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)

ISO 10079-3:2014 specifies safety and performance requirements for medical suction equipment powered from a vacuum or positive pressure gas source generating venturi suction. It applies to equipment connected to medical gas pipeline systems or cylinders and venturi attachments.
The equipment can be stand-alone or part of an integrated system.

Medizinische Absauggeräte - Teil 3: Vakuum- oder druckquellenbetriebene Absauggeräte (ISO 10079-3:2014)

Dieser Teil von ISO 10079 legt Anforderungen für die Sicherheit und für die Leistung von vakuum- oder druckquellenbetriebenen medizinischen Absauggeräten fest. Er gilt für Geräte, die an Rohrleitungssysteme für medizinische Gase oder Gasflaschen und Saugdüsen-Zubehör angeschlossen sind. Anhang D stellt die drei Teile von ISO 10079 dar, in dem eine schematische Darstellung der typischen Systeme angegeben wird.
Die Geräte können eigenständige Geräte oder Teil eines integrierten Systems sein.
Zusätzliche Anforderungen an Absauggeräte zur Verwendung im Freien und/oder beim Transport sind in diesem Teil von ISO 10079 enthalten.
Dieser Teil von ISO 10079 gilt nicht für Folgendes:
a) zentrale Leistungsversorgung (durch Erzeugung von Vakuum/Druckluft), Rohrleitungssysteme von Fahrzeugen und Gebäuden sowie Wandanschlüsse;
b) Endstücke wie Absaugkatheter, Yankauer-Sauger und Absaugtüllen;
c) Spritzen;
d) zahnmedizinische Absauggeräte;
e) Anästhesiegas-Fortleitungssysteme;
f) Laborabsaugung;
g) Autotransfusionssysteme;
h) geschlossene Systeme für Wunddrainage;
i) mundbetriebene Schleimabsauger, einschließlich Schleimabsauger für Neugeborene;
j) Geräte für Geburtshilfe;
k) Milchpumpen;
l) Fettabsaugung;
m) Absaugung aus dem Uterus;
n) Rauchgasabsaugsysteme.

Appareils d'aspiration médicale - Partie 3: Appareils d'aspiration alimentés par une source de vide ou de pression (ISO 10079-3:2014)

L'ISO 10079-3:2013 spécifie les exigences de sécurité et de performance relatives aux appareils d'aspiration médicale alimentés par une source de vide ou de gaz à pression positive générant une aspiration Venturi. Elle est applicable aux appareils raccordés à des bouteilles ou des systèmes de distribution de gaz médicaux et aux systèmes venturi.
L'appareil peut être autonome ou faire partie d'un système intégré.

Medicinska sukcijska (aspiracijska) oprema - 3. del: Podtlačna ali tlačna sukcijska (aspiracijska) oprema (ISO 10079-3:2014)

EN ISO 10079-3 določa zahteve glede varnosti in učinkovitosti za medicinsko podtlačno ali tlačno sukcijsko (aspiracijsko) opremo. Velja za opremo, ki je povezana s sistemi napeljav za medicinske pline ali jeklenkami in priključki venturijeve cevi. Priloga D s shematskim prikazom tipičnih sistemov prikazuje tri dele ISO 10079. Oprema je lahko samostojen sistem ali del integriranega sistema. Dodatne zahteve za sukcijsko (aspiracijsko) opremo, ki je namenjena uporabi na prostem in/ali med prevozom, so vključene v ta del standarda ISO 10079. Ta del standarda ISO 10079 ne velja za naslednje: a) centralno oskrbo z električno energijo (ustvarjeno z vakuumom ali stisnjenim zrakom), cevne sisteme vozil in stavb ter stenske priključke; b) zaključke, kot so aspiracijski katetri, aspiracijske cevke Yankauer in konice za sukcijo; c) injekcijske brizge; d) opremo za zobno sukcijo; e) sisteme za odstranjevanje anestezijskih plinov in hlapov; f) laboratorijsko sukcijo; g) sisteme za avtotransfuzijo; h) zaprte sisteme za drenažo rane; i) ekstrakcijske aparate za sluz, vključno z ekstrakcijskimi aparati za sluz za novorojenčke; j) opremo za vakuumsko ekstrakcijo (porodna oprema); k) prsne črpalke; l) liposukcijo; m) endometrijsko aspiracijo; n) sisteme za odvod dima.

