SIST EN ISO 10079-3:2009

Medical suction equipment - Part 3: Suction equipment powered from a vacuum or pressure source (ISO 10079-3:1999)

This part of ISO 10079 specifies safety and performance requirements for medical suction equipment powered from a vacuum or pressure source (see Figure 1). In particular it applies to connections for pipelines and Venturi attachments. Suction equipment with components controlled by electrical means, e.g. electronic timing, may also need to comply with IEC 60601-1. This part of ISO 10079 does not apply to electrically powered suction equipment, whether mains electricity or battery-powered, which is dealt with in ISO 10079-1, nor to manually powered suction equipment which is dealt with in ISO 10079-2, nor to the following: a) central power supply (by vacuum/compressed air generation), piping systems of vehicles and buildings, and wall connectors; b) catheter tubes, drains, curettes and suction tips; c) syringes; d) dental suction equipment; e) waste gas scavenging systems; f) laboratory suction; g) autotransfusion systems; h) passive urinary drainage; i) closed systems for wound drainage; j) gravity gastric drainage; k) orally operated mucous extractors; l) suction equipment where the collection container is downstream of the vacuum pump; m) equipment marked as suction unit for permanent tracheostomy; n) ventouse (obstetric) equipment; o) neonatal mucous extractors; p) breast pumps; q) liposuction; r) uterine aspiration.

Medizinische Absauggeräte - Teil 3: Vakuum- oder druckquellenbetriebene Absauggeräte (ISO 10079-3:1999)

Appareils d'aspiration médicale - Partie 3: Appareils d'aspiration alimentés par une source de vide ou de pression (ISO 10079-3:1999)

La présente partie de l'ISO 10079 spécifie les prescriptions de sécurité et de performance relatives aux appareils d'aspiration médicale alimentés par une source de vide ou de pression. Elle est applicable en particulier aux raccordements des canalisations et des systèmes venturi. Les éléments des appareils d'aspiration à commande électrique, par exemple une minuterie électronique, peuvent, en outre, être obligés de répondre aux prescriptions de la CEI 60601 -1. La présente partie de l'ISO 10079 n'est applicable ni aux appareils électriques d'aspiration, qu'ils soient alimentés sur secteur ou sur batterie, lesquels sont traités dans l'ISO 10079-1, ni aux appareils d'aspiration manuelle, lesquels sont traités dans l'ISO 10079-2, ni aux éléments énumérés ci-après: a) les alimentations motrices à partir d'une centrale (air comprimé/aspiration), les systèmes de canalisations des véhicules et bâtiments, ainsi que les raccords muraux; b) les sondes d'aspiration, les drains, les curettes et les embouts d'aspiration; c) les seringues; d) les appareils dentaires d'aspiration; e) les systèmes d'évacuation des gaz; f) l'aspiration en laboratoire; g) les systèmes d'autotransfusion; h) le drainage urinaire passif; i) les systèmes clos pour drainage des plaies; j) le drainage gastrique par gravité; k) les extracteurs de mucosité par voie orale; 1) les appareils d'aspiration dont le bocal de recueil est en aval de la pompe à vide; m) les appareils indiqués comme unités d'aspiration pour la trachéotomie permanente; n) les appareils avec ventouse (obstétrique); o) les extracteurs de mucosités pour nouveau-nés; p) les pompes tire-lait; q) la liposuccion; r) l'aspiration utérine.

Medicinska sukcijska (aspiracijska) oprema - 3. del: Podtlačna ali tlačna sukcijska (aspiracijska) oprema (ISO 10079-3:1999)

General Information

• Status: Withdrawn
• Publication Date: 11-May-2009
• Withdrawal Date: 04-Jun-2014
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 05-Jun-2014
• Due Date: 28-Jun-2014
• Completion Date: 05-Jun-2014
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN ISO 10079-3:2009 - Medical suction equipment - Part 3: Suction equipment powered from a vacuum or pressure source (ISO 10079-3:1999)

Relations

• Replaced By: SIST EN ISO 10079-3:2014 - Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2014)
• Effective Date: 01-Jul-2014
• Replaces: SIST EN ISO 10079-3:2000 - Medical suction equipment - Part 3: Suction equipment powered from vacuum or pressure source (ISO 10079-3:1999)
• Effective Date: 01-May-2009

