1、BS EN ISO3826-2:2008ICS 01.080.20; 11.040.20NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDPlastics collapsiblecontainers for humanblood and bloodcomponentsPart 2: Graphical symbols for use onlabels and instruction leaflets (ISO3826-2:2008)This British Standard
2、 was published under theauthority of the StandardsPolicy and StrategyCommittee on 31 2008 BSI 2008ISBN 978 0 580 54429 3Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 3826-2:2008National forewordThis British Standard is the UK implementation of EN ISO 3826-2:2008.The UK partici
3、pation in its preparation was entrusted to TechnicalCommittee CH/212, IVDs.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct ap
4、plication.Compliance with a British Standard cannot confer immunityfrom legal obligations.DecemberEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 3826-2August 2008ICS 01.080.20; 11.040.20English VersionPlastics collapsible containers for human blood and bloodcomponents - Part 2: Graphical symb
5、ols for use on labels andinstruction leaflets (ISO 3826-2:2008)Poches en plastique souple pour le sang et les composantsdu sang - Partie 2: Symboles graphiques utiliser sur lestiquettes et les notices dutilisation (ISO 3826-2:2008)Kunststoffbeutel fr menschliches Blut und Blutbestandteile- Teil 2: G
6、raphische Symbole zur Verwendung auf Etikettenund 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 EuropeanStandard the status of a nati
7、onal standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards 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 an
8、y other language made by translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Eston
9、ia, 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 STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHE
10、S KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2008 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 3826-2:2008: EBS EN ISO 3826-2:2008EN ISO 3826-2:2008 (E) 3 Foreword This document (EN ISO 3826-2:200
11、8) 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 th
12、e 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
13、 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 Di
14、rective(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, Bu
15、lgaria, 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 te
16、xt of ISO 3826-2:2008 has been approved by CEN as a EN ISO 3826-2:2008 without any modification. BS EN ISO 3826-2:2008EN ISO 3826-2:2008 (E) 4 Annex ZA (informative) Relationship between this International Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices This Inte
17、rnational 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
18、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
19、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 St
20、andard and EU Directive 93/42/EEC on Medical Devices Clause(s)/sub-clause(s) of this International Standard Essential Requirements (ERs) of EU Directive 93/42/EEC Qualifying remarks/Notes 4 Clauses 7 to 13 Annex A Clauses 7 to 13 WARNING Other requirements and other EU Directives may be applicable t
21、o the product(s) falling within the scope of this standard. BS EN ISO 3826-2:2008ISO 3826-2:2008(E) ISO 2008 All rights reserved iiiContents 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
22、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 propert
23、ies of blood or blood components containers 10 Bibliography . 11 BS EN ISO 3826-2:2008ISO 3826-2:2008(E) iv ISO 2008 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing
24、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 liaiso
25、n 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 tec
26、hnical 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 dra
27、wn 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 a
28、nd 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 integrate
29、d features BS EN ISO 3826-2:2008ISO 3826-2:2008(E) ISO 2008 All rights reserved vIntroduction 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 whic
30、h 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 th
31、e 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 l
32、iterature 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. BS EN ISO 3826-2:2008BS EN ISO 3826-2:2008INTERNATIONAL STAN
33、DARD ISO 3826-2:2008(E) ISO 2008 All rights reserved 1Plastics collapsible containers for human blood and blood components Part 2: Graphical symbols for use on labels and instruction leaflets 1 Scope This part of ISO 3826 addresses symbols that may be used to convey certain items of information rela
34、ted 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
35、 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 log
36、istics 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
37、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 count
38、ries 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 d
39、istribution 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 specifie
40、d 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 appl
41、ication in other areas of medical technology. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any a
42、mendments) applies. ISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements BS EN ISO 3826-2:2008ISO 3826-2:2008(E) 2 ISO 2008 All rights reserved3 Terms and definitions For the purposes of this document, the f
43、ollowing terms and definitions apply. 3.1 basic symbol graphical representation of a particular object or feature 3.2 compound symbol graphical representation of a concept formed by the combination of two or more basic symbols 4 Requirements for graphical symbols and their use 4.1 Use of symbols In
44、use, the graphical representation of symbols shall comply with that given in Table 1 and Table 2, especially with respect to dimensions, including relative line thickness, orientation and the absence or presence of filled or shaded areas. NOTE ISO and IEC jointly maintain an on-line database of grap
45、hical symbols for use on equipment, which contains the complete set of graphical symbols included in ISO 7000 1and IEC 60417 2, 3. In that database, each graphical symbol is identified by a reference number and contains a title (in English and French), a graphical representation in GIF and vectorize
46、d PDF format, and some additional data as applicable. Various search and navigation facilities allow for easy retrieval of graphical symbols. Information on how to access this database is available through the ISO Store 4, the IEC Web Store 5or by contacting your local national standards body. At a
47、distance that takes into account the specifics and size of the product and its packaging, the symbols and associated information shall be legible when viewed under an illumination of 215 lx using normal vision, corrected if necessary. 4.2 System of symbols The system of symbols shall comprise basic
48、symbols (see 4.3) that may be combined to form compound symbols (see 4.4). NOTE Illustrative examples of labels for blood treatment and transfusion medical devices, showing the use of this system of symbols, are given in Annex A. 4.3 Basic symbols Basic symbols can be used alone, or in combination,
49、to form compound symbols (see 4.4). BS EN ISO 3826-2:2008ISO 3826-2:2008(E) ISO 2008 All rights reserved 3Table 1 Basic symbols to convey information essential for proper use No. Symbol Title and description ISO 7000 registration number 4.3.1 Blood or blood component container On medical devices or blood process application: to indicate that the processing or final container is used for the purpose of whole blood or blood component storage. ISO 7000-27034.3.2 Double needle apheresis protocol On medical devices or bl
