prEN ISO 1135-4

Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed (ISO/DIS 1135-4:2023)

This document specifies requirements for single use transfusion gravity sets for medical use in order to ensure their compatibility with containers for blood and blood components as well as with intravenous equipment.
Secondary aims of this document are to provide guidance on specifications relating to the quality and performance of materials used in transfusion sets, to present designations for transfusion set components, and to ensure the compatibility of sets with a range of cellular and plasma blood components.
Note: In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this document.

Transfusionsgeräte zur medizinischen Verwendung - Teil 4: Transfusionsgeräte für Schwerkrafttransfusionen zur einmaligen Verwendung (ISO/DIS 1135‑4:2023)

Matériel de transfusion à usage médical - Partie 4: Transfuseurs non réutilisables, à alimentation par gravité (ISO/DIS 1135-4:2023)

ISO 1135-4:2015 spécifie les exigences relatives aux appareils de transfusion non réutilisables à alimentation par gravité à usage médical, afin d'assurer leur compatibilité avec les conteneurs de sang et de composants sanguins, ainsi qu'avec les dispositifs intraveineux.
Les objectifs secondaires de l'ISO 1135-4:2015 consistent à fournir des préconisations concernant les spécifications de qualité et de performance des matériaux utilisés dans les appareils de transfusion, de proposer des désignations pour les composants de ces appareils de transfusion, et d'assurer la compatibilité de ces appareils avec un large éventail de produits cellulaires et plasmiques du sang.
Dans certains pays, la pharmacopée ou d'autres règlements nationaux sont légalement obligatoires et ont donc préséance sur l'ISO 1135-4:2015.

Transfuzijska oprema za uporabo v medicini - 4. del: Transfuzijske garniture za enkratno uporabo, delujoče na osnovi gravitacije (ISO/DIS 1135-4:2023)

General Information

• Status: Not Published
• Publication Date: 13-Jan-2025
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205 - Non-active medical devices
• Current Stage: 4599 - Dispatch of FV draft to CMC - Finalization for Vote
• Start Date: 12-May-2024
• Completion Date: 12-May-2024
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Ref Project: oSIST prEN ISO 1135-4:2023 - Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed (ISO/DIS 1135-4:2023)

Relations

• Revises: EN ISO 1135-4:2015 - Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed (ISO 1135-4:2015)
• Effective Date: 19-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-december-2023
Nadomešča:
SIST EN ISO 1135-4:2016
Transfuzijska oprema za uporabo v medicini - 4. del: Transfuzijske garniture za
enkratno uporabo, delujoče na osnovi gravitacije (ISO/DIS 1135-4:2023)
Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity
feed (ISO/DIS 1135-4:2023)
Transfusionsgeräte zur medizinischen Verwendung - Teil 4: Transfusionsgeräte für
Schwerkrafttransfusionen zur einmaligen Verwendung (ISO/DIS 1135-4:2023)
Matériel de transfusion à usage médical - Partie 4: Transfuseurs non réutilisables, à
alimentation par gravité (ISO/DIS 1135-4:2023)
Ta slovenski standard je istoveten z: prEN ISO 1135-4
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT INTERNATIONAL STANDARD
ISO/DIS 1135-4
ISO/TC 76 Secretariat: DIN
Voting begins on: Voting terminates on:
2023-10-12 2024-01-04
Transfusion equipment for medical use —
Part 4:
Transfusion sets for single use, gravity feed
Matériel de transfusion à usage médical —
Partie 4: Appareils de transfusion non réutilisables à alimentation par gravité
ICS: 11.040.20
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 1135-4:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

ISO/DIS 1135-4:2023(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 1135-4
ISO/TC 76 Secretariat: DIN
Voting begins on: Voting terminates on:

Transfusion equipment for medical use —
Part 4:
Transfusion sets for single use, gravity feed
Matériel de transfusion à usage médical —
Partie 4: Appareils de transfusion non réutilisables à alimentation par gravité
ICS: 11.040.20
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
USER PURPOSES, DRAFT INTERNATIONAL
CP 401 • Ch. de Blandonnet 8
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
Phone: [phone]
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: [e-mail]
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 1135-4:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

ISO/DIS 1135-4:2023(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements . 2
5 Materials . 3
6 Physical requirements . 3
6.1 Particulate contamination . 3
6.2 Leakage . 3
6.3 Tensile strength . 3
6.4 Closure-piercing device . 3
6.5 Tubing . 4
6.6 Filter for blood and blood components . 4
6.7 Drip chamber and drip tube . 4
6.8 Flow regulator . 4
6.9 Flow rate of blood and blood components . 4
6.10 Injection site . 5
6.11 Male conical fitting . 5
6.12 Protective caps . 5
7 Chemical requirements . 5
7.1 Reducing (oxidizable) matter . 5
7.2 Metal ions . 5
7.3 Titration acidity or alkalinity. 5
7.4 Residue on evaporation . 5
7.5 UV absorption of extract solution . 6
8 Biological requirements . 6
8.1 General . 6
8.2 Sterility . 6
8.3 Pyrogenicity . 6
8.4 Haemolysis . 6
8.5 Toxicity . 6
8.6 Assessment of blood component depletion . 6
8.7 Assessment of damage to blood components. 6
9 Labelling . 7
9.1 General . 7
9.2 Unit container . 7
9.3 Shelf or multi-unit container . 8
10 Packaging. 8
11 Disposal . 8
Annex A (normative) Physical tests . .9
Annex B (normative) Chemical tests .13
Annex C (normative) Biological tests .15
Annex ZA (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered .16
Bibliography .20
iii
ISO/DIS 1135-4:2023(E)
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 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
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified
...