SIST EN ISO 10079-2:2009

Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:1999)

This part of ISO 10079 specifies safety and performance requirements for manually powered medical suction equipment intended for oro-pharyngeal suction. It covers equipment operated by foot or by hand or both (see Figure 1). Non-electrical suction equipment which may be integrated with electrical equipment is included in the scope of this part of ISO 10079. 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 suction equipment powered from a vacuum or pressure source which is dealt with in ISO 10079-3, nor to the following:
a) central power supply (by vacuum/compressed air generation), piping systems of vehicles and buildings, and wall connectors;
b) cathether 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;
s) thoracic drainage.

Medizinische Absauggeräte - Teil 2: Handbetriebene Absauggeräte (ISO 10079-2:1999)

Appareils d'aspiration médicale - Partie 2: Appareils d'aspiration manuelle (ISO 10079-2:1999)

La présente partie de l'ISO 10079 spécifie les prescriptions de sécurité et de performance relatives aux appareils d'aspiration médicale manuelle servant à l'aspiration oro-pharyngée. Elle traite des appareils actionnés avec le pied ou avec la main ou avec les deux. Les appareils non électriques d'aspiration pouvant être intégrés à des appareils électriques entrent dans le domaine d'application de la présente partie de l'ISO 10079. La présente partie de l'ISO 10097 n'est applicable ni aux appareils électriques d'aspiration, qu'ils soient alimentés sur secteur ou par batterie, lesquels sont traités dans l'ISO 10079-1, ni aux appareils d'aspiration alimentés par une source de vide ou de pression, lesquels sont traités dans l'ISO 10079-3, 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; l) 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; s) le drainage thoracique.

Medicinska sukcijska (aspiracijska) oprema - 2. del: Ročna sukcijska (aspiracijska) oprema (ISO 10079-2:1999)

General Information

• Status: Withdrawn
• Publication Date: 19-Apr-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 10079-2:2009 - Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:1999)

Relations

• Replaced By: SIST EN ISO 10079-2:2014 - Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2014)
• Effective Date: 01-Jul-2014
• Replaced By: SIST EN ISO 10079-2:2014 - Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2014)
• Effective Date: 08-Jun-2022
• Replaces: SIST EN ISO 10079-2:2000 - Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:1999)
• Effective Date: 01-May-2009

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10079-2:2009
01-maj-2009
1DGRPHãþD
SIST EN ISO 10079-2:2000
0HGLFLQVNDVXNFLMVNDDVSLUDFLMVNDRSUHPDGHO5RþQDVXNFLMVNDDVSLUDFLMVND
RSUHPD,62
Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-
2:1999)
Medizinische Absauggeräte - Teil 2: Handbetriebene Absauggeräte (ISO 10079-2:1999)
Appareils d'aspiration médicale - Partie 2: Appareils d'aspiration manuelle (ISO 10079-
2:1999)
Ta slovenski standard je istoveten z: EN ISO 10079-2:2009
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 10079-2:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10079-2:2009

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SIST EN ISO 10079-2:2009
EUROPEAN STANDARD
EN ISO 10079-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2009
ICS 11.040.10 Supersedes EN ISO 10079-2:1999
English Version
Medical suction equipment - Part 2: Manually powered suction
equipment (ISO 10079-2:1999)
Appareils d'aspiration médicale - Partie 2: Appareils Medizinische Absauggeräte - Teil 2: Handbetriebene
d'aspiration manuelle (ISO 10079-2:1999) Absauggeräte (ISO 10079-2:1999)
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 10079-2:2009: E
worldwide for CEN national Members.

