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1、 Reference number ISO 14630:2005(E) ISO 2005 INTERNATIONAL STANDARD ISO 14630 Second edition 2005-05-01 Non-active surgical implants General requirements Implants chirurgicaux non actifs Exigences gnrales ISO 14630:2005(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance wi
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4、ry 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 2005 All rights reserved. Unless otherwise specified, no part of this publicati
5、on 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 postale 56 CH-1211 Geneva 20
6、 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 2005 All rights reserved -,-,- ISO 14630:2005(E) ISO 2005 All rights reserved iii Contents Page Forewordiv Introduction v 1 Scope1 2 Normative references .1 3 Terms and definitions.2
7、 4 Intended performance 3 5 Design attributes.3 6 Materials.4 7 Design evaluation .5 7.1 General.5 7.2 Pre-clinical evaluation5 7.3 Clinical evaluation.5 7.4 Post market surveillance5 8 Manufacture.5 9 Sterilization5 9.1 General.5 9.2 Products supplied sterile.6 9.3 Sterilization by the user6 9.4 St
8、erilization residuals.6 10 Packaging 6 10.1 Protection from damage in storage and transport6 10.2 Maintenance of sterility in transit7 11 Information supplied by the manufacturer.7 11.1 General.7 11.2 Labelling.7 11.3 Instructions for use.8 11.4 Restrictions on combinations9 11.5 Marking on implants
9、.9 11.6 Marking for special purposes10 Annex A (informative) Correspondence of the clauses of this International Standard to the fundamental principles as outlined in ISO/TR 14283:2004.11 Bibliography .12 -,-,- ISO 14630:2005(E) iv ISO 2005 All rights reserved Foreword ISO (the International Organiz
10、ation 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 a subject for which a technical committee has been established
11、 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 Commission (IEC) on all matters of electrotechnical standardization. I
12、nternational 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 committees are circulated to the member bodies for voting. Publ
13、ication 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 not be held responsible for identifying any or all such patent
14、rights. ISO 14630 was prepared by Technical Committee ISO/TC 150, Implants for surgery. This second edition cancels and replaces the first edition (ISO 14630:1997), which has been technically revised. For the purposes of this International Standard, the CEN annex regarding fulfilment of European Cou
15、ncil Directives has been removed. ISO 14630:2005(E) ISO 2005 All rights reserved v Introduction This International Standard provides a method of addressing the fundamental principles outlined in ISO/TR 14283, as they apply to non-active surgical implants. It also provides a method to demonstrate com
16、pliance with the relevant essential requirements as outlined in general terms in Annex 1 of the European Community Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as they apply to non- active surgical implants, hereafter referred to as implants. It may also assist manufacture
17、rs to comply with the requirements of other regulatory bodies. There are three levels of standards dealing with non-active surgical implants and related instrumentation. For the implants themselves these are as follows, with Level 1 being the highest: Level 1: General requirements for non-active sur
18、gical implants; Level 2: Particular requirements for families of non-active surgical implants; Level 3: Specific requirements for types of non-active surgical implants. This standard is a Level 1 standard and contains requirements that apply to all non-active surgical implants. It also anticipates t
19、hat there are additional requirements in the Level 2 and Level 3 standards. The Level 2 standards 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. The Level 3 standards apply to spec
20、ific types of implants within a family of non-active surgical implants such as hip joints or arterial stents. To address all requirements for a specific implant the standard of the lowest available level should be consulted first. References to other International Standards can also be found in the
21、Bibliography. The requirements in this International Standard correspond to international consensus. Individual or national standards or regulatory bodies may prescribe other requirements. -,-,- INTERNATIONAL STANDARD ISO 14630:2005(E) ISO 2005 All rights reserved 1 Non-active surgical implants Gene
22、ral requirements 1 Scope This International Standard specifies general requirements for non-active surgical implants, hereafter referred to as implants. It is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants and intra-ocular lenses. With re
23、gard to safety, this International Standard gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests required to demonstrate compliance with these requirements. Addition
24、al tests are given or referred to in Level 2 and Level 3 standards. 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 doc
25、ument (including any amendments) applies. 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 ISO 10993-7, Biological ev
26、aluation of medical devices Part 7: Ethylene oxide sterilization residuals ISO 11135:1), Sterilization of health care products Ethylene oxide Requirements for development, validation and routine control of a sterilization process for medical devices ISO 11137, Sterilization of health care products R
27、equirements for validation and routine control Radiation sterilization2) ISO 11607, Packaging for terminally sterilized medical devices 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
