Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2019)

This document specifies requirements, including performance requirements, for plastics collapsible, non-vented, sterile containers (known as plastics 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 can contain anticoagulant and/or preservative solutions, depending on the application envisaged.
This document 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 this document apply to the plastics container as prepared ready for use.
This document is not applicable to plastics containers with an integrated filter.

Kunststoffbeutel für menschliches Blut und Blutbestandteile - Teil 1: Konventionelle Beutel (ISO 3826-1:2019)

Dieses Dokument legt Anforderungen einschließlich der geforderten Leistungsmerkmale fest für nicht belüftete, sterile Beutel (bekannt als Kunststoffbeutel), die mit Entnahmeschlauch, einem oder mehreren Einstechstutzen, integrierter Blutentnahmekanüle und wahlweise mit Überleitungsschlauch oder  schläuchen ausgestattet sind und die zur Aufnahme, Lagerung, Aufbereitung, zum Transport, zur Trennung und Verabreichung von Blut und Blutbestandteilen bestimmt sind. Die Kunststoffbeutel können, je nach vorgesehener Verwendung, Antikoagulans und/oder Stabilisatorlösungen enthalten.
Dieses Dokument 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 Dokument festgelegten Prüfungen für den gebrauchsfertigen Kunststoffbeutel.
Dieses Dokument 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 3826-1:2019)

Le présent document spécifie les exigences, y compris les exigences de performance, des poches en plastique souple, sans prise d'air, stériles (appelées poches en plastique), 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 composants du sang. Les poches en plastique peuvent contenir des solutions anticoagulantes et/ou de conservation, selon l'usage prévu.
Les exigences spécifiées dans le présent document sont également applicables aux poches en plastique multiples, par exemple les poches doubles, triples ou quadruples.
Sauf indication contraire, tous les essais spécifiés dans le présent document sont applicables aux poches en plastique prêtes à l'emploi.
Le présent document 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 3826-1:2019)

Ta dokument določa zahteve, vključno z zahtevami glede lastnosti, za plastične zložljive nezračene sterilne vsebnike (z drugim imenom plastične vsebnike) z izhodnimi priključki zbirne cevke, vdelano iglo in dodatnimi prenosnimi cevkami za odvzem, shranjevanje, obdelavo, transport, ločevanje ter dovajanje krvi in krvnih komponent. Plastični vsebniki lahko vsebujejo antikoagulant in/ali konzervans, odvisno od predvidene uporabe. Ta dokument se uporablja tudi za enote z več plastičnimi vsebniki, npr. za dvojne, trojne, četverne ali večje enote. Če ni navedeno drugače, se vsi preskusi, navedeni v tem dokumentu, uporabljajo za plastične vsebnike, pripravljene za uporabo. Ta dokument se ne uporablja za plastične vsebnike z vgrajenim filtrom.

General Information

Status
Published
Publication Date
15-Oct-2019
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
16-Oct-2019
Completion Date
16-Oct-2019

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SLOVENSKI STANDARD
SIST EN ISO 3826-1:2019
01-december-2019
Nadomešča:
SIST EN ISO 3826-1:2013

Plastični zložljivi vsebniki za človeško kri in krvne komponente - 1. del: Običajni

vsebniki (ISO 3826-1:2019)
Plastics collapsible containers for human blood and blood components - Part 1:
Conventional containers (ISO 3826-1:2019)

Kunststoffbeutel für menschliches Blut und Blutbestandteile - Teil 1: Konventionelle

Beutel (ISO 3826-1:2019)

Poches en plastique souple pour le sang et les composants du sang - Partie 1: Poches

conventionnelles (ISO 3826-1:2019)
Ta slovenski standard je istoveten z: EN ISO 3826-1:2019
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 3826-1:2019 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 3826-1:2019
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SIST EN ISO 3826-1:2019
EN ISO 3826-1
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2019
EUROPÄISCHE NORM
ICS 11.040.20 Supersedes EN ISO 3826-1:2013
English Version
Plastics collapsible containers for human blood and blood
components - Part 1: Conventional containers (ISO 3826-
1:2019)

Poches en plastique souple pour le sang et les Kunststoffbeutel für menschliches Blut und

composants du sang - Partie 1: Poches Blutbestandteile - Teil 1: Konventionelle Beutel (ISO

conventionnelles (ISO 3826-1:2019) 3826-1:2019)
This European Standard was approved by CEN on 25 August 2019.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,

Poland, Portugal, Republic of North Macedonia, Romania, Serbia, 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: Rue de la Science 23, B-1040 Brussels

© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 3826-1:2019 E

worldwide for CEN national Members.
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SIST EN ISO 3826-1:2019
EN ISO 3826-1:2019 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 3826-1:2019
EN ISO 3826-1:2019 (E)
European foreword

This document (EN ISO 3826-1:2019) 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 April 2020, and conflicting national standards shall be

withdrawn at the latest by April 2020.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN ISO 3826-1:2013.