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10079-3:2009
01-junij-2009
1DGRPHãþD
SIST EN ISO 10079-3:2000
0HGLFLQVNDVXNFLMVNDDVSLUDFLMVNDRSUHPDGHO3RGWODþQDDOLWODþQDVXNFLMVND
DVSLUDFLMVNDRSUHPD,62
Medical suction equipment - Part 3: Suction equipment powered from a vacuum or
pressure source (ISO 10079-3:1999)
Medizinische Absauggeräte - Teil 3: Vakuum- oder druckquellenbetriebene
Absauggeräte (ISO 10079-3:1999)
Appareils d'aspiration médicale - Partie 3: Appareils d'aspiration alimentés par une
source de vide ou de pression (ISO 10079-3:1999)
Ta slovenski standard je istoveten z: EN ISO 10079-3:2009
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 10079-3:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10079-3:2009

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SIST EN ISO 10079-3:2009
EUROPEAN STANDARD
EN ISO 10079-3
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2009
ICS 11.040.10 Supersedes EN ISO 10079-3:1999
English Version
Medical suction equipment - Part 3: Suction equipment powered
from a vacuum or pressure source (ISO 10079-3:1999)
Appareils d'aspiration médicale - Partie 3: Appareils Medizinische Absauggeräte - Teil 3: Vakuum- oder
d'aspiration alimentés par une source de vide ou de druckquellenbetriebene Absauggeräte (ISO 10079-3:1999)
pression (ISO 10079-3:1999)
This European Standard was approved by CEN on 24 February 2009.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10079-3:2009: E
worldwide for CEN national Members.

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SIST EN ISO 10079-3:2009
EN ISO 10079-3:2009 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4

2

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SIST EN ISO 10079-3:2009
EN ISO 10079-3:2009 (E)
Foreword
The text of ISO 10079-3:1999 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and
respiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as
EN ISO 10079-3:2009 by 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 September 2009, and conflicting national standards shall be
withdrawn at the latest by March 2010.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 10079-3:1999.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EC Directives.
For relationship with EC Directives, see informative Annex ZA, which is an integral part of this document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 10079-3:1999 has been approved by CEN as a EN ISO 10079-3:2009 without any
modification.
3

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SIST EN ISO 10079-3:2009
EN ISO 10079-3:2009 (E)
Annex ZA
(informative)

Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.

Table ZA.1 - Correspondence between this European Standard and EU Directives

Clause(s)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
EN of Directive 93/42/EEC
All 1
4.1, 4.2, 4.3, 4.4 4, 8.1
- 6a This relevant Essential
Requirement is not addressed in
this European Standard
st
5, 6 7.5 (1 paragraph) This relevant Essential
Requirement is not fully addressed
in this European Standard
5 1, 2, 3
5.1.1 9.1
5.1.2 9.2
5.1.3 9.2, 10.1, 10.2
5.1.4 9.2, 9.3
5.1.5 9.1
6 1, 2, 3, 9.2
6.1 7.2, 7.5, 8.1
6.2 7.2
6.3 4, 7.6, 9.2
6.4 9.1

4

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SIST EN ISO 10079-3:2009
EN ISO 10079-3:2009 (E)
Table ZA.1 - Correspondence between this European Standard and EU Directives (continued)

Clause(s)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
EN of Directive 93/42/EEC
6.5 2
6.5.1 12.8.2
6.5.2 8.1
6.5.3 7.2, 7.5, 12.8.2
6.5.4 12.6, 12.8.2, 13.2
6.6 10.1
6.6.1 bis 6.6.8 12.9
6.7 4
6.8 4, 7.6, 9.2, 12.7.1
6.9 4, 9.2
6.10 4, 7.2, 7.5, 9.2, 12.7.1
6.11 12.7.3
7 3
7.1, 7.2 9.2, 12.7.1
8 3
9.1, 9.2 9.1, 12.7.4
10 10.1, 12.8.1
11.1 4, 9.2
11.2 5, 9.2
12 9.1, 13.1
12 7.5 (2nd paragraph) This relevant Essential
Requirement is not fully addressed
in this European Standard
12.1 13.3 (a): This relevant Essential
Requirement is not fully addressed
in this European Standard
12.1 13.3 (f) This relevant Essential
Requirement is not fully addressed
in this European Standard
5

