ISO 10079-4:2021
(Main)Medical suction equipment — Part 4: General requirements
Medical suction equipment — Part 4: General requirements
This document specifies general requirements for medical suction equipment that are common to all parts of the ISO 10079 series. This document is not applicable to the following: a) end-pieces such as suction catheters, drains, curettes, Yankauer suckers and suction tips; b) syringes; c) dental suction equipment; d) anaesthetic gas scavenging systems; e) laboratory suction; f) autotransfusion systems; g) mucus extractors including neonatal mucus extractors; h) suction equipment where the collection container is downstream of the vacuum pump; i) ventouse (obstetric) equipment; j) suction equipment marked for endoscopic use only; and k) plume evacuation systems.
Appareils d’aspiration médicale — Partie 4: Exigences générales
Le présent document spécifie des exigences générales pour les appareils d’aspiration médicale qui sont communes à toutes les parties de la série de normes ISO 10079. Le présent document ne s’applique pas aux éléments suivants: a) les pièces d’extrémité, telles que les sondes d’aspiration, les drains, les curettes, les «Yankauer» et les embouts d’aspiration; b) les seringues; c) les appareils dentaires d’aspiration; d) les systèmes d’évacuation des gaz d’anesthésie; e) l’aspiration en laboratoire; f) les systèmes d’autotransfusion; g) les extracteurs de mucosités, y compris ceux pour nouveau-nés; h) les appareils d’aspiration dont le bocal de recueil est en aval de la pompe à vide; i) les appareils avec ventouse (obstétrique); j) les appareils d’aspiration à usage endoscopique uniquement (marqués comme tels); et k) les systèmes d’évacuation de fumée.
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INTERNATIONAL ISO
STANDARD 10079-4
First edition
2021-08
Medical suction equipment —
Part 4:
General requirements
Appareils d’aspiration médicale —
Partie 4: Exigences générales
Reference number
ISO 10079-4:2021(E)
©
ISO 2021
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ISO 10079-4:2021(E)
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ISO 10079-4:2021(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements . 4
4.1 Risk management . 4
4.2 Usability . 5
4.3 Clinical studies . 5
4.4 Biophysical or modelling research . 5
4.5 Test methods . 5
5 Materials . 5
5.1 Natural rubber latex . 5
5.2 Cleaning, disinfection and sterilization . 6
6 Design requirements . 6
6.1 General . 6
6.2 Collection containers . 6
6.2.1 Capacity . 6
6.2.2 Strength . 7
6.3 Connections . 7
6.3.1 Tubing connectors . 7
6.3.2 Collection container inlet ports . 7
6.3.3 Collection container exhaust ports . 7
6.4 Suction tubing and intermediate tubing . 8
6.5 Vacuum level indicators . 8
6.6 Environmental conditions for transport and storage . 9
7 Performance requirements .10
7.1 Operating position .10
7.2 Protection devices .10
7.2.1 Contamination protection .10
7.2.2 Overfill protection devices .10
7.2.3 Pressure protection .10
7.3 Noise .11
7.4 Air leakage .11
7.5 Vacuum levels and free air flows.11
7.6 Accuracy .11
7.7 Pharyngeal suction equipment .12
8 Additional/alternative requirements for suction equipment, suction tubing and
intermediate tubing designed for field use or transport use .12
8.1 Physical requirements .12
8.2 Strength .12
8.3 Stability .12
8.4 Environmental conditions during operation .12
8.5 Collection container capacity .13
9 Information supplied by the manufacturer .13
9.1 General .13
9.2 Symbols .14
9.3 Marking .14
9.4 Instructions for use .15
Annex A (informative) Rationale .17
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ISO 10079-4:2021(E)
Annex B (normative) Test methods .19
Annex C (informative) Schematic of medical suction equipment .34
Bibliography .35
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ISO 10079-4:2021(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment
subcommittee SC 8, Suction devices, in collaboration with the European Committee for Standardization
(CEN) Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment, in accordance with the
Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
A list of all parts in the ISO 10079 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
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ISO 10079-4:2021(E)
Introduction
[2]
Previously the ISO 10079 series of medical suction equipment standards comprised parts ISO 10079-1,
[3] [4]
ISO 10079-2 and ISO 10079-3 which had many common requirements. It was thought that
combining these common requirements into this new part 4 would prevent the inconsistencies that had
resulted from developing three different parts with common requirements and would make any future
revision/amendment easier to manage.
This document contains those requirements that are common to electrically, manually and gas-powered
medical suction equipment.
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INTERNATIONAL STANDARD ISO 10079-4:2021(E)
Medical suction equipment —
Part 4:
General requirements
1 Scope
This document specifies general requirements for medical suction equipment that are common to all
parts of the ISO 10079 series.
This document is not applicable to the following:
a) end-pieces such as suction catheters, drains, curettes, Yankauer suckers and suction tips;
b) syringes;
c) dental suction equipment;
d) anaesthetic gas scavenging systems;
e) laboratory suction;
f) autotransfusion systems;
g) mucus extractors including neonatal mucus extractors;
h) suction equipment where the collection container is downstream of the vacuum pump;
i) ventouse (obstetric) equipment;
j) suction equipment marked for endoscopic use only; and
k) plume evacuation systems.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 3744, Acoustics — Determination of sound power levels and sound energy levels of noise sources using
sound pressure — Engineering methods for an essentially free field over a reflecting plane
ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
ISO 7000, Graphical symbols for use on equipment — Registered symbols
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 20417, Medical devices — Information to be provided by the manufacturer
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ISO 10079-4:2021(E)
ISO 80369-2, Small-bore connectors for liquids and gases in healthcare applications — Part 2: Connectors
for respiratory applications
ISO 80369-3, Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors
for enteral applications
ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications — Part 6: Connectors
for neuraxial applications
ISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications—Part 7 Connectors for
intravascular or hypodermic applications
IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, Medical electrical equipment — Part 1: General requirements
for safety
IEC 61672-1, Electroacoustics - Sound level meters — Part 1: Specifications
IEC 80369-5, Small-bore connectors for liquids and gases in healthcare applications—Part 5 Connectors
limb cuff inflation applications
EN 15986, Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices
containing phthalates
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply:
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
collection container
container in which liquids and solid particles are collected
3.2
collection container assembly
collection container and its closure with connectors for suction
3.3
drainage
removal of liquid, solid particles or gas from a body cavity or wound
3.4
end-piece
part of the suction equipment applied to the patient which begins at the site where material is drawn in
and ends at the first detachable connection
EXAMPLE Commonly used end-pieces include Yankauer suckers and suction catheters.