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, France, Germany, Greece, Hungary, Iceland,

Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of

North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the

United Kingdom.
Endorsement notice

The text of ISO 3826-1:2019 has been approved by CEN as EN ISO 3826-1:2019 without any

modification.
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SIST EN ISO 3826-1:2019
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SIST EN ISO 3826-1:2019
INTERNATIONAL ISO
STANDARD 3826-1
Third edition
2019-09
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 3826-1:2019(E)
ISO 2019
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SIST EN ISO 3826-1:2019
ISO 3826-1:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019

All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
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SIST EN ISO 3826-1:2019
ISO 3826-1:2019(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

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

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

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Dimensions ................................................................................................................................................................................................................. 2

5 Design .............................................................................................................................................................................................................................. 2

5.1 General ........................................................................................................................................................................................................... 2

5.2 Air content .................................................................................................................................................................................................. 3

5.3 Emptying under pressure .............................................................................................................................................................. 3

5.4 Pilot samples ............................................................................................................................................................................................. 3

5.5 Rate of collection ................................................................................................................................................................................... 3

5.6 Collection and transfer tube(s) ................................................................................................................................................. 5

5.7 Blood-taking needle ......... ................................................................................................................................................................... 6

5.8 Outlet port(s) ............................................................................................................................................................................................ 6

5.9 Suspension .................................................................................................................................................................................................. 7

6 Requirements .......................................................................................................................................................................................................... 7

6.1 General ........................................................................................................................................................................................................... 7

6.2 Physical requirements ...................................................................................................................................................................... 7

6.2.1 Conditions of manufacture ...................................................................................................................................... 7

6.2.2 Sterilization .......................................................................................................................................................................... 7

6.2.3 Transparency ...................................................................................................................................................................... 7

6.2.4 Coloration .............................................................................................................................................................................. 8

6.2.5 Thermal stability.............................................................................................................................................................. 8

6.2.6 Water vapour transmission .................................................................................................................................... 8

6.2.7 Resistance to leakage ................................................................................................................................................... 8

6.2.8 Particulate contamination ....................................................................................................................................... 8

6.3 Chemical requirements.................................................................................................................................................................... 9

6.3.1 Requirements for the raw container or sheeting................................................................................. 9

6.3.2 Requirements for the test fluid ........................................................................................................................... 9

6.4 Biological requirements ...............................................................................................................................................................10

6.4.1 General...................................................................................................................................................................................10

6.4.2 Impermeability for microorganisms ...........................................................................................................10

6.4.3 Compatibility ....................................................................................................................................................................10

7 Packaging ..................................................................................................................................................................................................................10

8 Labelling .....................................................................................................................................................................................................................10

8.1 General ........................................................................................................................................................................................................10

8.2 Label on plastics container ........................................................................................................................................................11

8.3 Label on over-package ...................................................................................................................................................................11

8.4 Label on shipping box ....................................................................................................................................................................12

8.5 Label requirements ..........................................................................................................................................................................12

9 Anticoagulant and/or preservative solution .......................................................................................................................12

Annex A (normative) Chemical tests .................................................................................................................................................................13

Annex B (normative) Physical tests ....................................................................................................................................................................18

Annex C (normative) Biological tests ................................................................................................................................................................20

Bibliography .............................................................................................................................................................................................................................23

© ISO 2019 – All rights reserved iii
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SIST EN ISO 3826-1:2019
ISO 3826-1:2019(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 of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso

.org/iso/foreword .html.

This document was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection, and

blood processing equipment for medical and pharmaceutical use.

