ISO-16061-2008.pdf
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1、 Reference number ISO 16061:2008(E) ISO 2008 INTERNATIONAL STANDARD ISO 16061 Second edition 2008-12-01 Instrumentation for use in association with non-active surgical implants General requirements Instrumentation utiliser en association avec les implants chirurgicaux non actifs Exigences gnrales Co
2、pyright International Organization for Standardization Provided by IHS under license with ISO Licensee=Boeing Co/5910770001 Not for Resale, 01/31/2009 04:17:41 MSTNo reproduction or networking permitted without license from IHS -,-,- ISO 16061:2008(E) PDF disclaimer This PDF file may contain embedde
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4、 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 parameters wer
5、e 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 reser
6、ved. 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 request
7、er. 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 Lic
8、ensee=Boeing Co/5910770001 Not for Resale, 01/31/2009 04:17:41 MSTNo reproduction or networking permitted without license from IHS -,-,- ISO 16061:2008(E) ISO 2008 All rights reserved iii Contents Page Foreword iv 1 Scope . 1 2 Normative references. 1 3 Terms and definitions. 2 4 Intended performanc
9、e 2 5 Design attributes. 3 6 Selection of materials. 3 7 Design evaluation. 3 7.1 General. 3 7.2 Pre-clinical evaluation 4 7.3 Clinical evaluation 4 8 Manufacture. 4 9 Sterilization 4 9.1 Products supplied sterile. 4 9.2 Products provided non-sterile. 4 10 Packaging 4 10.1 Protection from damage in
10、storage and transport 4 10.2 Maintenance of sterility in transit 5 11 Information to be supplied by the manufacturer. 5 11.1 General. 5 11.2 Instruments with measuring function. 5 11.3 Restrictions in combinations 5 11.4 Marking on instruments. 5 11.5 Instructions for use 5 11.6 Instruments intended
11、 for single use. 6 Annex A (informative) Examples of typical instrument applications, together with materials found acceptable for instrument manufacture. 7 Bibliography. 18 Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=Boeing Co/5910770001
12、Not for Resale, 01/31/2009 04:17:41 MSTNo reproduction or networking permitted without license from IHS -,-,- ISO 16061:2008(E) iv ISO 2008 All rights reserved Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies)
13、. 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
14、-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
15、 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
16、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 16061 was prepared by Technical Committee ISO/TC 150, Implants for surgery. This second e
17、dition cancels and replaces the first edition (ISO 16061:2000), which has been technically revised. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=Boeing Co/5910770001 Not for Resale, 01/31/2009 04:17:41 MSTNo reproduction or networking permi
18、tted without license from IHS -,-,- INTERNATIONAL STANDARD ISO 16061:2008(E) ISO 2008 All rights reserved 1 Instrumentation for use in association with non-active surgical implants General requirements 1 Scope This International Standard specifies general requirements for instruments to be used in a
19、ssociation with non- active surgical implants. These requirements apply to instruments when they are manufactured and when they are resupplied after refurbishment. This International Standard also applies to instruments which may be connected to power-driven systems, but does not apply to the power-
20、driven systems themselves. With regard to safety, this International Standard gives requirements for intended performance, design attributes, selection of materials, design evaluation, manufacture, sterilization, packaging and information to be supplied by the manufacturer. This International Standa
21、rd is not applicable to instruments associated with dental implants, transendodontic and transradicular implants and ophthalmic implants. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited app
22、lies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 11135-1, Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices ISO 11
23、137-1, Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices ISO 11137-2, Sterilization of health care products Radiation Part 2: Establishing the sterilization dose ISO 11137-3, Sterilizati
24、on of health care products Radiation Part 3: Guidance on dosimetric aspects ISO 11607-1, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems ISO 11607-2, Packaging for terminally sterilized medical devices Part 2: Vali
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