[1]
[Source: ISO 4135:2001, 8.2.7]
3.5
exhaust port
opening through which exhaust gas is discharged
3.6
field use
use of suction equipment in situations outside of a healthcare facility or home environment
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ISO 10079-4:2021(E)
3.7
filter
device for retention of particulate matter
3.8
free air flow
rate of unrestricted flow of air through a designated inlet
3.9
high flow
free air flow ≥ 20 l/min
3.10
high vacuum
vacuum level of 60 kPa or stronger (absolute pressure 0 to 40 kPa)
3.11
inlet port
opening through which liquid, solid particles or gas enters
3.12
intermediate tubing
tubing between the collection container and the vacuum source
3.13
intermittent vacuum
suction in which the negative pressure applied to the end-piece is automatically and periodically
returned to atmospheric pressure
3.14
low flow
free air flow < 20 l/min
3.15
low vacuum
vacuum level of 20 kPa or weaker (absolute pressure 80 kPa to 100 kPa)
3.16
medium vacuum
vacuum level between 20 kPa and 60 kPa (absolute pressure 40 kPa to 80 kPa)
3.17
overfill protection device
device to prevent liquid or solid particles from entering the intermediate tubing
3.18
single fault condition
condition in which a single means for reducing a risk is defective or a single abnormal condition is
present
Note 1 to entry: Maintenance of equipment is considered a normal condition.
[SOURCE: IEC 60601:2005+AMD1: 2012+ AMD 2:2020, 3.116 modified by removing ME equipment.]
3.19
suction
application of vacuum to remove liquid, solid particles or gas
3.20
suction tubing
tubing for conduction of liquid, solid particles or gas between the end-piece and the collection container
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ISO 10079-4:2021(E)
3.21
thoracic drainage
drainage of liquid and gas from the thoracic cavity by application of suction to the thoracic cavity of the
patient
3.22
transport use
use during patient transport outside of a healthcare facility
EXAMPLE ambulance or aeroplane.
3.23
vacuum level
pressure less than atmospheric pressure
3.24
vacuum level indicator
device for displaying the vacuum level
3.25
vacuum regulator
device for controlling the applied vacuum level
3.26
vacuum source
component or device for generating a vacuum
4 General requirements
4.1 Risk management
4.1.1 An established risk management process, (e.g. ISO 14971), shall be applied to the design of the
suction equipment. The risk management process shall include the following elements:
— risk analysis;
— risk evaluation;
— risk control; and
— production and post-production information.
Check conformance by inspection of the risk management file.
4.1.2 Suction equipment shall, when transported, stored, installed, operated in normal use and
maintained according to the instructions for use, present no risks that are not reduced to an acceptable
level using risk management procedures in accordance with ISO 14971 and which are associated with
their intended application in normal and in single fault condition.
NOTE A situation in which a fault is not detected is considered a normal condition. Fault conditions/
hazardous situations might remain undetected over a period of time and as a consequence, might lead to an
unacceptable risk. In that case, a subsequent detected fault condition is considered a single fault condition. Specific
risk control measures to deal with such situations can be determined within the risk management process.
Check conformance by inspection of the risk management file.
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ISO 10079-4:2021(E)
4.1.3 Where requirements refer to freedom from unacceptable risk, the acceptability or unacceptability
of this risk shall be determined by the manufacturer in accordance with their policy for determining
acceptable risk.
Check conformance by inspection of the risk management file.
4.2 Usability
The manufacturer shall apply a usability engineering process to assess and mitigate any risks caused
[5]
by usability problems associated with correct use (i.e. normal use) and use errors (e.g. IEC 60601-1-6
[8]
and IEC 62366-1 ).
Check conformance by inspection of the usability engineering file.
4.3 Clinical studies
Where appropriate, clinical studies shall be performed under the conditions for which performance
is claimed and documented in the risk management file. The clinical studies shall comply with the
requirements of ISO 14155.
NOTE Clinical data can be sourced from the following:
— clinical investigation(s) of the device concerned;
— clinical investigation(s) or other studies reported in the scientific literature of a similar device for
which equivalence to the device in question can be demonstrated; or
— published and/or unpublished reports on other clinical experience of either the device in question
or a similar device for which equivalence to the device in question can be demonstrated.
Check conformance by inspection of the risk management and technical files.
4.4 Biophysical or modelling research
Where appropriate, validated biophysical or modelling research shall be performed under the
conditions for which performance is claimed and documented in the risk management file.
NOTE Biophysical or modelling research is the application of validated physical methods and theories to
biological problems. Examples include the use of a combination of models (i.e. mathematical, computer, physical,
cell and tissue culture, and animal) in a complementary and interactive manner to simulate the performance of
medical devices.
Check conformance by inspection of the technical file.
4.5 Test methods
Manufacturers can use type tests different from those detailed within this document if an equivalent
degree of safety is obtained. Alternative test methods shall be validated against the test methods
specified in Annex B.
5 Materials
5.1 Natural rubber latex
If any components of the suction equipment incorporate natural rubber latex, the manufacturer
shall provide a specific justification for using this substance in their technical file. See also 9.3 g) for
additional marking requirements.
Check conformance by inspection of the technical file.
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ISO 10079-4:2021(E)
5.2 Cleaning, disinfection and sterilization
5.2.1 Parts of the suction equipment which can be subject to contamination shall either be for single
use or capable of being cleaned and disinfected or sterilized as appropriate.
Check conformance by inspection of the technical file.
5.2.2 Parts of the suction equipment intended for re-use shall meet the requirements of Clause 7, as
appropriate, after those components have been subjected to 30 cycles of cleaning and disinfection or
sterilization as recommended by the manufacturer [see 9.4 g)].
Check conformance by the tests given in Annex B.
6 Design requirements
6.1 General
6.1.1 Suction equipment classified as medical electrical equipment, as defined in 3.63 of
IEC 60601-1:2005+AMD1:2012 +AMD2: 2020 shall meet the r elevant requirements of IEC 60601-1.
NOTE This applies not only to electrically powered suction equipment but also to suction equipment with
electrical components e.g. timers, indicators etc.