28、1: General requirements ISO 14160, Sterilization of single-use medical devices incorporating materials of animal origin Validation and routine control of sterilization by liquid chemical sterilants 1) To be published. (Revision of ISO 11135:1994). ISO 11135:1994 is not identical to EN 550, which was
29、 referenced in the last edition of ISO 14630. However, a revision of ISO 11135:1994 is under development and will be harmonized under the EU Medical Device Directive. 2) ISO 11137:1995 is not identical to EN 552 wich was referenced in the last edition of ISO 14630, however, a revision of this standa
30、rd is under development and will be harmonized. -,-,- ISO 14630:2005(E) 2 ISO 2005 All rights reserved 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
31、medical devices ISO 14971, Medical devices Application of risk management to medical devices ISO 17664, Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices ISO 17665:3), Sterilization of health care products Moist heat
32、Development, validation and routine control of a sterilization process for medical devices EN 12442-1, Animal tissues and their derivatives utilized in the manufacture of medical devices Part 1: Analysis and management of risk EN 12442-2, Animal tissues and their derivatives utilized in the manufact
33、ure of medical devices Part 2: Controls on sourcing, collection and handling EN 12442-3, Animal tissues and their derivatives utilized in the manufacture of medical devices Part 3: Validation of the elimination and/or inactivation of viruses and transmissible agents 3 Terms and definitions For the p
34、urposes of this document, the following terms and definitions apply. 3.1 surgical implant device which is intended to be totally introduced into the human body, or to replace an epithelial surface or the surface of the eye, by surgical intervention which is intended to remain in place after the proc
35、edure NOTE Any medical device intended to be partially introduced into the human body by surgical intervention and which is intended to remain in place after the procedure for at least 30 d is also considered a surgical implant. 3.2 non-active surgical implant surgical implant, the operation of whic
36、h 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 3.3 safety freedom from unacceptable risk 3.4 implantable state condition of an implant prepared for implantation into a human subject 3.5 leakage unintended move
37、ment of fluid including body fluids into or out of implants through a defect in the structure of the containing wall 3) To be published. -,-,- ISO 14630:2005(E) ISO 2005 All rights reserved 3 3.6 coating layer of material used to cover or partially cover a surface of an implant 4 Intended performanc
38、e The intended performance of an implant shall be described and documented by addressing the following: intended purpose(s); functional characteristics; intended conditions of use; with particular regard to safety. Account should also be taken of: published standards; published clinical and scientif
39、ic literature; validated test results. 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
40、properties and ageing (see Clauses 6 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 impla
41、nt and the body (see Clauses 6 and 7); e) extent and effect of leakage of substances (see Clauses 6 and 7); f) effect of manufacturing processes (including sterilization) on material characteristics and performance (see Clauses 6, 7, 8 and 9); g) possible effects on the implant and its function due
42、to interactions between its constituent materials and between its constituent materials and other materials and substances (see Clauses 6 and 7); h) interconnections and their effects on the intended performance (see Clause 7); i) interface(s) between the implant and body tissue(s), particularly rel
43、ative to fixation and connection, and surface conditions (see Clause 7); j) shape and dimensions including their possible effects on tissues and body fluids (see Clause 7); k) biocompatibility of the implant in its implantable state (see Clauses 6 and 7); ISO 14630:2005(E) 4 ISO 2005 All rights rese
44、rved l) physical and chemical effects of the body and external environment on the implant (see Clause 7); m) effects of radiation and electromagnetic fields on the implant and consequential effects on the body (see Clauses 6 and 7); NOTE Particular attention is drawn to the fields used for magnetic
45、resonance imaging (MRI) in respect of patient safety. n) ability to implant, to remove and to replace the implant (see Clause 7); o) ability to visualize the position and orientation of the implant by radiological procedures; p) microbiological and particulate contamination levels (see Clauses 8, 9
46、and 10); q) suitability and effectiveness of packaging (see Clause 10). Implant design attributes shall be documented. Where any of the above are not considered to be relevant, the reason shall be documented and justified. 6 Materials Implant materials shall be selected with regard to the properties
47、 required for the intended purpose, taking also into account the effects of manufacture, handling, sterilization and storage. Possible reactions of implant materials with human tissues and body fluids, other materials, other implants, substances and gases shall be considered. Possible effects of rad
48、iation and electro-magnetic fields on the material shall also be considered. When a medicinal product is an integral part of an implant, the medicinal product shall be assessed according to pharmaceutical principles. The performance of the medicinal product used in combination with the implant shall not be affected by the implant and/or vice versa. When assessing the safety, quality and usefulness of the medicinal product incorporated as an integral part of an implant, appropriate methods, such as specified in European Directive 2001/83/EC should be employed. M