ISO 23328-2:2002
(Main)Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects
Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects
ISO 23328-2:2002 specifies requirements for non-filtration aspects of breathing system filters (BSF) intended for anaesthetic and respiratory use, and addresses connection ports, leakage, resistance to flow, packaging, marking and information supplied. The test method is intended for BSF used with a clinical breathing system. It is not applicable to other types of filter, e.g. those designed to protect vacuum sources or gas sample lines, to filter compressed gases, or to protect test equipment for physiological respiratory measurements. A method for assessing filtration performance of BSF is given in ISO 23328-1.
Filtres pour matériel d'anesthésie et de réanimation respiratoire — Partie 2: Aspects autres que la filtration
L'ISO 23328-2:2002 spécifie les exigences s'appliquant aux aspects autres que la filtration des filtres pour systèmes respiratoires (BSF) pour matériel d'anesthésie et de réanimation. Elle traite des orifices de raccordement, des fuites, de la résistance au débit, de l'emballage, du marquage et des informations fournies. La méthode d'essai est destinée aux BSF utilisés avec un système respiratoire clinique. L'ISO 23328-2:2002 ne s'applique pas aux autres types de filtres, par exemple ceux conçus pour protéger les sources de vide ou les lignes de prélèvement de gaz, pour filtrer les gaz comprimés ou pour protéger le matériel d'essai utilisé pour les mesurages respiratoires physiologiques.
General Information
- Status
- Published
- Publication Date
- 21-Oct-2002
- Technical Committee
- ISO/TC 121/SC 2 - Airways and related equipment
- Drafting Committee
- ISO/TC 121/SC 2 - Airways and related equipment
- Current Stage
- 9093 - International Standard confirmed
- Start Date
- 14-Aug-2024
- Completion Date
- 13-Dec-2025
Overview
ISO 23328-2:2002 is an international standard developed by the International Organization for Standardization (ISO) that specifies essential non-filtration requirements for breathing system filters (BSF) used in anaesthetic and respiratory care. Unlike Part 1 of ISO 23328, which focuses on filtration performance, this Part 2 covers critical aspects including connectors, leakage, pressure resistance, packaging, marking, and manufacturer information.
This standard ensures that BSFs meet safety and usability criteria when integrated into clinical breathing systems. It is vital for manufacturers, healthcare providers, and regulatory bodies aiming to guarantee the reliability and safety of breathing system filters beyond their filtration efficiency.
Key Topics
Connection Ports
ISO 23328-2 mandates that BSF breathing system and patient connection ports comply with ISO 5356-1 standards, ensuring compatibility and safety when connecting to breathing circuits. Accessory ports must be designed to prevent misuse, avoiding connections to standard conical connectors and must include closure means to maintain system integrity.Pressure Drop and Leakage Testing
The standard defines protocols for measuring the pressure drop across the BSF at specified flow rates, correlating to adult and pediatric usage, which is critical for ensuring minimal respiratory resistance. Additionally, the BSF must undergo leakage testing to certify airtightness, supporting safe clinical performance.Packaging Requirements
Sterile BSFs must conform to the packaging requirements of ISO 11607, assuring product sterility integrity during storage and transport. Packaging must also be clearly marked to facilitate healthcare worker identification and enable proper storage and handling.Marking and Symbols
BSFs and their packaging are required to carry clear, standardized markings including orientation arrows, manufacturer information, single-use indicators, and safety symbols per ISO 15223 and ISO 7000. These markings provide essential guidance for proper application in clinical settings.Manufacturer Information
Detailed instructions must be supplied, covering usage parameters such as tidal volume ranges, pressure drops, internal volume, leakage rates, maintenance (for reusable components), potential hazards, cleaning protocols, and disposal guidelines. Clear warnings about possible risks, especially relating to inhalants or connector misuse, are mandated to safeguard patients and healthcare professionals.
Applications
ISO 23328-2:2002 applies specifically to breathing system filters used in anaesthetic and respiratory therapies where filters form part of clinical breathing circuits. Its focus is on guaranteeing the integrity, safety, and effective interface of the BSF within these systems by regulating non-filtration factors that directly impact patient safety and device reliability. This includes:
- Use in operating rooms for ventilation during anaesthesia.
- Critical respiratory care apparatus in intensive care units.
- Breathing circuits in diagnostic and therapeutic respiratory procedures.
- Devices integrated with mechanical ventilators and oxygen delivery systems.
This standard aids manufacturers in designing BSFs that minimize respiratory effort for patients, prevent gas leaks, and ensure compatibility with existing medical connectors and equipment, thereby minimizing clinical risks.
