ISO 15010:1998
(Main)Disposable hanging devices for transfusion and infusion bottles - Requirements and test methods
Disposable hanging devices for transfusion and infusion bottles - Requirements and test methods
Dispositifs de suspension à usage unique pour flacons de transfusion et de perfusion — Exigences et méthodes d'essai
General Information
- Status
- Published
- Publication Date
- 10-Jun-1998
- Current Stage
- 9093 - International Standard confirmed
- Start Date
- 04-Sep-2023
- Completion Date
- 13-Dec-2025
Overview
ISO 15010:1998 specifies requirements and test methods for single-use (disposable) hanging devices used with transfusion and infusion bottles. Developed by ISO/TC 76, this standard focuses on mechanical safety and functional performance to prevent bottle drop during blood or pharmaceutical administration. Key elements include designation codes tied to nominal capacity, material expectations, mechanical tests and marking/packaging requirements.
Key Topics
- Scope and designation: Devices are designated by a code block and nominal capacity (for example, a device for a 50 ml infusion bottle is designated with the ISO 15010 code). Test weights and designation codes are linked to nominal capacity.
- Materials: Materials must meet performance needs and retain properties after exposure to ultraviolet light and common disinfectants.
- Mechanical requirements: The device must withstand disassembly/reassembly without damage and must be designed to keep the bottle suspended upside-down.
- Surface quality and safety: Surfaces must be clean and free from sharp edges or burrs to protect users and patients.
- Test methods: The standard prescribes specific tests, including:
- Gravity (drop) test - a controlled drop arrangement verifies the device does not detach or sustain damage when the assembly is arrested so the device ends up 30 cm from the fixed point.
- Permanent loading test - the device is suspended on a specified hook for 24 hours at controlled temperature (23 ± 2 °C) and relative humidity (50 ± 3 %) with a test weight corresponding to the designated capacity. The device must prevent bottle fall during this test.
- Packaging and marking: Packaging and storage must maintain compliance through the product life. Marking of the package must include the year of manufacture and the designation per the standard (e.g., "1997 - Dispositif de suspension ISO 15010 - A 250").
Applications
ISO 15010:1998 is relevant for manufacturers, quality managers, procurement specialists and regulatory teams involved with medical devices for blood transfusion and parenteral administration. Practical applications include:
- Design validation and production control of disposable hanging devices for transfusion and infusion bottles.
- Supplier and incoming inspection criteria for single-use suspension components.
- Regulatory documentation and conformity evidence demonstrating adherence to international test methods and marking requirements.
By following ISO 15010, organizations can reduce the risk of bottle drops during administration, ensure consistent material resilience to disinfectants and UV exposure, and provide clear product identification for traceability.
Related Standards
- ISO 1135-1 - transfusion bottles, stoppers and seals (referenced by ISO 15010 for compatibility)
- ISO 8536-1 - infusion bottles (referenced by ISO 15010 for compatibility)
- ISO 2768-1 - general tolerances (referenced for dimensional tolerances)
These related ISO documents define the bottle forms and dimensional references that ISO 15010 devices are intended to accommodate. For implementation, consult the current editions of all referenced standards.
ISO 15010:1998 - Disposable hanging devices for transfusion and infusion bottles -- Requirements and test methods
ISO 15010:1998 - Dispositifs de suspension a usage unique pour flacons de transfusion et de perfusion -- Exigences et méthodes d'essai
Frequently Asked Questions
ISO 15010:1998 is a standard published by the International Organization for Standardization (ISO). Its full title is "Disposable hanging devices for transfusion and infusion bottles - Requirements and test methods". This standard covers: Disposable hanging devices for transfusion and infusion bottles - Requirements and test methods
Disposable hanging devices for transfusion and infusion bottles - Requirements and test methods
ISO 15010:1998 is classified under the following ICS (International Classification for Standards) categories: 11.040.20 - Transfusion, infusion and injection equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
ISO 15010:1998 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 15010
First edition
1998-06-15
Disposable hanging devices for transfusion
and infusion bottles — Requirements and
test methods
Dispositifs de suspension à usage unique pour flacons de transfusion et de
perfusion — Exigences et méthodes d’essai
A
Reference number
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.
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.
International Standard ISO 15010 was prepared by Technical Committee
ISO/TC 76, Transfusion, infusion and injection equipment for medical use.
© ISO 1998
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 the publisher.