General Information

• Status: Withdrawn
• Publication Date: 06-May-2014
• Withdrawal Date: 24-May-2022
• 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
• Completion Date: 25-May-2022
• 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 10079-3:2014 - Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2014)

Relations

• Replaces: EN ISO 10079-3:2009 - Medical suction equipment - Part 3: Suction equipment powered from a vacuum or pressure source (ISO 10079-3:1999)
• Effective Date: 28-May-2014
• Replaced By: EN ISO 10079-3:2022 - Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2022)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2014
1DGRPHãþD
SIST EN ISO 10079-2:2009
SIST EN ISO 10079-3:2009
0HGLFLQVNDVXNFLMVNDDVSLUDFLMVNDRSUHPDGHO3RGWODþQDDOLWODþQDVXNFLMVND
DVSLUDFLMVNDRSUHPD,62
Medical suction equipment - Part 3: Suction equipment powered from a vacuum or
positive pressure gas source (ISO 10079-3:2014)
Medizinische Absauggeräte - Teil 3: Vakuum- oder druckquellenbetriebene
Absauggeräte (ISO 10079-3:2014)
Appareils d'aspiration médicale - Partie 3: Appareils d'aspiration alimentés par une
source de vide ou de pression (ISO 10079-3:2014)
Ta slovenski standard je istoveten z: EN ISO 10079-3:2014
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
May 2014
ICS 11.040.10 Supersedes EN ISO 10079-3:2009
English Version
Medical suction equipment - Part 3: Suction equipment powered
from a vacuum or positive pressure gas source (ISO 10079-
3:2014)
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 10079-3:2014)
pression (ISO 10079-3:2014)
This European Standard was approved by CEN on 15 February 2014.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10079-3:2014 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
This document (EN ISO 10079-3:2014) 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 DIN.
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 November 2014, and conflicting national standards shall be withdrawn
at the latest by May 2017.
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 10079-3:2009.
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 EU Directive.
For relationship with EU Directive, 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, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 10079-3:2014 has been approved by CEN as EN ISO 10079-3:2014 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
Directive 93/42/EEC.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the normative 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 relevant Essential Requirements of that Directive.
NOTE When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC
Essential
Clause(s) / sub-
Requirements (ERs) of Qualifying remarks/notes
clause(s) of this EN
Directive 93/42/EEC
4.1, 4.4, 12 t) 7.1 Partly covered
There are no requirements for materials apart from a
requirement to perform a risk assessment and to
disclose the presence of latex.
As these devices are only for extracting body fluids
toxicity and biological compatibility is not considered
a risk.
4.1, 5, 7.5, 7.5.2, 7.7 7.2
4.1, 4.2, 5 7.3 Only the first part of this ER is covered
7.5.1, 7.5.2 8.1
4.1, 6.3, 6.5 9.1
4.1, 10 9.2 Only covered as far as temperature is concerned
7.4 12.7.1 Only covered as far as stability is concerned
7.6 12.7.3
6.5 12.7.4
11, 12 13.1
11.2 a) 13.3 a)
11.2 b) 13.3 b)
11.2 c) 13.3 c)
11.2 d) 13.3 d)
11.2 e) 13.3 e)
11.2 f) 13.3 f)
12 b) 13.4 Partly covered: disclosure of the intended purpose is
included in the Instructions for use but not the
labelling.
12 13.6a) Covered for the items in 13.3 a), b), c), f), i) and k)
12 b), c), d), f),g), h), j), 13.6 b)
k), o), t), u)
12 k) 13.6 c)
12 b), c), d), h), j), v) 13.6 d)
12 i) 13.6 h) First two paragraphs only
12 d) 13.6 i)
12 z) 13.6 q)
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
Third edition
2014-05-01
Medical suction equipment —
Part 3:
Suction equipment powered from
a vacuum or positive pressure gas
source
Appareils d’aspiration médicale —
Partie 3: Appareils d’aspiration alimentés par une source de vide ou
de pression
Reference number
ISO 10079-3:2014(E)
©
ISO 2014
ISO 10079-3:2014(E)
© ISO 2014
All rights reserved. Unless otherwise specified, 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
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ii © ISO 2014 – All rights reserved

ISO 10079-3:2014(E)
Contents Page
Foreword .v
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 investigation . 5
4.4 Biophysical or modelling research . 6
5 Cleaning, disinfection and sterilization . 6
6 Design requirements . 6
6.1 Collection container. 6
6.2 Connections . 7
6.3 Suction tubing . 7
6.4 Vacuum level indicators . 7
6.5 Supply connections . 8
7 Operational requirements . 8
7.1 Ease of operation . 8
7.2 Dismantling and reassembly . 8
7.3 Mechanical shock . 8
7.4 Stability . 9
7.5 Protective devices . 9
7.6 Noise . 9
7.7 Air leakage .10
8 Physical requirements for field and transport use suction equipment .10
8.1 (*)Dimensions .10
8.2 Mass .10
9 Performance requirements for vacuum level and flowrate .11
9.1
...