SIST EN ISO 10079-2:2014

Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2014)

EN ISO 10079-2 specifies safety and performance requirements for manually powered suction equipment intended for oro-pharyngeal suction. It applies to equipment operated by foot or by hand or both. Annex D illustrates the three parts of ISO 10079 by providing a schematic for typical systems. The commonest use of manually powered suction is in situations outside of health care settings often described as field use or transport use. Use in these situations may involve extreme conditions of weather or terrain. 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) end pieces such as suction catheters, Yankauer sucker and suction tips; b) dental suction equipment; c) mucus extractors, including neonatal mucus extractors.

Medizinische Absauggeräte - Teil 2: Handbetriebene Absauggeräte (ISO 10079-2:2014)

Dieser Teil von ISO 10079 legt Anforderungen für die Sicherheit einschließlich der Leistungsmerkmale von
handbetriebenen medizinischen Absauggeräten für oro-pharyngeale Absaugung fest. Er umfasst von Fuß
oder Hand oder von beidem betriebene Geräte (siehe Bild 1).
Handbetriebene Absauggeräte werden meistens außerhalb von Gesundheitseinrichtungen verwendet. Dieses
wird oft als Verwendung „im Freien" oder Verwendung „beim Transport" bezeichnet. Die Verwendung in
solchen Fällen kann extreme Wetter-und Bodenverhältnisse einschließen. Deshalb wurden in dieser Norm
zusätzliche Anforderungen an Absauggeräte zur Verwendung „im Freien" oder „beim Transport"
aufgenommen.
Nicht elektrische Absauggeräte, die in elektrische Geräte integriert sein können, sind im Anwendungsbereich
von diesem Teil von ISO 10079 enthalten.
Dieser Teil von ISO 10079 gilt weder für elektrisch betriebene Absauggeräte, die, ob durch Netz oder Batterie
betrieben, in ISO 10079-1 behandelt werden, noch für vakuum- oder druckquellenbetriebene Absauggeräte,
die in ISO 10079-3 behandelt werden, noch für Folgendes:
a) zentrale Leistungsversorgung (durch Erzeugung von Vakuum/Druckluft), Rohrleitungssysteme von Fahrzeugen
und Gebäuden sowie Wandanschlüsse;
b) Katheterschläuche, Drains, Küretten und Absaugtüllen;
c) Spritzen;
d) zahnmedizinische Absauggeräte;
e) Abgas-Fortleitungssysteme;
f) Laborabsaugung;
g) Autotransfusionssysteme;
h) passive Harndrainage;
i) geschlossene Systeme für Wunddrainage;
j) Magendrainage mittels Schwerkraft;
k) mundbetriebene Schleimabsauger;
l) Absauggeräte mit Sammelbehälter unterhalb der Vakuumpumpe;
m) als Absaugeeinheit für Dauertracheotomie gekennzeichnete Geräte;
n) Sauggeräte für Geburtshilfe;
o) Schleimabsauger für Neugeborene;
p) Milchpumpen;
q) Fettabsaugung;
r) Absaugung aus dem Uterus;
s) Thoraxdrainage.

Appareils d'aspiration médicale - Partie 2: Appareils d'aspiration manuelle (ISO 10079-2:2014)

L'ISO 10079-2:2013 spécifie les exigences de sécurité et de performance relatives aux appareils d'aspiration médicale manuelle servant à l'aspiration oro-pharyngée. Elle traite des appareils actionnés avec le pied ou avec la main ou avec les deux. L'Annexe C illustre les trois parties de l'ISO 10079 en fournissant une représentation schématique des systèmes types.
L'ISO 10079-2:2013 comporte des exigences supplémentaires pour les appareils d'aspiration prévus pour un emploi sur le terrain ou en transport.

Medicinska sukcijska (aspiracijska) oprema - 2. del: Ročna sukcijska (aspiracijska) oprema (ISO 10079-2:2014)

EN ISO 10079-2 določa zahteve glede varnosti in učinkovitosti ročne sukcijske (aspiracijske) opreme, ki je namenjena sukciji (aspiraciji) žrela. Velja za opremo, ki se upravlja nožno, ročno ali na oba načina. Priloga D s shematskim prikazom tipičnih sistemov prikazuje tri dele ISO 10079. V situacijah zunaj zdravstvenih ustanov se ročna sukcijska (aspiracijska) oprema običajno uporablja na prostem ali med prevozom. Uporaba lahko v takih primerih vključuje izredne vremenske ali terenske razmere. Dodatne zahteve za sukcijsko (aspiracijsko) opremo, ki je namenjena uporabi na prostem in/ali med prevozom, so vključene v ta del standarda ISO 10079. Ta del standarda ISO 10079 ne velja za naslednje: a) zaključke, kot so aspiracijski katetri, aspiracijske cevke Yankauer in konice za sukcijo; b) opremo za zobno sukcijo; c) ekstrakcijske aparate za sluz, vključno z ekstrakcijskimi aparati za sluz za novorojenčke.