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SIST EN ISO 10079-2:2009
EN ISO 10079-2:2009 (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 10079-2:2009
EN ISO 10079-2:2009 (E)
Foreword
The text of ISO 10079-2:1999 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 10079-2:2009 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 10079-2:1999.
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 10079-2:1999 has been approved by CEN as a EN ISO 10079-2:2009 without any
modification.
3

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SIST EN ISO 10079-2:2009
EN ISO 10079-2:2009 (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
Essential Requirements (ERs) of Qualifying remarks/Notes
this EN
Directive 93/42/EEC
1, 2, 6
All
4.1, 4.2, 4.3, 4.4 4, 8.1
5 1, 2, 3
5.1, 5.2 9.1
5.2.2 9.2
6 1, 2, 3, 9.2
6.1 9.2
4

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SIST EN ISO 10079-2:2009
EN ISO 10079-2:2009 (E)

Clause(s)/sub-clause(s) of Essential Requirements (ERs) Qualifying remarks/Notes
this EN of Directive 93/42/EEC
6.2 4, 8.1, 9.2
6.3 4, 7.6, 9.2, 12.7.1
6.4 4, 7.6
6.5 4, 7.2, 7.5, 9.2, 12.7.1
6.6 7.2, 8.1, 12.8.2
6a This relevant Essential Requirement is not
addressed in this European Standard
st
6.6 7.5 (1 paragraph) This relevant Essential Requirement is not
fully addressed in this European Standard
nd
- 7.5 (2 paragraph) This relevant Essential Requirement is not
fully addressed in this European Standard
rd
- 7.5 (3 paragraph) This relevant Essential Requirement is not
fully addressed in this European Standard
6.6.1, 6.6.2 7.5
6.7 10.1, 10.2, 10.3, 12.8.2, 12.9
6.7.1, 6.7.2, 6.7.3 10.2
7.1, 7.2, 7.3 9.2
5

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SIST EN ISO 10079-2:2009
EN ISO 10079-2:2009 (E)

Clause(s)/sub-clause(s) of Essential Requirements (ERs) Qualifying remarks/Notes
this EN of Directive 93/42/EEC
7.3.3 10.1, 10.2, 10.3
7.3.4 9.2, 12.8.2
8.1, 8.2, 8.3 12.8.1
9.1 4, 9.2
9.2 4, 5
10 d), 10 e), 11 a) b) e) i) o) 9.1
10 a) d) e) 12.9
10, 11 13
10 13.3 (a): This relevant Essential Requirement is not
fully addressed in this European Standard
11 13.3 (f) This relevant Essential Requirement is not
fully addressed in this European Standard
nd
11 13.6 (h)(2 paragraph) This relevant Essential Requirement is not
fully addressed in this European Standard
11 13.6 (q) This relevant Essential Requirement is not
addressed in this European Standard:
covered by EN ISO 13485: 2003,
subclause 4.2.3

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
6

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SIST EN ISO 10079-2:2009
INTERNATIONAL ISO
STANDARD 10079-2
Second edition
1999-08-15
Medical suction equipment —
Part 2:
Manually powered suction equipment
Appareils d'aspiration médicale —
Partie 2: Appareils d'aspiration manuelle
A
Reference number
ISO 10079-2:1999(E)

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SIST EN ISO 10079-2:2009
ISO 10079-2:1999(E)
Contents
1 Scope .1
2 Normative references .2
3 Terms and definitions .3
4 Cleaning and sterilization .3
5 Design requirements .3
6 Operational requirements .4
7 Physical requirements.5
8 Performance requirements for vacuum and flowrate .6
9 Resistance to environment.6
10 Marking .7
11 Information to be supplied by manufacturer .7
Annex A (normative) Test methods.8
Annex B (informative) Table of typical ranges of volume for collection containers for specific uses.12
Annex C (informative) Rationale statement.13
©  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 10079-2:2009
© ISO
ISO 10079-2:1999(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 10079-2 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 10079-2:1992), 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 vacuum or pressure source
Annex A forms a normative part of this part of ISO 10079. Annexes B and C are for information only.
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SIST EN ISO 10079-2:2009

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SIST EN ISO 10079-2:2009
INTERNATIONAL STANDARD  © ISO ISO 10079-2:1999(E)
Medical suction equipment —
Part 2:
Manually powered suction equipment
1 Scope
This part of ISO 10079 specifies safety and performance requirements for manually powered medical suction
equipment intended for oro-pharyngeal suction. It covers equipment operated by foot or by hand or both (see
Figure 1). Non-electrical suction equipment which may be integrated with electrical equipment is included in the
scope of this part of ISO 10079.
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 suction equipment powered from a vacuum or pressure
source which is dealt with in ISO 10079-3, nor to the following:
a) central power supply (by vacuum/compressed air generation), piping systems of vehicles and buildings, and
wall connectors;
b) cathether 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;
s) thoracic drainage.
1

