ISO 10079-3:2022
(Main)Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source
Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source
This document specifies basic safety and performance requirements for medical suction equipment powered from a vacuum or positive pressure gas source generating venturi suction. It applies to suction equipment connected to medical gas pipeline systems or cylinders and venturi attachments and can be standalone or part of an integrated system.
Appareils d'aspiration médicale — Partie 3: Appareils d'aspiration alimentés par une source de vide ou de pression
Le présent document spécifie les exigences de sécurité et de performance de base relatives aux appareils d'aspiration médicale alimentés par une source de vide ou de gaz à pression positive générant une aspiration Venturi. Il est applicable aux appareils d’aspiration raccordés à des bouteilles ou des systèmes de distribution de gaz médicaux et aux systèmes venturi. Les appareils peuvent être autonomes ou faire partie d'un système intégré.
General Information
- Status
- Published
- Publication Date
- 15-Mar-2022
- Technical Committee
- ISO/TC 121/SC 8 - Suction devices
- Drafting Committee
- ISO/TC 121/SC 8 - Suction devices
- Current Stage
- 6060 - International Standard published
- Start Date
- 16-Mar-2022
- Due Date
- 28-Jan-2022
- Completion Date
- 16-Mar-2022
Relations
- Effective Date
- 17-Jul-2021
Overview
ISO 10079-3:2022 - Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source - specifies basic safety and performance requirements for medical suction devices that generate venturi suction using a vacuum or positive-pressure gas source. The standard covers suction equipment connected to medical gas pipeline systems, cylinders, and venturi attachments. It applies to standalone units and components incorporated into integrated systems. The 2022 (fourth) edition updates the previous 2014 edition and aligns general requirements with ISO 10079-4:2021.
Key topics and requirements
- Scope and applicability: Devices powered from a vacuum or positive pressure gas source that create venturi suction; includes pipeline or cylinder connections and venturi attachments.
- Reference to general requirements: Material, design, performance, transport/field-use and manufacturer information requirements are applied via ISO 10079-4:2021 (referenced throughout the document).
- Supply connections:
- Direct connection to a medical gas pipeline terminal or pressure regulator outlet: must be fitted with a probe that complies with applicable national standards.
- Remote connection: must use a low‑pressure hose assembly compliant with ISO 5359.
- Conformance for supply connections is checked by inspection.
- Design and performance: The standard delegates detailed design, materials and performance criteria to ISO 10079-4:2021 while adding device-specific provisions for venturi-powered suction.
- Field and transport use: Additional or alternative requirements for equipment, tubing and intermittent tubing intended for field/transport use are handled via ISO 10079-4 clauses referenced in this part.
- Manufacturer information: Required labeling and documentation are specified by reference to ISO 10079-4.
Applications
ISO 10079-3:2022 is used to ensure safe, interoperable and reliable venturi-powered suction systems in clinical settings such as:
- Operating rooms, recovery areas and intensive care units where suction is required for airway clearance or surgical procedures.
- Emergency and ambulance/transport environments (field-use and transport-specific requirements apply).
- Integration into central medical gas pipeline systems or portable cylinder-based systems.
- Design and verification of venturi attachments and suction accessories.
Who should use this standard
- Medical device manufacturers and product designers of suction equipment
- Biomedical engineers and hospital facilities staff responsible for medical gas systems
- Regulatory and compliance professionals involved in medical device conformity
- Procurement teams specifying suction equipment compatibility with pipeline systems
- Test laboratories conducting safety and performance assessments
Related standards
- ISO 10079-4:2021 - Medical suction equipment - General requirements
- ISO 5359:2014/Amd 1:2017 - Low-pressure hose assemblies for medical gases
- ISO 7396-1:2016 - Medical gas pipeline systems
Keywords: ISO 10079-3:2022, medical suction equipment, venturi suction, medical gas pipeline, ISO 10079-4, ISO 5359, biomedical engineering, suction equipment standards.
