SIST EN ISO 10079-3:2022
(Main)Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2022)
Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2022)
This document specifies basic safety and performance requirements for medical suction equipment powered from a vacuum or positive pressure gas source generating venturi suction. It applies to suction equipment connected to medical gas pipeline systems or cylinders and venturi attachments and can be standalone or part of an integrated system.
Medizinische Absauggeräte - Teil 3: Vakuum- oder druckquellenbetriebene Absauggeräte (ISO 10079-3:2022)
Dieses Dokument legt Anforderungen für die Basissicherheit und für die Leistung von vakuum- oder druckquellenbetriebenen medizinischen Absauggeräten fest. Er gilt für Absauggeräte, die an Rohrleitungs¬systeme für medizinische Gase oder Gasflaschen und Saugdüsen-Zubehör angeschlossen sind und die eigenständig oder Teil eines integrierten Systems sein können.
Appareils d'aspiration médicale - Partie 3: Appareils d'aspiration alimentés par une source de vide ou de pression (ISO 10079-3:2022)
Le présent document spécifie les exigences de sécurité et de performance de base relatives aux appareils d'aspiration médicale alimentés par une source de vide ou de gaz à pression positive générant une aspiration Venturi. Il est applicable aux appareils d’aspiration raccordés à des bouteilles ou des systèmes de distribution de gaz médicaux et aux systèmes venturi. Les appareils peuvent être autonomes ou faire partie d'un système intégré.
Medicinska sukcijska (aspiracijska) oprema - 3. del: Podtlačna ali tlačna sukcijska (aspiracijska) oprema (ISO 10079-3:2022)
Ta dokument določa osnovne zahteve glede varnosti in učinkovitosti za medicinsko
podtlačno ali tlačno venturijevo sukcijsko (aspiracijsko) opremo. Uporablja se za sukcijsko (aspiracijsko)
opremo, ki je povezana s sistemi napeljav za medicinske pline ali jeklenkami in priključki venturijeve cevi ter je lahko samostojen sistem ali del integriranega sistema.
General Information
Relations
Overview
EN ISO 10079-3:2022 - Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2022) - specifies basic safety and performance requirements for medical suction devices that generate venturi suction from a vacuum or positive-pressure gas source. The standard covers suction equipment connected to medical gas pipeline systems or cylinders, including venturi attachments, whether they are standalone devices or part of an integrated system.
Key topics and requirements
- Scope and intent
- Applies specifically to suction equipment powered from a vacuum or a positive-pressure gas source that produces venturi suction.
- Reference to general requirements
- Many general requirements (materials, design, performance, manufacturer information) are handled by ISO 10079-4:2021; EN ISO 10079-3:2022 references these clauses rather than repeating them.
- Supply connections
- If designed for direct connection to a medical gas pipeline terminal or pressure regulator outlet, the equipment must be fitted with a probe complying with the relevant national standard.
- If designed for remote connection, a low‑pressure hose assembly complying with ISO 5359 must be used.
- Conformance of supply connections is verified by inspection.
- Performance, safety and field use
- Performance, materials, design and additional/alternative requirements for field use or transport use follow the clauses specified in ISO 10079-4:2021.
- Documentation
- Manufacturer-supplied information requirements are specified by reference to ISO 10079-4.
Practical applications
- Medical device manufacturers designing or certifying venturi-powered suction units for hospitals, clinics, ambulances, or field deployment.
- Clinical engineers and biomedical maintenance teams verifying that suction equipment complies with mandated safety and connection requirements before installation on medical gas pipeline systems or cylinder outlets.
- Procurement and regulatory professionals evaluating product compliance for purchase, certification, or national standard adoption.
- Designers of integrated operating-room or emergency-care systems that incorporate venturi suction modules.
Who should use this standard
- Manufacturers of medical suction equipment and venturi attachments
- Biomedical engineers and maintenance technicians
- Hospital procurement and compliance officers
- Test labs and conformity assessment bodies
- Regulators and national standards organizations
Related standards
- ISO 10079-4:2021 - General requirements for medical suction equipment (referenced extensively)
- ISO 5359 - Low-pressure hose assemblies for use with medical gases (for remote connections)
- ISO 7396-1:2016 - Medical gas pipeline systems (background for pipeline requirements)
EN ISO 10079-3:2022 is an essential reference for ensuring the safe design, connection and use of venturi-type medical suction equipment connected to gas supplies.
Frequently Asked Questions
SIST EN ISO 10079-3:2022 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2022)". This standard covers: This document specifies basic safety and performance requirements for medical suction equipment powered from a vacuum or positive pressure gas source generating venturi suction. It applies to suction equipment connected to medical gas pipeline systems or cylinders and venturi attachments and can be standalone or part of an integrated system.
This document specifies basic safety and performance requirements for medical suction equipment powered from a vacuum or positive pressure gas source generating venturi suction. It applies to suction equipment connected to medical gas pipeline systems or cylinders and venturi attachments and can be standalone or part of an integrated system.
SIST EN ISO 10079-3:2022 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.