Related Standards
ISO 23328-2:2002 complements several international standards crucial to anaesthetic and respiratory equipment:
- ISO 23328-1 – Specifies the salt test method for evaluating the filtration performance of breathing system filters.
- ISO 5356-1 & ISO 5356-2 – Define the specifications for conical and screw-threaded connectors used in anaesthetic and respiratory devices, ensuring interchangeability.
- ISO 9360-1 – Addresses heat and moisture exchangers (HMEs), relevant for understanding pressure drop testing methods referenced in ISO 23328-2.
- ISO 11607 – Specifies packaging requirements for terminally sterilized medical devices, directly related to sterile BSF packaging.
- ISO 15223 & ISO 7000 – Provide standardized symbols and markings for medical device labeling, referenced for BSF marking requirements.
- IEC 60601-1 – Covers general safety requirements for medical electrical equipment, including aspects applicable to BSF safety under flammable anaesthetic use.
Keywords: ISO 23328-2, breathing system filters, anaesthetic use, respiratory equipment, non-filtration aspects, pressure drop, leakage testing, packaging standards, connector ports, medical device labeling, clinical breathing system filters, ISO breathing filters standard.
ISO 23328-2:2002 - Breathing system filters for anaesthetic and respiratory use
ISO 23328-2:2002 - Filtres pour matériel d'anesthésie et de réanimation respiratoire
Frequently Asked Questions
ISO 23328-2:2002 is a standard published by the International Organization for Standardization (ISO). Its full title is "Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects". This standard covers: ISO 23328-2:2002 specifies requirements for non-filtration aspects of breathing system filters (BSF) intended for anaesthetic and respiratory use, and addresses connection ports, leakage, resistance to flow, packaging, marking and information supplied. The test method is intended for BSF used with a clinical breathing system. It is not applicable to other types of filter, e.g. those designed to protect vacuum sources or gas sample lines, to filter compressed gases, or to protect test equipment for physiological respiratory measurements. A method for assessing filtration performance of BSF is given in ISO 23328-1.
ISO 23328-2:2002 specifies requirements for non-filtration aspects of breathing system filters (BSF) intended for anaesthetic and respiratory use, and addresses connection ports, leakage, resistance to flow, packaging, marking and information supplied. The test method is intended for BSF used with a clinical breathing system. It is not applicable to other types of filter, e.g. those designed to protect vacuum sources or gas sample lines, to filter compressed gases, or to protect test equipment for physiological respiratory measurements. A method for assessing filtration performance of BSF is given in ISO 23328-1.
ISO 23328-2:2002 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 23328-2:2002 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 ISO
STANDARD 23328-2
First edition
2002-10-15
Breathing system filters for anaesthetic and
respiratory use —
Part 2:
Non-filtration aspects
Filtres pour matériel d'anesthésie et de réanimation respiratoire —
Partie 2: Aspects autres que filtration
Reference number
©
ISO 2002
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not
be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this
file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this
area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters
were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event
that a problem relating to it is found, please inform the Central Secretariat at the address given below.
© ISO 2002
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic
or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's member body
in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.ch
Web www.iso.ch
Printed in Switzerland
ii © ISO 2002 – All rights reserved
Contents Page
Foreword . iv
Introduction. v
1 Scope. 1
2 Normative references. 1
3 Terms and definitions. 1
4 BSF port connectors. 2
4.1 BSF breathing system and patient connection ports. 2
4.2 Accessory ports . 2
5 Test methods . 2
5.1 Ambient conditions of test. 2
5.2 Measurement of pressure drop . 2
5.3 Test for gas leakage. 3
6 Packaging of sterile BSF . 3
7 Marking. 3
7.1 Use of symbols. 3
7.2 Marking of BSF . 3
7.3 Marking of package. 3
7.4 BSF intended for single use. 3
8 Information to be provided by the manufacturer. 4
Bibliography. 5
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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.
The main task of technical committees is to prepare International Standards. Draft International Standards adopted
by the technical committees are circulated to the member bodies for voting. Publication as an International
Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this part of ISO 23328 may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 23328-2 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 3, Lung ventilators and related equipment.
ISO 23328 consists of the following parts, under the general title Breathing system filters for anaesthetic and
respiratory use:
Part 1: Salt test method to assess filtration performance
Part 2: Non-filtration aspects
iv © ISO 2002 – All rights reserved
Introduction
This part of ISO 23328 gives requirements for non-filtration aspects of breathing system filters (BSF).
BSF are used to reduce particulates, including microorganisms, in gases delivered to and exhaled from patients.
BSF are exposed to various levels of humidity during clinical use. Exposure of the BSF to humidified air to simulate
clinical use forms part of the test method, as it is possible that such exposure can influence the filtration
performance of the BSF. A test method to assess filtration pe
...
