Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2022)

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.

Medizinische Absauggeräte - Teil 2: Handbetriebene Absauggeräte (ISO 10079-2:2022)

Dieses Dokument legt Anforderungen für die Sicherheit und für die Leistung von handbetriebenen Absauggeräten für oro-pharyngeale Absaugung fest. Es gilt für von Fuß oder Hand oder von beidem betriebene Geräte.
Handbetriebene Absaugung wird meistens in Situationen außerhalb von Gesundheitseinrichtungen eingesetzt. Dies wird oft als Verwendung im Freien oder Verwendung beim Transport bezeichnet. Die Verwendung in solchen Fällen kann extreme Wetter  oder Bodenverhältnisse einschließen. Zusätzliche/alternative Anforderungen an handbetriebene Absauggeräte zur Verwendung im Freien oder zur Verwendung beim Transport sind in diesem Dokument enthalten.
Dieses Dokument gilt nicht für Schleimabsauger.

Appareils d'aspiration médicale - Partie 2: Appareils d'aspiration manuelle (ISO 10079-2:2022)

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.

Medicinska sukcijska (aspiracijska) oprema - 2. del: Ročna sukcijska (aspiracijska) oprema (ISO 10079-2:2022)

Ta dokument določa zahteve glede varnosti in učinkovitosti ročne sukcijske (aspiracijske) opreme, ki je namenjena sukciji (aspiraciji) žrela. Velja za opremo, ki se upravlja nožno, ročno ali na oba načina. Ročna sukcijska (aspiracijska) oprema se običajno uporablja v situacijah zunaj zdravstvenih ustanov oziroma na prostem ali med prevozom. Uporaba lahko v takih primerih vključuje izredne vremenske ali terenske razmere. V ta dokument so vključene dodatne/nadomestne zahteve za ročno sukcijsko (aspiracijsko) opremo, ki je namenjena uporabi na prostem. Ta dokument se ne uporablja za ekstrakcijske aparate za sluz.

General Information

Status
Published
Publication Date
24-May-2022
Withdrawal Date
29-Nov-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
25-May-2022
Completion Date
25-May-2022
Ref Project
SIST EN ISO 10079-2:2022 - Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2022)

Relations

Replaces
EN ISO 10079-2:2014 - Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2014)
Effective Date
08-Jun-2022

Overview

EN ISO 10079-2:2022 specifies safety and performance requirements for manually powered medical suction equipment designed for oro-pharyngeal suction. This standard applies to devices operated by hand, foot, or both and focuses on ensuring reliable function and user safety. The standard addresses equipment commonly used outside traditional healthcare settings, including extreme conditions encountered during field or transport use. Notably, EN ISO 10079-2:2022 excludes mucus extractors from its scope.

Key Topics

  • Manually Powered Suction Definition: Generation of vacuum through direct human effort, either by foot or hand operation.

  • Safety and Performance Requirements:

    • Equipment must meet the general requirements outlined in ISO 10079-4:2021.
    • Foot-operated devices should require less than 350 N force to operate.
    • Hand-operated devices should require less than 45 N force to operate.

  • Design and Material Standards:

    • Mandates use of materials and design principles consistent with ISO 10079-4:2021.
    • Emphasizes ease of operation, ensuring ergonomic function during emergency or field conditions.

  • Field Use and Transport Use Conditions:

    • Equipment must perform reliably even after immersion in water and exposure to rough handling.
    • Specific testing includes dropping the device from 1 meter into water, followed by suction performance verification.

  • Manufacturer’s Information Requirements:

    • Manufacturers must provide detailed operating instructions and performance data per ISO 10079-4:2021 guidelines.

Applications

EN ISO 10079-2:2022 is essential for manufacturers, healthcare providers, and emergency responders who use manually operated suction devices, especially in scenarios where electrical power is unavailable. Typical applications include:

  • Field Emergency Medical Services: Providing oro-pharyngeal suction in challenging outdoor environments, disaster sites, or remote locations.
  • Patient Transport: Use during ambulance transfer and non-clinical patient movement where portability and device robustness are critical.
  • Military and Rescue Operations: Suction equipment must withstand harsh conditions including exposure to water, dirt, and variable weather.
  • Pre-Hospital Care: Critical for first responders to maintain airway patency before hospital arrival.

This standard helps ensure that manually powered suction devices are safe, effective, and reliable in both clinical and non-clinical environments.

Related Standards

  • ISO 10079-4:2021 - Medical Suction Equipment – General Requirements
    Provides overarching safety and performance criteria referenced by EN ISO 10079-2:2022.

  • EN ISO 10079-1 - Electrically Powered Suction Equipment
    Covers electrically driven devices complementing the manually powered solutions described in Part 2.

  • ISO 8382 - Medical Devices – Tubing for Suction Equipment
    Specifies requirements for tubing materials, which are critical for maintaining performance and hygiene.

  • IEC 60601 Series - Medical Electrical Equipment Safety
    While EN ISO 10079-2 applies to manual devices, this standard is relevant for electrically powered suction devices used in parallel clinical settings.

Summary

EN ISO 10079-2:2022 establishes comprehensive requirements for manually powered medical suction equipment focused on oro-pharyngeal use, emphasizing functionality under extreme conditions typical of field and transport scenarios. This standard guides manufacturers and users to ensure device safety, ergonomic operation, durability, and reliable performance, thereby supporting critical medical airflow and fluid removal needs in diverse environments where power sources may be limited.

Keywords: medical suction equipment, manually powered suction, oro-pharyngeal suction, field use suction, transport use suction, handheld suction devices, foot-operated suction, CEN standard, ISO 10079-2, emergency medical equipment.

Frequently Asked Questions

EN ISO 10079-2:2022 is a standard published by the European Committee for Standardization (CEN). Its full title is "Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2022)". 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.

EN 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.

EN ISO 10079-2:2022 has the following relationships with other standards: It is inter standard links to EN ISO 10079-2:2014. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

EN ISO 10079-2:2022 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.

Standards Content (Sample)


SLOVENSKI STANDARD
01-julij-2022
Nadomešča:
SIST EN ISO 10079-2:2014
Medicinska sukcijska (aspiracijska) oprema - 2. del: Ročna sukcijska (aspiracijska)
oprema (ISO 10079-2:2022)
Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-
2:2022)
Medizinische Absauggeräte - Teil 2: Handbetriebene Absauggeräte (ISO 10079-2:2022)
Appareils d'aspiration médicale - Partie 2: Appareils d'aspiration manuelle (ISO 10079-
2:2022)
Ta slovenski standard je istoveten z: EN ISO 10079-2:2022
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 10079-2
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2022
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 10079-2:2014
English Version
Medical suction equipment - Part 2: Manually powered
suction equipment (ISO 10079-2:2022)
Appareils d'aspiration médicale - Partie 2: Appareils Medizinische Absauggeräte - Teil 2: Handbetriebene
d'aspiration manuelle (ISO 10079-2:2022) Absauggeräte (ISO 10079-2:2022)
This European Standard was approved by CEN on 18 May 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 10079-2:2022 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 10079-2:2022) 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 November 2022, and conflicting national standards
shall be withdrawn at the latest by November 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 10079-2:2014.
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 10079-2:2022 has been approved by CEN as EN ISO 10079-2:2022 without any
modification.
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 10079-2:2022(E)
ISO 10079-2:2022(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 10079-2:2022(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 .2
6.1 Ge
...

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