ISO-14708-4-2008.pdf
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1、 Reference number ISO 14708-4:2008(E) ISO 2008 INTERNATIONAL STANDARD ISO 14708-4 First edition 2008-11-15 Implants for surgery Active implantable medical devices Part 4: Implantable infusion pumps Implants chirurgicaux Dispositifs mdicaux implantables actifs Partie 4: Pompes dinfusion en implant Co
2、pyright International Organization for Standardization Provided by IHS under license with ISO Licensee=Boeing Co/5910770001 Not for Resale, 01/31/2009 01:26:29 MSTNo reproduction or networking permitted without license from IHS -,-,- ISO 14708-4:2008(E) PDF disclaimer This PDF file may contain embed
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5、ere optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. COPYRIGHT PROTECTED DOCUMENT ISO 2008 All rights res
6、erved. Unless otherwise 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 in writing from either ISO at the address below or ISOs member body in the country of the reque
7、ster. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2008 All rights reserved Copyright International Organization for Standardization Provided by IHS under license with ISO L
8、icensee=Boeing Co/5910770001 Not for Resale, 01/31/2009 01:26:29 MSTNo reproduction or networking permitted without license from IHS -,-,- ISO 14708-4:2008(E) ISO 2008 All rights reserved iii Contents Page Foreword. v Introduction. vi 1 Scope . 1 2 Normative references. 1 3 Terms and definitions. 2
9、4 Symbols and abbreviated terms . 3 5 General requirements for non-implantable parts 3 6 Requirements for particular active implantable medical devices . 3 7 General arrangement of the packaging 5 8 General markings for active implantable medical devices 5 9 Markings on the sales packaging . 6 10 Co
10、nstruction of the sales packaging 6 11 Markings on the sterile pack . 6 12 Construction of the non-reusable pack 7 13 Markings on the active implantable medical device. 7 14 Protection from unintentional biological effects caused by the active implantable medical device. 7 15 Protection from harm to
11、 the patient or user caused by external physical features of the active implantable medical device 8 16 Protection from harm to the patient caused by electricity. 8 17 Protection from harm to the patient caused by heat 9 18 Protection from ionizing radiation released or emitted from the active impla
12、ntable medical device 9 19 Protection from unintended effects caused by the device. 9 20 Protection of the device from damage caused by external defibrillators. 10 21 Protection of the device from changes caused by high-power electrical fields applied directly to the patient 10 22 Protection of the
13、active implantable medical device from changes caused by miscellaneous medical treatments. 10 23 Protection of the active implantable medical device from mechanical forces 10 24 Protection of the active implantable medical device from damage caused by electrostatic discharge. 11 25 Protection of the
14、 active implantable medical device from damage caused by atmospheric pressure changes. 11 26 Protection of the active implantable medical device from damage caused by temperature changes . 11 27 Protection of the active implantable medical device from electromagnetic non-ionizing radiation. 11 Copyr
15、ight International Organization for Standardization Provided by IHS under license with ISO Licensee=Boeing Co/5910770001 Not for Resale, 01/31/2009 01:26:29 MSTNo reproduction or networking permitted without license from IHS -,-,- ISO 14708-4:2008(E) iv ISO 2008 All rights reserved 28 Accompanying d
16、ocumentation17 Annex AA (informative) Relationship between the fundamental principles in ISO/TR 14283 8 and the clauses of this part of ISO 14708 20 Annex BB (informative) Relationship between the clauses of this part of ISO 14708 and the fundamental principles listed in Annex AA30 Annex CC (informa
17、tive) Rationale.32 Bibliography .41 Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=Boeing Co/5910770001 Not for Resale, 01/31/2009 01:26:29 MSTNo reproduction or networking permitted without license from IHS -,-,- ISO 14708-4:2008(E) ISO 2008
18、 All rights reserved v 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
19、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 Commissi
20、on (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 c
21、ommittees 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 n
22、ot be held responsible for identifying any or all such patent rights. ISO 14708-4 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 6, Active implants. ISO 14708 consists of the following parts, under the general title Implants for surgery Active implantable medic
23、al devices: Part 1: General requirements for safety, marking and for information to be provided by the manufacturer Part 2: Cardiac pacemakers Part 3: Implantable neurostimulators Part 4: Implantable infusion pumps Copyright International Organization for Standardization Provided by IHS under licens
24、e with ISO Licensee=Boeing Co/5910770001 Not for Resale, 01/31/2009 01:26:29 MSTNo reproduction or networking permitted without license from IHS -,-,- ISO 14708-4:2008(E) vi ISO 2008 All rights reserved Introduction This part of ISO 14708 specifies particular requirements for active implantable medi
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