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1、INTERNATIONAL STANDARD IS0 15223 First edition AMENDMENT 2 2000-04-1 5 2004-02-1 5 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied AMENDMENT 2 Dispositifs mdicaux - Symboles utiliser avec les tiquettes, ltiquetage et les informations fournir
2、relatifs aux dispositifs mdicaux AMENDEMENT 2 Reference number IS0 1 5223:2000/Amd .2:2004( E) IS0 2004 -,-,- IS0 15223:2000/Amd.2:2004(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or viewed but shall not be edit
3、ed unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobes licensing policy. The IS0 Central Secretariat accepts no liability in this area. Adobe is a tr
4、ademark of Adobe Systems Incorporated. Details of the sofiware products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by IS0 member bod
5、ies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. O IS02004 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechani
6、cal, including photocopying and microfilm, without permission in writing from either IS0 at the address below or ISOs member body in the country of the requester. IS0 copyright office Case postale 56 CH-I211 Geneva 20 Tel. + 41 22 749 O 1 11 Fax +41 227490947 E-mail copyrightiso.org Web www.iso.org
7、Published in Switzerland ii O IS0 2004 -All rights reserved -,-,- IS0 15223:2000/Amd.2:2004(E) Foreword IS0 (the International Organization for Standardization) is a worldwide federation of national standards bodies (IS0 member bodies). The work of preparing International Standards is normally carri
8、ed out through IS0 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. I
9、S0 collaborates closely with the International Electrotechnical Commission (I EC) 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 Internat
10、ional 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 e
11、lements of this document may be the subject of patent rights. IS0 shall not be held responsible for identifying any or all such patent rights. Amendment 2 to IS0 15223:2000 was prepared by Technical Committee ISOTC 210, Qualify management and corresponding general aspects for medical devices. It is
12、in addition to Amendment 1 which was published in 2002. O IS0 2004 -All rights reserved iii -,-,- -,-,- IS0 15223:2000/Amd.2:2004(E) Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied AMENDMENT 2 Page 5, Table 1 Add the following symbols to Tabl
13、e 1 No. 3.30 3.31 Symbol I Referent Humidity limitation Atmospheric pressure limitation O IS0 2004 -All rights reserved 1 -,-,- IS0 15223:2000/Amd.2:2004(E) ICs 01.080.99; 11.040.01 Price based on 1 page O IS0 2004 -All rights reserved -,-,- INTERNATIONAL STANDARD IS0 15223 First edition AMENDMENT 1
14、 2000-04-1 5 2002-08-01 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied AMENDMENT 1 Dispositifs mdicaux - Symboles utiliser avec les tiquettes, ltiquetage et les informations fournir relatifs aux dispositifs mdicaux AMENDEMENT 1 Reference num
15、ber IS0 15223:2000/Amd.l:2002(E) IS0 2002 -,-,- IS0 15223:2000/Amd.l:2002(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and
16、 installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobes licensing policy. The IS0 Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software
17、 products used to create this PDF file can be found in the General Info relative to the file; the PDFcreation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by IS0 member bodies. In the unlikely event that a problem relating to it is fou
18、nd, please inform the Central Secretariat at the address given below. o IS02002 All rights reserved. Unless othetwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission i
19、n writing from either IS0 at the address below or ISOs member body in the country of the requester. IS0 copyright office Case postale 56 CH-1 21 1 Geneva 20 Tel. + 41 22 749 O 1 11 Fax +41 227490947 E-mail copyrightiso.ch Web www.iso.ch Printed in Switzerland ii 0 IS0 2002 -All rights reserved -,-,-
20、 IS0 15223:2000/Amd.l:2002(E) Foreword IS0 (the International Organization for Standardization) is a worldwide federation of national standards bodies (IS0 member bodies). The work of preparing International Standards is normally carried out through IS0 technical committees. Each member body interes
21、ted 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 SO, also take part in the work. IS0 collaborates closely with the International Electrotechnical Co
22、mmission (i EC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication
23、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 Amendment may be the subject of patent rights. IS0 shall not be held responsible for identifying any or all such patent rights.
