SIST EN ISO 3826-3:2008

Plastics collapsible containers for human blood and blood components - Part 3: Blood bag systems with integrated features (ISO 3826-3:2006)

This part of ISO 3826 specifies requirements, including performance requirements, for integrated features on plastics collapsible, non-vented, sterile containers (blood bag systems). Blood bag systems need not contain all of the integrated features identified in this standard.
The integrated features refer to:
- leucocyte filter,
- pre-donation sampling device,
- top and bottom bag,
- platelet storage bag,
- needle stick protection device.
In addition to ISO 3826-1, which specifies the requirements of conventional containers, this part of ISO 3826 specifies additional requirements for blood bag systems using multiple units. This part of ISO 3826 does not cover automated blood collection systems.
Unless otherwise specified, all tests specified in this part of ISO 3826 apply to the plastics container as prepared ready for use. Use chemical, physical and biological tests in accordance with ISO 3826-1, where applicable.

Kunststoffbeutel für menschliches Blut und Blutbestandteile - Teil 3: Blutbeutelsysteme mit integrierten Merkmalen (ISO 3826-3:2006)

Dieser Teil von ISO 3826 legt Anforderungen — einschließlich der geforderten Leistungsmerkmale — für
integrierte Merkmale bei nicht belüfteten, sterilen Kunststoffbeuteln (Blutbeutelsysteme) fest. Blutbeutelsysteme
brauchen nicht alle der in diesem Dokument festgelegten integrierten Merkmale enthalten.
Die integrierten Merkmale beziehen sich auf:
⎯ Leukozytenfilter;
⎯ Vorrichtung zum Abtrennen des ersten Spendevolumens vor der Spende;
⎯ Oben-/Unten-Beutel;
⎯ Thrombozyten-Lagerungsbeutel;
⎯ Durchstichschutzvorrichtung.
In Ergänzung zu den in ISO 3826-1 festgelegten Anforderungen an konventionelle Beutel werden in diesem
Teil der ISO 3826 Zusatzanforderungen an Blutbeutelsysteme festgelegt, die Mehrfacheinheiten verwenden.
Der vorliegende Teil der ISO 3826 bezieht sich nicht auf automatische Blutentnahmesysteme.
Sofern nicht anders festgelegt, gelten alle in diesem Teil der ISO 3826 festgelegten Prüfungen für
Kunststoffbeutel im gebrauchsfertigen Zustand. Sofern zutreffend, sind chemische, physikalische und
biologische Prüfungen nach ISO 3826-1 anzuwenden.

Poches en plastique souple pour le sang et les composants du sang - Partie 3: Systèmes de poches pour le sang avec accessoires intégrés (ISO 3826-3:2006)

L'ISO 3826-3:2006 spécifie les exigences, y compris les exigences de performance, relatives aux accessoires intégrés aux poche en plastique souple stériles, sans prise d'air (systèmes de poches pour le sang).
Les accessoires intégrés désignent
le filtre à déleucocyter,
le dispositif d'échantillonnage pré-don,
la poche à sorties supérieure et inférieure,
la poche de stockage des plaquettes,
le dispositif protecteur d'aiguille.
En complément de l'ISO 3826-1:2003, qui spécifie les exigences relatives aux poches conventionnelles, l'ISO 3826-3:2006 spécifie des exigences supplémentaires portant sur les systèmes de poches multiples.
Sauf spécification contraire, tous les essais spécifiés dans l'ISO 3826-3:2006 s'appliquent aux poches prêtes à l'emploi.

Plastične vrečke za človeško kri in krvne komponente - 3. del: Sistemi vrečk za kri z integrirano oznako (ISO 3826-3:2006)

General Information

• Status: Published
• Publication Date: 17-Feb-2008
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 28-Jan-2008
• Due Date: 03-Apr-2008
• Completion Date: 18-Feb-2008
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN ISO 3826-3:2007 - Plastics collapsible containers for human blood and blood components - Part 3: Blood bag systems with integrated features (ISO 3826-3:2006)

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 3826-3:2008
01-april-2008
3ODVWLþQHYUHþNH]DþORYHãNRNULLQNUYQHNRPSRQHQWHGHO6LVWHPLYUHþN]DNUL
]LQWHJULUDQRR]QDNR,62
Plastics collapsible containers for human blood and blood components - Part 3: Blood
bag systems with integrated features (ISO 3826-3:2006)
Kunststoffbeutel für menschliches Blut und Blutbestandteile - Teil 3: Blutbeutelsysteme
mit integrierten Merkmalen (ISO 3826-3:2006)
Poches en plastique souple pour le sang et les composants du sang - Partie 3:
Systèmes de poches pour le sang avec accessoires intégrés (ISO 3826-3:2006)
Ta slovenski standard je istoveten z: EN ISO 3826-3:2007
ICS:
11.040.20
SIST EN ISO 3826-3:2008 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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EUROPEAN STANDARD
EN ISO 3826-3
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2007
ICS 11.040.20

English Version
Plastics collapsible containers for human blood and blood
components - Part 3: Blood bag systems with integrated
features (ISO 3826-3:2006)
Poches en plastique souple pour le sang et les composants Kunststoffbeutel für menschliches Blut und Blutbestandteile
du sang - Partie 3: Systèmes de poches pour le sang avec - Teil 3: Blutbeutelsysteme mit integrierten Merkmalen (ISO
accessoires intégrés (ISO 3826-3:2006) 3826-3:2006)
This European Standard was approved by CEN on 19 November 2007.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, 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
© 2007 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 3826-3:2007: E
worldwide for CEN national Members.

