EN ISO 10079-2:2014

Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2014)

ISO 10079-2:2014 specifies safety and performance requirements for medical, manually powered suction equipment intended for oro-pharyngeal suction. It covers equipment operated by foot or by hand or both. Annex C illustrates the three parts of ISO 10079 by providing a schematic for typical systems.
ISO 10079-2:2014 has additional requirements for suction equipment intended for field use or transport use.

Medizinische Absauggeräte - Teil 2: Handbetriebene Absauggeräte (ISO 10079-2:2014)

Dieser Teil von ISO 10079 legt Anforderungen für die Sicherheit und für die Leistung von handbetriebenen Absauggeräten für oro-pharyngeale Absaugung fest. Er gilt für von Fuß oder Hand oder von beidem betriebene Geräte. Anhang D stellt die drei Teile von ISO 10079 dar, in dem eine schematische Darstellung der typischen Systeme angegeben wird.
Handbetriebene Absaugung wird meistens in Situationen außerhalb von Gesundheitseinrichtungen eingesetzt. Dies wird oft als Verwendung im Freien oder Verwendung beim Transport bezeichnet. Die Verwendung in solchen Fällen kann extreme Wetter- oder Bodenverhältnisse einschließen. 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) Endstücke, wie beispielsweise Absaugkatheter, Yankauer-Sauger und Absaugtüllen;
b) zahnmedizinische Absauggeräte;
c) Schleimabsauger, einschließlich Schleimabsauger für Neugeborene.

Appareils d'aspiration médicale - Partie 2: Appareils d'aspiration manuelle (ISO 10079-2:2014)

L'ISO 10079-2:2013 spécifie les exigences 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. L'Annexe C illustre les trois parties de l'ISO 10079 en fournissant une représentation schématique des systèmes types.
L'ISO 10079-2:2013 comporte des exigences supplémentaires pour les appareils d'aspiration prévus pour un emploi sur le terrain ou en transport.

Medicinska sukcijska (aspiracijska) oprema - 2. del: Ročna sukcijska (aspiracijska) oprema (ISO 10079-2:2014)

EN ISO 10079-2 določa zahteve glede varnosti in učinkovitosti ročne sukcijske (aspiracijske) opreme, ki je namenjena sukciji (aspiraciji) žrela. Velja za opremo, ki se upravlja nožno, ročno ali na oba načina. Priloga D s shematskim prikazom tipičnih sistemov prikazuje tri dele ISO 10079. V situacijah zunaj zdravstvenih ustanov se ročna sukcijska (aspiracijska) oprema običajno uporablja na prostem ali med prevozom. Uporaba lahko v takih primerih vključuje izredne vremenske ali terenske razmere. 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) zaključke, kot so aspiracijski katetri, aspiracijske cevke Yankauer in konice za sukcijo; b) opremo za zobno sukcijo; c) ekstrakcijske aparate za sluz, vključno z ekstrakcijskimi aparati za sluz za novorojenčke.

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 10079-2:2014 - Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2014)

Relations

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

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2014
1DGRPHãþD
SIST EN ISO 10079-2:2009
0HGLFLQVNDVXNFLMVNDDVSLUDFLMVNDRSUHPDGHO5RþQDVXNFLMVNDDVSLUDFLMVND
RSUHPD,62
Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-
2:2014)
Medizinische Absauggeräte - Teil 2: Handbetriebene Absauggeräte (ISO 10079-2:2014)
Appareils d'aspiration médicale - Partie 2: Appareils d'aspiration manuelle (ISO 10079-
2:2014)
Ta slovenski standard je istoveten z: EN ISO 10079-2:2014
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 10079-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2014
ICS 11.040.10 Supersedes EN ISO 10079-2:2009
English Version
Medical suction equipment - Part 2: Manually powered suction
equipment (ISO 10079-2:2014)
Appareils d'aspiration médicale - Partie 2: Appareils Medizinische Absauggeräte - Teil 2: Handbetriebene
d'aspiration manuelle (ISO 10079-2:2014) Absauggeräte (ISO 10079-2:2014)
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 10079-2:2014 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 10079-2:2014) 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 10079-2:2009.
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 10079-2:2014 has been approved by CEN as EN ISO 10079-2:2014 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
Clause(s)/sub- Essential Requirements
clause(s) of this (ERs) of Directive Qualifying remarks/notes
EN 93/42/EEC
4.1, 4.4, 12 s) 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, 6.1.3, 7.5.2 7.2
4.1, 4.2, 5, 6.1.3, 7.3 Only the first part of this ER is covered
7.6, 10
4.1, 5, 6.1.3, 7.5.2 8.1
4.1, 6.2, 6.3, 12 c), 9.1
10 9.2 Only covered as far as temperature is concerned
7.4 12.7.1 Only covered as far as stability is concerned
11, 12 13.1
11.1 13.2
11.2 a) 13.3a)
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)
11.2 k) 13.3 k)
12 b) 13.4 Partly covered: disclosure of the intended purpose is
included in the Instructions for use but not the labelling.
12 13.6 a) Covered for the items in 13.3 a), b), c), f), i) and k)
12 d), e), f), g), j), 13.6 b)
k), l), o), t)
12 k) 13.6 c)
12 d), f), g), j), u), 13.6 d)
v), x)
12 i) 13.6 h) First two paragraphs only
12 f), g) 13.6 i)
12 y) 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 10079-2
Third edition
2014-05-01
Medical suction equipment —
Part 2:
Manually powered suction equipment
Appareils d’aspiration médicale —
Partie 2: Appareils d’aspiration manuelle
Reference number
ISO 10079-2:2014(E)
©
ISO 2014
ISO 10079-2:2014(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 10079-2:2014(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 3
4.1 Risk management . 3
4.2 Usability . 4
4.3 Clinical investigation . 4
4.4 Biophysical or modelling research . 4
5 Cleaning, disinfection and sterilization . 4
6 Design requirements . 4
6.1 Collection container. 4
6.2 Connections . 5
6.3 Suction tubing . 5
6.4 Vacuum level indicators . 6
7 Operational requirements . 6
7.1 Ease of operation . 6
7.2 Dismantling and reassembly . 6
7.3 Mechanical shock . 6
7.4 Stability . 6
7.5 Protection devices . 7
7.6 Immersion in water . 7
8 Physical requirements for field and transport use suction equipment .7
8.1 (*)Dimensions . 7
8.2 Mass . 7
9 Performance requirements for vacuum level and flowrate . 8
9.1 Vacuum level . 8
9.2 Free air flowrate . 8
9.3 Pharyngeal suction . 8
10 (*)Resistance to environment of suction equipment for field and/or transport use .8
10.1 Opera
...