EN ISO 10079-1:2015

Medical suction equipment - Part 1: Electrically powered suction equipment (ISO 10079-1:2015)

ISO 10079-1:2015 specifies safety and performance requirements for electrically powered medical and surgical suction equipment. It applies to equipment used in health care facilities such as hospitals, for domiciliary care of patients and for field and transport use.
ISO 10079-1:2015 does not apply to the following:
a) central power supply (by vacuum/compressed air generation), piping systems of vehicles and buildings, and wall connectors;
b) end-pieces such as suction catheters, drains, curettes, Yankauer suckers and suction tips;
c) syringes;
d) dental suction equipment;
e) anaesthetic gas scavenging systems;
f) laboratory suction;
g) autotransfusion systems;
h) mucus extractors including neonatal mucus extractors;
i) suction equipment where the collection container is downstream of the vacuum pump;
j) ventouse (obstetric) equipment;
k) suction equipment marked for endoscopic use only;
l) plume evacuation systems.

Medizinische Absauggeräte - Teil 1: Elektrisch betriebene Absauggeräte (ISO 10079-1:2015)

Appareils d'aspiration médicale - Partie 1: Appareils électriques d'aspiration (ISO 10079-1:2015)

ISO 10079-1:2015 spécifie les exigences de sécurité et de performance pour les appareils électriques d'aspiration médicale et chirurgicale. Elle s'applique aux appareils utilisés dans les établissements de soins tels que les hôpitaux, pour les soins des patients à domicile, ainsi que pour une utilisation sur le terrain et lors d'un transport.
ISO 10079-1:2015 ne s'applique pas 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 pièces d'extrémité, telles que les sondes d'aspiration, les drains, les curettes, les « Yankauer » et les embouts d'aspiration;
c) les seringues;
d) les appareils dentaires d'aspiration;
e) les systèmes d'évacuation des gaz d'anesthésie;
f) l'aspiration en laboratoire;
g) les systèmes d'autotransfusion;
h) les extracteurs de mucosités, y compris ceux pour nouveau-nés;
i) les appareils d'aspiration dont le bocal de recueil est en aval de la pompe à vide;
j) les appareils avec ventouse (obstétrique);
k) les appareils d'aspiration à usage endoscopique uniquement (marqués comme tels);
l) les systèmes d'évacuation de fumée.

Medicinska sukcijska (aspiracijska) oprema - 1. del: Električna sukcijska (aspiracijska) oprema (ISO 10079-1:2015)

Ta del standarda ISO 10079 določa varnostne in tehnične zahteve za električno medicinsko
in kirurško sukcijsko (aspiracijsko) opremo. Velja za opremo, ki se uporablja v zdravstvenih ustanovah, kot so bolnišnice,
za oskrbo pacientov na domu ter za uporabo na terenu in med transportom.
Ta del standarda ISO 10079 se ne uporablja 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) ekstrakcijske aparate za sluz, vključno z ekstrakcijskimi aparati za sluz za novorojenčke;
i) sukcijsko opremo, pri kateri je zbiralni zabojnik priključen za vakuumsko črpalko;
j) opremo za vakuumsko ekstrakcijo (porodna oprema);
k) sukcijsko opremo, ki je namenjena izključno endoskopiji;
n) sisteme za odvod dima.

General Information

• Status: Withdrawn
• Publication Date: 24-Nov-2015
• Withdrawal Date: 29-Mar-2022
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215/WG 4 - Tracheal tubes and other equipment
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 30-Mar-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 10079-1:2016 - Medical suction equipment - Part 1: Electrically powered suction equipment (ISO 10079-1:2015)

Relations

• Replaces: EN ISO 10079-1:2009 - Medical suction equipment - Part 1: Electrically powered suction equipment - Safety requirements (ISO 10079-1:1999)
• Effective Date: 25-Jul-2012
• Replaced By: EN ISO 10079-1:2022 - Medical suction equipment - Part 1: Electrically powered suction equipment (ISO 10079-1:2022)
• Effective Date: 06-Apr-2022
• Amended By: EN ISO 10079-1:2015/A1:2019 - Medical suction equipment - Part 1: Electrically powered suction equipment - Amendment 1: Changes to requirements for operating at extremes of temperature (ISO 10079-1:2015/Amd 1:2018)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
01-februar-2016
1DGRPHãþD
SIST EN ISO 10079-1:2009
0HGLFLQVNDVXNFLMVNDDVSLUDFLMVNDRSUHPDGHO(OHNWULþQDVXNFLMVND
DVSLUDFLMVNDRSUHPD,62
Medical suction equipment - Part 1: Electrically powered suction equipment (ISO 10079-
1:2015)
Medizinische Absauggeräte - Teil 1: Elektrisch betriebene Absauggeräte (ISO 10079-
1:2015)
Appareils d'aspiration médicale - Partie 1: Appareils électriques d'aspiration (ISO 10079-
1:2015)
Ta slovenski standard je istoveten z: EN ISO 10079-1:2015
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.