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EN ISO 3826-3:2007 (E)
Contents Page
Foreword.3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC Medical Device.4

2

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EN ISO 3826-3:2007 (E)
Foreword
The text of ISO 3826-3:2006 has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion
and injection equipment for medical and pharmaceutical use” of the International Organization for
Standardization (ISO) and has been taken over as EN ISO 3826-3:2007 by 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 June 2008, and conflicting national standards shall be withdrawn at
the latest by June 2008.
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 EC Directive(s).
For relationship with EC Directive(s), 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, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 3826-3:2006 has been approved by CEN as a EN ISO 3826-3:2007 without any modification.

3

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EN ISO 3826-3:2007 (E)
Annex ZA
(informative)

Relationship between this European Standard and the Essential Requirements of
EU Directive 93/42/EEC Medical Device
This European Standard has been prepared under a mandate given to CEN/CENELEC by the European
Commission to provide a means of conforming to Essential Requirements of the New Approach 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 normative
clauses of this standard confers, within the limits of the scope of this standard, a presumption of conformity
with the relevant Essential Requirements of that Directive and associated EFTA regulations.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.



4

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INTERNATIONAL ISO
STANDARD 3826-3
First edition
2006-09-15


Plastics collapsible containers for human
blood and blood components —
Part 3:
Blood bag systems with integrated
features
Poches en plastique souple pour le sang et les composants du sang —
Partie 3: Systèmes de poches pour le sang avec accessoires intégrés





Reference number
ISO 3826-3:2006(E)
©
ISO 2006

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ISO 3826-3:2006(E)
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ii © ISO 2006 – All rights reserved

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ISO 3826-3:2006(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
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 document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 3826-3 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment
for medical and pharmaceutical use.
ISO 3826 consists of the following parts, under the general title Plastics collapsible containers for human
blood and blood components:
— Part 1: Conventional containers
— Part 3: Blood bag systems with integrated features
Part 2, which will cover the use of graphical symbols, is currently in preparation.
© ISO 2006 – All rights reserved iii

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ISO 3826-3:2006(E)
Introduction
In some countries national pharmacopoeias, or other government regulations, are legally binding and these
requirements take precedence over this part of ISO 3826.
The manufacturers or suppliers of the plastic containers are expected to disclose in confidence to the national
control authority, if requested by them, full details of the plastic material(s) and the components of the
materials and their methods of manufacture, details of the manufacture of the plastic containers including the
chemical names and quantities of any additives, whether incorporated by the manufacturer of the plastic
containers or present in the raw material, as well as full details of any additives that have been used.

iv © ISO 2006 – All rights reserved

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INTERNATIONAL STANDARD ISO 3826-3:2006(E)

Plastics collapsible containers for human blood and blood
components —
Part 3:
Blood bag systems with integrated features
1 Scope
This part of ISO 3826 specifies requirements, including performance requirements, for integrated features on
plastic, collapsible, non-vented, sterile containers (blood bag systems). Blood bag systems need not contain
all of the integrated features identified in this document.
The integrated features refer to:
⎯ leucocyte filter;
⎯ pre-donation sampling device;
⎯ top-and-bottom bag;
⎯ platelet storage bag;
⎯ needle stick protection device.
In addition to ISO 3826-1, which specifies the requirements of conventional containers, this part of ISO 3826
specifies additional requirements for blood bag systems using multiple units. This part of ISO 3826 does not
cover automated blood collection systems.
Unless otherwise specified, all tests specified in this part of ISO 3826 apply to the plastic container as
prepared ready for use. Use chemical, physical and biological tests in accordance with ISO 3826-1, where
applicable.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 3826-1:2003, Plastics collapsible containers for human blood and blood components — Part 1:
Conventional containers
© ISO 2006 – All rights reserved 1

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ISO 3826-3:2006(E)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 3826-1 and the following apply.
3.1
leucocyte filter
LCF
filter used to reduce the content of leucocytes in blood or blood components
3.2
pre-donation sampling device
PDS
device integrated in the donor line of blood bag systems and designed to separate the first volume of donated
blood
NOTE The pre-donation sampling device is integrated in the donor line through a Y-piece, such that blood may only
flow into the pre-donation sampling device or into the blood bag.
3.3
top-and-bottom bag
TBB
bag containing top-and-bottom inlets and outlets
NOTE The top-and-bottom bag is part of a multiple bag system and is designed to allow centrifugation of
anticoagulated whole blood. After centrifugation the plasma is separated through the top and red cell concentrate through
the bottom outlet of the bag.
3.4
platelet storage bag
PSB
bag suitable for appropriate storage of a therapeutic dose of platelet concentrates, obtained from a single
donation or a pool of donations
NOTE The platelet storage ba
...