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
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
19-Aug-2015
Completion Date
19-Aug-2015

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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.

---------------------- Page: 1 ----------------------
SIST EN ISO 3826-4:2015
---------------------- Page: 2 ----------------------
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.
---------------------- Page: 3 ----------------------
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

---------------------- Page: 4 ----------------------
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, Malta, Netherlands, Norway, Poland, Portugal,

Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.

Endorsement notice

The text of ISO 3826-4:2015 has been approved by CEN as EN ISO 3826-4:2015 without any modification.

The following referenced documents are indispensable for the application of this document. For undated

references, the latest edition of the referenced document (including any amendments) applies. For dated

references, only the edition cited applies. However, for any use of this standard ‘within the meaning of

Annex ZA’, the user should always check that any referenced document has not been superseded and that its

relevant contents can still be considered the generally acknowledged state-of-art.

When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a normative

reference to the corresponding EN standard, if available, and otherwise to the dated ISO or IEC standard, as

listed below.

NOTE The way in which these references documents are cited in normative requirements determines the extent (in

whole or in part) to which they apply.
---------------------- Page: 5 ----------------------
SIST EN ISO 3826-4:2015
EN ISO 3826-4:2015 (E)

Table — Correlations between undated normative references and dated EN and ISO standards

Normative references as listed Equivalent dated standard
in Clause 2
EN ISO
ISO 594-2 — ISO 594-2:1998
a a
ISO 1135-4 EN ISO 1135-4:— ISO 1135-4:—
ISO 3696 EN ISO 3696:1995 ISO 3696:1987
ISO 3826-1 EN ISO 3826-1:2013 ISO 3826-1:2013
ISO 3826-2 EN ISO 3826-2:2008 ISO 3826-2:2008
ISO 3826-3 EN ISO 3826-3:2007 ISO 3826-3:2006
ISO 8536-4 EN ISO 8536-4:2013 and ISO 8536-4:2010 and
EN ISO 8536-4:2013/A1:2013 Amd.1:2013
ISO 10993-1 EN ISO 10993-1:2009 ISO 10993-1:2009
ISO 10993-4 EN ISO 10993-4:2009 ISO 10993-4:2002 plus
Amd.1:2006
ISO 10993-5 EN ISO 10993-5:2009 ISO 10993-5:2009
ISO 10993-10 EN ISO 10993-10:2013 ISO 10993-10:2010
ISO 10993-11 EN ISO 10993-11:2009 ISO 10993-11:2006
ISO 10993-12 EN ISO 10993-12:2012 ISO 10993-12:2012
ISO 15223-1 EN ISO 15223-1:2012 ISO 15223-1:2012
ISO 15747 EN ISO 15747:2011 ISO 15747:2010
ISO 23908 EN ISO 23908:2013 ISO 23908:2011
To be published.
---------------------- Page: 6 ----------------------
SIST EN ISO 3826-4:2015
EN ISO 3826-4:2015 (E)
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.

NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk

management process needs to be in compliance with Directive 93/42/EEC / Directive 90/385/EEC, as amended by

2007/47/EC. This means that risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’,

‘minimized’ or ‘removed’, according to the wording of the corresponding essential requirement.

NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with essential requirements

1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.

NOTE 3 This Annex ZA is based on Normative References according to Table of References, replacing the references

in the core text.

NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this

European Standard.

Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC, Medical

devices
Clause(s)/sub-clause(s) Essential Requirements (ERs) Qualifying remarks/Notes
of this EN of Directive 93/42/EEC
6.2.1, 6.2.3, 6.2.7, 6.2.8, 6.2.9, 7.2 Only the protection to the patients
6.2.10, 6.2.11, 6.3, 7 is explicitly addressed.
The part of ER 7.2 regarding the
packaging is not fully addressed.
For packaging, see Clause 7 of this
part of EN ISO 3826.
5.1 to 5.8, 6.2, 6.3, 6.4 7.3 Only the first half sentence of ER
7.3 is addressed. ER covered by
biological evaluation.

