ISO 10079-2:2022
(Main)Medical suction equipment - Part 2: Manually powered suction equipment
Medical suction equipment - Part 2: Manually powered suction equipment
This document specifies safety and performance requirements for manually powered suction equipment intended for oro-pharyngeal suction. It applies to equipment operated by foot or by hand or both. The commonest use of manually powered suction is in situations outside of healthcare settings often described as field use or transport use. Use in these situations may involve extreme conditions of weather or terrain. Additional/alternative requirements for manually powered suction equipment intended for field use or transport use are included in this document. This document does not apply to mucus extractors.
Appareils d'aspiration médicale — Partie 2: Appareils d'aspiration manuelle
Le présent document spécifie les exigences de sécurité et de performance relatives aux appareils d'aspiration manuelle servant à l'aspiration oro-pharyngée. Elle s'applique aux appareils actionnés avec le pied ou avec la main ou avec les deux. Les appareils d'aspiration manuelle sont le plus souvent utilisés dans des situations en dehors des établissements de soins souvent décrites comme des utilisations sur le terrain ou lors d’un transport. L'utilisation dans ces conditions peut impliquer des situations météorologiques ou de terrain extrêmes. Le présent document comporte des exigences supplémentaires/alternatives pour les appareils d'aspiration manuelle prévus pour une utilisation sur le terrain ou une utilisation lors d’un transport. Le présent document ne s’applique pas aux les extracteurs de mucosités.
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
- 06-Jun-2022
- Effective Date
- 17-Jul-2021
Overview
ISO 10079-2:2022 specifies the safety and performance requirements for manually powered medical suction equipment used for oro-pharyngeal suction. This standard applies to suction devices operated by hand, foot, or both, commonly utilized outside traditional healthcare facilities. These conditions typically include field use or transport scenarios where equipment may face extreme weather or terrain challenges. The standard ensures that manually powered suction devices meet stringent criteria for reliability, usability, and durability in demanding environments. Notably, this document excludes mucus extractors from its scope.
Key Topics
Safety and Performance Requirements
ISO 10079-2:2022 outlines essential safety specifications to guarantee effective oro-pharyngeal suction while minimizing risks to both patient and operator. Performance metrics focus on operational force thresholds and durability under harsh conditions.Design Criteria
Devices must be designed for ease of use:- Foot-operated suction devices require a maximum operating force of 350 N.
- Hand-operated devices require a maximum operating force of 45 N. Design standards also reference ISO 10079-4:2021 for general requirements related to materials, construction, and performance.
Field and Transport Use
Additional requirements address suction equipment used in mobile or outdoor settings:- Equipment must withstand immersion in water, simulating accidental drops into water during transport.
- Devices should maintain functionality after a drop from 1 meter and water immersion for at least 10 seconds.
- Subsequent testing ensures the device meets operational standards post-immersion.
Material Specifications
The standard adopts material requirements from ISO 10079-4:2021 to ensure biocompatibility, durability, and resistance to environmental factors encountered during field and transport use.Manufacturer Information
Manufacturers are required to provide clear and comprehensive information about their devices, consistent with ISO 10079-4:2021 guidance. This includes instructions for use, maintenance, and safety precautions.
Applications
Manually powered suction equipment compliant with ISO 10079-2 is critical in a variety of practical contexts:
Emergency Medical Services and First Responders
Portable suction devices ensure airway clearance during pre-hospital care, especially in remote or resource-limited environments.Field Hospitals and Disaster Relief
Robust suction equipment designed for harsh outdoor conditions supports lifesaving interventions amid natural disasters, military operations, or humanitarian missions.Patient Transport and Ambulance Services
Equipment adapted to withstand movement, shock, and exposure to weather enhances patient safety during transit between facilities.Outdoor and Remote Healthcare Settings
Devices that meet this standard provide reliable suction capability where conventional electric suction systems are unavailable.
By adhering to ISO 10079-2:2022, manufacturers ensure that manually powered suction devices deliver consistent performance and safety in critical, off-site medical scenarios.
Related Standards
ISO 10079-4:2021 – Medical Suction Equipment: General Requirements
This companion part specifies overarching safety, design, and performance criteria applicable across medical suction devices, including those manually powered.ISO 10079-1:2010 – Medical Suction Equipment: Electrically Powered Suction Equipment
For electrically operated suction systems, this standard complements the manual equipment requirements by detailing specifications for powered suction devices.ISO 13485:2016 – Medical Devices Quality Management Systems
Relevant for manufacturers ensuring compliance with quality management practices aligned with international medical device standards.IEC 60601-1 – Medical Electrical Equipment: General Requirements for Safety
Though mainly applicable to electrical devices, this standard offers a framework for safety management, complementary to ISO 10079-2 for overall device safety assurance.
Adoption of ISO 10079-2:2022 enhances the reliability and usability of manually powered oro-pharyngeal suction devices, contributing to improved patient outcomes in emergency and field care settings worldwide. Key SEO keywords: manually powered suction equipment, oro-pharyngeal suction, field medical suction, transport suction devices, ISO 10079-2, medical suction standards, emergency medical suction, portable suction devices.
ISO 10079-2:2022 - Medical suction equipment — Part 2: Manually powered suction equipment Released:3/16/2022
ISO 10079-2:2022 - Medical suction equipment — Part 2: Manually powered suction equipment Released:3/16/2022
Frequently Asked Questions
ISO 10079-2:2022 is a standard published by the International Organization for Standardization (ISO). Its full title is "Medical suction equipment - Part 2: Manually powered suction equipment". This standard covers: This document specifies safety and performance requirements for manually powered suction equipment intended for oro-pharyngeal suction. It applies to equipment operated by foot or by hand or both. The commonest use of manually powered suction is in situations outside of healthcare settings often described as field use or transport use. Use in these situations may involve extreme conditions of weather or terrain. Additional/alternative requirements for manually powered suction equipment intended for field use or transport use are included in this document. This document does not apply to mucus extractors.
This document specifies safety and performance requirements for manually powered suction equipment intended for oro-pharyngeal suction. It applies to equipment operated by foot or by hand or both. The commonest use of manually powered suction is in situations outside of healthcare settings often described as field use or transport use. Use in these situations may involve extreme conditions of weather or terrain. Additional/alternative requirements for manually powered suction equipment intended for field use or transport use are included in this document. This document does not apply to mucus extractors.
ISO 10079-2:2022 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 10079-2:2022 has the following relationships with other standards: It is inter standard links to ISO/IEC TR 27103:2018, ISO 10079-2:2014. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase ISO 10079-2:2022 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 10079-2
Fourth edition
2022-03
Medical suction equipment —
Part 2:
Manually powered suction equipment
Appareils d'aspiration médicale —
Partie 2: Appareils d'aspiration manuelle
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 Ease of operation . 2
7 Performance requirements . .2
8 Additional/alternative requirements for suction equipment, suction tubing and
intermediate tubing designed for field use or transport use .2
8.1 General . 2
8.2 Immersion in water . 2
9 Information to be supplied by the manufacturer . 2
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
...
NORME ISO
INTERNATIONALE 10079-2
Quatrième édition
2022-03
Appareils d'aspiration médicale —
Partie 2:
Appareils d'aspiration manuelle
Medical suction equipment —
Part 2: Manually powered suction equipment
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 . 1
6 Exigences de conception .2
6.1 Généralités . 2
6.2 Facilité d’utilisation . 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
8.1 Généralités . 2
8.2 Immersion dans l’eau . 2
9 Informations à fournir par le fabricant . 2
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 d
...
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