Check conformance by inspection of the technical file.
6.1.2 Suction equipment intended to be dismantled by the user (e.g. for cleaning) shall be designed to
facilitate correct assembly or marked to indicate correct reassembly.
Check conformance by inspection of the technical file.
6.1.3 Suction equipment shall meet the requirements of Clause 7, as appropriate, after dismantling and
reassembly in accordance with the manufacturer’s instructions.
Check conformance by the tests given in Annex B after the suction equipment has been reassembled.
6.1.4 Suction equipment shall be designed to be operated by one person, unaided.
Check conformance by functional testing.
6.1.5 Means shall be provided to prevent foam passing from the collection container into the vacuum
source.
NOTE This does not apply to suction equipment designed to continue to operate when the collection container
is full. [See 8.5 b)].
Check conformance by the tests given in B.2.3.
6.2 Collection containers
6.2.1 Capacity
Collection containers shall:
a) clearly show the level of contents, and
b) have a usable volume ≥ 500 ml.
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ISO 10079-4:2021(E)
NOTE 1 See A.2 for rationale.
NOTE 2 Transparent or translucent collection containers allow a qualitative assessment of the contents.
NOTE 3 See Clause 8 for additional/alternative requirements for the capacity of collection containers for
suction equipment for field use or transport use.
Check conformance by the tests given in B.2.
6.2.2 Strength
Collection containers shall not implode, crack or permanently deform and shall meet the requirements
of Clause 7, as appropriate, after being subjected to a pressure of either 120 % of the manufacturer’s
recommended maximum vacuum level or 95 kPa below atmospheric, whichever is the stronger vacuum
level, for 5 min.
Reusable collection containers shall be tested after 30 cycles of cleaning and disinfection or sterilization
as recommended by the manufacturer [see 9.4 g)].
Check conformance by the tests given in B.3.
6.3 Connections
6.3.1 Tubing connectors
Connectors for suction tubing and intermediate tubing shall:
a) be designed to facilitate correct assembly or clearly marked to indicate correct assembly when all
parts are mated and
b) have an inside diameter equal to or larger than the inside diameter of the largest suction tubing or
intermediate tubing size specified by the manufacturer [see 9.4 n)].
NOTE Incorrect connections have frequently been a cause of spill over into the vacuum source and a loss of
suction.
Check conformance by functional testing and inspection.
6.3.2 Collection container inlet ports
Collection container inlet ports shall:
a) not be compatible with any of the conical connectors specified in ISO 5356-1 or any of the small-
bore connectors specified in ISO 80369-2, ISO 80369-3, IEC 80369-5, ISO 80369-6, ISO 80369-7 and
b) have an inside diameter ≥ 6 mm.
Check conformance by functional testing.
6.3.3 Collection container exhaust ports
It shall not be possible to connect suction tubing or intermediate tubing to collection container exhaust
ports.
Check conformance by functional testing.
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ISO 10079-4:2021(E)
6.4 Suction tubing and intermediate tubing
6.4.1 Suction tubing and intermediate tubing shall have:
a) an inside diameter ≥ 6 mm and
b) a degree of collapse ≤ 0,5 throughout its entire length.
NOTE 1 See A.3 for rationale.
NOTE 2 Special surgical procedures such as liposuction and suction curettage often use large-bore suction
tubing and intermediate tubing and connectors.
Check conformance by functional testing and the test given in B.4
6.4.2 Suction tubing shall have a l
...
NORME ISO
INTERNATIONALE 10079-4
Première édition
2021-08
Appareils d’aspiration médicale —
Partie 4:
Exigences générales
Medical suction equipment —
Part 4: General requirements
Numéro de référence
ISO 10079-4:2021(F)
© ISO 2021
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ISO 10079-4:2021(F)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2021
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
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Publié en Suisse
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ISO 10079-4:2021(F)
Sommaire Page
Avant-propos .v
Introduction . vi
1 Domaine d’application . 1
2 Références normatives .1
3 Termes et définitions . 2
4 Exigences générales . .4
4.1 Gestion des risques . 4
4.2 Aptitude à l’utilisation . 5
4.3 Étude clinique . 5
4.4 Recherches en biophysique ou de modélisation . 5
4.5 Méthodes d’essai . 5
5 Matériaux . 6
5.1 Latex de caoutchouc naturel . 6
5.2 Nettoyage, désinfection et stérilisation . 6
6 Exigences de conception .6
6.1 Généralités . 6
6.2 Bocaux de recueil . 7
6.2.1 Capacité . 7
6.2.2 Résistance . 7
6.3 Raccords . 7
6.3.1 Raccords de tuyaux . 7
6.3.2 Orifices d’entrée des bocaux de recueil . 7
6.3.3 Orifices d’évacuation des bocaux de recueil . 8
6.4 Tuyau d’aspiration et tuyau intermédiaire . 8
6.5 Indicateurs de niveau de dépression . 9
6.6 Conditions environnementales pour le transport et le stockage . 9
7 Exigences de performance .10
7.1 Position de fonctionnement . 10
7.2 Dispositifs de protection . 10
7.2.1 Protection contre la contamination . 10
7.2.2 Trop-plein . 10
7.2.3 Protection contre la pression . 11
7.3 Bruit . 11
7.4 Fuite d’air . 11
7.5 Niveaux de dépression et débits d’air à débit libre . 11
7.6 Exactitude . 12
7.7 Appareil d’aspiration pharyngée .12
8 Exigences supplémentaires/alternatives pour les appareils d’aspiration, tuyaux
d’aspiration et tuyaux intermédiaires prévus pour une utilisation sur le terrain ou
une utilisation lors d’un transport.12
8.1 Exigences physiques .12
8.2 Résistance .13
8.3 Stabilité . 13
8.4 Conditions environnementales pendant le fonctionnement .13
8.5 Capacité du bocal de recueil . 13
9 Informations fournies par le fabricant .14
9.1 Généralités . 14
9.2 Symboles . 14
9.3 Marquage . 15
9.4 Instructions d’utilisation . . 16
iii
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ISO 10079-4:2021(F)
Annexe A (informative) Justification .18
Annexe B (normative) Méthodes d’essai .20
Annexe C (informative) Représentation schématique des appareils d’aspiration médicale .35
Bibliographie .36
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ISO 10079-4:2021(F)
Avant-propos
L’ISO (Organisation internationale de normalisation) est une fédération mondiale d’organismes
nationaux de normalisation (comités membres de l’ISO). L’élaboration des Normes internationales est
en général confiée aux comités techniques de l’ISO. Chaque comité membre intéressé par une étude
a le droit de faire partie du comité technique créé à cet effet. Les organisations internationales,
gouvernementales et non gouvernementales, en liaison avec l’ISO participent également aux travaux.