General Information

• Status: Withdrawn
• Public Enquiry End Date: 19-Jun-2012
• Publication Date: 05-Jun-2014
• Withdrawal Date: 06-Jun-2022
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 03-Jun-2022
• Due Date: 26-Jun-2022
• Completion Date: 07-Jun-2022
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN ISO 10079-2:2014 - Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2014)

Relations

• Replaced By: SIST EN ISO 10079-2:2022 - Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2022)
• Effective Date: 01-Jul-2022
• Replaces: SIST EN ISO 10079-2:2009 - Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:1999)
• Effective Date: 01-Jul-2014
• Replaces: SIST EN ISO 10079-2:2009 - Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:1999)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10079-2:2014
01-julij-2014
1DGRPHãþD
SIST EN ISO 10079-2:2009
0HGLFLQVNDVXNFLMVNDDVSLUDFLMVNDRSUHPDGHO5RþQDVXNFLMVNDDVSLUDFLMVND
RSUHPD,62
Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-
2:2014)
Medizinische Absauggeräte - Teil 2: Handbetriebene Absauggeräte (ISO 10079-2:2014)
Appareils d'aspiration médicale - Partie 2: Appareils d'aspiration manuelle (ISO 10079-
2:2014)
Ta slovenski standard je istoveten z: EN ISO 10079-2:2014
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 10079-2:2014 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10079-2:2014

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SIST EN ISO 10079-2:2014

EUROPEAN STANDARD
EN ISO 10079-2

NORME EUROPÉENNE

EUROPÄISCHE NORM
May 2014
ICS 11.040.10 Supersedes EN ISO 10079-2:2009
English Version
Medical suction equipment - Part 2: Manually powered suction
equipment (ISO 10079-2:2014)
Appareils d'aspiration médicale - Partie 2: Appareils Medizinische Absauggeräte - Teil 2: Handbetriebene
d'aspiration manuelle (ISO 10079-2:2014) Absauggeräte (ISO 10079-2:2014)
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 10079-2:2014 E
worldwide for CEN national Members.

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SIST EN ISO 10079-2:2014
EN ISO 10079-2:2014 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
2

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SIST EN ISO 10079-2:2014
EN ISO 10079-2:2014 (E)
Foreword
This document (EN ISO 10079-2:2014) 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 10079-2:2009.
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 10079-2:2014 has been approved by CEN as EN ISO 10079-2:2014 without any modification.
3

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SIST EN ISO 10079-2:2014
EN ISO 10079-2:2014 (E)
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
Clause(s)/sub- Essential Requirements
clause(s) of this (ERs) of Directive Qualifying remarks/notes
EN 93/42/EEC
4.1, 4.4, 12 s) 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, 6.1.3, 7.5.2 7.2
4.1, 4.2, 5, 6.1.3, 7.3 Only the first part of this ER is covered
7.6, 10
4.1, 5, 6.1.3, 7.5.2 8.1
4.1, 6.2, 6.3, 12 c), 9.1
10 9.2 Only covered as far as temperature is concerned
7.4 12.7.1 Only covered as far as stability is concerned
11, 12 13.1
11.1 13.2
11.2 a) 13.3a)
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)
4

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SIST EN ISO 10079-2:2014
EN ISO 10079-2:2014 (E)
11.2 k) 13.3 k)
12 b) 13.4 Partly covered: disclosure of the intended purpose is
included in the Instructions for use but not the labelling.
12 13.6 a) Covered for the items in 13.3 a), b), c), f), i) and k)
12 d), e), f), g), j), 13.6 b)
k), l), o), t)
12 k) 13.6 c)
12 d), f), g), j), u), 13.6 d)
v), x)
12 i) 13.6 h) First two paragraphs only
12 f), g) 13.6 i)
12 y) 13.6 q)

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.

