EN ISO 10079-3:2009

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

2019-02-19 - JO - TC decision 17/2018  (BT N 11332 - BT C160/2018)  to remove this work item from the harmonisation process linked with the MDD (93/42/EEC) thereby removing the need for annex ZA and allowing the standard to be publish without change as EN ISO.

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• Status: Withdrawn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: 03-Mar-2009
• Withdrawal Date: 06-May-2014
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 07-May-2014
• Completion Date: 07-May-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: SIST EN ISO 10079-3:2009 - Medical suction equipment - Part 3: Suction equipment powered from a vacuum or pressure source (ISO 10079-3:1999)

Relations

• Replaces: EN ISO 10079-3:1999 - Medical suction equipment - Part 3: Suction equipment powered from vacuum or pressure source (ISO 10079-3:1999)
• Effective Date: 11-Mar-2009
• Replaced By: 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: 28-May-2014

Standards Content (Sample)

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

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 10079-3:1999 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
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.
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
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
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
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.
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)
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
© 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:
 Pa
...