L’ISO collabore étroitement avec la Commission électrotechnique internationale (IEC) en ce qui
concerne la normalisation électrotechnique.
Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont
décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier de prendre note des différents
critères d’approbation requis pour les différents types de documents ISO. Le présent document
a été rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2
(voir www.iso.org/directives).
L’attention est appelée sur le fait que certains des éléments du présent document peuvent faire l’objet de
droits de propriété intellectuelle ou de droits analogues. L’ISO ne saurait être tenue pour responsable
de ne pas avoir identifié de tels droits de propriété et averti de leur existence. Les détails concernant
les références aux droits de propriété intellectuelle ou autres droits analogues identifiés lors de
l’élaboration du document sont indiqués dans l’Introduction et/ou dans la liste des déclarations de
brevets reçues par l’ISO (voir www.iso.org/brevets).
Les appellations commerciales éventuellement mentionnées dans le présent document sont données
pour information, par souci de commodité, à l’intention des utilisateurs et ne sauraient constituer un
engagement.
Pour une explication de la nature volontaire des normes, la signification des termes et expressions
spécifiques de l’ISO liés à l’évaluation de la conformité, ou pour toute information au sujet de l’adhésion
de l’ISO aux principes de l’Organisation mondiale du commerce (OMC) concernant les obstacles
techniques au commerce (OTC), voir le lien suivant: www.iso.org/iso/fr/avant-propos.
Le présent document a été élaboré par le Comité technique ISO/TC 121, Matériel d’anesthésie et de
réanimation respiratoire, sous-comité SC 8, Dispositifs d’aspiration, en collaboration avec le comité
technique CEN/TC 215, Équipement respiratoire et anesthésique, du Comité européen de normalisation
(CEN), conformément à l’Accord de coopération technique entre l’ISO et le CEN (Accord de Vienne).
Une liste de toutes les parties de la série ISO 10079 se trouve sur le site web de l’ISO.
Il convient que l’utilisateur adresse tout retour d’information ou toute question concernant le présent
document à l’organisme national de normalisation de son pays. Une liste exhaustive desdits organismes
se trouve à l’adresse www.iso.org/fr/members.html.
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ISO 10079-4:2021(F)
Introduction
Auparavant, la série de normes ISO 10079 relative aux appareils d’aspiration médicale comprenait
[2] [3] [4]
les parties ISO 10079-1, ISO 10079-2 et ISO 10079-3 qui présentaient de nombreuses exigences
communes. Il a été estimé que le regroupement de ces exigences communes dans cette nouvelle Partie 4
permettrait d’éviter les incohérences résultant de l’élaboration de trois parties différentes avec des
exigences communes et de simplifier le traitement de tout(e) révision/amendement ultérieur(e).
Le présent document contient les exigences qui sont communes aux appareils électriques d’aspiration,
aux appareils d’aspiration manuelle et aux appareils d’aspiration alimentés au gaz.
vi
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NORME INTERNATIONALE ISO 10079-4:2021(F)
Appareils d’aspiration médicale —
Partie 4:
Exigences générales
1 Domaine d’application
Le présent document spécifie des exigences générales pour les appareils d’aspiration médicale qui sont
communes à toutes les parties de la série de normes ISO 10079.
Le présent document ne s’applique pas aux éléments suivants:
a) les pièces d’extrémité, telles que les sondes d’aspiration, les drains, les curettes, les «Yankauer» et les
embouts d’aspiration;
b) les seringues;
c) les appareils dentaires d’aspiration;
d) les systèmes d’évacuation des gaz d’anesthésie;
e) l’aspiration en laboratoire;
f) les systèmes d’autotransfusion;
g) les extracteurs de mucosités, y compris ceux pour nouveau-nés;
h) les appareils d’aspiration dont le bocal de recueil est en aval de la pompe à vide;
i) les appareils avec ventouse (obstétrique);
j) les appareils d’aspiration à usage endoscopique uniquement (marqués comme tels); et
k) les systèmes d’évacuation de fumée.
2 Références normatives
Les documents suivants sont cités dans le texte de sorte qu’ils constituent, pour tout ou partie de leur
contenu, des exigences du présent document. Pour les références datées, seule l’édition citée s’applique.
Pour les références non datées, la dernière édition du document de référence s’applique (y compris les
éventuels amendements).
ISO 3744, Acoustique — Détermination des niveaux de puissance acoustique et des niveaux d'énergie
acoustique émis par les sources de bruit à partir de la pression acoustique — Méthodes d'expertise pour des
conditions approchant celles du champ libre sur plan réfléchissant
ISO 5356-1, Matériel d'anesthésie et de réanimation respiratoire — Raccords coniques — Partie 1: Raccords
mâles et femelles
ISO 7000, Symboles graphiques utilisables sur le matériel — Symboles enregistrés
ISO 10993-1, Évaluation biologique des dispositifs médicaux — Partie 1: Évaluation et essais au sein d'un
processus de gestion du risque
ISO 14155, Investigation clinique des dispositifs médicaux pour sujets humains — Bonne pratique clinique
1
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ISO 10079-4:2021(F)
ISO 14971, Dispositifs médicaux — Application de la gestion des risques aux dispositifs médicaux
ISO 20417, Dispositifs médicaux — Informations à fournir par le fabricant
ISO 80369-2, Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé — Partie 2:
Raccords destinés à des applications respiratoires
ISO 80369-3, Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé — Partie 3:
Raccords destinés à des applications entérales
ISO 80369-6, Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé — Partie 6:
Raccords destinés à des applications en contact avec le système nerveux (neuraxiales)
ISO 80369-7, Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé — Partie 7:
Connecteurs pour les applications intravasculaires ou hypodermiques
I EC 6 06 01-1:20 05+A M D1: 2012 , Appareils électromédicaux — Partie 1: Exigences générales pour la
sécurité de base et les performances essentielles
IEC 61672-1, Électroacoustique — Sonomètres — Partie 1: Spécifications
IEC 80369-5, Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé — Partie 5:
Raccords destinés à des applications au gonflement de ballonnet
EN 15986, Symbole à utiliser pour l’étiquetage des dispositifs médicaux — Exigences relatives à l’étiquetage
des dispositifs médicaux contenant des phtalates
3 Termes et définitions
Pour les besoins du présent document, les termes et définitions suivants s’appliquent.
