ISO 10079-1:2022
(Main)Medical suction equipment - Part 1: Electrically powered suction equipment
Medical suction equipment - Part 1: Electrically powered suction equipment
This document specifies safety and performance requirements for electrically powered medical and surgical suction equipment. It applies to equipment used in health care facilities such as hospitals, for domiciliary care of patients and for field use and transport use.
Appareils d'aspiration médicale — Partie 1: Appareils électriques d'aspiration
Le présent document spécifie les exigences de sécurité et de performance pour les appareils électriques d’aspiration médicale et chirurgicale. Il s’applique aux appareils utilisés dans les établissements de soins tels que les hôpitaux, pour les soins des patients à domicile, ainsi que pour une utilisation sur le terrain et lors d’un transport.
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
- Revises
ISO 10079-1:2015 - Medical suction equipment - Part 1: Electrically powered suction equipment - Effective Date
- 17-Jul-2021
- Effective Date
- 10-Jul-2021
Overview
ISO 10079-1:2022 specifies safety and performance requirements for electrically powered medical suction equipment. This international standard applies to devices used in hospitals, domiciliary care, field use, and patient transport. Its purpose is to ensure these suction devices meet stringent safety, reliability, and operational criteria critical for medical and surgical applications.
Developed by ISO Technical Committee ISO/TC 121 and in cooperation with CEN/TC 215, this fourth edition replaces previous versions and aligns with ISO 10079-4:2021 for general requirements. The standard supports healthcare providers and manufacturers in delivering high-quality suction equipment that safeguards patient safety and enhances clinical efficiency.
Key Topics
Scope and Application
Covers electrically powered suction units for hospital care, home care, field and transport scenarios-critical for diverse healthcare environments.Safety and Performance Requirements
Aligns with ISO 10079-4:2021 for general, material, and design requirements, emphasizing device safety, durability, and performance consistency.Ingress Protection Classification (IP Code)
Specifies protection levels against solid objects and liquids, referencing IEC 60529:- Hospital and home healthcare equipment: IP22
- Field and transport use: IP33
Ensures device reliability and safety under different environmental conditions.
Battery Powered Equipment
Sets minimum operational time of 20 minutes on a full charge, maintaining vacuum levels ≥40 kPa and free air flow ≥2 l/min, with battery charge indication for user awareness.Electrical Stability on Power Interruption
Vacuum level and free air flow must remain within ±10% of set values after power interruptions, guaranteeing consistent suction performance during critical moments.Manufacturer Information and Instructions
Requires clear guidance on device operation, battery replacement, and disposal to support safe and effective user handling.
Applications
ISO 10079-1:2022 is essential for the design, manufacturing, and clinical deployment of electrically powered medical suction equipment. Key applications include:
Hospital and Surgical Facilities
Ensures suction equipment used in surgery, emergency rooms, and intensive care units meet safety and performance standards to protect patients and staff.Domiciliary and Home Healthcare
Guarantees the safety and reliability of suction devices operated by patients or caregivers, whether at home or during transport in wheelchairs or vehicles.Field and Transport Use
Supports emergency medical services and mobile care providers with robust suction equipment designed to perform reliably under varying field conditions.Medical Device Manufacturing
Guides manufacturers in meeting international compliance requirements, enabling market access and promoting uniform quality standards.
Related Standards
ISO 10079-4:2021 - Medical suction equipment: General requirements
Provides overarching safety and performance criteria applicable to all types of suction devices, referenced throughout ISO 10079-1.IEC 60529 - Degrees of protection provided by enclosures (IP Code)
Defines classifications for protection against ingress of dust and water, crucial for determining device resilience in different use environments.ISO 10079 Series
A collection of standards covering various aspects of medical suction equipment, facilitating comprehensive regulatory adherence.
By conforming to ISO 10079-1:2022, healthcare providers and manufacturers ensure electrically powered suction devices deliver optimal safety, functional performance, and durability-essential for effective patient care across multiple settings. This standard empowers the medical community with reliable equipment that meets international benchmarks, enhancing both clinical outcomes and user confidence.
ISO 10079-1:2022 - Medical suction equipment — Part 1: Electrically powered suction equipment Released:3/16/2022
ISO 10079-1:2022 - Medical suction equipment — Part 1: Electrically powered suction equipment Released:3/16/2022
Frequently Asked Questions
ISO 10079-1:2022 is a standard published by the International Organization for Standardization (ISO). Its full title is "Medical suction equipment - Part 1: Electrically powered suction equipment". This standard covers: This document specifies safety and performance requirements for electrically powered medical and surgical suction equipment. It applies to equipment used in health care facilities such as hospitals, for domiciliary care of patients and for field use and transport use.
This document specifies safety and performance requirements for electrically powered medical and surgical suction equipment. It applies to equipment used in health care facilities such as hospitals, for domiciliary care of patients and for field use and transport use.
ISO 10079-1:2022 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 10079-1:2022 has the following relationships with other standards: It is inter standard links to ISO/IEC 27102:2019, ISO 10079-1:2015, ISO 10079-1:2015/Amd 1:2018. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase ISO 10079-1:2022 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 10079-1
Fourth edition
2022-03
Medical suction equipment —
Part 1:
Electrically powered suction
equipment
Appareils d'aspiration médicale —
Partie 1: Appareils électriques d'aspiration
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 .1
6.1 General . 1
6.2 Protection against ingress of solid objects and liquids . 2
6.3 Battery powered suction equipment . 2
7 Performance requirements . .2
7.1 General . 2
7.2 Effect of an interruption of power supply on the vacuum level and free air flow . 2
8 Additional/alternative requirements for suction equipment and suction tubing
designed for field use or transport use. 3
9 Information to be supplied by the manufacturer . 3
9.1 General . 3
9.2 Instructions for use . 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
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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
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constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expre
...
NORME ISO
INTERNATIONALE 10079-1
Quatrième édition
2022-03
Appareils d'aspiration médicale —
Partie 1:
Appareils électriques d'aspiration
Medical suction equipment —
Part 1: Electrically 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 .1
6.1 Généralités . 1
6.2 Protection contre la pénétration d'objets solides et de liquides . 2
6.3 Appareils d’aspiration alimentés sur batterie . 2
7 Exigences de performance .2
7.1 Généralités . 2
7.2 Effet d’une coupure de l’alimentation sur le niveau de dépression et le débit d’air à
débit libre . 3
8 Exigences supplémentaires/alternatives pour les appareils d’aspiration et tuyaux
d’aspiration prévus pour une utilisation sur le terrain ou une utilisation lors d’un
transport . 3
9 Informations à fournir par le fabricant . 3
9.1 Généralités . 3
9.2 Instructions d’utilisation . 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
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