This third edition cancels and replaces the second edition (ISO 3826-1:2013), which has been technically

revised.
The main changes compared to the previous edition are as follows:
— in Clause 3 'Terms and definitions' four new entries have been added;
— in Clause 4, the designation example has been removed;

— Clause 5 'Design' has been revised, especially regarding the pilot samples, collection and transfer

tube(s), blood-taking needle and outlet port(s);
— the physical requirements in 6.2 have been slightly amended;
— Clause 8 'Labelling' has been reviewed and amended with barcoding information;
— the normative references in Clause 2 and the Bibliography have been updated.
A list of all parts in the ISO 3826 series can be found on the ISO website.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/members .html.
iv © ISO 2019 – All rights reserved
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SIST EN ISO 3826-1:2019
ISO 3826-1:2019(E)
Introduction

The manufacturers, or the suppliers, of plastics containers are expected to disclose in confidence to

control authorities, 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 document is considered as a basic

for other standards which include technical innovations.
The requirements in this document 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,

— 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 or ISO 1135-5,
d) provide a package with appropriate resistance to breakage and deterioration.
© ISO 2019 – All rights reserved v
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SIST EN ISO 3826-1:2019
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SIST EN ISO 3826-1:2019
INTERNATIONAL STANDARD ISO 3826-1:2019(E)
Plastics collapsible containers for human blood and blood
components —
Part 1:
Conventional containers
1 Scope

This document specifies requirements, including performance requirements, for plastics collapsible,

non-vented, sterile containers (known as plastics 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 can

contain anticoagulant and/or preservative solutions, depending on the application envisaged.

This document 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 this document apply to the plastics container as

prepared ready for use.

This document is not applicable to plastics containers with an integrated filter.

2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements 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 1135-4, Transfusion equipment for medical use — Part 4: Transfusion sets for single use, gravity feed

ISO 1135-5, Transfusion equipment for medical use — Part 5: Transfusion sets for single use with pressure

infusion apparatus
ISO 3696, Water for analytical laboratory use — Specification and test methods

ISO 10993-4, Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood

ISO 10993-5, Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity

ISO 10993-10, Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization

ISO 10993-11, Biological evaluation of medical devices — Part 11: Tests for systemic toxicity

3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— IEC Electropedia: available at http: //www .electropedia .org/
— ISO Online browsing platform: available at http: //www .iso .org/obp
© ISO 2019 – All rights reserved 1
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SIST EN ISO 3826-1:2019
ISO 3826-1:2019(E)
3.1
plastics container

bag, of plastics material, complete with collecting tube and needle, port(s) and where applicable

anticoagulant, preservative solutions, transfer tube(s) and associated container(s)

3.2
shelf life

period between the date of sterilization and the use-by date (expiry date) of the

plastics collapsible container for human blood and blood components after which the plastics container

shall not be used for the collection of blood
3.3
sheeting
plastics material intended for the production of empty containers
[SOURCE: ISO 15747:2018, 3.12]
3.4
raw container
empty container that has not yet been sterilized and has no identification
[SOURCE: ISO 15747:2018, 3.11]
3.5
empty container

raw container with identification, which is suitable for the acceptance and storage of fluids where

applicable and to be used for testing purposes

[SOURCE: ISO 15747:2018, 3.3, modified — "and administration of the injection solution" has been

replaced by "of fluids where applicable and to be used for testing purposes".]
3.6
gauge pressure
pressure zero-referenced against local atmospheric pressure
Note 1 to entry: Container internal gauge pressure is:

— positive when the container is pressurized above the surrounding atmospheric pressure, and is

— negative when the container is subjected to suction.
[SOURCE: ISO 15747:2018, 3.4]
4 Dimensions

Figure 1 illustrates the components of a plastics container. The values of the dimensions shown in

Figure 1 are binding and form part of the requirements of this document; the dimensions given in

Table 1 are for guidance only.
5 Design
5.1 General

The design and manufacture of the plastics container shall provide for the safe and convenient collection,

storage, processing, transport, separation, and administration of whole blood and blood components.

The plastics container shall permit the collection of blood and the preparation of plasma or centrifuged

or resuspended cellular components with a minimal hazard of contamination by microorganisms. The

plastics container shall be functionally compatible with the transfusion set specified in ISO 1135-4 or

ISO 1135-5. Its design shall also ensure that it can be used in a centrifuge cup.