L’ISO et l’IEC tiennent à jour des bases de données terminologiques destinées à être utilisées en
normalisation, consultables aux adresses suivantes:
— ISO Online browsing platform: disponible à l’adresse https:// www .iso .org/ obp;
— IEC Electropedia: disponible à l’adresse https:// www .electropedia .org/ .
3.1
bocal de recueil
bocal dans lequel sont recueillis les liquides et les particules solides
3.2
montage du bocal de recueil
bocal de recueil avec son couvercle muni des raccords d’aspiration
3.3
drainage
retrait d’un liquide, de particules solides ou d’un gaz d’une cavité ou d’une blessure du corps
3.4
pièce d’extrémité
partie de l’appareil d’aspiration appliquée au patient, comprise entre le point où les matières sont
aspirées et le premier raccord démontable
EXEMPLE Les «Yankauer» et les sondes d’aspiration sont des exemples courants de pièces d’extrémité.
[1]
[SOURCE: ISO 4135:2001, 8.2.7]
3.5
orifice d’évacuation
ouverture par laquelle le gaz est évacué hors de l’appareil
2
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ISO 10079-4:2021(F)
3.6
utilisation sur le terrain
utilisation de l’appareil d’aspiration hors d’un établissement de soins ou pour les soins à domicile
3.7
filtre
dispositif de retenue de matières particulaires
3.8
débit d’air à débit libre
débit d’air non limité passant par une entrée déterminée
3.9
fort débit
débit d’air à débit libre ≥ 20 l/min
3.10
forte dépression
niveau de dépression d’au moins 60 kPa (pression absolue de 0 à 40 kPa)
3.11
orifice d’entrée
ouverture par laquelle le liquide, les particules solides ou le gaz pénètrent
3.12
tuyau intermédiaire
tuyau qui raccorde le bocal de recueil à la source de vide
3.13
dépression intermittente
aspiration dans laquelle la pression négative appliquée à la pièce d’extrémité est automatiquement et
périodiquement ramenée à la pression atmosphérique
3.14
faible débit
débit d’air à débit libre < 20 l/min
3.15
faible dépression
niveau de dépression inférieur ou égal à 20 kPa (pression absolue de 80 kPa à 100 kPa)
3.16
moyenne dépression
niveau de dépression entre 20 kPa et 60 kPa (pression absolue de 40 kPa à 80 kPa)
3.17
trop-plein
dispositif destiné à empêcher la pénétration des liquides ou des particules solides dans le tuyau
intermédiaire
3.18
condition de premier défaut
condition dans laquelle un seul moyen de réduction d’un risque est défectueux ou présence d’une seule
condition anormale
Note 1 à l'article: La maintenance de l’appareil est considérée comme une condition normale.
[SOURCE: IEC 60601‑1:2005+AMD1: 2012+ AMD2: 2020, 3.116, modifié en supprimant «appareil EM»]
3.19
aspiration
application d’une dépression pour éliminer le liquide, les particules solides ou le gaz
3
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ISO 10079-4:2021(F)
3.20
tuyau d’aspiration
tuyau pour le transfert d’un liquide, de particules solides ou d’un gaz depuis la pièce d’extrémité jusqu’au
bocal de recueil
3.21
drainage thoracique
drainage de fluides et de gaz dans la cavité thoracique par application d’une aspiration sur la cavité
thoracique du patient
3.22
utilisation lors d’un transport
utilisation pendant le transport du patient hors d’un établissement de soins
EXEMPLE Ambulance ou avion.
3.23
niveau de dépression
pression inférieure à la pression atmosphérique
3.24
indicateur de niveau de dépression
dispositif destiné à indiquer le niveau de dépression
3.25
régulateur de dépression
dispositif permettant de commander le niveau de dépression appliqué
3.26
source de vide
composant d’un dispositif permettant de produire un vide
4 Exigences générales
4.1 Gestion des risques
4.1.1 Un processus de gestion des risques établi (tel que celui de l’ISO 14971) doit être appliqué à la
conception de l’appareil d’aspiration. Ce processus doit inclure les éléments suivants:
— l’analyse des risques;
— l’évaluation des risques;
— la maîtrise des risques; et
— des informations de production et de postproduction.
Vérifier la conformité par examen du dossier de gestion des risques.
4.1.2 Pendant le transport, le stockage, l’installation, le fonctionnement en utilisation normale et
l’entretien conformément aux instructions d’utilisation, un appareil d’aspiration ne doit présenter aucun
risque lié à son application prévue, que ce soit en condition normale ou en condition de premier défaut,
et qui n’est pas réduit à un niveau acceptable en appliquant des procédures de gestion des risques
conformément à l’ISO 14971.
NOTE Une situation dans laquelle un défaut n’est pas détecté est considérée comme une condition normale.
Les conditions de défaut/situations dangereuses pourraient ne pas être détectées pendant un certain temps et
conduire, par conséquent, à un risque inacceptable. Dans ce cas, une condition de défaut détectée par la suite est
considérée comme une condition de premier défaut. Les mesures spécifiques de maîtrise des risques pour gérer
de telles situations peuvent être déterminées dans le cadre du processus de gestion des risques.
4
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ISO 10079-4:2021(F)
Vérifier la conformité par examen du dossier de gestion des risques.
4.1.3 Lorsque des exigences se réfèrent à l’absence de risque inacceptable, l’acceptabilité ou
l’inacceptabilité de ce risque doit être déterminée par le fabricant conformément à sa politique de
détermination du risque acceptable.
Vérifier la conformité par examen du dossier de gestion des risques.
4.2 Aptitude à l’utilisation
Le fabricant doit appliquer un processus d’ingénierie d’aptitude à l’utilisation, pour évaluer et atténuer
les risques causés par les problèmes d’aptitude à l’utilisation associés à l’utilisation correcte (c’est-à-
[5] [8]
dire l’utilisation normale) et les erreurs d’utilisation (par exemple IEC 60601-1-6 et IEC 62366-1 ).