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SIST EN ISO 10079-3:2009
EN ISO 10079-3:2009 (E)
Table ZA.1 - Correspondence between this European Standard and EU Directives (continued)

Clause(s)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
EN of Directive 93/42/EEC
13 9.1, 13, 13.1
13 7.5 (3rd paragraph) This relevant Essential
Requirement is not fully addressed
in this European Standard
13 13.6 (h)(2nd paragraph) This relevant Essential
Requirement is not fully addressed
in this European Standard
13 13.6 (q) This relevant Essential
Requirement is not addressed in
this European Standard: covered
by EN ISO 13485: 2003, subclause
4.2.3

6

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SIST EN ISO 10079-3:2009
EN ISO 10079-3:2009 (E)

For devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC on Machinery,
in accordance with Article 3 of Directive 93/42/EEC the following table ZA.2 details the relevant essential
requirements of Directive 2006/42/EC on Machinery to the extent to which they are more specific than those
of Directive 93/42/EEC along with the corresponding clauses of this European Standard. Table ZA.2,
however, does not imply any citation in the OJEU under the machinery directive and thus does not provide
presumption of conformity for the machinery directive.
Table ZA.2 – Relevant Essential Requirements from Directive 2006/42/EC on
machinery that are addressed by this European Standard
(according to article 3 of amended Directive 93/42/EEC)

Clause(s)/sub-clause(s) of Essential Health and Safety Qualifying remarks/Notes
this EN Requirements (EHSRs) of
Directive 2006/42/EC
- 1.2.2 This relevant EHSR is not addressed in
this European Standard
- 1.5.4 This relevant EHSR is not fully
addressed in this European Standard
- 1.6.1 This relevant EHSR is not addressed in
this European Standard
- 1.6.2 This relevant EHSR is not addressed in
this European Standard
- 1.6.3 This relevant EHSR is not addressed in
this European Standard
- 3.4.5 This relevant EHSR is not addressed in
this European Standard
- 3.6.2 This relevant EHSR is not addressed in
this European Standard

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


7

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SIST EN ISO 10079-3:2009

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SIST EN ISO 10079-3:2009
INTERNATIONAL ISO
STANDARD 10079-3
Second edition
1999-08-15
Medical suction equipment —
Part 3:
Suction equipment powered from a vacuum or
pressure source
Appareils d'aspiration médicale —
Partie 3: Appareils d'aspiration alimentés par une source de vide ou de
pression
A
Reference number
ISO 10079-3:1999(E)

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SIST EN ISO 10079-3:2009
ISO 10079-3:1999(E)
Contents
1 Scope .1
2 Normative references .2
3 Terms and definitions .3
4 Cleaning, disinfection and sterilization.3
5 Design requirements .3
6 Operational requirements .4
7 Physical requirements.7
8 Performance requirements for vacuum and flowrate .7
9 Gas supply.8
10 Vacuum regulator .8
11 Resistance to environment.9
12 Marking .9
13 Information to be supplied by manufacturer .10
Annex A (normative) Test methods.11
©  ISO 1999
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced
or utilized in any form or by any means, electronic or mechanical, including photocopying and
microfilm, without permission in writing from the publisher.
International Organization for Standardization
Case postale 56 • CH-1211 Genève 20 • Switzerland
Internet [e-mail]
Printed in Switzerland
ii

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SIST EN ISO 10079-3:2009
© ISO
ISO 10079-3:1999(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.
Draft International Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.
International Standard ISO 10079-3 was prepared by Technical Committee ISO/TC 121, Anaesthetic and
respiratory equipment, Subcommittee SC 8, Suction devices for hospital and emergency care use.
This second edition cancels and replaces the first edition (ISO 10079-3:1992), which has been technically revised.
ISO 10079 consists of the following parts, under the general title Medical suction equipment:
 Part 1: Electrically powered suction equipment — Safety requirements
 Part 2: Manually powered suction equipment
 Part 3: Suction equipment powered from a vacuum or pressure source
Annex A forms a normative part of this part of ISO 10079.
iii