6.2.7, 6.2.10, 6.3, 6.4 7.5 (first and second paragraph) The part of ER 7.5 relating to

phthalates is not explicitly covered.
Only the first sentence is covered.
Presumption of conformity with the
Essential Requirements relating to
the biological evaluation can only
be provided if the manufacturer
chooses to apply the
EN ISO 10993 series of standards.
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SIST EN ISO 3826-4:2015
EN ISO 3826-4:2015 (E)
Clause(s)/sub-clause(s) Essential Requirements (ERs) Qualifying remarks/Notes
of this EN of Directive 93/42/EEC
5.3.1, 5.3.3, 5.4, 5.5.1, 5.5.4, 5.9.1, 7.6
5.10.3, 5.10.5, 5.11, 6.1, 6.2.1,
6.2.2, 6.2.6, 6.2.7, 6.2.10, 6.2.11,
6.4.2
5, 6 8.1 The part of ER 8.1 relating to easy
handling is not addressed.
Manufacturing processes are not
covered. Only sterility of product is
covered.
7 8.3
6.2.1, 6.2.2 8.4
6.2.1 8.5
5.8, 5.9, 5.10, 5.11 9.1 Restrictions indicated on the label
or in the instructions for use are not
addressed.
4, 5.4 9.2
6.2.7, 6.2.8, 6.2.9, 6.2.10 12.7.1 Only resistance to mechanical
stress is addressed.
8.2 to 8.6 13.1
8.1 13.2 EN ISO 15223-1 and
EN ISO 3826-2 are addressed
when using symbols.
8.2 to 8.6 13.3 The part of ER 13.3 related to
authorized representative is not
addressed.
13.3 d) is only covered if the batch
number is preceded by the word
'LOT'.
13.3 f) Requirement indication of
single use must be consistent
across the Community is not
addressed in this part of
EN ISO 3826.
13.3 g) and h) are not addressed in
this part of EN ISO 3826.
8.2 to 8.6 13.4

WARNING — Other requirements and other EU Directives can be applicable to the product(s) falling

within the scope of this part of EN ISO 3826.
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SIST EN ISO 3826-4:2015
INTERNATIONAL ISO
STANDARD 3826-4
First edition
2015-08-01
Plastics collapsible containers for
human blood and blood components —
Part 4:
Aphaeresis blood bag systems with
integrated features
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
Reference number
ISO 3826-4:2015(E)
ISO 2015
---------------------- Page: 9 ----------------------
SIST EN ISO 3826-4:2015
ISO 3826-4:2015(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2015, Published in Switzerland

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.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2015 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 3826-4:2015
ISO 3826-4:2015(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 2

4 Dimensions ................................................................................................................................................................................................................. 4

5 Design ...........................................................................................................................................................................................................................10

5.1 Leucocyte filter ....................................................................................................................................................................................10

5.2 Pilot samples ..........................................................................................................................................................................................10

5.3 Access line needle and return line needle ....................................................................................................................11

5.4 Needle stick protection device ...............................................................................................................................................11

5.5 Pre-collection sampling device ..............................................................................................................................................11

5.6 Red blood cell storage bag .........................................................................................................................................................11

5.7 Plasma storage bag ...........................................................................................................................................................................12

5.8 Platelet storage bag ..........................................................................................................................................................................12

5.9 Post-collection sampling device ............................................................................................................................................12

5.10 Collection and transfer tube(s) ..............................................................................................................................................12

5.11 Outlet port(s) .........................................................................................................................................................................................13

5.12 Suspension ...............................................................................................................................................................................................13

6 Requirements .......................................................................................................................................................................................................13

6.1 General ........................................................................................................................................................................................................13

6.2 Physical requirements ...................................................................................................................................................................14

6.2.1 Conditions of manufacture ...................................................................................................................................14

6.2.2 Sterilization .......................................................................................................................................................................14

6.2.3 Transparency ...................................................................................................................................................................14

6.2.4 Coloration ...........................................................................................................................................................................14

6.2.5 Thermal stability...........................................................................................................................................................14

6.2.6 Water vapour transmission for plastics containers prefilled with storage

solution or anticoagulant ......................................................................................................................................14

6.2.7 Resistance to leakage ................................................................................................................................................15

6.2.8 Insertion force .................................................................................................................................................................15

6.2.9 Pull force ..............................................................................................................................................................................15

6.2.10 Leakage after closure piercing ..........................................................................................................................15

6.2.11 Particulate contamination ....................................................................................................................................15

