SIST EN ISO 10079-4:2021
(Main)Medical suction equipment - Part 4: General requirements (ISO 10079-4:2021)
Medical suction equipment - Part 4: General requirements (ISO 10079-4:2021)
This document specifies general requirements for medical suction equipment that are common to all parts of the 10079 series.
The ISO 10079 series does not apply 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.
Medizinische Absauggeräte - Teil 4: Allgemeine Anforderungen (ISO 10079-4:2021)
Dieses Dokument legt die allgemeinen Anforderungen an medizinische Absauggeräte fest, die für alle Teile der Normenreihe ISO 10079 gelten.
Dieses Dokument ist nicht anzuwenden für Folgendes:
a) Endstücke wie Absaugkatheter, Drainagen, Küretten und Yankauer-Sauger und Absaugtüllen;
b) Spritzen;
c) zahnmedizinische Absauggeräte;
d) Anästhesiegas-Fortleitungssysteme;
e) Laborabsaugung;
f) Autotransfusionssysteme;
g) Schleimabsauger einschließlich Schleimabsauger für Neugeborene;
h) Absauggeräte mit Sammelbehälter unterhalb der Vakuumpumpe;
i) Beatmungsgeräte (für die Geburtshilfe);
j) Absauggeräte, die nur für endoskopische Verwendung gekennzeichnet sind; und
k) Rauch-Gasabsaugsysteme.
Appareils d’aspiration médicale - Partie 4: Exigences générales (ISO 10079-4:2021)
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.
Medicinska sukcijska (aspiracijska) oprema - 4. del: Splošne zahteve (ISO 10079-4:2021)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 10079-4:2021
01-december-2021
Medicinska sukcijska (aspiracijska) oprema - 4. del: Splošne zahteve (ISO 10079-
4:2021)
Medical suction equipment - Part 4: General requirements (ISO 10079-4:2021)
Medizinische Absauggeräte - Teil 4: Allgemeine Anforderungen (ISO 10079-4:2021)
Appareils d’aspiration médicale - Partie 4: Exigences générales (ISO 10079-4:2021)
Ta slovenski standard je istoveten z: EN ISO 10079-4:2021
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 10079-4:2021 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 10079-4:2021
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SIST EN ISO 10079-4:2021
EN ISO 10079-4
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2021
EUROPÄISCHE NORM
ICS 11.040.10
English Version
Medical suction equipment - Part 4: General requirements
(ISO 10079-4:2021)
Appareils d'aspiration médicale - Partie 4: Exigences Medizinische Absauggeräte - Teil 4: Allgemeine
générales (ISO 10079-4:2021) Anforderungen (ISO 10079-4:2021)
This European Standard was approved by CEN on 26 July 2021.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10079-4:2021 E
worldwide for CEN national Members.
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SIST EN ISO 10079-4:2021
EN ISO 10079-4:2021 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 10079-4:2021
EN ISO 10079-4:2021 (E)
European foreword
This document (EN ISO 10079-4:2021) has been prepared by Technical Committee ISO/TC 121
"Anaesthetic and respiratory equipment" in collaboration with Technical Committee CEN/TC 215
“Respiratory and anaesthetic equipment” the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by April 2022, and conflicting national standards shall be
withdrawn at the latest by April 2022.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 10079-4:2021 has been approved by CEN as EN ISO 10079-4:2021 without any
modification.
