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)

ISO 3826-3:2006 specifies requirements, including performance requirements, for integrated features on plastic, collapsible, non-vented, sterile containers (blood bag systems).
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 3826-1:2003, which specifies the requirements of conventional containers, ISO 3826-3:2006 specifies additional requirements for blood bag systems using multiple units.
Unless otherwise specified, all tests specified in ISO 3826-3:2006 apply to the plastic container as prepared ready for use.

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: 11-Dec-2007
• Withdrawal Date: 29-Jun-2008
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: ISO/TC 76 - ISO/TC 76
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 12-Dec-2007
• Due Date: 31-Oct-2008
• Completion Date: 12-Dec-2007
• 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: 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)

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

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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.

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

Relationship between this
...