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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
25、eves its intended performance. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) appl
26、ies. ISO 31 (all parts), Quantities and units ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management system ISO 10993-7, Biological evaluat
27、ion of medical devices Part 7: Ethylene oxide sterilization residuals 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 11137-1, Sterilization of health care produc
28、ts 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 11607-1, Packaging for terminally sterilized medical devices P
29、art 1: Requirements for materials, sterile barrier systems and packaging systems ISO 13408-1, Aseptic processing of health care products Part 1: General requirements ISO 14155-1, Clinical investigation of medical devices for human subjects Part 1: General requirements ISO 14155-2, Clinical investiga
30、tion of medical devices for human subjects Part 2: Clinical investigation plans -,-,- ISO 14630:2008(E) 2 ISO 2008 All rights reserved ISO 14160, Sterilization of single-use medical devices incorporating materials of animal origin Validation and routine control of sterilization by liquid chemical st
31、erilants ISO 14937, Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices ISO 14971, Medical devices Application of risk management to medical devices I
32、SO 17664, Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices ISO 17665-1, Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization pro
33、cess for medical devices ISO 22442-1, Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management ISO 22442-2, Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling ISO 22442-3, Medical devices u
34、tilizing animal tissues and their derivatives Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 coating layer of mater
35、ial covering or partially covering a surface of an implant 3.2 implantable state condition of an implant prepared for implantation into a human subject 3.3 leakage unintended movement of fluid, including body fluids, into or out of an implant NOTE An unintended diffusion phenomenon is an example of
36、leakage for the purposes of this International Standard. 3.4 magnetic resonance environment MR environment volume within the 0,50 mT 5 gauss (G) line of a magnetic resonance imaging (MRI) system, which includes the entire three-dimensional volume surrounding the magnetic resonance imaging scanner AS
37、TM F2503-05 1), definition 3.1.7 NOTE For cases where the 0,50 mT line is contained within the Faraday shielded volume, the entire room is considered the MR environment. For cases where the 0,50 mT line is outside the Faraday shielded volume (e.g. in the adjacent room or area), it is advisable that
38、the entire adjacent room or area be considered part of the MR environment. 1) Definitions for magnetic resonance environment and magnetic resonance imaging are reproduced from ASTM F2503-05 and ASTM F2119-01 respectively, copyright ASTM. Reproduced with permission of ASTM International, http:/www.as
39、tm.org/. ISO 14630:2008(E) ISO 2008 All rights reserved 3 3.5 magnetic resonance imaging MRI diagnostic imaging technique that uses static and time varying magnetic fields to provide images of tissue by the magnetic resonance of nuclei ASTM F2119-01 1), definition 2.1.4 3.6 non-active surgical impla
40、nt surgical implant, the operation of which does not depend on a source of electrical energy or any source of power other than that directly generated by the human body or gravity 3.7 safety freedom from unacceptable risk ISO/IEC Guide 51:1999, definition 3.1 3.8 surgical implant device that is inte
41、nded to be totally introduced into the human body, or to replace an epithelial surface or the surface of the eye, by means of surgical intervention and that is intended to remain in place after the procedure, or any medical device that is intended to be partially introduced into the human body by me
42、ans of surgical intervention and that is intended to remain in place after the procedure for at least 30 days 4 Intended performance The intended performance of an implant shall be described and documented by addressing the following, with particular regard to safety: a) intended purpose(s); b) func
43、tional characteristics; c) intended conditions of use; d) intended lifetime. NOTE For this purpose, it is advisable that particular account be taken of published standards, published clinical and scientific literature, and validated test results. -,-,- ISO 14630:2008(E) 4 ISO 2008 All rights reserve
44、d 5 Design attributes The design attributes to meet the intended performance shall take into account at least the following: a) materials and their biocompatibility (see Clause 6); b) physical, mechanical and chemical properties of materials, including endurance properties and ageing (see Clauses 6
45、and 7); c) wear characteristics of materials and the effects of wear and wear products on the implant and the body (see Clauses 6 and 7); d) degradation characteristics of materials, and the effects of degradation, degradation products and leachables on the implant and the body (see Clauses 6 and 7)
46、; e) the extent and effect of leakage (see Clauses 6 and 7); f) safety with respect to viruses and other transmissible agents (unclassified pathogenic entities, prions and similar entities), of animal tissues or derivatives of animal tissue utilized in the implant or during its manufacture (see Clau
47、se 6); g) the effect of manufacturing processes (including sterilization) on material characteristics and performance (see Clauses 6, 7, 8 and 9); h) possible effects on the implant and its function due to interactions between its constituent materials and between its constituent materials and other
48、 materials and substances (see Clauses 6 and 7); i) interconnections and their effects on the intended performance (see Clause 7); j) interface(s) between the implant and body tissue(s), particularly relative to fixation and connection, and surface conditions (see Clause 7); k) shape and dimensions, including their possible effects on tissues and body fluids (see Clause 7); l) biocompatibility of the implant in its implantable state (see Clauses 6 and 7); m) physical and chemical effects of th