NORME ISO
INTERNATIONALE 23328-2
Première édition
2002-10-15
Filtres pour matériel d'anesthésie
et de réanimation respiratoire —
Partie 2:
Aspects autres que la filtration
Breathing system filters for anaesthetic and respiratory use —
Part 2: Non-filtration aspects
Numéro de référence
©
ISO 2002
PDF – Exonération de responsabilité
Le présent fichier PDF peut contenir des polices de caractères intégrées. Conformément aux conditions de licence d'Adobe, ce fichier
peut être imprimé ou visualisé, mais ne doit pas être modifié à moins que l'ordinateur employé à cet effet ne bénéficie d'une licence
autorisant l'utilisation de ces polices et que celles-ci y soient installées. Lors du téléchargement de ce fichier, les parties concernées
acceptent de fait la responsabilité de ne pas enfreindre les conditions de licence d'Adobe. Le Secrétariat central de l'ISO décline toute
responsabilité en la matière.
Adobe est une marque déposée d'Adobe Systems Incorporated.
Les détails relatifs aux produits logiciels utilisés pour la création du présent fichier PDF sont disponibles dans la rubrique General Info
du fichier; les paramètres de création PDF ont été optimisés pour l'impression. Toutes les mesures ont été prises pour garantir
l'exploitation de ce fichier par les comités membres de l'ISO. Dans le cas peu probable où surviendrait un problème d'utilisation,
veuillez en informer le Secrétariat central à l'adresse donnée ci-dessous.
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2002
Droits de reproduction réservés. Sauf prescription différente, 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 et les microfilms, sans l'accord écrit
de l'ISO à l'adresse ci-après ou du comité membre de l'ISO dans le pays du demandeur.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax. + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Version française parue en 2007
Publié en Suisse
ii © ISO 2002 – Tous droits réservés
Sommaire Page
Avant-propos. iv
Introduction . v
1 Domaine d'application. 1
2 Références normatives . 1
3 Termes et définitions. 1
4 Raccords d'orifices du BSF . 2
4.1 Système respiratoire du BSF et orifices de raccordement côté patient. 2
4.2 Orifices accessoires. 2
5 Méthodes d'essai . 2
5.1 Conditions d'essai ambiantes . 2
5.2 Mesurage de la chute de pression. 3
5.3 Essai de détermination des fuites de gaz . 3
6 Emballage du BSF stérile. 3
7 Marquage . 3
7.1 Utilisation des symboles. 3
7.2 Marquage du BSF . 3
7.3 Marquage de l'emballage . 3
7.4 BSF non réutilisable . 4
8 Informations à fournir par le fabricant. 4
Bibliographie . 5
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 (CEI) en ce qui concerne la normalisation électrotechnique.
Les Normes internationales sont rédigées conformément aux règles données dans les Directives ISO/CEI,
Partie 2.
La tâche principale des comités techniques est d'élaborer les Normes internationales. Les projets de Normes
internationales adoptés par les comités techniques sont soumis aux comités membres pour vote. Leur
publication comme Normes internationales requiert l'approbation de 75 % au moins des comités membres
votants.
L'attention est appelée sur le fait que certains des éléments du présent document peuvent faire l'objet de
droits de propriété intellectuelle ou de droits analogues. L'ISO ne saurait être tenue pour responsable de ne
pas avoir identifié de tels droits de propriété et averti de leur existence.
L'ISO 23328-2 a été élaborée par le comité technique ISO/TC 121, Matériel d'anesthésie et de réanimation
respiratoire, sous-comité SC 3, Ventilateurs pulmonaires et équipements connexes.
L'ISO 23328 comprend les parties suivantes, présentées sous le titre général Filtres pour matériel
d'anesthésie et de réanimation respiratoire:
⎯ Partie 1: Méthode d'essai à l'aide d'une solution saline pour l'évaluation de l'efficacité de filtration
⎯ Partie 2: Aspects autres que la filtration
iv © ISO 2002 – Tous droits réservés
Introduction
La présente partie de l'ISO 23328 spécifie les exigences relatives aux aspects autres que la filtration des
filtres pour systèmes respiratoires (BSF).
Les BSF sont utilisés afin de réduire la transmission de particules, y compris de micro-organismes, par des
gaz inspirés et expirés par les patients.
Lors de leur utilisation clinique, les BSF sont exposés à différents niveaux d'humidité. L'exposition d'un BSF à
l'air humidifié pour la simulation d'une utilisation clinique fait partie de la méthode d'essai, car il est possible
que cette exposition influe sur les performances de la filtration du BSF. Une méthode d'essai visant à évaluer
la performance de la filtration est présentée dans l'ISO 23328-1.
----------
...
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...