3
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SIST EN ISO 10079-4:2021
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SIST EN ISO 10079-4:2021
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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SIST EN ISO 10079-4:2021
ISO 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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SIST EN ISO 10079-4:2021
ISO 10079-4:2021(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements . 4
4.1 Risk management . 4
4.2 Usability . 5
4.3 Clinical studies . 5
4.4 Biophysical or modelling research . 5
4.5 Test methods . 5
5 Materials . 5
5.1 Natural rubber latex . 5
5.2 Cleaning, disinfection and sterilization . 6
6 Design requirements . 6
6.1 General . 6
6.2 Collection containers . 6
6.2.1 Capacity . 6
6.2.2 Strength . 7
6.3 Connections . 7
6.3.1 Tubing connectors . 7
6.3.2 Collection container inlet ports . 7
6.3.3 Collection container exhaust ports . 7
6.4 Suction tubing and intermediate tubing . 8
6.5 Vacuum level indicators . 8
6.6 Environmental conditions for transport and storage . 9
7 Performance requirements .10
7.1 Operating position .10
7.2 Protection devices .10
7.2.1 Contamination protection .10
7.2.2 Overfill protection devices .10
7.2.3 Pressure protection .10
7.3 Noise .11
7.4 Air leakage .11
7.5 Vacuum levels and free air flows.11
7.6 Accuracy .11
7.7 Pharyngeal suction equipment .12
8 Additional/alternative requirements for suction equipment, suction tubing and
intermediate tubing designed for field use or transport use .12
8.1 Physical requirements .12
8.2 Strength .12
8.3 Stability .12
8.4 Environmental conditions during operation .12
8.5 Collection container capacity .13
9 Information supplied by the manufacturer .13
9.1 General .13
9.2 Symbols .14
9.3 Marking .14
9.4 Instructions for use .15
Annex A (informative) Rationale .17
© ISO 2021 – All rights reserved iii
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SIST EN ISO 10079-4:2021
ISO 10079-4:2021(E)
Annex B (normative) Test methods .19
Annex C (informative) Schematic of medical suction equipment .34
Bibliography .35
iv © ISO 2021 – All rights reserved
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SIST EN ISO 10079-4:2021
ISO 10079-4:2021(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment
subcommittee SC 8, Suction devices, in collaboration with the European Committee for Standardization
(CEN) Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment, in accordance with the
Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
A list of all parts in the ISO 10079 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
© ISO 2021 – All rights reserved v
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SIST EN ISO 10079-4:2021
ISO 10079-4:2021(E)
Introduction
[2]
Previously the ISO 10079 series of medical suction equipment standards comprised parts ISO 10079-1,
[3] [4]
ISO 10079-2 and ISO 10079-3 which had many common requirements. It was thought that
combining these common requirements into this new part 4 would prevent the inconsistencies that had
resulted from developing three different parts with common requirements and would make any future
revision/amendment easier to manage.
This document contains those requirements that are common to electrically, manually and gas-powered
medical suction equipment.
vi © ISO 2021 – All rights reserved
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SIST EN ISO 10079-4:2021
INTERNATIONAL STANDARD ISO 10079-4:2021(E)
Medical suction equipment —
Part 4:
General requirements
1 Scope
This document specifies general requirements for medical suction equipment that are common to all
parts of the ISO 10079 series.
This document is not applicable to the following:
a) end-pieces such as suction catheters, drains, curettes, Yankauer suckers and suction tips;
b) syringes;
c) dental suction equipment;
d) anaesthetic gas scavenging systems;
e) laboratory suction;
f) autotransfusion systems;
g) mucus extractors including neonatal mucus extractors;
h) suction equipment where the collection container is downstream of the vacuum pump;
i) ventouse (obstetric) equipment;
j) suction equipment marked for endoscopic use only; and
k) plume evacuation systems.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 3744, Acoustics — Determination of sound power levels and sound energy levels of noise sources using
sound pressure — Engineering methods for an essentially free field over a reflecting plane
ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
ISO 7000, Graphical symbols for use on equipment — Registered symbols
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 20417, Medical devices — Information to be provided by the manufacturer
© ISO 2021 – All rights reserved 1
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SIST EN ISO 10079-4:2021
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
2 © ISO 2021 – All rights reserved
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SIST EN ISO 10079-4:2021
ISO 10079-4:2021(E)
3.7
filter
device for retention of particulate matter
3.8
free air flow
rate of unrestricted flow of air through a designated inlet
3.9
high flow
free air flow ≥ 20 l/min
3.10
high vacuum
vacuum level of 60 kPa or stronger (absolute pressure 0 to 40 kPa)
3.11
inlet port
opening through which liquid, solid particles or gas enters
3.12
intermediate tubing
tubing between the collection container and the vacuum source
3.13
intermittent vacuum
suction in which the negative pressure applied to the end-piece is automatically and periodically
returned to atmospheric pressure
3.14
low flow
free air flow < 20 l/min
3.15
low vacuum
vacuum level of 20 kPa or weaker (absolute pressure 80 kPa to 100 kPa)
3.16
medium vacuum
vacuum level between 20 kPa and 60 kPa (absolute pressure 40 kPa to 80 kPa)
3.17
overfill protection device
device to prevent liquid or solid particles from entering the intermediate tubing
3.18
single fault condition
condition in which a single means for reducing a risk is defective or a single abnormal condition is
present
Note 1 to entry: Maintenance of equipment is considered a normal condition.