Vérifier la conformité par examen du dossier d’ingénierie d’aptitude à l’utilisation.
4.3 Étude clinique
Le cas échéant, des études cliniques doivent être effectuées dans les conditions pour lesquelles la
performance est déclarée et doivent être documentées dans le dossier de gestion des risques. Les
études cliniques doivent être conformes aux exigences de l’ISO 14155.
NOTE Les données cliniques peuvent être issues:
— d’une ou plusieurs investigations cliniques du dispositif concerné;
— d’une ou plusieurs investigations cliniques ou d’autres études rapportées dans la littérature
scientifique concernant un dispositif similaire pour lequel l’équivalence avec le dispositif en question
peut être démontrée; ou
— de rapports publiés et/ou non publiés concernant d’autres expériences cliniques menées avec le
dispositif concerné ou avec un dispositif similaire pour lequel l’équivalence avec le dispositif en
question peut être démontrée.
Vérifier la conformité par examen du dossier de gestion des risques et du dossier technique.
4.4 Recherches en biophysique ou de modélisation
Le cas échéant, des recherches en biophysique ou de modélisation validées doivent être effectuées
dans les conditions pour lesquelles les performances sont déclarées et documentées dans le dossier de
gestion des risques.
NOTE La recherche biophysique ou de modélisation est l’application de méthodes et de théories physiques
validées par rapport à des problèmes biologiques. Des exemples incluent l’utilisation d’une combinaison de
modèles (mathématiques, informatiques, physiques, cultures cellulaires et tissulaires, et animaux) d’une manière
complémentaire et interactive pour simuler les performances des dispositifs médicaux.
Vérifier la conformité par examen du dossier technique.
4.5 Méthodes d’essai
Les fabricants peuvent utiliser des essais de type différents de ceux décrits dans le présent document si
un degré de sécurité équivalent est obtenu. Les méthodes d’essai de remplacement doivent être validées
par rapport aux méthodes d’essai spécifiées dans l’Annexe B.
5
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ISO 10079-4:2021(F)
5 Matériaux
5.1 Latex de caoutchouc naturel
Si des composants de l’appareil d’aspiration contiennent du latex de caoutchouc naturel, le fabricant doit
fournir une justification spécifique de l’utilisation de cette substance dans son dossier technique. Voir
également 9.3 g) pour des exigences supplémentaires relatives au marquage.
Vérifier la conformité par examen du dossier technique.
5.2 Nettoyage, désinfection et stérilisation
5.2.1 Les parties de l’appareil d’aspiration pouvant être sujettes à la contamination doivent soit être à
usage unique, soit pouvoir être nettoyées et désinfectées ou stérilisées, suivant le cas.
Vérifier la conformité par examen du dossier technique.
5.2.2 Les pièces réutilisables de l’appareil d’aspiration doivent répondre aux exigences données à
l’Article 7, suivant le cas, lorsque ces éléments ont fait l’objet de 30 cycles de nettoyage, de désinfection
ou de stérilisation, selon les recommandations du fabricant [voir 9.4 g)].
Vérifier la conformité au moyen de l’essai décrit dans l’Annexe B.
6 Exigences de conception
6.1 Généralités
6.1.1 Un appareil d’aspiration classé comme appareil électromédical, tel que défini en 3.63 dans
l’IEC 60601-1:2005+AMD1: 2012+ AMD2: 2020, doit satisfaire aux exigences applicables de l’IEC 60601-1.
NOTE Cela s’applique non seulement aux appareils électriques d’aspiration, mais aussi aux appareils
d’aspiration dotés de composants électriques, tels que des dispositifs de chronométrage, des indicateurs, etc.
Vérifier la conformité par examen du dossier technique.
6.1.2 Un appareil d’aspiration destiné à être démontré par l’utilisateur (par exemple, pour le
nettoyage) doit être conçu de façon à faciliter le montage correct ou être clairement marqué pour
permettre un remontage correct.
Vérifier la conformité par examen du dossier technique.
6.1.3 Un appareil d’aspiration doit satisfaire aux exigences de l’Article 7, suivant le cas, après
démontage et remontage conformément aux instructions du fabricant.
Vérifier la conformité au moyen des essais décrits dans l’Annexe B, une fois que l’appareil d’aspiration a
été remonté.
6.1.4 L’appareil d’aspiration doit être conçu pour pouvoir être utilisé par une seule personne, sans
aide extérieure.
Vérifier la conformité au moyen d’un essai fonctionnel.
6.1.5 Des moyens doivent être prévus pour empêcher la mousse de passer du bocal de recueil à la
source de vide.
6
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ISO 10079-4:2021(F)
NOTE Cela ne s’applique pas aux appareils d’aspiration conçus pour continuer à fonctionner lorsque le bocal
de recueil est plein [voir 8.5 b)].
Vérifier la conformité au mo
...
FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 10079-4
ISO/TC 121/SC 8
Medical suction equipment —
Secretariat: SA
Voting begins on:
Part 4:
2021-04-30
General requirements
Voting terminates on:
2021-06-25
Appareils d’aspiration médicale —
Partie 4: Exigences générales
ISO/CEN PARALLEL PROCESSING
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 10079-4:2021(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
©
NATIONAL REGULATIONS. ISO 2021
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ISO/FDIS 10079-4:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
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ISO/FDIS 10079-4:2021(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements . 4
4.1 Risk management . 4
4.2 Usability . 5
4.3 Clinical studies . 5
4.4 Biophysical or modelling research . 5
4.5 Test methods . 5
5 Materials . 5
5.1 Natural rubber latex . 5
5.2 Cleaning disinfection and sterilization . 6
6 Design requirements . 6
6.1 General . 6
6.2 Collection containers . 6
6.2.1 Capacity (See also Annex A Subclause 6.2.1 for rationale). 6
6.2.2 Strength . 7
6.3 Connections . 7
6.3.1 Tubing connectors . 7
6.3.2 Collection container inlet ports . 7
6.3.3 Collection container exhaust ports . 7
6.4 Suction tubing and intermediate tubing (See also Annex A Subclause 6.4 for rationale) 8
6.5 Vacuum level indicators . 8
6.6 Environmental conditions for transport and storage . 9
7 Performance requirements .10
7.1 Operating position .10
7.2 Protection devices .10
7.2.1 Contamination protection .10
7.2.2 Overfill protection devices .10
7.2.3 Pressure protection .10
7.3 Noise .11
7.4 Air leakage .11
7.5 Vacuum levels and free air flows .11
7.6 Accuracy .11
7.7 Pharyngeal suction equipment .12
8 Additional/alternative requirements for suction equipment, suction tubing and
intermediate tubing designed for field use or transport use .12
8.1 Physical requirements (See also Annex A, Subclause 8.1 for rationale) .12
8.2 Strength .12
8.3 Stability .12
8.4 Environmental conditions during operation (See also Annex A, Subclause 8.4 for
rationale).12
8.5 Collection container capacity .13
9 Information supplied by the manufacturer .13
9.1 General .13
9.2 Symbols .14
9.3 Marking .14
9.4 Instructions for use .15
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ISO/FDIS 10079-4:2021(E)
Annex A (Informative) Rationale .17
Annex B (Normative) Test methods .19
Annex C (informative) Schematic of medical suction equipment .34
Bibliography .35
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ISO/FDIS 10079-4:2021(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory
equipment subcommittee SC 8, Suction equipment, in collaboration with the European Committee for
Standardization (CEN) Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment, in
accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
A list of all parts in the ISO 10079 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
© ISO 2021 – All rights reserved v
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ISO/FDIS 10079-4:2021(E)
Introduction
[2]
Previously the ISO 10079 series of medical suction equipment standards comprised parts ISO 10079-1,
[3] [4]
ISO 10079-2 and ISO 10079-3 which had many common requirements. It was thought that
combining these common requirements into this new part 4 would prevent the inconsistencies that had
resulted from developing three different parts with common requirements and would make any future
revision/amendment easier to manage.
This document contains those requirements that are common to electrically, manually and gas-powered
medical suction equipment.
vi © ISO 2021 – All rights reserved
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FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 10079-4:2021(E)
Medical suction equipment —
Part 4:
General requirements
1 Scope
This document specifies general requirements for medical suction equipment that are common to all
parts of the ISO 10079 series.
This document is not applicable to the following:
a) end-pieces such as suction catheters, drains, curettes, Yankauer suckers and suction tips;
b) syringes;
c) dental suction equipment;
d) anaesthetic gas scavenging systems;
e) laboratory suction;
f) autotransfusion systems;
g) mucus extractors including neonatal mucus extractors;
h) suction equipment where the collection container is downstream of the vacuum pump;
i) ventouse (obstetric) equipment;
j) suction equipment marked for endoscopic use only
k) plume evacuation systems.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 3744, Acoustics — Determination of sound power levels and sound energy levels of noise sources using
sound pressure — Engineering methods for an essentially free field over a reflecting plane
ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
ISO 7000, Graphical symbols for use on equipment — Registered symbols
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 20417, Medical devices — Information to be provided by the manufacturer
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ISO/FDIS 10079-4:2021(E)
ISO 80369-2, Small-bore connectors for liquids and gases in healthcare applications — Part 2: Connectors
for respiratory applications
ISO 80369-3, Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors
for enteral applications
ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications — Part 6: Connectors
for neuraxial applications
ISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications—Part 7 Connectors for
intravascular or hypodermic applications
I EC 6 06 01-1:20 05+A 1: 2012+ A 2: 2020, Medical electrical equipment — Part 1: General requirements for
safety
IEC 61672-1, Electroacoustics - Sound level meters — Part 1: Specifications
IEC 80369-5, Small-bore connectors for liquids and gases in healthcare applications—Part 5 Connectors
limb cuff inflation applications
EN 15986, Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices
containing phthalates
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply:
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
collection container
container in which liquids and solid particles are collected
3.2
collection container assembly
collection container and its closure with connectors for suction
3.3
drainage
removal of liquid, solid particles or gas from a body cavity or wound
3.4
end-piece
part of the suction equipment applied to the patient which begins at the site where material is drawn in
and ends at the first detachable connection
EXAMPLE Commonly used end-pieces include Yankauer sucker, suction catheters.
[1]
[Source: ISO 4135:2001, 8.2.7]
3.5
exhaust port
opening through which exhaust gas is discharged
3.6
field use
use of suction equipment in situations outside of a healthcare facility or home environment
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ISO/FDIS 10079-4:2021(E)
3.7
filter
device for retention of particulate matter
3.8
free air flow
rate of unrestricted flow of air through a designated inlet
3.9
high flow
free air flow ≥ 20 l/min
3.10
high vacuum
vacuum level of 60 kPa or stronger (absolute pressure 0 to 40 kPa)
3.11
inlet port
opening through which liquid, solid particles or gas enters
3.12
intermediate tubing
tubing between the collection container and the vacuum source
3.13
intermittent vacuum
suction in which the negative pressure applied to the end-piece is automatically and periodically
returned to atmospheric pressure
3.14
low flow
free air flow < 20 l/min
3.15
low vacuum
vacuum level of 20 kPa or weaker (absolute pressure 80 kPa to 100 kPa)
3.16
medium vacuum
vacuum level between 20 kPa and 60 kPa (absolute pressure 40 kPa to 80 kPa)
3.17
overfill protection device
device to prevent liquid or solid particles from entering the intermediate tubing
3.18
single fault condition
condition in which a single means for protection against a safety hazard in equipment is defective or a
single external abnormal condition is present
Note 1 to entry: Note 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 and the collection container
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ISO/FDIS 10079-4:2021(E)
3.21
thoracic drainage
drainage of liquid and gas from the thoracic cavity by application of suction to the thoracic cavity of the
patient
3.22
transport use
use during patient transport outside of a healthcare facility
EXAMPLE ambulance or aeroplane.
3.23
vacuum level
pressure less than atmospheric pressure
3.24
vacuum level indicator
device for displaying the vacuum level
3.25
vacuum regulator
device for controlling the applied vacuum level
3.26
vacuum source
component of device for generating vacuum
4 General requirements
4.1 Risk management
4.1.1 An established risk management process, (e.g. ISO 14971), shall be applied to the design of the
suction equipment. The risk management process shall include the following elements:
— risk analysis;
— risk evaluation; and
— risk control;
— production and post-production information.
Check conformance by inspection of the risk management file.
4.1.2 Suction equipment shall, when transported, stored, installed, operated in normal use and
maintained according to the instructions for use, present no risks that are not reduced to an acceptable
level using risk management procedures in accordance with ISO 14971 and which are associated with
their intended application in normal and in single fault condition.
