SIST EN ISO 3826-2:2008
(Main)Plastics collapsible containers for human blood and blood components - Part 2: Graphical symbols for use on labels and instruction leaflets (ISO 3826-2:2008)
Plastics collapsible containers for human blood and blood components - Part 2: Graphical symbols for use on labels and instruction leaflets (ISO 3826-2:2008)
This part of ISO 3826 addresses symbols that may be used to convey certain items of information related to medical devices dedicated to blood collection processes and storage. The information may be required on the device itself, as part of the label, or provided with the device. Many countries require that their own language be used to display textual information with medical devices. This raises problems to device manufacturers and users. The symbols specified in this part of ISO 3826 do not replace current national regulatory requirements. Manufacturers seek to take costs out of labelling by reducing or rationalizing variants. This results in a major problem of translation, design and logistics when multiple languages are included on a single label or piece of documentation. As other medical devices, blood medical devices, labelled in a number of different languages, can experience confusion and delay in locating the appropriate language. This part of ISO 3826 proposes solutions to these problems through the use of internationally recognized symbols with precisely defined meanings. This part of ISO 3826 is primarily intended to be used by manufacturers of medical devices dedicated to the blood collection, process storage and distribution, who market identical products in countries having different language requirements for medical device labelling. This part of ISO 3826 may also be of assistance to different stages of the blood supply chain, e.g.: - distributors of blood collection devices (manual or automated) or other representatives of manufacturers; - blood centres and distribution centres to simplify and secure the operating procedures. The use of these symbols is primarily intended for the medical device rather than the therapeutic product. This part of ISO 3826 does not specify requirements relating to the size and colour of symbols although the symbols specified have been specially designed so as to be clearly legible when reproduced in the space typically available on the labels of blood treatment and transfusion devices, and also so as to be suitable for on-line printing. Several of the symbols specified in this part of ISO 3826 may be suitable for application in other areas of medical technology.
Kunststoffbeutel für menschliches Blut und Blutbestandteile - Teil 2: Graphische Symbole zur Verwendung auf Etiketten und Beipackzetteln (ISO 3826-2:2008)
Dieser Teil von ISO 3826-2 behandelt Symbole, die für die Lieferung bestimmter Einzelheiten von Informationen bezogen auf Medizinprodukte für Blutspendevorgänge und Lagerung angewendet werden dürfen. Die Informationen können auf dem Produkt selbst als Teil der Aufschrift oder als Mitlieferung mit diesem gefordert werden. Viele Länder fordern die Verwendung ihrer eigenen Sprache(n), um Textangaben bei Medizinprodukten anzuzeigen. Das schafft Probleme für die Hersteller und Anwender der Produkte.
Die in diesem Teil von ISO 3826-2 festgelegten Symbole ersetzen nicht bestehende nationale behördliche Anforderungen.
Die Hersteller suchen die Aufschriften billiger zu machen, indem sie Varianten verringern oder rationalisieren. Das führt zu einem wesentlichen Problem von Übersetzung, Gestaltung und Logistik, wenn mehrere Sprachen auf eine einzige Aufschrift oder ein Dokumententeil aufgenommen werden. Die Anwender von Medizinprodukten für Blut wie auch von anderen Medizinprodukten können mit Aufschriften in einer Anzahl unterschiedlicher Sprachen verwirrt werden und Zeitverzug erfahren, wenn sie die geeignete Sprache suchen müssen. Dieser Teil von ISO 3826 schlägt Lösungen für diese Probleme durch die Verwendung international anerkannter Symbole mit genau festgelegter Bedeutung vor.
Dieser Teil von ISO 3826 ist in erster Linie für die Verwendung durch Hersteller von Medizinprodukten für Blutspendevorgänge, Lagerung und Vertrieb vorgesehen, die identische Produkte in Ländern mit unterschiedlichen sprachlichen Anforderungen an die Kennzeichnung von Medizinprodukten auf den Markt bringen.
Dieser Teil von ISO 3826 kann jedoch auch eine Unterstützung darstellen für die verschiedene Stufen der Blutversorgungskette, z. B.:
Vertreiber von Blutspendeprodukten (manuell oder automatisiert) oder sonstige Vertreter von Herstellern;
Blutzentren und Vertreiberzentren zur Vereinfachung und Sicherung der Betriebsabläufe.