[SOURCE: IEC 60601:2005+AMD1: 2012+ AMD 2:2020, 3.116 modified by removing ME equipment.]
3.19
suction
application of vacuum to remove liquid, solid particles or gas
3.20
suction tubing
tubing for conduction of liquid, solid particles or gas between the end-piece and the collection container
© ISO 2021 – All rights reserved 3
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SIST EN ISO 10079-4:2021
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.
4 © ISO 2021 – All rights reserved
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SIST EN ISO 10079-4:2021
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 lat
...
SLOVENSKI STANDARD
oSIST prEN ISO 10079-4:2020
01-marec-2020
Medicinska sukcijska (aspiracijska) oprema - 4. del: Splošne zahteve (ISO/DIS
10079-4:2020)
Medical suction equipment - Part 4: General requirements (ISO/DIS 10079-4:2020)
Ta slovenski standard je istoveten z: prEN ISO 10079-4
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 10079-4:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 10079-4:2020
---------------------- Page: 2 ----------------------
oSIST prEN ISO 10079-4:2020
DRAFT INTERNATIONAL STANDARD
ISO/DIS 10079-4
ISO/TC 121/SC 8 Secretariat: SA
Voting begins on: Voting terminates on:
2020-01-03 2020-03-27
Medical suction equipment — Part 4: General
requirements
ICS: 11.040.10
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 10079-4:2020(E)
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 SUPPORTING DOCUMENTATION. ISO 2020
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oSIST prEN ISO 10079-4:2020
ISO/DIS 10079-4:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
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oSIST prEN ISO 10079-4:2020
ISO/DIS 10079-4:2020(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
6.2.3 Compliance . 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 . 8
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 .10
7.4 Air leakage .11
7.5 Vacuum levels and free air flows .11
7.6 Accuracy .11
7.7 Pharyngeal suction equipment .11
8 Additional/alternative requirements for suction equipment and suction 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 .12
8.4.1 Environmental conditions during operation .12
8.5 Collection container capacity .13
9 Information to be supplied by the manufacturer .13
9.1 General .13
9.2 Symbols .13
9.3 Marking .14
9.4 Instructions for use .14
© ISO 2020 – All rights reserved iii
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oSIST prEN ISO 10079-4:2020
ISO/DIS 10079-4:2020(E)
Annex A (Informative) Rationale .17
Annex B (Normative) Test methods .18
Annex C (informative) Lumen size and its effect on flow .31
Annex D (informative) Schematic of medical suction equipment .32
Bibliography .33
iv © ISO 2020 – All rights reserved
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oSIST prEN ISO 10079-4:2020
ISO/DIS 10079-4:2020(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.
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URL: www .iso .org/ iso/ foreword .html.
This document was prepared by Technical Committee 121, Anaesthetic and respiratory equipment
Subcommittee SC 8, suction devices for hospital and emergency care use.
This is the first edition.
[1][2][3]
The ISO 10079 series comprises 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.
Part 4: Medical suction equipment –general requirements.
Throughout this document the following print types are used:
— Requirements and definitions: roman type;
— Test specifications: italic type;
— Informative material appearing outside of tables, such as notes, examples and references: smaller
type. The normative text of tables is also in smaller type;
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates
that there is guidance or rationale related to that item in Annex A.
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oSIST prEN ISO 10079-4:2020
ISO/DIS 10079-4:2020(E)
Introduction
The 10079 series of medical suction equipment comprised three parts which had many common
requirements. It was thought combining these common requirements into this one document would
prevent inconsistencies that result from developing three different parts with common requirements
and would make any future revision/amendment/corrigendum easier to manage.
This document contains those requirements that are common to electrically, manually and gas-powered
medical suction equipment and will be cross referenced by the separate parts.
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oSIST prEN ISO 10079-4:2020
DRAFT INTERNATIONAL STANDARD ISO/DIS 10079-4:2020(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 10079 series.
