ISO-16061-2000.pdf
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1、Reference number ISO 16061:2000(E) ISO 2000 INTERNATIONAL STANDARD ISO 16061 First edition 2000-03-15 Instrumentation for use in association with non-active surgical implants General requirements Instrumentation utiliser en association avec les implants chirurgicaux non actifs Exigences gnrales Copy
2、right International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 00:25:41 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 16061:2000(E) PDF disclaimer This PDF file may
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4、sibility of not infringing Adobes licensing policy. The ISO 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
5、 parameters were 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. ISO 2000 All rights reserved. Unless ot
6、herwise 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 requester. ISO copyri
7、ght office Case postale 56 ? CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 734 10 79 E-mail copyrightiso.ch Web www.iso.ch Printed in Switzerland ii ISO 2000 All rights reserved Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Techn
8、ical Standards 1/9972545001 Not for Resale, 04/19/2007 00:25:41 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 16061:2000(E) ISO 2000 All rights reservediii ContentsPage Foreword.iv 1Scope 1 2Normative references1 3Terms and definitions .2 4Intended performance.2 5Desi
9、gn attributes2 6Selection of materials3 7Design evaluation3 7.1General3 7.2Pre-clinical evaluation.3 7.3Clinical evaluation .3 8Manufacture3 9Sterilization.4 9.1Products supplied sterile4 9.2Products provided non-sterile4 10Packaging.4 10.1Protection from damage in storage and transport.4 10.2Mainte
10、nance of sterility in transit.4 11Information to be supplied by the manufacturer4 11.1General4 11.2Instruments with measuring function4 11.3Restrictions in combinations .5 11.4Marking on instruments5 11.5Instructions for use .5 11.6Instruments intended for single use5 Annex A (informative) Examples
11、of typical instrument applications, together with materials found acceptable for instrument manufacture6 Bibliography18 Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 00:25:41 M
12、DTNo reproduction or networking permitted without license from IHS -,-,- ISO 16061:2000(E) iv ISO 2000 All rights reserved Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International
13、 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, a
14、lso 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 3. Draft International Standards ado
15、pted 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 International Standard may be the
16、subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. International Standard ISO 16061 was prepared by Technical Committee ISO/TC 150,Implants for surgery. Annex A of this International Standard is for information only. Copyright International Org
17、anization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 00:25:41 MDTNo reproduction or networking permitted without license from IHS -,-,- INTERNATIONAL STANDARDISO 16061:2000(E) ISO 2000 All rights reserved1 Inst
18、rumentation for use in association with non-active surgical implants General requirements 1Scope This International Standard specifies general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured
19、and when they are resupplied after refurbishment. This International Standard applies to instruments which may be connected to power-driven systems, but does not apply to the power-driven systems themselves. With regard to safety, this International Standard gives requirements for intended performan
20、ce, design attributes, selection of materials, design evaluation, manufacture, sterilization, packaging and information to be supplied by the manufacturer. This International Standard is not applicable to instruments associated with dental implants, transendodontic and transradicular implants and op
21、hthalmic implants. NOTEReferences to standards for non-active surgical implants are listed in the Bibliography. 2Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this International Standard. For dated references
22、, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated referenc
23、es, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards. ISO 11134,Sterilization of health care products Requirements for validation and routine control Industrial moist heat sterilization. ISO 11135,M
24、edical devices Validation and routine control of ethylene oxide sterilization. ISO 11137,Sterilization of health care products Requirements for validation and routine control Radiation sterilization. ISO 11607,Packaging for terminally sterilized medical devices. ISO 14155,Clinical investigation of m
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