(E)
Parts intended for re-use shall meet the requirements of Clause 7 and Clause 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
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.
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.
Check compliance by 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 Clause 7 and Clause 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.
6.2 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 © ISO 2015 – All rights reserved

ISO 10079-1:2015(E)
6.2.2 Inlet port
The inside diameter of the suction tubing connector (inlet port of the collection container) shall be at
least 6 mm 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 specified by the manufacturer.
The inlet port 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 If the internal diameter is greater than 14 mm, there is a risk of misconnection.
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.
NOTE Special surgical procedures such as liposuction and suction curettage might require suction tubing
and connectors of a larger bore.
6.3.2 (*) Suction tubing supplied or recommended by the manufacturer shall have a minimum
length of 1,3 m.
NOTE Suction performance might be markedly affected by the length and diameter of the suction tubing
between the end-piece and collection container (see Annex C).
6.4 Vacuum level indicators
6.4.1 Suction equipment with an operator-adjustable vacuum regulator shall have a means of
indicating the vacuum level at the patient end when attached to a suction catheter or drainage tube.
6.4.2 The full scale of analog vacuum level indicators shall be not more than 200 % of the maximum
vacuum level specified by the manufacturer.
6.4.3 Analog displays shall have graduations not less than 2 mm apart with each graduation
representing not more than 5 % of the full-scale value.
Movement of a rotary analog vacuum level indicator should be anti-clockwise for an increase in
vacuum level.
6.4.4 Digital displays shall display vacuum level at intervals of not greater than 5 % of the full-scale value.
6.4.5 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.
6.4.6 Vacuum level indicators on suction equipment, except as specified in 6.4.5, shall be accurate to
within ± 5 % of the full-scale value.
ISO 10079-1:2015(E)
6.4.7 Low vacuum equipment shall be fitted with a vacuum level indicator between the vacuum source
and collection container.
6.4.8 Suction equipment having a vacuum regulator with a variable control shall have a vacuum
indicator displaying the vacuum level on the inlet side of the vacuum regulator.
Check compliance by inspection and functional testing.
6.5 Spillage on electrical suction equipment
Suction equipment not intended for use in the field, other than suction equipment intended for use in
the home healthcare environment, shall be classified as specified in IEC 60601-1:2005, 6.3 and 11.6.5.
Suction equipment intended for use in home healthcare environment shall be classified as specified in
IEC 60601-1-11:2010, 8.3.
Suction equipment intended for use in the field shall be classified as specified in IEC 60601-1-12:2014, 8.1.
Remote foot switches with electrical switching parts shall be of watertight construction classified as at
least IPX6 as specified in IEC 60529.
Check compliance by the tests specified in IEC 60529.
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 assembly or marked to indicate correct reassembly.
Suction equipment shall meet the requirements of Clause 9 as appropriate after dismantling and
reassembly in accordance with the manufacturer’s instructions.
Check compliance by functional testing.
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.
7.4 Stability
7.4.1 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.
8 © ISO 2015 – All rights reserved

ISO 10079-1:2015(E)
7.4.2 Suction equipment not intended for field and/or transport use shall meet the requirements given
in Clause 9 as appropriate when placed in any position on a surface (10 ± 1)° slope from the horizontal.
Check compliance by functional testing.
7.5 Protective devices
7.5.1 Contamination protection
There shal
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