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EN ISO 10079-4:2021

(Main)

Medical suction equipment - Part 4: General requirements (ISO 10079-4:2021)

Medical suction equipment - Part 4: General requirements (ISO 10079-4:2021)

This document specifies general requirements for medical suction equipment that are common to all parts of the ISO 10079 series.
This document is not applicable to the following:
a) end-pieces such as suction catheters, drains, curettes, Yankauer suckers and suction tips;
b) syringes;
c) dental suction equipment;
d) anaesthetic gas scavenging systems;
e) laboratory suction;
f) autotransfusion systems;
g) mucus extractors including neonatal mucus extractors;
h) suction equipment where the collection container is downstream of the vacuum pump;
i) ventouse (obstetric) equipment;
j) suction equipment marked for endoscopic use only; and
k) plume evacuation systems.

Medizinische Absauggeräte - Teil 4: Allgemeine Anforderungen (ISO 10079-4:2021)

Dieses Dokument legt die allgemeinen Anforderungen an medizinische Absauggeräte fest, die für alle Teile der Normenreihe ISO 10079 gelten.
Dieses Dokument ist nicht anzuwenden für Folgendes:
a)   Endstücke wie Absaugkatheter, Drainagen, Küretten und Yankauer-Sauger und Absaugtüllen;
b)   Spritzen;
c)   zahnmedizinische Absauggeräte;
d)   Anästhesiegas-Fortleitungssysteme;
e)   Laborabsaugung;
f)   Autotransfusionssysteme;
g)   Schleimabsauger einschließlich Schleimabsauger für Neugeborene;
h)   Absauggeräte mit Sammelbehälter unterhalb der Vakuumpumpe;
i)   Beatmungsgeräte (für die Geburtshilfe);
j)   Absauggeräte, die nur für endoskopische Verwendung gekennzeichnet sind; und
k)   Rauch-Gasabsaugsysteme.

Appareils d’aspiration médicale - Partie 4: Exigences générales (ISO 10079-4:2021)

Le présent document spécifie des exigences générales pour les appareils d’aspiration médicale qui sont communes à toutes les parties de la série de normes ISO 10079.
Le présent document ne s’applique pas aux éléments suivants:
a) les pièces d’extrémité, telles que les sondes d’aspiration, les drains, les curettes, les «Yankauer» et les embouts d’aspiration;
b) les seringues;
c) les appareils dentaires d’aspiration;
d) les systèmes d’évacuation des gaz d’anesthésie;
e) l’aspiration en laboratoire;
f) les systèmes d’autotransfusion;
g) les extracteurs de mucosités, y compris ceux pour nouveau-nés;
h) les appareils d’aspiration dont le bocal de recueil est en aval de la pompe à vide;
i) les appareils avec ventouse (obstétrique);
j) les appareils d’aspiration à usage endoscopique uniquement (marqués comme tels); et
k) les systèmes d’évacuation de fumée.

Medicinska sukcijska (aspiracijska) oprema - 4. del: Splošne zahteve (ISO 10079-4:2021)

General Information

Status
Published
Publication Date
19-Oct-2021
Withdrawal Date
29-Apr-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
6060 - Definitive text made available (DAV) - Publishing
Start Date
20-Oct-2021
Completion Date
20-Oct-2021
Directive
2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
Mandate
M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
Ref Project
SIST EN ISO 10079-4:2021 - Medical suction equipment - Part 4: General requirements (ISO 10079-4:2021)

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Standards Content (Sample)


SLOVENSKI STANDARD
01-december-2021
Medicinska sukcijska (aspiracijska) oprema - 4. del: Splošne zahteve (ISO 10079-
4:2021)
Medical suction equipment - Part 4: General requirements (ISO 10079-4:2021)
Medizinische Absauggeräte - Teil 4: Allgemeine Anforderungen (ISO 10079-4:2021)
Appareils d’aspiration médicale - Partie 4: Exigences générales (ISO 10079-4:2021)
Ta slovenski standard je istoveten z: EN ISO 10079-4:2021
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 10079-4
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2021
EUROPÄISCHE NORM
ICS 11.040.10
English Version
Medical suction equipment - Part 4: General requirements
(ISO 10079-4:2021)
Appareils d'aspiration médicale - Partie 4: Exigences Medizinische Absauggeräte - Teil 4: Allgemeine
générales (ISO 10079-4:2021) Anforderungen (ISO 10079-4:2021)
This European Standard was approved by CEN on 26 July 2021.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, 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: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10079-4:2021 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 10079-4:2021) 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 April 2022, and conflicting national standards shall be
withdrawn at the latest by April 2022.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 10079-4:2021 has been approved by CEN as EN ISO 10079-4:2021 without any
modification.
INTERNATIONAL ISO
STANDARD 10079-4
First edition
2021-08
Medical suction equipment —
Part 4:
General requirements
Appareils d’aspiration médicale —
Partie 4: Exigences générales
Reference number
ISO 10079-4:2021(E)
©
ISO 2021
ISO 10079-4:2021(E)
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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 the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved

ISO 10079-4:2021(E)
Contents Page
Foreword .v
Introduction .vi
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 studies . 5
4.4 Biophysical or modelling research . 5
4.5 Test methods . 5
5 Materials . 5
5.1 Natural rubber latex . 5
5.2 Cleaning, disinfection and sterilization . 6
6 Design requirements . 6
6.1 General . 6
6.2 Collection containers . 6
6.2.1 Capacity . 6
6.2.2 Strength . 7
6.3 Connections . 7
6.3.1 Tubing connectors . 7
6.3.2 Collection container inlet ports . 7
6.3.3 Collection container exhaust ports . 7
6.4 Suction tubing and intermediate tubing . 8
6.5 Vacuum level indicators . 8
6.6 Environmental conditions for transport and storage . 9
7 Performance requirements .10
7.1 Operating position .10
7.2 Protection devices .10
7.2.1 Contamination protection .10
7.2.2 Overfill protection devices .10
7.2.3 Pressure protection .10
7.3 Noise .11
7.4 Air leakage .11
7.5 Vacuum levels and free air flows.11
7.6 Accuracy .11
7.7 Pharyngeal suction equipment .12
8 Additional/alternative requirements for suction equipment, suction tubing and
intermediate tubing designed for field use or transport use .12
8.1 Physical requirements .12
8.2 Strength .12
8.3 Stability .12
8.4 Environmental conditions during operation .12
8.5 Collection container capacity .13
9 Information supplied by the manufacturer .13
9.1 General .13
9.2 Symbols .
...

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d)       PESs integrated into other equipment;
e)       PESs for endoscopic procedures (e.g., minimally invasive, laparoscopic)
This document applies to all healthcare facilities where PESs are used, including, but not limited to
a)       surgical facilities;
b)       medical offices;
c)        cosmetic treatment facilities;
d)       medical teaching facilities;
e)       dental clinics;
f)         veterinary facilities.
This document provides guidance on the following aspects of PESs:
a)       importance;
b)       purchasing;
c)        design;
d)       manufacture;
e)       documentation;
f)         function;
g)       performance;
h)       installation;
i)         commissioning;
j)         testing;
k)       training;
l)         use;
m)     risk assessment;
n)       servicing;
o)       maintenance.
This document does not apply to the following:
a)       anaesthetic gas scavenging systems (AGSSs) which are covered in ISO 7396-2;
b)       medical vacuum systems which are covered in ISO 7396-1;
c)        heating, ventilation, and air-conditioning (HVAC) systems;
d)       aspects of laser safety other than airborne contamination; and
e)       aspects of electrosurgery, electrocautery, and mechanical surgical tools other than airborne contamination produced by such equipment resulting from interaction with tissue or materials.

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CEN
EN ISO 15002:2024(Main)
Flow control devices for connection to a medical gas supply system (ISO 15002:2023)
SIST EN ISO 15002:2024

This document specifies requirements for flow control devices that can be connected by the user either directly, by means of a probe or a gas-specific connector, or indirectly by means of a low-pressure hose assembly conforming with ISO 5359 to:
a)    a terminal unit conforming with ISO 9170-1 of a medical gas pipeline system conforming with ISO 7396-1:2016;
b)    the pressure outlet of a regulator conforming with ISO 10524-1:2018; or
c)    to the pressure outlet of a valve integrated pressure regulator (VIPR) conforming with ISO 10524-3 (see 5.2 gas inlets).
This document applies to the following types of flow control devices (FCDs):
a)    flowmeters;
b)    flowgauge FCDs; and
c)    fixed orifice FCDs.
NOTE       Flow control devices that are classed as medical electrical equipment can be subject to additional requirements of IEC 60601-1.
This document applies to flow control devices for the following gases:
—    oxygen;
—    oxygen 93 %;
—    nitrous oxide;
—    medical air;
—    carbon dioxide;
—    oxygen/nitrous oxide mixture 50/50 (% volume fraction);
—    oxygen-enriched air;
—    helium;
—    xenon; and
—    specified mixtures of the gases listed above.
NOTE Flow control devices can be available for other gases.
This document does not apply to flow control devices that are:
a)    for use with gases for driving surgical tools;
b)    an integral part of a regulator (see ISO 10524-1:2018); or
c)           an integral part of a valve with integrated pressure regulator (VIPR) (see ISO 10524-3).

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CEN
EN ISO 80601-2-55:2018/A1:2023(Amendment)
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors - Amendment 1 (ISO 80601-2-55:2018/Amd 1:2023)
SIST EN ISO 80601-2-55:2018/A1:2024
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