6.3 Chemical requirements.................................................................................................................................................................16

6.3.1 Requirements for the raw container or sheeting..............................................................................16

6.3.2 Requirements for the test fluid ........................................................................................................................16

6.4 Biological requirements ...............................................................................................................................................................17

6.4.1 General...................................................................................................................................................................................17

6.4.2 Impermeability for microorganisms ...........................................................................................................17

6.4.3 Compatibility ....................................................................................................................................................................17

7 Packaging ..................................................................................................................................................................................................................17

7.1 General ........................................................................................................................................................................................................17

7.2 Shelf-life .....................................................................................................................................................................................................17

7.3 Over-package materials ................................................................................................................................................................17

7.4 Over-package sealing ......................................................................................................................................................................17

7.5 Over-package strength ..................................................................................................................................................................18

7.6 Arrangement of components in the over-package ................................................................................................18

8 Labelling .....................................................................................................................................................................................................................18

8.1 General ........................................................................................................................................................................................................18

8.2 Label on plastics containers .....................................................................................................................................................18

© ISO 2015 – All rights reserved iii
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SIST EN ISO 3826-4:2015
ISO 3826-4:2015(E)

8.3 Label on over-package ...................................................................................................................................................................18

8.4 Package insert or instructions for use .............................................................................................................................19

8.5 Label on shipping box ....................................................................................................................................................................19

8.6 Label requirements ..........................................................................................................................................................................20

9 Anticoagulant and/or preservative solution .......................................................................................................................20

Annex A (normative) Chemical tests .................................................................................................................................................................21

Annex B (normative) Physical tests ....................................................................................................................................................................26

Annex C (normative) Biological tests ................................................................................................................................................................28

Bibliography .............................................................................................................................................................................................................................31

iv © ISO 2015 – All rights reserved
---------------------- Page: 12 ----------------------
SIST EN ISO 3826-4:2015
ISO 3826-4:2015(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.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).

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. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www.iso.org/patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation on the meaning of ISO specific terms and expressions related to conformity

assessment, as well as information about ISO’s adherence to the WTO principles in the Technical

Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information

The committee responsible for this document is ISO/TC 76, Transfusion, infusion and injection, and blood

processing 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 2: Graphical symbols for use on labels and instruction leaflets
— Part 3: Blood bag systems with integrated features
— Part 4: Aphaeresis blood bag systems with integrated features
© ISO 2015 – All rights reserved v
---------------------- Page: 13 ----------------------
SIST EN ISO 3826-4:2015
ISO 3826-4:2015(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 of the plastics container or the suppliers are expected to disclose in confidence

to the national control authority, if requested by them, full details of the plastics material(s) and the

components of the materials and their methods of manufacture, details of manufacture of the plastics

containers including the chemical names and quantities of any additives, whether incorporated by the

manufacturer of the plastics containers or present in the raw material, as well as full details of any

additives that have been used.

Universal leucocyte depletion is mandatory in various countries. This part of ISO 3826 is considered a

basic document for other standards which include technical innovations.
The requirements in this part of ISO 3826 are intended to

a) ensure that the quality of blood and blood components is maintained as high as necessary,

b) make possible efficient and safe collection, identification, storage, separation, and transfusion of

the contents with special attention to reducing or minimizing the risks resulting from

— contamination, in particular microbiological contamination,
— air embolism,

— errors in identification of plastics containers and any representative samples of contents, and

— interaction between the plastics container and its contents,

c) ensure functional compatibility when used in combination with transfusion sets as specified in

ISO 1135-4 and ISO 1135-5, and
d) provide a package with appropriate resistance to breakage and deterioration.
vi © ISO 2015 – All rights reserved
---------------------- Page: 14 ----------------------
SIST EN ISO 3826-4:2015
INTERNATIONAL STANDARD ISO 3826-4:2015(E)
Plastics collapsible containers for human blood and
blood components —
Part 4:
Aphaeresis blood bag systems with integrated features
1 Scope

This part of ISO 3826 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.

This part of ISO 3826 specifies additional requirements for blood bag systems used to collect varying

quantities of blood components or cells by apheresis. This part of ISO 3826 can be used on automated or

semi-automated blood collection systems.
In some countri
...

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