EN ISO 3826-1:2013

Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2013)

ISO 3826-1:2013 specifies requirements, including performance requirements, for plastics collapsible, non-vented, sterile containers complete with collecting tube outlet port(s), integral needle, and with optional transfer tube(s), for the collection, storage, processing, transport, separation, and administration of blood and blood components. The plastics containers may contain anticoagulant and/or preservative solutions, depending on the application envisaged.
ISO 3826-1:2013 is also applicable to multiple units of plastics containers, e.g. to double, triple, quadruple, or multiple units.
Unless otherwise specified, all tests specified in ISO 3826-1:2013 apply to the plastics container as prepared ready for use.

Kunststoffbeutel für menschliches Blut und Blutbestandteile - Teil 1: Konventionelle Beutel (ISO 3826-1:2013)

Dieser Teil von ISO 3826 legt Anforderungen einschließlich der geforderten Leistungsmerkmale fest für nicht belüftete, sterile Kunststoffbeutel, die mit Entnahmeschlauch, einem oder mehreren Einstechstutzen, integrierter Blutentnahmekanüle und wahlweise mit Überleitungsschlauch oder  schläuchen ausgestattet sind und die zur Aufnahme, Lagerung, Aufbereitung, zum Transport, zur Trennung und Verabreichung von Blut und Blutbestandteilen bestimmt sind. Die Kunststoffbeutel können, je nach vorgesehener Verwendung, Antikoagulans und/oder Stabilisatorlösung enthalten.
Dieser Teil von ISO 3826 ist auch anwendbar auf Mehrfachsysteme von Kunststoffbeuteln, die sich z. B. aus zwei, drei, vier oder mehr Einheiten zusammensetzen.
Soweit nichts anderes vorgegeben ist, gelten alle in diesem Teil von ISO 3826 festgelegten Prüfungen für den gebrauchsfertigen Kunststoffbeutel.
Dieser Teil von ISO 3826 gilt nicht für Kunststoffbeutel mit einem integrierten Filter.

Poches en plastique souple pour le sang et les composants du sang - Partie 1: Poches conventionnelles (ISO 3826-1:2013)

L'ISO 3826-1:2013 spécifie les exigences, y compris les exigences de performance, des poches en plastique souple, sans prise d'air, stériles, présentées complètes avec tubulure de prélèvement à aiguille solidaire, raccord(s) de sortie, et, éventuellement, tubulure(s) de transfert, destinées au prélèvement, au stockage, au traitement, au transport, à la séparation et à la transfusion du sang et des composants du sang. Les poches en plastique peuvent contenir des solutions anticoagulantes et/ou de conservation, selon l'usage prévu.
Les exigences spécifiées dans l'ISO 3826-1:2013 sont également applicables aux poches en plastique multiples, par exemple les poches doubles, triples ou quadruples.
Sauf indication contraire, tous les essais spécifiés dans l'ISO 3826-1:2013 sont applicables aux poches en plastique prêtes à l'emploi.
L'ISO 3826-1:2013 n'est pas applicable aux poches en plastique comportant un filtre intégré.

Plastični zložljivi vsebniki za človeško kri in krvne komponente - 1. del: Običajni vsebniki (ISO 3826-1:2013)

Ta del standarda ISO 3826 določa posebne zahteve, vključno z zahtevami glede zmogljivosti, za plastične zložljive nezračene sterilne vsebnike z izhodnimi priključki zbirne cevke, vdelano iglo in dodatnimi prenosnimi cevkami za zbiranje, shranjevanje, obdelavo, transport, ločevanje in upravljanje krvi in krvnih komponent. Plastični vsebniki lahko vsebujejo antikoagulant in/ali konzervans, odvisno od predvidene uporabe. Ta del standarda ISO 3826 se uporablja tudi za enote z več plastičnimi vsebniki, npr. za dvojne, trojne, četverne ali večje enote. Razen če je navedeno drugače, vsi preskusi, navedeni v tem delu standarda ISO 3826, veljajo za plastične vsebnike, pripravljene za uporabo.

