ISO-14630-2008.pdf
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1、 Reference number ISO 14630:2008(E) ISO 2008 INTERNATIONAL STANDARD ISO 14630 Third edition 2008-01-15 Non-active surgical implants General requirements Implants chirurgicaux non actifs Exigences gnrales ISO 14630:2008(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance wit
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4、y 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 reserved. Unless otherwise specifie
5、d, 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 copyright office Case
6、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 -,-,- ISO 14630:2008(E) ISO 2008 All rights reserved iii Contents Page Foreword iv Introduction v 1 Scope 1 2 Normative reference
7、s1 3 Terms and definitions .2 4 Intended performance.3 5 Design attributes4 6 Materials .5 7 Design evaluation5 7.1 General5 7.2 Pre-clinical evaluation.5 7.3 Clinical evaluation .6 7.4 Post-market surveillance 6 8 Manufacture6 9 Sterilization.6 9.1 General6 9.2 Products supplied sterile6 9.3 Steril
8、ization by the user 7 9.4 Sterilization residuals7 10 Packaging.7 10.1 Protection from damage in storage and transport.7 10.2 Maintenance of sterility in transit.8 11 Information supplied by the manufacturer .8 11.1 General8 11.2 Labelling .9 11.3 Instructions for use .9 11.4 Restrictions on combina
9、tions11 11.5 Marking on implants11 11.6 Marking for special purposes.11 Annex A (informative) Correspondence between this International Standard and ISO/TR 14283:2004.12 Bibliography13 ISO 14630:2008(E) iv ISO 2008 All rights reserved Foreword ISO (the International Organization for Standardization)
10、 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 a subject for which a technical committee has been established has the right to be repre
11、sented 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 Commission (IEC) on all matters of electrotechnical standardization. International Standards are
12、 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 committees are circulated to the member bodies for voting. Publication as an Internationa
13、l 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 not be held responsible for identifying any or all such patent rights. ISO 14630 was prep
14、ared by Technical Committee ISO/TC 150, Implants for surgery. This third edition cancels and replaces the second edition (ISO 14630:2005), which has been technically revised. -,-,- ISO 14630:2008(E) ISO 2008 All rights reserved v Introduction This International Standard provides a method of addressi
15、ng the fundamental principles outlined in ISO/TR 14283, as they apply to non-active surgical implants. It also provides a method to demonstrate compliance with the relevant essential requirements as outlined in general terms in Annex 1 of the European Council Directive 93/42/EEC of 14 June 1993 conc
16、erning medical devices, as they apply to non-active surgical implants, hereafter referred to as implants. It might also assist manufacturers to comply with the requirements of other regulatory bodies. There are three levels of standards dealing with non-active surgical implants and related instrumen
17、tation. For the implants themselves these are as follows, with level 1 being the highest: level 1: general requirements for non-active surgical implants; level 2: particular requirements for families of non-active surgical implants; level 3: specific requirements for types of non-active surgical imp
18、lants. Level 1 standards, such as this International Standard and reference 4 in the Bibliography, contain requirements that apply to all non-active surgical implants. They also anticipate that there are additional requirements in the level 2 and level 3 standards. Level 2 standards (e.g. references
19、 5 9 in the Bibliography) apply to a more restricted set or family of non- active surgical implants, such as those designed for use in neurosurgery, cardiovascular surgery, or joint replacement. Level 3 standards (e.g. references 10 13 in the Bibliography) apply to specific types of implants within
20、a family of non-active surgical implants, such as hip joints or arterial stents. To address all requirements for a specific implant, it is advisable that the standard of the lowest available level be consulted first. NOTE The requirements in this International Standard correspond to international co
21、nsensus. Individual or national standards or regulatory bodies can prescribe other requirements. -,-,- -,-,- INTERNATIONAL STANDARD ISO 14630:2008(E) ISO 2008 All rights reserved 1 Non-active surgical implants General requirements 1 Scope This International Standard specifies general requirements fo
22、r non-active surgical implants, hereafter referred to as implants. This International Standard is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal tissue. With regard to safety, this
23、 International Standard gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate compliance with these requirements. Additional tests are given or referre
24、d to in level 2 and level 3 standards. NOTE This International Standard does not require that the manufacturer have a quality management system in place. However, the application of a quality management system, such as that described in ISO 13485, could be appropriate to help ensure the implant achi
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