SIST EN ISO 10079-3:2022 has the following relationships with other standards: It is inter standard links to SIST EN ISO 10079-3:2014. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase SIST EN ISO 10079-3:2022 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 SIST standards.
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2022
Nadomešča:
SIST EN ISO 10079-3:2014
Medicinska sukcijska (aspiracijska) oprema - 3. del: Podtlačna ali tlačna sukcijska
(aspiracijska) oprema (ISO 10079-3:2022)
Medical suction equipment - Part 3: Suction equipment powered from a vacuum or
positive pressure gas source (ISO 10079-3:2022)
Medizinische Absauggeräte - Teil 3: Vakuum- oder druckquellenbetriebene
Absauggeräte (ISO 10079-3:2022)
Appareils d'aspiration médicale - Partie 3: Appareils d'aspiration alimentés par une
source de vide ou de pression (ISO 10079-3:2022)
Ta slovenski standard je istoveten z: EN ISO 10079-3:2022
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 10079-3
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2022
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 10079-3:2014
English Version
Medical suction equipment - Part 3: Suction equipment
powered from a vacuum or positive pressure gas source
(ISO 10079-3:2022)
Appareils d'aspiration médicale - Partie 3: Appareils Medizinische Absauggeräte - Teil 3: Vakuum- oder
d'aspiration alimentés par une source de vide ou de druckquellenbetriebene Absauggeräte (ISO 10079-
pression (ISO 10079-3:2022) 3:2022)
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 10079-3:2022 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 10079-3:2022) 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 10079-3:2014.
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 10079-3:2022 has been approved by CEN as EN ISO 10079-3:2022 without any
modification.
INTERNATIONAL ISO
STANDARD 10079-3
Fourth edition
2022-03
Medical suction equipment —
Part 3:
Suction equipment powered from
a vacuum or positive pressure gas
source
Appareils d'aspiration médicale —
Partie 3: Appareils d'aspiration alimentés par une source de vide ou
de pression
Reference number
ISO 10079-3:2022(E)
ISO 10079-3:2022(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
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CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 10079-3:2022(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 .
...
The SIST EN ISO 10079-3:2022 standard outlines crucial safety and performance requirements for medical suction equipment powered by a vacuum or positive pressure gas source that generates venturi suction. This standard is particularly relevant in the context of healthcare, where it applies to suction equipment linked to medical gas pipeline systems or cylinders, along with venturi attachments. Notably, the versatility of this standard allows for the equipment to function as standalone units or as components of larger integrated systems. One of the significant strengths of SIST EN ISO 10079-3:2022 is its focus on safety, ensuring that medical suction equipment meets rigorous performance criteria. This is vital for maintaining patient safety and effective medical procedures in various healthcare settings. The standard emphasizes the importance of reliability and functionality, which are critical for emergency and routine medical applications, thereby ensuring that the equipment can operate effectively under different circumstances. Moreover, the comprehensive scope of this standard reinforces its relevance, as it addresses a wide array of medical suction applications. This inclusivity is beneficial for manufacturers and healthcare providers, as it sets a globally recognized benchmark for production and usage, fostering compliance with regulatory requirements. By establishing clear guidelines for the design and application of suction equipment, SIST EN ISO 10079-3:2022 aids in enhancing the overall quality of care provided in medical facilities. In summary, the SIST EN ISO 10079-3:2022 standard serves as a necessary framework for the safety and performance of medical suction equipment powered from gas sources. Its robust focus on safety, combined with its broad applicability within medical environments, underscores its crucial role in promoting efficient healthcare operations.
La norme SIST EN ISO 10079-3:2022 est un document essentiel qui établit des exigences de sécurité et de performance pour les équipements de suction médicale alimentés par une source de vide ou de gaz sous pression positive, générant une suction venturi. Cette norme revêt une grande importance dans le domaine médical puisqu'elle s'applique aux équipements de suction connectés à des systèmes de pipelines de gaz médicaux ou à des cylindres, ainsi qu'aux accessoires venturi, qu'ils soient autonomes ou intégrés dans un système. L'un des principaux atouts de la norme SIST EN ISO 10079-3:2022 est sa portée exhaustive qui garantit que tous les aspects critiques de la sécurité et de l'efficacité des équipements de suction médicale sont couverts. En définissant des critères précis pour les dispositifs alimentés par des sources de vide ou de gaz sous pression, la norme assure une utilisation sûre et efficace dans des environnements cliniques exigeants. De plus, la norme contribue significativement à l'harmonisation des pratiques de sécurité à l'échelle internationale, ce qui permet aux fabricants et aux utilisateurs de bénéficier de standards universels. Cette approche améliore non seulement la fiabilité des équipements médicaux, mais renforce également la confiance des praticiens et des patients dans l’utilisation de ces technologies. En somme, la norme SIST EN ISO 10079-3:2022 est d'une pertinence cruciale pour le secteur de la santé, car elle favorise à la fois la sécurité et la performance des équipements de suction médicale, tout en soutenant les efforts d'intégration et d'interopérabilité au sein des systèmes de soins de santé.