International Organization for Standardization
Case postale 56 • CH-1211 Genève 20 • Switzerland
Internet iso@iso.ch
Printed in Switzerland
ii
©
ISO
Introduction
This International Standard deals with hanging devices for transfusion bottles
in accordance with ISO 1135-1 and infusion bottles in accordance with
ISO 8536-1. The intended purpose of hanging devices is to avoid drop-
downs of transfusion and infusion bottles during administering of blood or
pharmaceutical solutions.
iii
©
INTERNATIONAL STANDARD ISO ISO 15010:1998(E)
Disposable hanging devices for transfusion and infusion
bottles — Requirements and test methods
1 Scope
This International Standard specifies requirements for hanging devices for transfusion bottles in accordance with
ISO 1135-1 and infusion bottles in accordance with ISO 8536-1 . The hanging devices are intended for single use only.
The purpose of this International Standard is to establish a safe hanging device for transfusion and infusion bottles
during administering of their contents.
2 Normative references
The following standards contain provisions which, through reference in this text, constitute provisions of this
International Standard. At the time of publication, the editions indicated were valid. All standards are subject to revision,
and parties to agreements based on this International Standard are encouraged to investigate the possibility of
applying the most recent editions of the standards indicated below. Members of IEC and ISO maintain registers of
currently valid International Standards.
ISO 1135-1:1987, Transfusion equipment for medical use — Part 1: Glass transfusion bottles, closures and caps.
ISO 2768-1:1989, General tolerances — Part 1: Tolerances for linear and angular dimensions without individual
tolerance indications.
ISO 8536-1:1991, Infusion equipment for medical use — Part 1: Infusion glass bottles.
3 Designation code and test weights
Disposable hanging devices in accordance with the requirements of this International Standard are
...
NORME ISO
INTERNATIONALE 15010
Première édition
1998-06-15
Dispositifs de suspension à usage unique
pour flacons de transfusion et
de perfusion — Exigences et méthodes
d’essai
Disposable hanging devices for transfusion and infusion bottles —
Requirements and test methods
A
Numéro de référence
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 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.
La Norme internationale ISO 15010 a été élaborée par le comité technique
ISO/TC 76, Appareils de transfusion, de perfusion et d'injection à usage
médical.
© ISO 1998
Droits de reproduction réservés. Sauf prescription différente, aucune partie de cette publi-
cation ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun pro-
cédé, électronique ou mécanique, y compris la photocopie et les microfilms, sans l'accord
écrit de l'éditeur.
Organisation internationale de normalisation
Case postale 56 • CH-1211 Genève 20 • Suisse
Internet iso@iso.ch
Imprimé en Suisse
ii
©
ISO ISO 15010:1998(F)
Introduction
La présente Norme internationale traite des dispositifs de suspension pour
des flacons de transfusion conformes à l'ISO 1135-1 et des flacons de
perfusion conformes à l'ISO 8536-1. Les dispositifs de suspension sont
destinés à éviter la chute des flacons de transfusion et de perfusion pendant
l'administration de sang ou de solutions pharmaceutiques.
iii
©
NORME INTERNATIONALE ISO ISO 15010:1998(F)
Dispositifs de suspension à usage unique pour flacons de
transfusion et de perfusion — Exigences et méthodes d’essai
1 Domaine d'application
La présente Norme internationale spécifie les exigences des dispositifs de suspension pour flacons de transfusion
conformes à l'ISO 1135-1 et pour flacons de perfusion conformes à l'ISO 8536-1. Les dispositifs de suspension sont
destinés à un usage unique.
La présente Norme internationale a pour objectif la réalisation d’un dispositif de suspension sûr pour flacons de
transfusion et de perfusion pendant l'administration de leur contenu.
2 Références normatives
Les normes suivantes contiennent des dispositions qui, par suite de la référence qui en est faite, constituent des
dispositions valables pour la présente Norme internationale. Au moment de la publication, les éditions indiquées
étaient en vigueur. Toute norme est sujette à révision et les parties prenantes des accords fondés sur la présente
Norme internationale sont invitées à rechercher la possibilité d'appliquer les éditions les plus récentes des normes
indiquées ci-après. Les membres de la CEI et de l'ISO possèdent le registre des Normes internationales en vigueur
à un moment donné.
ISO 1135-1:1987, Matériel de transfusion à usage médical — Partie 1: Flacons de transfusion en verre, bouchons
et capsules.
ISO 2768-1:1989, Tolérances générales — Partie 1: Tolérances pour dimensions linéaires et angulaires non
affectées de tolérances individuelles.
ISO 8536-1:1991, Matériel de perfusion à usage médical — Partie 1: Flacons en verre pour perfusion.
3 Code de désignation et poids d'essai
Les dispositifs de suspension conformes aux exigences de la présente Norme internationale sont désignés par le
bloc descripteur, suivi d’une référence à la présente Norme internationale, suivi du code de désignation tel qu
...
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