Poches en plastique souple pour le sang et les composants du sang - Partie 2: Symboles graphiques à utiliser sur les étiquettes et les notices d'utilisation (ISO 3826-2:2008)
L'ISO 3826-2:2008 concerne les symboles qui peuvent être utilisés pour la transmission de certaines informations relatives aux dispositifs médicaux utilisés lors des opérations de collecte ou de conservation de sang. Le symbole peut apparaître sur l'appareil lui-même, au niveau de l'étiquette, il peut aussi être fourni à part. De nombreux pays demandent que les informations figurant sur les dispositifs médicaux soient rédigées dans leur langue, cela pose donc des problèmes aux fabricants et aux futurs utilisateurs de ces appareils.
Les symboles spécifiés dans l'ISO 3826-2:2008 ne remplacent pas les exigences des réglementations nationales en vigueur.
En réduisant ou en uniformisant les variantes, les fabricants de ces dispositifs cherchent à en optimiser l'étiquetage. Cela créé alors un problème de traduction, de présentation et de logistique quand on retrouve plusieurs langues sur une seule étiquette ou notice. Pour les dispositifs utilisés pour le sang, de même que pour d'autres dispositifs médicaux, le fait que les étiquettes soient rédigées en plusieurs langues peut provoquer une certaine confusion et un retard à cause du temps perdu à chercher la langue appropriée. L'ISO 3826-2:2008 propose des solutions à ce type de problèmes en instaurant un système de symboles reconnus à l'échelle internationale et ayant une signification définie de façon précise.
L'ISO 3826-2:2008 est principalement destinée aux fabricants de dispositifs médicaux utilisés pour la collecte de sang, sa conservation et sa distribution, fabricants qui commercialisent des produits identiques dans des pays fixant des exigences linguistiques différentes en matière d'étiquetage des dispositifs médicaux.
L'ISO 3826-2:2008 peut aussi s'avérer utile à divers stades de la chaîne d'approvisionnement du sang, par exemple
pour les distributeurs d'appareils de collecte de sang (manuels ou automatiques) ou pour d'autres représentants des fabricants,
pour les centres de collecte et de distribution du sang dans le but de simplifier et de sécuriser les diverses opérations.
Ces symboles sont principalement destinés aux dispositifs médicaux plutôt qu'aux produits thérapeutiques.
Plastične vrečke za človeško kri in krvne komponente - 3. del: Grafični simboli, ki se uporabljajo na označbah in navodilih (ISO 3826-2:2008)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 3826-2:2008
01-november-2008
3ODVWLþQHYUHþNH]DþORYHãNRNULLQNUYQHNRPSRQHQWHGHO *UDILþQLVLPEROLNL
VHXSRUDEOMDMRQDR]QDþEDKLQQDYRGLOLK ,62
Plastics collapsible containers for human blood and blood components - Part 2:
Graphical symbols for use on labels and instruction leaflets (ISO 3826-2:2008)
Kunststoffbeutel für menschliches Blut und Blutbestandteile - Teil 2: Graphische
Symbole zur Verwendung auf Etiketten und Beipackzetteln (ISO 3826-2:2008)
Poches en plastique souple pour le sang et les composants du sang - Partie 2:
Symboles graphiques à utiliser sur les étiquettes et les notices d'utilisation (ISO 3826-
2:2008)
Ta slovenski standard je istoveten z: EN ISO 3826-2:2008
ICS:
01.080.20 *UDILþQLVLPEROL]DSRVHEQR Graphical symbols for use on
RSUHPR specific equipment
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 3826-2:2008 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 3826-2:2008
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SIST EN ISO 3826-2:2008
EUROPEAN STANDARD
EN ISO 3826-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2008
ICS 01.080.20; 11.040.20
English Version
Plastics collapsible containers for human blood and blood
components - Part 2: Graphical symbols for use on labels and
instruction leaflets (ISO 3826-2:2008)
Poches en plastique souple pour le sang et les composants Kunststoffbeutel für menschliches Blut und Blutbestandteile
du sang - Partie 2: Symboles graphiques à utiliser sur les - Teil 2: Graphische Symbole zur Verwendung auf Etiketten
étiquettes et les notices d'utilisation (ISO 3826-2:2008) und Beipackzetteln (ISO 3826-2:2008)
This European Standard was approved by CEN on 9 August 2008.