24、 Amendment 1 to International Standard IS0 15223:2000 was prepared by Technical Committee ISOTC 210, Qualify management and corresponding general aspects for medical devices. O IS0 2002 -All rights reserved iii -,-,- IS0 15223:2000/Amd.l:2002(E) I nt rod uct ion This Amendment considers certain item
25、s of information which may be considered by regulatory authorities to be essential for the safe and proper use of medical devices. As such, the items are required by the laws and regulations of certain political jurisdictions to be presented with the device. This information may be required on the d
26、evice itself, part of the label of the device on its packaging, or provided with the device in an information document. These items of information are subject to international harmonization in order to ensure agreement on information to be provided. However, there is no harmonization with regard to
27、the language to be used when presenting this information. This presents potential problems to manufacturers, users and regulatory authorities. Device manufacturers, desiring to minimize the indirect costs not associated with healthcare purposes, seek to minimize costs of labelling by reducing or rat
28、ionalizing labeling variants. In the European Union alone, there are thirteen languages which may be required. This presents a major problem of design and logistics. In addition, technical translation can present difficulties in transferring the precise meaning from one language to another. Users ma
29、y be presented with devices labelled in a number of different languages. This can cause confusion and delay in locating the appropriate language. It can also create confusion as to the precise meanings for multilingual users. Regulatory authorities might be presented with labelling not in their nati
30、onal language and might have difficulty in ascertaining the safety and fitness for use of a device required in emergencies or other exceptional circumstances. This Amendment proposes solutions to these problems through the use of internationally recognized symbols, with precisely defined meanings th
31、at transcend language. iv O IS0 2002 -All rights reserved -,-,- IS0 15223:2000/Amd.l:2002(E) Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied AMENDMENT 1 Page 5, Table 1 Add the following symbols to Table 1 No. 3.25 3.26 3.27 3.28 3.29 Symbol
32、r 1 L J ISO 7000-2608 r 1 / STERILE L A ISO 7000-2609 r 1 L A ISO 7000-2606 r 1 L A r 1 a L A ISO 7000-261 O Referent Do not re-sterilize Non-sterile Do not use if package is damaged in vitro diagnostic device Patient num ber O IS0 2002 -All rights reserved 1 -,-,- IS0 15223:2000/Amd.l:2002(E) ICs 0
33、1.080.99; 11.040.01 Price based on 1 page O IS0 2002 -All rights reserved -,-,- STD=ISO 15223-ENGL i!OOO m 9853903 0824904 1T5 INTERNATIONAL STANDARD IS0 15223 Second edition 2000-04-1 5 Medical devices - Symbols to be used with medical device labels, labelling and _- - information to be supplied Di
34、spositifs mdicaux - Symboles utiliser avec les tiquettes, ltiquetage et /es informations fournir relatifs aux dispositifs mdicaux Reference number IS0 15223:2000(E) Q IS0 2000 -,-,- STD=ISO 15223-ENGL 2000 W 4851903 OB24905 831 w1 r PDF disclaimer This PDF file may contain embedded typefaces. In acc
35、ordance with Adobes licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobes
36、licensing policy. The IS0 Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for pri
37、nting. Every care has been taken to ensure that the file is suitable for use by IS0 member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. IS0 15223:2000(E) o Is02000 All rights reserved. UnleSS otherwise specifi
38、ed, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either IS0 at the address below or ISOs member body in the country of the requester. IS0 copyright office Case
39、 postale 56 CH-121 1 Geneva 20 Tel. + 4 1 22 749 O1 11 Fax +41227341079 E-mail copyrightOiso.ch Web www.iso.ch Printed in Switzerland O IS0 2000 -All rights reserved -,-,- STDeISO 15223-ENGL 2000 I I 4853903 082490b 778 111 IS0 15223:2000(E) Foreword IS0 (the International Organization for Standardi
40、zation) is a worldwide federation of national standards bodies (IS0 member bodies). The work of preparing International Standards is normally carried out through IS0 technical committees. Each member body interested in a subject for which a technical committee has been established has the right to b
41、e represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. IS0 collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standa
42、rds are drafted in accordance with the rules given in the ISOAEC Directives, Part 3. 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 cast
43、ing a vote. Attention is drawn to the possibility that some of the elements of this International Standard may be the subject of patent rights. IS0 shall not be held responsible for identifying any or all such patent rights. International Standard IS0 15223 was prepared by Technical Committee ISO/TC
44、 21 O, Qualify management and corresponding general aspects for medical devices. This first edition cancels and replaces ISO/TR 15223:1998. Annex A of this International Standard is for information only. Q IS0 2000 -All rights reserved iii -,-,- STDmISO 35223-ENGL 2000 4853903 0824907 504 Is0 15223:
45、2000(E) Introduction This International Standard considers certain items of information that may be considered by regulatory authorities to be essential for the safe and proper use of medical devices. As such, the items are required by laws and regulations of certain political jurisdictions to be pr
46、esented with the device. This information may be required on the device itself, as part of the label of the device on its packaging, or provided with the device in an information document. There is a considerable degree of international harmonization of the information to be provided. However, there
47、 is no harmonization with regard to the language to be used when presenting this information. This presents potential problems to manufacturers, users and regulatory authorities. Device manufacturers, desiring to minimize the indirect costs not associated with healthcare purposes, seek to minimize costs of labelling by reducing or rationalizing labelling variants. In the European Union alone, there are thirteen languages that may be required. This presents a major problem of design and logistics. In addition, technical translation can present difficulties in transf