Die Norm SIST EN ISO 10079-3:2022 beschreibt wesentliche Sicherheits- und Leistungsanforderungen für medizinische Absauggeräte, die aus einer Vakuum- oder Überdruckgasquelle betrieben werden und Venturi-Absaugung erzeugen. Ihr Anwendungsbereich ist klar definiert und umfasst Absauggeräte, die an medizinische Gaspipeline-Systeme oder Zylinder angeschlossen sind sowie Venturi-Anschlüsse, sowohl als eigenständige Geräte als auch als integrierte Systeme. Ein herausragendes Merkmal dieser Norm ist ihre umfassende Abdeckung der Sicherheitsanforderungen. Sie stellt sicher, dass die Geräte unter verschiedenen Bedingungen zuverlässig und sicher arbeiten, was für Einrichtungen im Gesundheitswesen von größter Bedeutung ist. Auch die Leistungsanforderungen sind ein wichtiger Aspekt, da sie garantieren, dass die Absauggeräte die notwendige Effizienz und Effektivität erreichen, um den spezifischen medizinischen Anforderungen gerecht zu werden. Darüber hinaus ist die Relevanz der Norm in der gegenwärtigen medizinischen Praxis besonders hervorzuheben. Mit dem zunehmenden Einsatz von Technologien im Gesundheitswesen wird die Garantie von Sicherheit und Effektivität durch standardisierte Verfahren immer wichtiger. Die Norm SIST EN ISO 10079-3:2022 leistet einen entscheidenden Beitrag zur Harmonisierung und anwendbaren Standards in der Medizin, indem sie eine klare Richtlinie für die Entwicklung und den Betrieb von Absauggeräten liefert. Insgesamt bietet die Norm SIST EN ISO 10079-3:2022 einen umfassenden Rahmen, der sowohl die Sicherheit als auch die Leistungsfähigkeit von medizinischen Absauggeräten berücksichtigt und damit einen bedeutenden Mehrwert für alle Beteiligten im Gesundheitssektor bietet.
SIST EN ISO 10079-3:2022 표준은 의료 흡입 장비에 대한 안전 및 성능 요구 사항을 정의하고 있습니다. 이 표준은 진공 또는 양압 가스 원천에서 구동되며 벤투리 흡입을 생성하는 흡입 장비에 적용됩니다. 의료 가스 배관 시스템이나 실린더에 연결될 수 있는 흡입 장비를 대상으로 하며, 독립형 장비이거나 통합 시스템의 일부로 사용될 수 있습니다. 이 표준의 강점 중 하나는 안전성을 중시한다는 점입니다. 의료 분야에서 사용하는 장비의 안전 기준을 명확하게 제시함으로써 환자와 의료진의 안전을 보장합니다. 또한, 성능 요구 사항을 통해 장비가 안정적으로 작동하고 효율적인 치료를 지원할 수 있도록 합니다. SIST EN ISO 10079-3:2022의 범위는 의료 분야에서 매우 중요합니다. 벤투리 흡입 시스템을 통한 의료 가스 사용에 대한 체계적인 기준을 제공함으로써, 다양한 의료 환경에서 흡입 장비의 신뢰성을 높이는 데 기여합니다. 의료 기관 및 제조업체는 이 표준을 준수함으로써 법적 요건을 충족하고, 동시에 고객에게 안전하고 효과적인 제품을 제공할 수 있는 기회를 가지게 됩니다. 결국, SIST EN ISO 10079-3:2022는 의료 흡입 장비의 안전성과 성능을 보장하는 필수적인 기준으로 여겨지며, 이는 의료 서비스의 질 향상에 중요한 역할을 합니다.
SIST EN ISO 10079-3:2022は、真空または正圧ガス源から供給される医療用吸引機器に関する標準であり、特にベンチュリ吸引を生成する装置に焦点を当てています。この文書は、医療ガスパイプラインシステムやシリンダーに接続される吸引機器、およびベンチュリアタッチメントに関連する基本的な安全要件と性能要件を明確に定義しています。 この標準の強みは、その包括的な安全性とパフォーマンス基準です。医療環境において、患者の安全と機器の信頼性は極めて重要です。このため、SIST EN ISO 10079-3:2022では、吸引機器が供給源から正確に機能することを保証するための要件が明記されており、医療従事者や患者に対するリスクを最小限に抑えることに貢献しています。 また、この標準の適用範囲も広く、独立した装置として使用される場合や、統合システムの一部として機能する場合の両方を考慮しています。この柔軟性により、さまざまな医療環境での使用が可能となり、実際の運用ニーズに応じて適切な吸引機器を選択する助けとなります。 さらに、国際標準に基づいているため、異なる国や地域での医療機器の標準化を促進し、グローバルな医療環境における共通の基盤を確保しています。この点でも、SIST EN ISO 10079-3:2022は、医療用吸引技術の市場において重要な役割を果たすことが期待されます。 全体として、SIST EN ISO 10079-3:2022は医療用吸引機器における重要な標準であり、安全性、パフォーマンス、および適用範囲の観点から、医療現場に欠かせない基準を提供しています。
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