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SIST EN ISO 10079-3:2009

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SIST EN ISO 10079-3:2009
INTERNATIONAL STANDARD  © ISO ISO 10079-3:1999(E)
Medical suction equipment —
Part 3:
Suction equipment powered from a vacuum or pressure source
1 Scope
This part of ISO 10079 specifies safety and performance requirements for medical suction equipment powered from
a vacuum or pressure source (see Figure 1). In particular it applies to connections for pipelines and Venturi
attachments.
Suction equipment with components controlled by electrical means, e.g. electronic timing, may also need to comply
with IEC 60601-1.
This part of ISO 10079 does not apply to electrically powered suction equipment, whether mains electricity or
battery-powered, which is dealt with in ISO 10079-1, nor to manually powered suction equipment which is dealt with
in ISO 10079-2, nor to the following:
a) central power supply (by vacuum/compressed air generation), piping systems of vehicles and buildings, and
wall connectors;
b) catheter tubes, drains, curettes and suction tips;
c) syringes;
d) dental suction equipment;
e) waste gas scavenging systems;
f) laboratory suction;
g) autotransfusion systems;
h) passive urinary drainage;
i) closed systems for wound drainage;
j) gravity gastric drainage;
k) orally operated mucous extractors;
l) suction equipment where the collection container is downstream of the vacuum pump;
m) equipment marked as suction unit for permanent tracheostomy;
n) ventouse (obstetric) equipment;
o) neonatal mucous extractors;
p) breast pumps;
q) liposuction;
r) uterine aspiration.
1

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SIST EN ISO 10079-3:2009
© ISO
ISO 10079-3:1999(E)
Key
1 Vacuum indicator
2 Filter
3 Collection container
4 Vacuum regulator
NOTE 1 ISO 10079-1 applies to mains electricity and battery-powered suction equipment. ISO 10079-2 applies to manually
powered suction equipment. ISO 10079-3 applies to suction equipment powered from a vacuum or pressure source.
NOTE 2 Components illustrated are not necessarily required by this part of ISO 10079.
NOTE 3 Suction equipment shown is an example only, and actual systems may consist of other arrangements and
components not illustrated.
Figure 1 — Schematic drawing of suction equipment
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of
this part of ISO 10079. For dated references, subsequent amendments to, or revisions of, any of these publications
do not apply. However, parties to agreements based on this part of ISO 10079 are encouraged to investigate the
possibility of applying the most recent editions of the normative documents indicated below. For undated
references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain
registers of currently valid International Standards.
ISO 3744:1994, Acoustics — Determination of sound power levels of noise sources — Engineering methods for
free-field conditions over a reflecting plane.
ISO 5356-1:1996, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets.
ISO 5359:1989, Low-pressure flexible connecting assemblies (hose assemblies) for use with medical gas systems.
2

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SIST EN ISO 10079-3:2009
© ISO
ISO 10079-3:1999(E)
ISO 8836:1997, .
Suction catheters for use in the respiratory tract
ISO 10079-1:1999, Medical suction equipment — Part 1: Electrically powered suction equipment — Safety
requirements.
IEC 60601-1:1988, Medical electrical equipment — Part 1: General requirements for safety; Amd. 1:1991 and
Amd. 2:1995.
IEC 60651:1979, Sound pressure meters.
3 Terms and definitions
For the purposes of this part of ISO 10079, the terms and definitions given in ISO 10079-1 apply.
4 Cleaning, disinfection and sterilization
4.1  Any filters installed shall either be of the single-use type or be capable of being cleaned, disinfected and/or
sterilized for re-use.
4.2  Equipment with filters intended for re-use shall comply with the requirements given in 8.1 to 8.7, as
appropriate, after the filters have been subjected to 30 cycles of sterilization as recommended by the manufacturer.
4.3  Suction tubing shall either be for single use or be capable of being cleaned, disinfected and/or sterilized as
recommended by the manufacturer.
4.4  Suction equipment incorporating a re-usable collection container assembly shall comply with the requirements
given in 8.1 to 8.7, as appropriate, before and after the collection container has been subjected to 30 cycles of
cleaning, disinfection and/or sterilization as recommended by the manufacturer.
5 Design requirements
NOTE The constructional requirements may deviate from those detailed in this part of ISO 10079 if an equivalent degree of
safety can be achieved.
5.1 Collection container
5.1.1  The inlet of the collection container shall have an inside diameter of not less than 6 mm and not less than the
maximum inside diameter of the suction tubing recommended by the manufacturer. The inlet shall not be
compatible with any conical connector specified in ISO 5356-1.
5.1.2  For suction equipment solely for field use which is intended to continue operating when the collection
container is full, the volume of the collection container shall be not less than 200 ml. For other suction equipment
intended solely for field use, the usable volume of the collection container shall be not less than 300 ml. For all other
suction equipment, including suction equipment intended for field and/or transport use, the usable volume of the
collection container shall be not less than 500 ml.
NOTE "Field use" of suction equipment is intended to cover use in situations outside of the health care facility at the site of
accidents or other emergencies. The use of suction equipment in these situations may expose the equipment to water
(including rain), dirt, uneven support, mechanical shock and extremes of temperature. “Transport use” of suction equipment is
intended to cover situations outside of the health care facility such as in ambulances, cars or airplanes. Use of suction
equipment in these situations may expose the equipment to uneven support, dirt, mechanical shock and a wider range of
temperature than normally found in health care facilities.
5.1.3  For suction equipment not intended for field use, one or more collection containers recommended by the
manufacturer and either for single-use or of a re-usable type, shall be used. For all collection containers, the level of
the contents shall be clearly visible in the position of normal use. The collection container shall be marked with its
usable volume, expressed in millilitres. For collection containers having a capacity of 500 ml or greater, an
3

