EN ISO 3826-4:2015

Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated features (ISO 3826-4:2015)

ISO 3826-4:2015 specifies requirements including performance requirements for aphaeresis blood bag systems with integrated features. Aphaeresis blood bag systems need not contain all of the integrated features identified in this part of ISO 3826.
The integrated features refer to: needle stick protection device, leucocyte filter, sterile barrier filter, pre-collection sampling device, red blood cell storage bag, plasma storage bag, platelet storage bag, polymorphonucleic (e.g. stem) cell storage bag, post-collection sampling devices, and connections for storage solutions, anticoagulant, and replacement fluid.
ISO 3826-4:2015 specifies additional requirements for blood bag systems used to collect varying quantities of blood components or cells by apheresis. It can be used on automated or semi-automated blood collection systems.

Kunststoffbeutel für menschliches Blut und Blutbestandteile - Teil 4: Apherese-Blutbeutelsysteme mit integrierten Merkmalen (ISO 3826-4:2015)

Dieser Teil von ISO 3826 legt Anforderungen, einschließlich der geforderten Leistungsmerkmale, fest für Apherese-Blutbeutelsysteme mit integrierten Merkmalen. Apherese-Blutbeutelsysteme müssen nicht alle der in diesem Dokument identifizierten integrierten Merkmale umfassen.
Die integrierten Merkmale beziehen sich auf Folgendes:
-   Durchstichschutzvorrichtung;
-   Leukozytenfilter;
-   Sterilbarrierefilter;
-   Vorrichtung für die Probenahme vor der Blutentnahme;
-   Erythrozyten-Lagerungsbeutel;
-   Plasma-Lagerungsbeutel;
-   Thrombozyten Lagerungsbeutel;
-   Lagerungsbeutel für polymorphonukleäre Zellen (z. B. Stammzellen);
-   Vorrichtung für die Probenahme nach der Blutentnahme;
-   Anschlüsse für Aufbewahrungs-, Antikoagulanzien- und Austauschflüssigkeiten.
Der vorliegende Teil der ISO 3826 legt zusätzliche Anforderungen an Blutbeutelsysteme für die Entnahme verschiedener Mengen von Blutbestandteilen oder Zellen durch Apherese fest. Der vorliegende Teil der ISO 3826 kann für sowohl automatische als auch halbautomatische Blutentnahmesysteme angewendet werden.

Poches en plastique souple pour le sang et les composants du sang - Partie 4: Systèmes de poches d'aphérèse pour le sang avec accessoires intégrés (ISO 3826-4:2015)

L'ISO 3826-4:2015 spécifie les exigences, y compris les exigences de performance, des systèmes de poches d'aphérèse pour le sang avec accessoires intégrés. Il n'est pas nécessaire que les systèmes de poches pour le sang comportent tous les accessoires intégrés identifiés dans l'ISO 3826-4:2015.
Les accessoires intégrés désignent : le dispositif protecteur d'aiguille, le filtre à déleucocyter, le filtre barrière stérile, le dispositif d'échantillonnage pré-don, la poche de stockage des globules rouges, la poche de stockage du plasma, la poche de stockage des plaquettes, la poche de stockage des cellules polymorphonucléaires (par exemple : les cellules souches), les dispositifs d'échantillonnage post?don, et les connexions pour les solutions de conservation, anticoagulantes et de perfusion.
L'ISO 3826-4:2015 spécifie des exigences supplémentaires relatives aux systèmes de poches pour le sang utilisés pour prélever, par aphérèse, des composants sanguins ou des cellules en quantités variables. Elle peut être utilisée pour les systèmes de prélèvement automatiques ou semi-automatiques du sang.

Plastični zložljivi vsebniki za človeško kri in krvne komponente - 4. del: Aferezni sistemi vrečk za kri z integrirano oznako (ISO 3826-4:2015)

Ta del standarda EN ISO 3826 določa zahteve, vključno z zahtevami glede zmogljivosti, za aferezne sisteme vrečk za kri z integrirano oznako. Afereznim sistemom vrečk za kri ni treba vsebovati vseh integriranih funkcij, navedenih v tem dokumentu. Integrirane funkcije se nanašajo na:  pripomoček za zaščito pred poškodbami z injekcijsko iglo;  filter za levkocite;  filter sterilne pregrade;  napravo za vzorčenje pred zbiranjem;  vrečko za shranjevanje rdečih krvničk;  vrečko za shranjevanje plazme;  vrečko za shranjevanje trombocitov;  vrečko za shranjevanje polimorfonuklearnih (matičnih) celic;  napravo za vzorčenje po zbiranju;  povezave za rešitve za shranjevanje, antikoagulans in nadomestno tekočino. Ta del standarda ISO 3826 določa dodatne zahteve za sisteme vrečk za kri, ki se uporabljajo za zbiranje različnih količin krvnih komponent ali celic z aferezo. Ta del standarda ISO 3826 je mogoče uporabiti pri avtomatiziranih ali polavtomatiziranih sistemih za zbiranje krvi.

General Information

• Status: Published
• Publication Date: 18-Aug-2015
• Withdrawal Date: 28-Feb-2016
• 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: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 19-Aug-2015
• Completion Date: 19-Aug-2015
• 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 3826-4:2015 - Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated features (ISO 3826-4:2015)

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 3826-4:2015
01-oktober-2015
3ODVWLþQL]ORåOMLYLYVHEQLNL]DþORYHãNRNULLQNUYQHNRPSRQHQWHGHO$IHUH]QL
VLVWHPLYUHþN]DNUL]LQWHJULUDQRR]QDNR,62
Plastics collapsible containers for human blood and blood components - Part 4:
Aphaeresis blood bag systems with integrated features (ISO 3826-4:2015)
Kunststoffbeutel für menschliches Blut und Blutbestandteile - Teil 4: Apherese-
Blutbeutelsysteme mit integrierten Merkmalen (ISO 3826-4:2015)
Poches en plastique souple pour le sang et les composants du sang - Partie 4:
Systèmes de poches d'aphérèse pour le sang avec accessoires intégrés (ISO 3826-
4:2015)
Ta slovenski standard je istoveten z: EN ISO 3826-4:2015
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 3826-4:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 3826-4:2015

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SIST EN ISO 3826-4:2015

EUROPEAN STANDARD
EN ISO 3826-4

NORME EUROPÉENNE

EUROPÄISCHE NORM
August 2015
ICS 11.040.20
English Version
Plastics collapsible containers for human blood and blood
components - Part 4: Aphaeresis blood bag systems with
integrated features (ISO 3826-4:2015)
Poches en plastique souple pour le sang et les composants Kunststoffbeutel für menschliches Blut und Blutbestandteile
du sang - Partie 4: Systèmes de poches d'aphérèse pour le - Teil 4: Apherese-Blutbeutelsysteme mit integrierten
sang avec accessoires intégrés (ISO 3826-4:2015) Merkmalen (ISO 3826-4:2015)
This European Standard was approved by CEN on 23 April 2015.

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

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 3826-4:2015 E
worldwide for CEN national Members.

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SIST EN ISO 3826-4:2015
EN ISO 3826-4:2015 (E)
Contents Page
European foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical devices .5

2

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SIST EN ISO 3826-4:2015
EN ISO 3826-4:2015 (E)
European foreword
This document (EN ISO 3826-4:2015) has been prepared by Technical Committee ISO/TC 76 “Transfusion,
infusion and injection, and blood processing 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 February 2016, and conflicting national standards shall be withdrawn
at the latest by February 2016.
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.
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, Malt
...