EN ISO 10079-1
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2015
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 10079-1:2009
English Version
Medical suction equipment - Part 1: Electrically powered
suction equipment (ISO 10079-1:2015)
Appareils d'aspiration médicale - Partie 1: Appareils Medizinische Absauggeräte - Teil 1: Elektrisch
électriques d'aspiration (ISO 10079-1:2015) betriebene Absauggeräte (ISO 10079-1:2015)
This European Standard was approved by CEN on 13 May 2015.

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
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10079-1:2015 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered . 4

European foreword
This document (EN ISO 10079-1:2015) 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 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 May 2016, and conflicting national standards shall be
withdrawn at the latest by November 2018.
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 10079-1:2009.
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(s).
For relationship with EU Directive(s), 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 10079-1:2015 has been approved by CEN as EN ISO 10079-1:2015 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered
This European Standard has been prepared under a Commission’s standardization request M/023
concerning the development of European Standards related to medical devices to provide one voluntary
means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June 1993
concerning medical devices [OJ L 169].
Once this standard is cited in the Official Journal of the European Union under that Directive,
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 corresponding essential requirements
of that Directive and associated EFTA regulations.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Directive 93/42/EEC as amended by 2007/47/EC. This
means that risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’
or ‘removed’, according to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with Essential
Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.
NOTE 3 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 Annex I of
Directive 93/42/EEC [OJ L 169]
Essential Requirements of Clause(s)/sub-clause(s) of this EN Remarks/Notes
Directive 93/42/EEC
7.1 4.4
Third indent only
7.2 5; 7.5 Partly covered
There are no requirements for
packaging.
7.3 6.1.3
First part only
7.6 6.2.3; 6.5; 7.5.1; 7.5.2
8.1 4.2; 5; 7.5.1
8.7 11.3 c)
9.1 6.2; 6.3
First sentence only
9.2 4; 6.1.3 Partly covered
Electrical safety is by ref to
IEC 60601–1 and risk management
by ref to ISO 14971.
Essential Requirements of Clause(s)/sub-clause(s) of this EN Remarks/Notes
Directive 93/42/EEC
10.1 6.4.6 Partly covered.
There are no requirements for the
manufacturer to disclose the
accuracy of the vacuum level
indicator.
10.2 6.4
10.3 11.3 i) Covered for volume measurements
only
12.1 4 Covered by ref to IEC 60601–1
12.1a) 4 Covered by ref to IEC 60601–1
12.2 4 Covered by ref to IEC 60601–1
although suction equipment is not
considered life-support equipment.
12.5 4 Covered by ref to IEC 60601–1 and
thereby to IEC 60601–1–2
12.6 4; 6.5 Covered by ref to IEC 60601–1
12.7.1 6.1.3; 7.4
12.7.2 4 Covered by ref to IEC 60601–1
12.7.3 7.6
12.7.4 4 Covered by ref to IEC 60601–1
12.7.5 4 Covered by ref to IEC 60601–1
12.8.2 7.5.3.2
Second sentence only
12.9 11.3 i); j); k); l); m); n); o); p); q); r)
13.1 11
13.2 11.2
13.3a) 11.3 a)
13.3b) 11.3 b)
13.3c) 11.3 c)
13.3d) 11.3 d)
13.3e) 11.3 e)
13.3 f) 11.3 f)
13.3 k) 11.4 c); q); y)
13.3 l) 11.3 d)
13.3 m) 11.4 i)
13.4 11.4 b)
13.6 a) 11.4 Not covered for the requirement of
ER 13.3b)
13.6 b) 11.4 d); e)
Essential Requirements of Clause(s)/sub-clause(s) of this EN Remarks/Notes
Directive 93/42/EEC
13.6 c) 11.4 d) ;k)
13.6 d) 11.4 d); j); v) Calibration is not covered
13.6 f) 11.4 x)
13.6 h) 11.4 i)
First two paragraphs only
13.6 i) 11.4 j)
13.6 q) 11.4 z)
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
Standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other Union legislation may be applicable to the products falling within the scope of
this standard.
INTERNATIONAL ISO
STANDARD 10079-1
Third edition
2015-11-01
Medical suction equipment —
Part 1:
Electrically powered suction
equipment
Appareils d’aspiration médicale —
Partie 1: Appareils électriques d’aspiration
Reference number
ISO 10079-1:2015(E)
©
ISO 2015
ISO 10079-1:2015(E)
© ISO 2015, Published in Switzerland
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
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
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ii © ISO 2015 – All rights reserved

ISO 10079-1:2015(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 . 5
4.5 Test methods . 5
5 Cleaning, disinfection and sterilization . 5
6 Design requirements . 6
6.1 Collection container. 6
6.1.1 General. 6
6.1.2 Container capacity . 6
6.1.3 Container strength . 6
6.2 Connections . 6
6.2.1 Tubing connectors for collection containers . 6
6.2.2 Inlet port . 7
6.2.3 Exhaust port. 7
6.3 Suction tubing . 7
6.4 Vacuum leve
...