EN ISO 10079-2:2009

SLOVENSKI STANDARD
01-maj-2009
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SIST EN ISO 10079-2:2000
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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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4

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
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.
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
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
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.
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)
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 iso@iso.ch
Printed in Switzerland
ii
© 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.
iii
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.
© 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-po
...