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SIST EN ISO 10079-3:2009
© ISO
ISO 10079-3:1999(E)
approximate indication of the volume of the contents shall be given by graduations. The intervals of the graduation
should not be less than 50 ml and not more than 250 ml.
5.1.4  The collection container shall not implode, crack or permanently deform when tested in accordance with A.2.
Following this test, the suction equipment shall meet the requirements of 6.1, 6.3 and 8.1 to 8.7, as appropriate.
5.1.5  The connectors for the suction tubing and the intermediate tubing shall be designed to facilitate correct
assembly or marked to indicate correct assembly when all parts are mated. Compliance shall be checked by
inspection.
NOTE Incorrect connections have frequently been a cause of spillover into the vacuum source and/or a loss of suction.
5.2 Suction tubing
5.2.1  When tested in accordance with A.3, the degree of collapse of the suction tubing supplied with the equipment
shall be less than 0,5 throughout its entire length.
5.2.2  The inside diameter of the suction tubing shall be recommended by the manufacturer but shall not be less
than 6 mm.
NOTE Suction performance may be markedly affected by the length and diameter of the tubing between the collection
container and end-piece.
5.3 End-piece
Suction catheters, if supplied or recommended by the manufacturer, shall comply with ISO 8836.
6 Operational requirements
6.1 Overfill protection devices
6.1.1  An overfill protection device shall be provided to prevent fluids entering the intermediate tubing. Suction shall
cease when the overfill protection device operates. When tested in accordance with A.4, not more than 5 ml of fluid
shall pass downstream of the overfill protection device.
NOTE 1 Protective means should be provided to prevent foam passing downstream into the vacuum source.
NOTE 2 An overfill protection device may be an integral part of the suction equipment.
6.1.2  If the overfill protection device is integral with the collection container, when tested in accordance with A.4 it
shall not activate until at least 90 % of the stated capacity of the collection container has been reached.
6.2 Spillage
After testing in accordance with A.5, the suction equipment shall meet the requirements given in 8.1 to 8.7, as
appropriate.
6.3 Air leakage
6.3.1 Collection containers for general use
6.3.1.1  When tested in accordance with A.6.1, for single-use containers, the maximum leakage into the collection
container assembly shall not exceed 200 ml/min if the collection container is intended for use with suction
equipment having a free air flowrate of more than 1 l/min. The pressure increase shall be less than 3,3 kPa/V in
10 s, where V is the total volume, in litres, of the collection container.
6.3.1.2  A re-usable collection container assembly shall meet the requirements given in 6.3.1.1, before and after
being subjected to 30 cycles of cleaning, disinfection and/or sterilization as recommended by the manufacturer.
4

