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CEN

EN ISO 10079-1:2022

(Main)

Medical suction equipment - Part 1: Electrically powered suction equipment (ISO 10079-1:2022)

Medical suction equipment - Part 1: Electrically powered suction equipment (ISO 10079-1:2022)

This document 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 use and transport use.

Medizinische Absauggeräte - Teil 1: Elektrisch betriebene Absauggeräte (ISO 10079-1:2022)

Dieses Dokument legt Anforderungen für die Sicherheit und für die Leistung von elektrisch betriebenen medizinischen und chirurgischen Absauggeräten fest. Es gilt für Geräte, die in Gesundheitseinrichtungen wie Krankenhäusern eingesetzt werden, für Geräte für die Heimpflege von Patienten und für Geräte zur Verwendung im Freien und zur Verwendung beim Transport.

Appareils d'aspiration médicale - Partie 1: Appareils électriques d'aspiration (ISO 10079-1:2022)

Le présent document spécifie les exigences de sécurité et de performance pour les appareils électriques d’aspiration médicale et chirurgicale. Il 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.

Medicinska sukcijska (aspiracijska) oprema - 1. del: Električna sukcijska (aspiracijska) oprema (ISO 10079-1:2022)

Ta dokument določa varnostne in tehnične zahteve za električno medicinsko in kirurško sukcijsko opremo. Uporablja za opremo, ki se uporablja v zdravstvenih ustanovah, kot so bolnišnice, za oskrbo bolnikov na domu ter za uporabo na terenu in med transportom.

General Information

Status
Published
Publication Date
29-Mar-2022
Withdrawal Date
29-Sep-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
30-Mar-2022
Completion Date
30-Mar-2022
Ref Project
SIST EN ISO 10079-1:2022 - Medical suction equipment - Part 1: Electrically powered suction equipment (ISO 10079-1:2022)

Relations

Replaces
EN ISO 10079-1:2015 - Medical suction equipment - Part 1: Electrically powered suction equipment (ISO 10079-1:2015)
Effective Date
06-Apr-2022
Replaces
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
12-Aug-2020

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Standards Content (Sample)


SLOVENSKI STANDARD
01-junij-2022
Nadomešča:
SIST EN ISO 10079-1:2016
SIST EN ISO 10079-1:2016/A1:2019
Medicinska sukcijska (aspiracijska) oprema - 1. del: Električna sukcijska
(aspiracijska) oprema (ISO 10079-1:2022)
Medical suction equipment - Part 1: Electrically powered suction equipment (ISO 10079-
1:2022)
Medizinische Absauggeräte - Teil 1: Elektrisch betriebene Absauggeräte (ISO 10079-
1:2022)
Appareils d'aspiration médicale - Partie 1: Appareils électriques d'aspiration (ISO 10079-
1:2022)
Ta slovenski standard je istoveten z: EN ISO 10079-1:2022
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
March 2022
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 10079-1:2015, EN ISO 10079-
1:2015/A1:2019
English Version
Medical suction equipment - Part 1: Electrically powered
suction equipment (ISO 10079-1:2022)
Appareils d'aspiration médicale - Partie 1: Appareils Medizinische Absauggeräte - Teil 1: Elektrisch
électriques d'aspiration (ISO 10079-1:2022) betriebene Absauggeräte (ISO 10079-1:2022)
This European Standard was approved by CEN on 3 January 2022.

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
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10079-1:2022 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 10079-1:2022) 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 September 2022, and conflicting national standards
shall be withdrawn at the latest by September 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.
This document supersedes EN ISO 10079-1:2015.
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 10079-1:2022 has been approved by CEN as EN ISO 10079-1:2022 without any
modification.
INTERNATIONAL ISO
STANDARD 10079-1
Fourth edition
2022-03
Medical suction equipment —
Part 1:
Electrically powered suction
equipment
Appareils d'aspiration médicale —
Partie 1: Appareils électriques d'aspiration
Reference number
ISO 10079-1:2022(E)
ISO 10079-1:2022(E)
© ISO 2022
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 10079-1:2022(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 1
5 Materials . 1
6 Design requirements .1
6.1 General . 1
6.2 Protection against ingress of solid objects and liquids . 2
6.3 Battery powered suction equipment . 2
7 Performance requirements . .2
7.1 General . 2
7.2 Effect of an interruption of power supply on the vacuum level and free air flow
...

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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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