ISO 10079-3:2022 - Medical suction equipment — Part 3: Suction equipment powered from a vacuum or positive pressure gas source Released:3/16/2022
ISO 10079-3:2022 - Medical suction equipment — Part 3: Suction equipment powered from a vacuum or positive pressure gas source Released:3/16/2022
Frequently Asked Questions
ISO 10079-3:2022 is a standard published by the International Organization for Standardization (ISO). Its full title is "Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source". This standard covers: This document specifies basic safety and performance requirements for medical suction equipment powered from a vacuum or positive pressure gas source generating venturi suction. It applies to suction equipment connected to medical gas pipeline systems or cylinders and venturi attachments and can be standalone or part of an integrated system.
This document specifies basic safety and performance requirements for medical suction equipment powered from a vacuum or positive pressure gas source generating venturi suction. It applies to suction equipment connected to medical gas pipeline systems or cylinders and venturi attachments and can be standalone or part of an integrated system.
ISO 10079-3:2022 is classified under the following ICS (International Classification for Standards) categories: 11.040.10 - Anaesthetic, respiratory and reanimation equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
ISO 10079-3:2022 has the following relationships with other standards: It is inter standard links to ISO 10079-3:2014. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase ISO 10079-3:2022 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of ISO standards.
Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 10079-3
Fourth edition
2022-03
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 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
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 .2
6.1 General . 2
6.2 Supply connections . 2
7 Performance requirements . .2
8 Additional/alternative requirements for suction equipment, suction tubing and
intermittent tubing designed for field use or transport use . 2
9 Information to be supplied by the manufacturer . 2
Bibliography . 3
iii
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible
...
NORME ISO
INTERNATIONALE 10079-3
Quatrième édition
2022-03
Appareils d'aspiration médicale —
Partie 3:
Appareils d'aspiration alimentés par
une source de vide ou de pression
Medical suction equipment —
Part 3: Suction equipment powered from a vacuum or positive
pressure gas source
Numéro de référence
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2022
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
Tél.: +41 22 749 01 11
E-mail: copyright@iso.org
Web: www.iso.org
Publié en Suisse
ii
Sommaire Page
Avant-propos .iv
1 Domaine d’application . 1
2 Références normatives .1
3 Termes et définitions . 1
4 Exigences générales . .1
5 Matériaux . 2
6 Exigences de conception .2
6.1 Généralités . 2
6.2 Raccordements d'approvisionnement . 2
7 Exigences de performance .2
8 Exigences supplémentaires/alternatives pour les appareils d’aspiration, tuyaux
d’aspiration et tuyaux intermédiaires prévus pour une utilisation sur le terrain ou
une utilisation lors d’un transport. 2
9 Informations à fournir par le fabricant . 2
Bibliographie . 3
iii
Avant-propos
L'ISO (Organisation internationale de normalisation) est une fédération mondiale d'organismes
nationaux de normalisation (comités membres de l'ISO). L'élaboration des Normes internationales est
en général confiée aux comités techniques de l'ISO. Chaque comité membre intéressé par une étude
a le droit de faire partie du comité technique créé à cet effet. Les organisations internationales,
gouvernementales et non gouvernementales, en liaison avec l'ISO participent également aux travaux.
L'ISO collabore étroitement avec la Commission électrotechnique internationale (IEC) en ce qui
concerne la normalisation électrotechnique.
Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont
décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier, de prendre note des différents
critères d'approbation requis pour les différents types de documents ISO. Le présent document a
été rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2 (voir
www.iso.org/directives).
L'attention est attirée sur le fait que certains des éléments du présent document peuvent faire l'objet de
droits de propriété intellectuelle ou de droits analogues. L'ISO ne saurait être tenue pour responsable
de ne pas avoir identifié de tels droits de propriété et averti de leur existence. Les détails concernant
les références aux droits de propriété intellectuelle ou autres droits analogues identifiés lors de
l'élaboration du document sont indiqués dans l'Introduction et/ou dans la liste des déclarations de
brevets reçues par l'ISO (voir www.iso.org/brevets).
Les a
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