General Information

• Status: Withdrawn
• Publication Date: 04-Jun-2013
• Withdrawal Date: 15-Oct-2019
• 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: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 16-Oct-2019
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 3826-1:2013 - Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2013)

Relations

• Replaces: EN ISO 3826-1:2003 - Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2003)
• Effective Date: 12-Jun-2013
• Replaced By: EN ISO 3826-1:2019 - Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2019)
• Effective Date: 10-Feb-2016

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2013
1DGRPHãþD
SIST EN ISO 3826-1:2004
3ODVWLþQL]ORåOMLYLYVHEQLNL]DþORYHãNRNULLQNUYQHNRPSRQHQWHGHO2ELþDMQL
YVHEQLNL,62
Plastics collapsible containers for human blood and blood components - Part 1:
Conventional containers (ISO 3826-1:2013)
Kunststoffbeutel für menschliches Blut und Blutbestandteile - Teil 1: Konventionelle
Beutel (ISO 3826-1:2013)
Poches en plastique souple pour le sang et les composants du sang - Partie 1: Poches
conventionnelles (ISO 3826-1:2013)
Ta slovenski standard je istoveten z: EN ISO 3826-1:2013
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.

EUROPEAN STANDARD
EN ISO 3826-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2013
ICS 11.040.20 Supersedes EN ISO 3826-1:2003
English Version
Plastics collapsible containers for human blood and blood
components - Part 1: Conventional containers (ISO 3826-
1:2013)
Poches en plastique souple pour le sang et les composants Kunststoffbeutel für menschliches Blut und Blutbestandteile
du sang - Partie 1: Poches conventionnelles (ISO 3826- - Teil 1: Konventionelle Beutel (ISO 3826-1:2013)
1:2013)
This European Standard was approved by CEN on 22 May 2013.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 3826-1:2013: E
worldwide for CEN national Members.

Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical devices .4

Foreword
This document (EN ISO 3826-1:2013) has been prepared by Technical Committee ISO/TC 76 "Transfusion,
infusion and injection equipment for medical and pharmaceutical use" in collaboration with Technical
Committee CEN/TC 205 “Non-active medical devices” the secretariat of which is held by DIN.
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 December 2013, and conflicting national standards shall be withdrawn
at the latest by December 2013.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 3826-1:2003.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 3826-1:2013 has been approved by CEN as EN ISO 3826-1:2013 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical devices
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC, Medical devices.
Once this standard is cited in the Official Journal of the European Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC, Medical
devices
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
EN of Directive 93/42/EEC
6.2.3, 6.2.8, 6.3, 7.5 7.2 Only the protection to the
patients is explicitly addressed.
The part of ER 7.2 regarding the
packaging is not fully addressed.
5.1 to 5.8, 6.2.5 to 6.2.8, 6.3 7.3 Only the first half sentence of ER
7.3 is addressed.
5.6.3, 6.2.6, 6.2.7, 6.3, 6.4.3, 8.1 7.5 (first and second paragraph) The part of ER 7.5 relating to
phthalates is not explicitly
covered.
5.7, 5.8, 6.4.2 7.6
5.7, 5.8, 6.2.2, 6.4.2 8.1 The part of ER 8.1 relating to
easy handling is not addressed.
6.2.2, 7.4, 7.5 8.3
6.2.2 8.4
6.2.1 8.5
5.8, 5.9 9.1 Restrictions indicated on the
label or in the instructions for
use are not addressed.
5.7, 5.8.1 9.2 (first indent)
5.6, 5.9, 6.2.7 12.7.1 Only resistance to mechanical
stress is addressed.
8.2 to 8.5 13.1
8.1 13.2
8.2 to 8.5 13.3 The part of ER 13.3 related to
authorized representative is not
addressed.
8.2 to 8.5 13.4
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
INTERNATIONAL ISO
STANDARD 3826-1
Second edition
2013-06-01
Plastics collapsible containers for
human blood and blood components —
Part 1:
Conventional containers
Poches en plastique souple pour le sang et les composants du sang —
Partie 1: Poches conventionnelles
Reference number
ISO 3826-1:2013(E)
©
ISO 2013
ISO 3826-1:2013(E)
© ISO 2013
All rights reserved. Unless otherwise specified, 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.
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ii © ISO 2013 – All rights reserved

ISO 3826-1:2013(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Dimensions and designation . 2
4.1 Dimensions . 2
4.2 Designation example . 2
5 Design . 2
5.1 General . 2
5.2 Air content . 2
5.3 Emptying under pressure . 2
5.4 Pilot samples . 2
5.5 Rate of collection . 3
5.6 Collection and transfer tube(s) . 5
5.7 Blood-taking needle . . 5
5.8 Outlet port(s) . 6
5.9 Suspension . 6
6 Requirements . 6
6.1 General . 6
6.2 Physical requirements . 7
6.3 Chemical requirements. 8
6.4 Biological requirements . 9
7 Packaging .10
8 Labelling .10
8.1 General .10
8.2 Label on plastics container .10
8.3 Label on over-package .11
8.4 Label on shipping box .11
8.5 Label requirements .
...