The ISO 10079 series does not apply 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 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
I EC 6 06 01-1:20 05+A 1: 2012 , Medical electrical equipment — Part 1: General requirements for safety
IEC 60601-1-6, Medical electrical equipment — Part 1-6: General requirements for basic safety and essential
performance — Collateral standard: Usability
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oSIST prEN ISO 10079-4:2020
ISO/DIS 10079-4:2020(E)
IEC/TR 60878, Graphical symbols for electrical equipment in medical practice
IEC 61672-1, Electroacoustics - Sound level meters — Part 1: Specifications
IEC 62366, Medical devices — Application of usability engineering to medical devices
EN 1041, Information supplied by the manufacturer of medical devices
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:
— IEC Electropedia: available at http:// www .electropedia .org/
— ISO Online browsing platform: available at https:// www .iso .org/ obp
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
thoracic drainage
drainage of liquid and gas from the thoracic cavity by application of suction to the thoracic cavity of
the patient
3.5
suction
application of vacuum to remove liquid, solid particles or gas
3.6
end-piece
part of the suction equipment applied to the patient which begins at the site where material is drawn in
and ends at the first detachable connection
Note 1 to entry: to entry: Examples of commonly used end-pieces are a Yankauer sucker and a suction catheter.
[1]
Source ISO 4135
3.7
exhaust port
opening through which exhaust gas is discharged
3.8
inlet port
opening through which liquid, solid particles or gas enter
3.9
outlet port
opening through which gas exits from the collection container assembly
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3.10
field use
use of suction equipment in situations outside of the health care facility and home environment
3.11
transport use
use during patient transport outside of a health care facility (e.g. in an ambulance or airplane)
3.12
filter
device for retention of particulate matter
3.13
free air flow
rate of unrestricted flow of air through a designated inlet
3.14
high flow
free air flow ≥ 20 l/min
3.15
low flow
free air flow < 20 l/min
3.16
high vacuum
vacuum level of 60 kPa or more
3.17
low vacuum
vacuum level of < 20 kPa
3.18
intermittent vacuum
suction in which the negative pressure applied to the end-piece is automatically and periodically
returned to atmospheric pressure
3.19
medium vacuum
vacuum level ≥ 20 kPa, but < 60 kPa
3.20
intermediate tubing
tubing between the collection container and the vacuum source
3.21
suction tubing
tubing for conduction of liquid, solid particles or gas between the end-piece and the collection container
3.22
overfill protection device
device to prevent liquid or solid particles from entering the intermediate tubing
3.23
reference box
hypothetical right parallelepiped terminating on the reflecting plane(s) on which the noise source under
test is located, that just encloses the source including all the significant sound radiating components
and any test table on which the source is mountedSource ISO 3744:2010
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3.24
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: to entry: Maintenance of equipment is considered a normal condition.
3.25
vacuum level
pressure less than atmospheric pressure
3.26
vacuum level indicator
device for displaying the vacuum level
3.27
vacuum regulator
device for controlling the applied vacuum level
3.28
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;
— risk control;
— production and post-production information.
Check compliance 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 needs to be considered as a single fault
condition. Specific risk control measures to deal with such situations need to be determined within the risk
management process.
Check compliance by inspection of the risk management file.
4.1.3 Where requirements 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.
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4.2 Usability
The manufacturer shall apply a usability engineering process to assess and mitigate any risks caused
by usability problems associated with correct use (i.e. normal use) and use errors (see IEC 60601-1-6
and IEC 62366).
Check compliance 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;
— published and/or unpublished reports on other clinical experience of either the device in question or a similar
device for which equivalence to the device in question can be demonstrated.
Check compliance by inspection of the risk management and technical files.
4.4 Biophysical or modelling research
Where appropriate, validated biophysical or modelling research shall be performed under the
conditions for which performance is claimed and documented in the risk management file.
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 compliance by inspection of the technical file.
4.5 Test methods
The manufacturer 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 compliance by inspection of the manufacturer’s technical file.
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5.2 Cleaning disinfection and sterilization
5.2.1 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.
Check compliance 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 compliance 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, subclause 3.63, shall meet the relevant requirements of IEC 60601-1:2005+A1:2012.
NOTE: This applies not only to electrically powered suction equipment but to suction equipment with
electrical components e.g. timers, indicators etc.
Check compliance 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 compliance 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 compliance 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 compliance by functional testing.
6.1.5 Means shall be provided to prevent foam passing from the collection container into the
vacuum source.
Check compliance 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
NOTE 1 Transparent collection containers allow a qualitative assessment of the c
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