2 © ISO 2019 – All rights reserved
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SIST EN ISO 3826-1:2019
ISO 3826-1:2019(E)
5.2 Air content

5.2.1 The total volume of air contained in the plastics container system divided by the number of

containers shall not exceed 15 ml.
NOTE Typical plastics container systems are described in ISO 3826-3.

5.2.2 When used in accordance with the manufacturer's instructions, the plastics container shall be

capable of being filled with blood without air being introduced.
5.3 Emptying under pressure

The plastics container, when filled with a volume of water at a temperature of (23 ± 5) °C equal to its

nominal capacity and connected to a transfusion set as specified in ISO 1135-4 or ISO 1135-5 inserted

in an outlet port (see 5.8), shall empty without visual leakage (see 6.2.7) within 2 min when gradually

squeezed between two plates to a gauge pressure of 50 kPa.
5.4 Pilot samples

The plastics container shall be designed so that pilot samples of unmistakable identity can be collected

for the performance of blood tests in the blood centre without the closed system of the plastics

container being penetrated. This may be accomplished, e.g. by using an unmistakable numbering

system on the tubing.

The tubing shall be designed so that stripping of the tubing up to 5 times with a tube stripper is possible

and if applicable will not remove the existing numbering system when following the plastics containers

instruction for use concerning tube stripping.
5.5 Rate of collection

The plastics container shall be designed so that it is capable of being filled to its nominal capacity in less

than 8 min when tested in accordance with B.2.
© ISO 2019 – All rights reserved 3
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SIST EN ISO 3826-1:2019
ISO 3826-1:2019(E)
Dimensions in millimetres
Key
1 tamper evident protector(s) 8 tamper evident protective cap
2 transfer tube 9 blood-taking needle
3 means of closure (optional) 10 needle hub
4 outlet port(s) 11 eyelets
5 collection tube 12 puncturable non-resealable closure(s)
6 tear line of protector 13 side slits
7 label area
Length ≥ 200 mm, internal diameter ≥ 2,7 mm, wall thickness ≥ 0,5 mm.
4 © ISO 2019 – All rights reserved
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SIST EN ISO 3826-1:2019
ISO 3826-1:2019(E)

Length ≥ 800 mm if used for gravitational collection, internal diameter ≥ 2,7 mm, wall thickness ≥ 0,5 mm.

External view.
Cross-sectional view.
NOTE See Table 1 for explanation of dimensions.
Figure 1 — Schematic representation of plastics container
Table 1 — Dimensions for plastics containers, label areas, and nominal capacity
Dimensions in millimetres
Size of label area
Nominal capacity Inside width Inside height
ml w h
1 1 w ± 5 h ± 5
2 2
100 75 120 60 85
250 120 130 90 85
400 120 170 105 105
500/600 120 185 105 105
5.6 Collection and transfer tube(s)

5.6.1 The plastics container may be provided with one or more collection or transfer tube(s) to allow

the collection and separation of blood and blood components.

If a transfer tube is present, and if necessary to avoid unexpected flow between containers, it shall be

fitted with a device which first acts as a seal and then, when opened, permits the free flow of blood

components.

5.6.2 The tubes shall be such that they can be sealed hermetically and do not collapse under normal use.

5.6.3 The plastics container, filled with water to its nominal capacity and sealed, and the tubes

connected to the plastics container shall form a hermetic tight leakproof connection (see 6.2.7) which

will withstand, without leakage occurring, a tensile force of 20 N applied to the tubing for 15 s. The

tensile force shall be applied at right angles to the edge of the joint and along the longitudinal axis of the

plane of the plastics container at a temperature of (23 ± 2) °C.

There shall be no leakage at the connection and the plastics container shall also conform to the

requirements specified in 6.2.7.

5.6.4 Under visual inspection, the tubing shall not display cracks, blisters, kinks, or other defects.

5.6.5 Requirements for sterile connection of transfer tubing. Tubing design shall allow the efficient

transfer of blood and blood components between packs. Design should also allow the joining of tubes

supplied by a single manufacturer or from different manufacturers using a sterile tube welding device.

Typically, this is to enable the connection of separate satellite packs when preparing blood components

by a ‘secondary process’. Sterile tube welding devices join the two opposing ends of the tube while

maintaining a sterile fluid pathway.

Manufacturers of sterile tube welding devices typically specify acceptable tube dimensions (external

and/or in
...

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