ISO 10079-1:2022/PRF Amd 1
(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
- Not Published
- Technical Committee
- ISO/TC 121/SC 8 - Suction devices
- Drafting Committee
- ISO/TC 121/SC 8 - Suction devices
- Current Stage
- 5020 - FDIS ballot initiated: 2 months. Proof sent to secretariat
- Start Date
- 23-Jan-2026
- Completion Date
- 12-Feb-2026
Relations
- Effective Date
- 12-Feb-2026
- Effective Date
- 08-Mar-2025
- Effective Date
- 15-Feb-2025
Overview
ISO 10079-1:2022/PRF Amd 1 is an important amendment to the international standard on medical suction equipment, specifically addressing electrically powered suction equipment. This amendment, focused on the "Ingress of Water," introduces updated requirements and reference documents to ensure enhanced safety and performance of suction devices in various medical environments. Developed by ISO Technical Committee 121/SC 8 in coordination with the European Committee for Standardization (CEN), this document contributes to the ongoing alignment of international best practices for medical device safety and reliability, particularly regarding protection against water and solid ingress.
Key Topics
- Water Ingress Protection: The amendment refines the requirements for resistance to entry of liquids and solids, ensuring that electrically powered medical suction equipment remains safe and functional even when exposed to challenging conditions.
- Reference to International Standards: Updated normative references now include essential IEC standards, such as:
- IEC 60601-1: General requirements for medical electrical equipment
- IEC 60601-1-11: Requirements for home healthcare environments
- IEC 60601-1-12: Requirements for emergency medical services environments
- IEC 60529: Degrees of protection provided by enclosures (IP Code)
- Testing and Compliance: Suction equipment must pass tests for ingress protection as specified in IEC 60529, ensuring conformity with international safety expectations for medical devices.
- Specific Use Cases: The amendment outlines standards to be used depending on the intended environment:
- Hospital use
- Home healthcare use
- Field and transport use
Applications
ISO 10079-1:2022/PRF Amd 1 is highly relevant for manufacturers, health institutions, and healthcare professionals involved in the design, procurement, and maintenance of medical suction equipment. Its primary applications include:
- Design and Manufacturing: Device manufacturers must ensure their suction equipment meets the updated ingress protection requirements, using the referenced IEC and ISO standards as a guide for both design and quality control processes.
- Procurement and Compliance: Hospitals and clinics can specify compliance with this amendment in procurement documents to ensure devices are robust against water and dust ingress, enhancing patient safety.
- Home Healthcare: The amendment supports safe use by patients or caretakers outside clinical environments, providing clear criteria for equipment used in homes, vehicles, or during patient transport.
- Emergency Services: Reliability in pre-hospital and transport settings is critical; this amendment ensures suction equipment functions effectively even in unpredictable, harsh conditions.
Related Standards
This amendment integrates and aligns with several fundamental international standards in the field of medical electrical equipment:
- ISO 10079 Series: The ISO 10079 series outlines technical requirements for different types of medical suction equipment, contributing to global harmonization.
- IEC 60529: Provides the IP code system, defining levels of protection provided by enclosures against solids and liquids.
- IEC 60601-1 Family: Addressing safety and essential performance for all medical electrical equipment, the IEC 60601-1 standards are central to device testing and certification worldwide.
- IEC 60601-1-11 and IEC 60601-1-12: Specialize in the safety of equipment used in home, field, and emergency environments, ensuring broad applicability and patient protection in diverse settings.
By referencing and updating compliance requirements, ISO 10079-1:2022/PRF Amd 1 enhances the safety, reliability, and regulatory confidence in electrically powered medical suction devices across healthcare environments worldwide.
ISO 10079-1:2022/PRF Amd 1 - Medical suction equipment — Part 1: Electrically powered suction equipment — Amendment 1: Ingress of water Released:23. 01. 2026
REDLINE ISO 10079-1:2022/PRF Amd 1 - Medical suction equipment — Part 1: Electrically powered suction equipment — Amendment 1: Ingress of water Released:23. 01. 2026
ISO 10079-1:2022/PRF Amd 1 - Appareils d'aspiration médicale — Partie 1: Appareils électriques d'aspiration — Amendement 1: Pénétration d'eau Released:4. 02. 2026
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Frequently Asked Questions
ISO 10079-1:2022/PRF Amd 1 is a draft 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/PRF Amd 1 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/PRF Amd 1 has the following relationships with other standards: It is inter standard links to EN ISO 10079-1:2022/prA1:2025, 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/PRF Amd 1 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
equipment
AMENDMENT 1: Ingress of water
Appareils d'aspiration médicale —
Partie 1: Appareils électriques d'aspiration
AMENDEMENT 1: Pénétration d'eau
PROOF/ÉPREUVE
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
PROOF/ÉPREUVE
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 voluntary natur
...
ISO 10079-1:2022/DAMPRF Amd 1:2025(en)
ISO/TC 121/SC 8
Secretariat: SA
Date: 2025-06-092026-01-23
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
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ISO #####-#:####(X)
PROOF
© ISO #### – All rights reserved
ISO 10079-1:2022/DAMPRF Amd 1:2025(en)
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
EmailE-mail: copyright@iso.org
Website: www.iso.org
Published in Switzerland
iii
ISO #####-#:####(X 10079-1:2022/PRF Amd 1(en)
Contents
© ISO #### 2026 – All rights reserved
iv
ISO 10079-1:2022/DAMPRF Amd 1:2025(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 cauti
...
Norme
internationale
ISO 10079-1
Quatrième édition
Appareils d'aspiration médicale —
2022-03
Partie 1:
AMENDEMENT 1
Appareils électriques d'aspiration
AMENDEMENT 1: Pénétration d'eau
Medical suction equipment —
Part 1: Electrically powered suction equipment
AMENDMENT 1: Ingress of water
PROOF/ÉPREUVE
Numéro de référence
ISO 10079-1:2022/Amd.1:2026(fr) © ISO 2026
Norme
ISO 10079-1:2022/Amd.1:2026(fr)
internationale
ISO 10079-1
Quatrième édition
Appareils d'aspiration médicale —
2022-03
Partie 1:
Appareils électriques d'aspiration AMENDEMENT 1
AMENDEMENT 1: Pénétration d'eau
Medical suction equipment —
Part 1: Electrically powered suction equipment
AMENDMENT 1: Ingress of water
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
PROOF/ÉPREUVE
CH-1214 Vernier, Genève
Tél.: +41 22 749 01 11
E-mail: copyright@iso.org
Web: www.iso.org
Publié en Suisse Numéro de référence
ISO 10079-1:2022/Amd.1:2026(fr) © ISO 2026
PROOF/ÉPREUVE
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 pas
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 brevet.
Les appellations commerciales éventuellement mentionnées dans le présent document sont données pour
information, par souci de commodité, à l’intention
...












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