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SIST EN ISO 10079-2:2009
© ISO
ISO 10079-2:1999(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 which are not illustrated.
Figure 1 — Examples 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 5356-1:1996, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets.
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.
2

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SIST EN ISO 10079-2:2009
© ISO
ISO 10079-2:1999(E)
3 Terms and definitions
For the purposes of this part of ISO 10079, the terms and definitions given in ISO 10079-1 and the following apply.
3.1
manually powered vacuum
manually generated vacuum
generation of vacuum by human effort with a hand or foot or both
3.2
transportable equipment
equipment which is intended to be easily moved from one place to another, whether or not connected to the vacuum
supply, without an appreciable restriction of range
4 Cleaning and sterilization
The suction equipment shall meet the requirements given in 8.1 to 8.3 after those components which are
4.1
subject to contamination and which are intended for re-use have been submitted to 30 cycles of cleaning,
disinfection and/or sterilization as recommended by the manufacturer.
4.2  Any filters installed shall either be of the disposable type or be capable of being cleaned, disinfected and/or
sterilized for re-use in accordance with 4.1.
4.3  Suction equipment incorporating a re-usable collection container assembly shall comply with the requirements
given in 8.1 to 8.3, as appropriate, before and after the collection container assembly has been subjected to 30
cycles of cleaning, disinfection and/or sterilization as recommended by the manufacturer.
4.4  Suction tubing shall either be for single use or be capable of being cleaned, disinfected and/or sterilized as
recommended by the manufacturer.
5 Design requirements
NOTE The constructional requirements may deviate from those detailed in this part of ISO 10079 if the equivalent level of
safety is obtained.
5.1 Connectors
5.1.1 Collection container connectors
The connectors for the suction tubing and the intermediate tubing to the vacuum source shall be designed to
facilitate correct assembly or marked to indicate correct assembly when all parts are mated. Compliance shall be
checked by inspection.
The construction of the connections has frequently been a source of spillover into a vacuum pump. The use of
mechanical fittings so as to ensure correct attachment is highly desirable.
5.1.2 Inside diameter of suction tubing connection
The inside diameter of the suction tubing connection (inlet port) shall be equal to or larger than the inside diameter
of the largest tubing size recommended by the manufacturer.
5.1.3 Exhaust opening
It shall not be possible to connect suction tubing to the exhaust opening.
3

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SIST EN ISO 10079-2:2009
© ISO
ISO 10079-2:1999(E)
5.2 Suction tubing
5.2.1 General
If supplied, suction tubing shall have an inside diameter of not less than 6 mm.
Suction performance may be markedly affected by the length, diameter and degree of collapse of the suction tubing.
When tested in accordance with A.2, 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 Length of suction tubing for foot-operated suction equipment
When the foot-operated vacuum pump is on the floor in the operating position, the length of suction tubing, if
supplied, shall be such that the endpiece can be positioned at least 1,3 m above the floor.
NOTE See also annex C for rationale.
5.3 End-pieces
Suction catheters, if supplied or recommended by the manufacturer, shall comply with ISO 8836.
6 Operational requirements
6.1 Ease of operation
The suction equipment shall be designed to be operated by one person unaided.
6.2 Dismantling and reassembly
Suction equipment intended to be dismantled by the user (for example, for cleaning) shall be designed to facilitate
correct assembly or marked to indicate correct reassembly when all parts are mated. After dismantling, reassembly
and testing in accordance with the manufacturer's instructions, the suction equipment shall meet the requirements
given in 8.1 to 8.3, as appropriate.
6.3 Mechanical shock
After suction equipment intended for field or transport use or both has been drop-tested in accordance with A.3, it
shall meet the requirements given in 8.1 to 8.3, as appropriate.
Field use of suction equipment
...