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SIST EN ISO 10079-3:2009
© ISO
ISO 10079-3:1999(E)
6.3.2 Collection containers for thoracic drainage
6.3.2.1  When tested in accordance with A.6.2, no more than three bubbles shall be observed in 10 s.
NOTE Three bubbles in 10 s is a leakage of approximately 4 ml/min.
6.3.2.2  Re-usable collection container assemblies shall meet the requirement given in 6.3.2.1 before and after
being subjected to 30 cycles of cleaning and/or sterilization as recommended by the manufacturer.
NOTE These tests are intended to ensure satisfactory overall performance of the vacuum system when parts are supplied
by different manufacturers.
6.4 Exhaust air
It shall not be possible to connect tubing to any exhaust opening.
6.5 Protective devices
6.5.1 Positive- and negative-pressure protection
6.5.1.1  If a device intended to limit the maximum level of vacuum is fitted, when tested in accordance with A.7, the
vacuum shall not exceed the limit by more than ± 4 kPa.
NOTE In vacuum regulators, a positive-pressure relief valve should be included to prevent positive-pressure buildup at the
patient if misconnected to a positive-pressure source.
6.5.1.2  When tested in accordance with A.8, thoracic drainage systems shall not develop a pressure in excess of
1 kPa.
6.5.2 Filter assembly
6.5.2.1  Any part of a filter assembly which is reusable shall be capable of being cleaned, disinfected and/or
sterilized according to the manufacturer’s instructions, and shall then meet the requirements of 6.1 and 8.1 to 8.7,
as appropriate.
Air leaving the collection container should pass through a microbiological filter before entering the suction
equipment.
6.5.2.2  The filter assembly shall not implode, crack or permanently deform when tested in accordance with A.2.
6.5.3 Anti-blow-back in suction equipment powered by Venturi device
6.5.3.1  In Venturi-powered suction equipment, the device shall not produce a positive pressure of more than 1 kPa
under any single fault condition.
6.5.3.2  When tested in accordance with A.9, a positive pressure of greater than 1 kPa shall not be developed by
occlusion of the Venturi outlet(s).
6.5.4 Electrical protection
When tested in accordance with A.10, suction equipment marked as “CF compatible” shall have an electrical
resistance (impedance) of greater than 10 MV.
6.6 Vacuum indicators
6.6.1  Suction equipment having a vacuum regulator with a variable control shall have a vacuum indicator
displaying the vacuum level on the inlet side of the vacuum regulator.
6.6.2  Analog displays shall have graduations not less than 2 mm apart, each graduation representing not more
than 5 % of the full-scale value.
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SIST EN ISO 10079-3:2009
© ISO
ISO 10079-3:1999(E)
Digital displays shall display vacuum level at intervals of not greater than 2 % of the full-scale value. The
6.6.3
maximum vacuum for which the equipment is designed shall be marked prominently on the display case or
immediately adjacent to it.
6.6.4  All low vacuum equipment shall be fitted with a vacuum indicator between the vacuum source and collection
container.
6.6.5  The full scale of analog vacuum indicators shall be not more than 200 % of the maximum negative pressure
for which the suction equipment is designed.
6.6.6  Vacuum indicators on suction equipment, except as specified in 6.6.7, shall be accurate to within ± 5 % of
the full-scale value.
6.6.7  Vacuum indicators on suction equipment intended for thoracic drainage shall be accurate to within ± 5 % of
the full-scale value in the middle three-fifths of the indicator range.
6.6.8  All markings on the vacuum indicator shall be legible to an operator having visual acuity, corrected if
necessary, of at least 1,0, seated or standing 1 m from the vacuum indicator at an illuminance of 215 lx of white
(simulated day-) light.
NOTE Movement of a rotary analog vacuum indicator should be anticlockwise for an increase in vacuum.
6.7 Dismantling and reassembly
Suction equipment intended to be dismantled by the user (for example, for cleaning) shall be designed so as to
minimize incorrect reassembly when all parts are mated. After dismantling and reassembly, the suction equipment
shall meet the requirements given in 6.1, 6.3 and 8.1 to 8.7, as appropriate.
6.8 Mechanical shock
After suction equipment intended for field and/or transport use has been drop-tested in accordance with A.11, it
shall meet the requirements given in 6.1, 6.3 and 8.1 to 8.7, as appropriate.
If the suction equipment can be operated outside of its carrying case, it shall meet the requirements given in 6.1 and
8.1 to 8.7, as appropriate, after the individual parts of the suction equipment, exclu
...