NOTE A situation in which a fault is not detected is considered a normal condition. Fault conditions/
hazardous situations might remain undetected over a period of time and as a consequence, might lead to an
unacceptable risk. In that case, a subsequent detected fault condition is considered a single fault condition. Specific
risk control measures to deal with such situations can be determined within the risk management process.
Check conformance by inspection of the risk management file.
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ISO/FDIS 10079-4:2021(E)
4.1.3 Where requirements refer to freedom from unacceptable risk, the acceptability or unacceptability
of this risk shall be determined by the manufacturer in accordance with their policy for determining
acceptable risk.
Check conformance by inspection of the risk management file.
4.2 Usability
The manufacturer shall apply a usability engineering process to assess and mitigate any risks caused
[5]
by usability problems associated with correct use (i.e. normal use) and use errors (e.g. IEC 60601-1-6
[8]
and IEC 62366-1 ).
Check conformance by inspection of the usability engineering file.
4.3 Clinical studies
Where appropriate, clinical studies shall be performed under the conditions for which performance
is claimed and documented in the risk management file. The clinical studies shall comply with the
requirements of ISO 14155.
NOTE Clinical data can be sourced from the following:
— clinical investigation(s) of the device concerned;
— clinical investigation(s) or other studies reported in the scientific literature of a similar device for
which equivalence to the device in question can be demonstrated or
— published and/or unpublished reports on other clinical experience of either the device in question
or a similar device for which equivalence to the device in question can be demonstrated.
Check conformance by inspection of the risk management and technical files.
4.4 Biophysical or modelling research
Where appropriate, validated biophysical or modelling research shall be performed under the
conditions for which performance is claimed and documented in the risk management file.
NOTE Biophysical or modelling research is the application of validated physical methods and theories to
biological problems. Examples include the use of a combination of models, i.e. mathematical, computer, physical,
cell and tissue culture, and animal, in a complementary and interactive manner to simulate the performance of
medical devices.
Check conformance by inspection of the technical file.
4.5 Test methods
Manufacturers can use type tests different from those detailed within this document if an equivalent
degree of safety is obtained. Alternative test methods shall be validated against the test methods
specified in Annex B.
5 Materials
5.1 Natural rubber latex
If any components of the suction equipment incorporate natural rubber latex, the manufacturer
shall provide a specific justification for using this substance in their technical file. See also 9.3 g) for
additional marking requirements.
Check conformance by inspection of the technical file.
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ISO/FDIS 10079-4:2021(E)
5.2 Cleaning disinfection and sterilization
5.2.1 Parts of the suction equipment which can be subject to contamination shall either be for single
use or capable of being cleaned and disinfected or sterilized as appropriate.
Check conformance by inspection of the technical file.
5.2.2 Parts of the suction equipment intended for re-use shall meet the requirements of Clause 7, as
appropriate, after those components have been subjected to 30 cycles of cleaning and disinfection or
sterilization as recommended by the manufacturer [see 9.4 g)].
Check conformance by the tests given in Annex B.
6 Design requirements
6.1 General
6.1.1 Suction equipment classified as medical electrical equipment, as defined in IEC 60601-1:2005+A1:
2012 +A2:2020: 3 .63 shall meet the relevant requirements of IEC 60601-1.
NOTE This applies not only to electrically powered suction equipment but also to suction equipment with
electrical components e.g. timers, indicators etc.
Check conformance by inspection of the technical file.
6.1.2 Suction equipment intended to be dismantled by the user (e.g. for cleaning) shall be designed to
facilitate correct assembly or marked to indicate correct reassembly.
Check conformance by inspection of the technical file.
6.1.3 Suction equipment shall meet the requirements of Clause 7, as appropriate, after dismantling and
reassembly in accordance with the manufacturer’s instructions.
Check conformance by the tests given in Annex B after the suction equipment has been reassembled.
6.1.4 Suction equipment shall be designed to be operated by one person, unaided.
Check conformance by functional testing.
6.1.5 Means shall be provided to prevent foam passing from the collection container into the vacuum
source.
NOTE This does not apply to suction equipment designed to continue to operate when the collection container
is full. [See 8.5 b)].
Check conformance by the tests given in B.2.3.
6.2 Collection containers
6.2.1 Capacity (See also Annex A Subclause 6.2.1 for rationale)
Collection containers shall:
a) clearly show the level of contents, and
b) have a usable volume ≥500 ml.
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ISO/FDIS 10079-4:2021(E)
NOTE 1 Transparent or translucent collection containers allow a qualitative assessment of the contents.
NOTE 2 See Clause 8 for additional/alternative requirements for the capacity of collection containers for
suction equipment for field use.
Check conformance by the tests given in B.2.
6.2.2 Strength
Collection containers shall not implode, crack or permanently deform and shall meet the requirements
of Clause 7, as appropriate, after being subjected to a pressure of either 120 % of the manufacturer’s
recommended maximum vacuum level or 95 kPa below atmospheric, whichever is the stronger vacuum
level, for 5 min.
Reusable collection containers shall be tested after 30 cycles of cleaning and disinfection or sterilization
as recommended by the manufacturer [see 9.4 g)].
Check conformance by the tests given in B.3.
6.3 Connections
6.3.1 Tubing connectors
Connectors for suction tubing and intermediate tubing shall:
a) be designed to facilitate correct assembly or clearly marked to indicate correct assembly when all
parts are mated and
b) have an inside diameter equal to or larger than the inside diameter of the largest suction tubing or
intermediate tubing size specified by the manufacturer [see 9.4 n)].
NOTE Incorrect connections have frequently been a cause of spill over into the vacuum source and a loss of
suction.
Check conformance by functional testing and inspection.
6.3.2 Collection container inlet ports
Collection container inlet ports shall:
a) not be compatible with any of the conical connectors specified in ISO 5356-1 or any of the small-
bore connectors specified in ISO 80369-2, ISO 80369-3, ISO 80369-4, ISO 80369-5, ISO 80369-6,
ISO 80369-7 and
b) have an inside diameter ≥6 mm.
Check conformance by functional testing.
6.3.3 Collection container exhaust ports
It shall not be possible to connect suction tubing or intermediate tubing to collection container exhaust
ports.
Check conformance by functional testing.
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