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
© 2008 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 3826-2:2008: E
worldwide for CEN national Members.
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SIST EN ISO 3826-2:2008
EN ISO 3826-2:2008 (E)
Contents Page
Foreword.3
Annex ZA (informative) Relationship between this International Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical Devices .4
2
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SIST EN ISO 3826-2:2008
EN ISO 3826-2:2008 (E)
Foreword
This document (EN ISO 3826-2:2008) has been prepared by Technical Committee ISO/TC 76 "Transfusion,
infusion and injection 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 2009, and conflicting national standards shall be withdrawn
at the latest by February 2009.
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.
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, 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 3826-2:2008 has been approved by CEN as a EN ISO 3826-2:2008 without any modification.
3
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SIST EN ISO 3826-2:2008
EN ISO 3826-2:2008 (E)
Annex ZA
(informative)
Relationship between this International Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical Devices
This International 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, Council Directive of 14 June 1993 on the approximation of the laws of
the Member States concerning medical devices (Medical Device Directive).
Once this International 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 International Standard given in Table ZA.1 confers, within the limits of the scope of this
International Standard, a presumption of conformity with the corresponding essential requirements of that
Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this International Standard and EU Directive 93/42/EEC on
Medical Devices
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) of EU Qualifying remarks/Notes
International Standard Directive 93/42/EEC
4 Clauses 7 to 13
Annex A Clauses 7 to 13
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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SIST EN ISO 3826-2:2008
INTERNATIONAL ISO
STANDARD 3826-2
First edition
2008-08-01
Plastics collapsible containers for human
blood and blood components —
Part 2:
Graphical symbols for use on labels and
instruction leaflets
Poches en plastique souple pour le sang et les composants du sang —
Partie 2: Symboles graphiques à utiliser sur les étiquettes et les notices
d'utilisation
Reference number
ISO 3826-2:2008(E)
©
ISO 2008
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SIST EN ISO 3826-2:2008
ISO 3826-2:2008(E)
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ii © ISO 2008 – All rights reserved
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SIST EN ISO 3826-2:2008
ISO 3826-2:2008(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 2
4 Requirements for graphical symbols and their use. 2
4.1 Use of symbols . 2
4.2 System of symbols . 2
4.3 Basic symbols. 2
4.4 Compound symbols . 4
4.5 Other symbols. 6
Annex A (informative) Illustrative examples of symbols used in the labelling of medical devices
used for blood treatment and transfusion . 7
Annex B (informative) Symbols as applied to properties of blood or blood components containers. 10
Bibliography . 11
© ISO 2008 – All rights reserved iii
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SIST EN ISO 3826-2:2008
ISO 3826-2:2008(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 3826-2 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 2: Graphical symbols for use on labels and instruction leaflets
⎯ Part 3: Blood bag systems with integrated features
iv © ISO 2008 – All rights reserved
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SIST EN ISO 3826-2:2008
ISO 3826-2:2008(E)
Introduction
This part of ISO 3826 has been prepared to:
⎯ reduce the need for multiple translations of words into national languages;
⎯ simplify and rationalize the labelling of blood treatment and transfusion devices which are medical
devices used in critical situations, thereby reducing risk of misidentification, promoting safety for the
patient and reducing the amount of training required by healthcare personnel;
⎯ promote the movement of blood treatment and transfusion devices across national boundaries;
⎯ support the essential requirements of relevant EU Directives.
The meaning of many of these graphical symbols should be self-evident. The meaning of others will become
clear with use or when viewed in the context of the device itself. If appropriate, the meaning of symbols should
be explained in accompanying literature when provided. Annex A provides examples of how the symbols
specified in this part of ISO 3826 can be used. These are illustrative only and do not represent the only ways
in which requirements of this part of ISO 3826 can be met.
© ISO 2008 – All rights reserved v
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SIST EN ISO 3826-2:2008
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SIST EN ISO 3826-2:2008
INTERNATIONAL STANDA
...
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