EN ISO 3826-1:2003

Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2003)

ISO 3826-1:2003 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 3826-1:2003 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 3826-1:2003 apply to the plastics container as prepared ready for use.
ISO 3826-1:2003 is not applicable to plastics containers with an integrated filter.

Kunststoffbeutel für menschliches Blut und Blutbestandteile - Teil 1: Konventionelle Beutel (ISO 3826-1:2003)

Dieser Teil von ISO 3826 enthält Anforderungen einschließlich der geforderten Leistungsmerkmale für nicht-belüftete, sterile Kunststoffbeutel, die mit Entnahmeschlauch, einem oder mehreren Einstechstutzen, inte-grierter Blutentnahmekanüle und wahlweise mit Überleitungsschlauch bzw. -schläuchen ausgestattet sind und die zur Aufnahme, Lagerung, Aufbereitung, Transport, Trennung und Verabreichung von Blut und Blut-bestandteilen 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 3826-1:2003)

L'ISO 3826-1:2003 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 produits du sang. Les poches en plastique peuvent contenir des solutions anticoagulantes et/ou de solution de conservation, selon l'usage prévu.
Les exigences spécifiées dans la présente partie de l'ISO 3826-1:2003 sont également applicables aux poches en plastique multiples, par exemple les poches doubles, triples ou quadruples.
Sauf indication contraire, tous les essais spécifiés dans la présente partie de l'ISO 3826-1:2003 sont applicables aux poches en plastique prêtes à l'emploi.
L'ISO 3826-1:2003 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 3826-1:2003)

General Information

• Status: Withdrawn
• Publication Date: 14-Nov-2003
• Withdrawal Date: 04-Jun-2013
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205/WG 11 - Transfusion, infusion and injection equipment
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 05-Jun-2013
• Completion Date: 05-Jun-2013
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 3826-1:2004 - Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2003)

Relations

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

Standards Content (Sample)

SLOVENSKI STANDARD
01-februar-2004
3ODVWLþQL]ORåOMLYLYVHEQLNL]DþORYHãNRNULLQNUYQHNRPSRQHQWH±GHO2ELþDMQL
YVHEQLNL,62
Plastics collapsible containers for human blood and blood components - Part 1:
Conventional containers (ISO 3826-1:2003)
Kunststoffbeutel für menschliches Blut und Blutbestandteile - Teil 1: Konventionelle
Beutel (ISO 3826-1:2003)
Poches en plastique souple pour le sang et les composants du sang - Partie 1: Poches
conventionnelles (ISO 3826-1:2003)
Ta slovenski standard je istoveten z: EN ISO 3826-1:2003
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
November 2003
ICS 11.040.20
English version
Plastics collapsible containers for human blood and blood
components - Part 1: Conventional containers (ISO 3826-
1:2003)
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 3826-1:2003)
1:2003)
This European Standard was approved by CEN on 14 November 2003.
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 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 Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2003 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 3826-1:2003 E
worldwide for CEN national Members.

CORRECTED 2003-12-17
Foreword
This document (EN ISO 3826-1:2003) 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 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 May 2004, and conflicting national standards
shall be withdrawn at the latest by May 2004.
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(s), see informative Annex ZB, 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, Czech
Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and
the United Kingdom.
Endorsement notice
The text of ISO 3826-1:2003 has been approved by CEN as EN ISO 3826-1:2003 without any
modifications.
NOTE Normative references to International Standards are listed in Annex ZA (normative).
Annex ZA
(normative)
Normative references to international publications
with their relevant European publications
This European Standard incorporates by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the text and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions of
any of these publications apply to this European Standard only when incorporated in it by
amendment or revision. For undated references the latest edition of the publication referred to
applies (including amendments).
NOTE Where an International Publication has been modified by common modifications, indicated
by (mod.), the relevant EN/HD applies.
Publication Year Title EN Year
ISO 3696 1987 Water for analytical laboratory EN ISO 3696 1995
use - Specification and test
methods
Annex ZB
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93 /42 / EEC
This European Standard has been prepared under a mandate given to CEN by the European
Commission to provide a means of conforming to Essential Requirements of the New Approach
Directive (European Directive 93 / 42 / EEC)
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 ZB 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 ZB — Correspondence between this European Standard and Directive
(European Directive 93 / 42 / EEC)
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) of Qualifying remarks/Notes
EN Directive 93/42/EEC
6 Clauses 1 to 6
6.1 Clauses 7 to 13 Clause 7.1
For formulation of the plastic
material reference is given to
National Pharmacopeia.
No reference is given to the
flammability of the device.
6.2 Clauses 7 to 13
6.3 Clauses 7 to 13
6.4 Clauses 7 to 13
7 Clauses 7 to 13
8 Clauses 7 to 13
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
First edition
2003-11-15
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 3826-1:2003(E)
©
ISO 2003
ISO 3826-1:2003(E)
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ISO 3826-1:2003(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 . 2
5.6 Collection and transfer tube(s). 4
5.7 Blood-taking needle. 4
5.8 Outlet port(s). 4
5.9 Suspension. 5
6 Requirements. 5
6.1 General. 5
6.2 Physical requirements. 5
6.3 Chemical requirements. 7
6.4 Biological requirements. 8
7 Packaging. 8
8 Labelling. 9
8.1 General. 9
8.2 Label on plastics container. 9
8.3 Label on over-package . 9
8.4 Label on shipping box . 10
8.5 Label requirements. 10
9 Anticoagulant and/or preservative solution. 10
Annex A (normative) Chemical tests. 11
Annex B (normative) Physical tests . 16
Annex C (normative) Biological tests. 17
Bibliography . 20

ISO 3826-1:2003(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 clos
...