5

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SIST EN ISO 10079-2:2014

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SIST EN ISO 10079-2:2014
INTERNATIONAL ISO
STANDARD 10079-2
Third edition
2014-05-01
Medical suction equipment —
Part 2:
Manually powered suction equipment
Appareils d’aspiration médicale —
Partie 2: Appareils d’aspiration manuelle
Reference number
ISO 10079-2:2014(E)
©
ISO 2014

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SIST EN ISO 10079-2:2014
ISO 10079-2:2014(E)

COPYRIGHT PROTECTED DOCUMENT
© 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 [e-mail]
Web www.iso.org
Published in Switzerland
ii © ISO 2014 – All rights reserved

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SIST EN ISO 10079-2:2014
ISO 10079-2:2014(E)

Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 3
4.1 Risk management . 3
4.2 Usability . 4
4.3 Clinical investigation . 4
4.4 Biophysical or modelling research . 4
5 Cleaning, disinfection and sterilization . 4
6 Design requirements . 4
6.1 Collection container. 4
6.2 Connections . 5
6.3 Suction tubing . 5
6.4 Vacuum level indicators . 6
7 Operational requirements . 6
7.1 Ease of operation . 6
7.2 Dismantling and reassembly . 6
7.3 Mechanical shock . 6
7.4 Stability . 6
7.5 Protection devices . 7
7.6 Immersion in water . 7
8 Physical requirements for field and transport use suction equipment .7
8.1 (*)Dimensions . 7
8.2 Mass . 7
9 Performance requirements for vacuum level and flowrate . 8
9.1 Vacuum level . 8
9.2 Free air flowrate . 8
9.3 Pharyngeal suction . 8
10 (*)Resistance to environment of suction equipment for field and/or transport use .8
10.1 Operating conditions . 8
10.2 Storage . 8
11 Marking . 8
11.1 Use of symbols . 8
11.2 Equipment . 8
11.3 Equipment or carrying case . 9
12 Information to be supplied by the manufacturer . 9
Annex A (normative) Test methods .11
Annex B (informative) Rationale statement .17
Annex C (informative) Lumen size and its effect on flowrate .18
Annex D (informative) Schematic of suction equipment .19
Bibliography .20
© ISO 2014 – All rights reserved iii

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SIST EN ISO 10079-2:2014
ISO 10079-2:2014(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 10079-2:1999), 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.
iv © ISO 2014 – All rights reserved

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SIST EN ISO 10079-2:2014
INTERNATIONAL STANDARD ISO 10079-2:2014(E)
Medical suction equipment —
Part 2:
Manually powered suction equipment
1 Scope
This part of ISO 10079 specifies safety and performance requirements for manually powered suction
equipment intended for oro-pharyngeal suction. It applies to equipment operated by foot or by hand or
both. Annex D illustrates the three parts of ISO 10079 by providing a schematic for typical systems.
The commonest use of manually powered suction is in situations outside of health care settings often
described as field use or transport use. Use in these situations may involve extreme conditions of
weather or terrain. 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) end pieces such as suction catheters, Yankauer sucker and suction tips;
b) dental suction equipment;
c) mucus extractors, including neonatal mucus extractors.
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 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
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 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.
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 2014 – All rights reserved 1

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SIST EN ISO 10079-2:2014
ISO 10079-2:2014(E)

3.1
collection container
container in which liquids and solid particles are collected
3.2
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.
3.3
exhaust port
opening through which exhaust gas is discharged
3.4
field use
use of suction equipment in situations outside of the health care facility at the site of accidents or other
emergencies
3.5
filter
device for retention of particulate matter
3.6
free air flowrate
rate of unrestricted flow of air through a designated inlet
3.7
inlet port
opening through which liquid, solid particles or gas enter
3.8
intermediate tubing
tubing between the collection container and the vacuum source
3.9
manually powered suction
generation of vacuum by direct human effort
3.10
overfill protection device
device intended to prevent liquid or solid particles from entering the intermediate tubing
3.11
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.
3.12
suction
application of vacuum to remove liquid, solid particles or gas
3.13
suction tubing
tubing for conduction of liquid, solid particles or gas between the end-piece and the collection container
3.14
transport use
use during patient transport outside of a health care facility (e.g. in an ambulance or aeroplane)
2 © ISO 2014 – All rights reserved

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SIST EN ISO 10079-2:2014
ISO 10079-2:2014(E)

3.15
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.
3.16
vacuum level indicator
device for displaying the vacuum level
3.17
vacuum source
component of device for generating vacuum
4 General requirements
4.1 Risk management
4.1.1 This part of ISO 10079 specifies requirements that are generally applicable to risks associated
with manually powered 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 Manually 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.
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.
© ISO 2014 – All rights reserved 3

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SIST EN ISO 10079-2:2014
ISO 10079-2:2014(E)

4.2 Usability
The manufacturer shall address, in accordance with 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.
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.
4 © ISO 2014 – All rights reserved

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SIST EN ISO 10079-2:2014
ISO 10079-2:2014(E)

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 comp
...