ISO 10079-1:2022/Amd 1:2026
(Amendment)Medical suction equipment — Part 1: Electrically powered suction equipment — Amendment 1: Ingress of water
Medical suction equipment — Part 1: Electrically powered suction equipment — Amendment 1: Ingress of water
Appareils d'aspiration médicale — Partie 1: Appareils électriques d'aspiration — Amendement 1: Pénétration d'eau
General Information
- Status
- Published
- Publication Date
- 16-Mar-2026
- 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
- 17-Mar-2026
- Due Date
- 12-Aug-2026
- Completion Date
- 17-Mar-2026
Relations
- Effective Date
- 12-Feb-2026
- Effective Date
- 08-Mar-2025
- Effective Date
- 15-Feb-2025
Overview
ISO 10079-1:2022/Amd 1:2026 is an amendment to the International Standard ISO 10079-1 for medical suction equipment, specifically targeting electrically powered suction equipment. This amendment focuses on the critical issue of ingress of water and other liquids, updating and clarifying requirements for resistance to environmental factors that may compromise device safety and performance. This ISO amendment ensures improved safety, durability, and reliability of medical suction devices across various healthcare environments, including hospitals, homes, and emergency field settings.
Key Topics
- Ingress Protection (IP): Requirements and conformance testing for resistance to solids and water intrusion in suction equipment
- Normative References: Integration with IEC and ISO standards, such as IEC 60529 and IEC 60601 series, for safety and performance
- Use Environments:
- Hospital use: Emphasis on spillage and solid foreign object resistance
- Home healthcare use: Specific guidelines for devices used by patients or laypersons
- Field and transport use: Considerations for devices operated by healthcare professionals in mobile and emergency scenarios
- Compliance and Testing: Mandatory conformity tests as defined by referenced IEC standards
- Alignment with Global Standards: Harmonization with European (CEN) requirements and technical committees
Applications
ISO 10079-1:2022/Amd 1:2026 is applicable to manufacturers, healthcare providers, and regulatory authorities involved with electrically powered medical suction equipment. The amendment provides:
- Enhanced Device Safety: Addresses potential hazards associated with water and liquid ingress, reducing risks of electrical failure and contamination
- Guidance for Manufacturers: Clear expectations for ingress protection levels ensure development of equipment suitable for diverse environments, from clinical settings to patient homes and ambulances
- Support for Quality Assurance: By specifying conformance testing and standards alignment, this document aids in meeting regulatory requirements and facilitating access to international markets
- Reliability in Critical Care: Assures healthcare professionals and users that medical suction devices remain safe and effective during exposure to spills, cleaning processes, and challenging environmental conditions
- Suitability for Home Use: Promotes the safe operation and maintenance of suction equipment by non-clinical users, reducing the potential for device malfunction and user injury
Related Standards
Several key standards are referenced in this amendment, ensuring a comprehensive approach to device safety and performance:
- IEC 60529: Degrees of protection provided by enclosures (IP Code) - Focused on protection against ingress of water and solid particles
- IEC 60601-1: General requirements for basic safety and essential performance of medical electrical equipment
- IEC 60601-1-11: Requirements for medical electrical equipment and systems in home healthcare environments
- IEC 60601-1-12: Requirements for medical electrical equipment and systems in emergency medical services environments
- ISO 10079 Series: Comprehensive coverage of medical suction equipment, with other parts addressing manually operated equipment and other aspects of suction device design
ISO 10079-1:2022/Amd 1:2026 supports global harmonization and regulatory compliance for manufacturers and users, reinforcing the importance of ingress protection in the safe operation of medical suction equipment in all healthcare environments. For further information or to purchase the standard, visit www.iso.org.
Buy Documents
ISO 10079-1:2022/Amd 1:2026 - Medical suction equipment — Part 1: Electrically powered suction equipment — Amendment 1: Ingress of water
ISO 10079-1:2022/Amd 1:2026 - Appareils d'aspiration médicale — Partie 1: Appareils électriques d'aspiration — Amendement 1: Pénétration d'eau
Get Certified
Connect with accredited certification bodies for this standard
BSI Group
BSI (British Standards Institution) is the business standards company that helps organizations make excellence a habit.
TÜV Rheinland
TÜV Rheinland is a leading international provider of technical services.
TÜV SÜD
TÜV SÜD is a trusted partner of choice for safety, security and sustainability solutions.
Sponsored listings
Frequently Asked Questions
ISO 10079-1:2022/Amd 1:2026 is a standard published by the International Organization for Standardization (ISO). Its full title is "Medical suction equipment — Part 1: Electrically powered suction equipment — Amendment 1: Ingress of water". This standard covers: Medical suction equipment — Part 1: Electrically powered suction equipment — Amendment 1: Ingress of water
Medical suction equipment — Part 1: Electrically powered suction equipment — Amendment 1: Ingress of water
ISO 10079-1:2022/Amd 1:2026 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 10079-1:2022/Amd 1:2026 has the following relationships with other standards: It is inter standard links to EN ISO 10079-1:2022/A1:2026, ISO/IEC 8825-5:2021, ISO 10079-1:2022. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
ISO 10079-1:2022/Amd 1:2026 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)
International
Standard
ISO 10079-1
Fourth edition
Medical suction equipment —
2022-03
Part 1:
AMENDMENT 1
Electrically powered suction
2026-03
equipment
AMENDMENT 1: Ingress of water
Appareils d'aspiration médicale —
Partie 1: Appareils électriques d'aspiration
AMENDEMENT 1: Pénétration d'eau
Reference number
ISO 10079-1:2022/Amd.1:2026(en) © ISO 2026
ISO 10079-1:2022/Amd.1:2026(en)
© ISO 2026
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/Amd.1:2026(en)
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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the volun
...
Norme
internationale
ISO 10079-1
Quatrième édition
Appareils d'aspiration médicale —
2022-03
Partie 1:
AMENDEMENT 1
Appareils électriques d'aspiration
2026-03
AMENDEMENT 1: Pénétration d'eau
Medical suction equipment —
Part 1: Electrically powered suction equipment
AMENDMENT 1: Ingress of water
Numéro de référence
ISO 10079-1:2022/Amd.1:2026(fr) © ISO 2026
ISO 10079-1:2022/Amd.1:2026(fr)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2026
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
ISO 10079-1:2022/Amd.1:2026(fr)
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’ISO attire l’attention sur le fait que la mise en application du présent document peut entraîner l’utilisation
d’un ou de plusieurs brevets. L’ISO ne prend pas position quant à la preuve, à la validité et à l’applicabilité
de tout droit de brevet revendiqué à cet égard. À la date de publication du présent document, l’ISO n'avait
reçu notification qu’un ou plusieurs brevets pouvaient être nécessaires à sa mise en application. Toutefois,
il y a lieu d’avertir les responsables de la mise en application du présent document que des informations
plus récentes sont susceptibles de figurer dans la base de données de brevets, disponible à l'adresse
www.iso.org/brevets. L’ISO ne saurait être tenue pour responsable de ne pas avoir identifié tout ou partie de
tels droits de propriété.
Les appellations commerciales éventuellement mentionnées dans le présent document sont données pour
information, par souci de commodité, à l’intention des utilisateurs et ne sauraient constituer un engagement.
Pour une explication de la nature volontaire des normes, la signification des termes et expressions
spécifi
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.
Loading comments...