SIST EN ISO 14630:2009

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Neaktivni kirurški vsadki (implantati) - Splošne zahteve (ISO 14630:2008)Nichtaktive chirurgische Implantate - Allgemeine Anforderungen (ISO 14630:2008)Implants chirurgicaux non actifs - Exigences générales (ISO 14630:2008)Non-active surgical implants - General requirements (ISO 14630:2008)11.040.40Implantanti za kirurgijo, protetiko in ortetikoImplants for surgery, prosthetics and orthoticsICS:Ta slovenski standard je istoveten z:EN ISO 14630:2009SIST EN ISO 14630:2009en01-julij-2009SIST EN ISO 14630:2009SLOVENSKI
STANDARDSIST EN ISO 14630:20081DGRPHãþD



SIST EN ISO 14630:2009



EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 14630May 2009ICS 11.040.40Supersedes EN ISO 14630:2008
English VersionNon-active surgical implants - General requirements (ISO14630:2008)Implants chirurgicaux non actifs - Exigences générales(ISO 14630:2008)Nichtaktive chirurgische Implantate - AllgemeineAnforderungen (ISO 14630:2008)This European Standard was approved by CEN on 19 April 2009.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre:
Avenue Marnix 17,
B-1000 Brussels© 2009 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 14630:2009: ESIST EN ISO 14630:2009



EN ISO 14630:2009 (E) 2 Contents Page Foreword .3Annex ZA (informative)
Relationship between this
European
Standard and the Essential Requirements
of EU Directive 93/42/EEC .4 SIST EN ISO 14630:2009



EN ISO 14630:2009 (E) 3 Foreword The text of ISO 14630:2008 has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 14630:2009 by Technical Committee CEN/TC 285 “Non-active surgical implants” the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by November 2009, and conflicting national standards shall be withdrawn at the latest by March 2010. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 14630:2008. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EC Directive. For relationship with EC Directive, see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 14630:2008 has been approved by CEN as a EN ISO 14630:2009 without any modification. SIST EN ISO 14630:2009



EN ISO 14630:2009 (E) 4 Annex ZA (informative)
Relationship between this
European
Standard and the Essential Requirements
of EU Directive 93/42/EEC This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Communities under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in table ZA confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA — Correspondence between this
European
Standard and Directive 93/42/EEC Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 4 1 - 2 – 3 - 4 – 5- 7. 1
5 1 - 2 - 3 - 4 - 5 - 7.1 - 7.2 - 7.3 - 7.5 - 7.6 - 8 - 9.1 - 9.2
Part of ER 1 relating to risk of use error is not addressed by this European Standard.
6 1 - 2 - 7.1 - 7.2 - 7.3 - 7.4 - 7.5 - 8.2 - 9.2
7 1 - 2 - 3 - 4 - 6 -6.a - 7.1 - 7.2 - 7.3 - 7.5 - 7.6 - 8 - 9.1 - 9.2 -
Part of ER 7.1 relating to the results of biophysical or modelling research is not explicitly addressed by this European Standard.
8 1 - 2 - 3 - 5 - 7.1 - 7.2
9 1 - 2 - 7.2
- 8.1 - 8.3 - 8.4 - 8.5
10 1 - 2 - 3 - 5 - 7.2 - 8.3 - 8.6
SIST EN ISO 14630:2009



EN ISO 14630:2009 (E) 5
11 1 - 2 - 8.7 - 13 The part of ER 13.3.a concerning the information on the authorized representative is not addressed in this European Standard
ER: 13.3 f) is only partially addressed: Safety issue is addressed, but not the regulatory requirement (consistency around Europe).
ER: 13.6.h) relating to single use is not addressed by this European Standard.
ER 13.6 q) is not addressed by this European Standard.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard.
SIST EN ISO 14630:2009



SIST EN ISO 14630:2009



Reference numberISO 14630:2008(E)© ISO 2008
INTERNATIONAL STANDARD ISO14630Third edition2008-01-15Non-active surgical implants — General requirements Implants chirurgicaux non actifs — Exigences générales
SIST EN ISO 14630:2009



ISO 14630:2008(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's 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 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.
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ISO 2008 All rights reserved. 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 ISO's member body in the country of the requester. ISO copyright office Case postale 56 • CH-1211 Geneva 20 Tel.
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ii © ISO 2008 – All rights reserved
SIST EN ISO 14630:2009



ISO 14630:2008(E) © ISO 2008 – All rights reserved iiiContents Page Foreword.iv Introduction.v 1 Scope.1 2 Normative references.1 3 Terms and definitions.2 4 Intended performance.3 5 Design attributes.4 6 Materials.5 7 Design evaluation.5 7.1 General.5 7.2 Pre-clinical evaluation.5 7.3 Clinical evaluation.6 7.4 Post-market surveillance.6 8 Manufacture.6 9 Sterilization.6 9.1 General.6 9.2 Products supplied sterile.6 9.3 Sterilization by the user.7 9.4 Sterilization residuals.7 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 General.8 11.2 Labelling.9 11.3 Instructions for use.9 11.4 Restrictions on combinations.11 11.5 Marking on implants.11 11.6 Marking for special purposes.11 Annex A (informative)
Correspondence between this International Standard and ISO/TR 14283:2004.12 Bibliography.13
SIST EN ISO 14630:2009



ISO 14630:2008(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). 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-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 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 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 prepared 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. SIST EN ISO 14630:2009



ISO 14630:2008(E) © ISO 2008 – All rights reserved vIntroduction 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 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 concerning 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 instrumentation. 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 implants. 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 [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 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 consensus. Individual or national standards or regulatory bodies can prescribe other requirements.
SIST EN ISO 14630:2009



SIST EN ISO 14630:2009



INTERNATIONAL STANDARD ISO 14630:2008(E) © ISO 2008 – All rights reserved 1Non-active surgical implants — General requirements 1 Scope This International Standard specifies general requirements for 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 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 referred 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 achieves 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) 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 within a risk management system ISO 10993-7, Biological evaluation 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 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 11607-1, Packaging for terminally sterilized medical devices — Part 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 investigation of medical devices for human subjects — Part 2: Clinical investigation plans SIST EN ISO 14630:2009



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 sterilants 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 ISO 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 process 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 utilizing 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 material 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 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 [ASTM 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 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.astm.org/. SIST EN ISO 14630:2009



ISO 14630:2008(E) © ISO 2008 – All rights reserved 33.5 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 implant 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 intended 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 means 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) functional 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. SIST EN ISO 14630:2009



ISO 14630:2008(E) 4 © ISO 2008 – All rights reserved 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 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); 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 Clause 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 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 the body and external environment on the implant (see Clause 7); n) effects of radiation, electromagnetic and magnetic fields on the implant and its function, and any consequential effects on the body (see Clauses 6 and 7); NOTE Particular attention is drawn to the fields used for magnetic resonance imaging (MRI) in respect of patient safety. The test methods in ASTM F2052, ASTM F2119, ASTM F2182 and ASTM F2213 can be used to evaluate the safety of an implant in the MR environment. o) the ability to implant and, when applicable, to remove or replace the implant (see Clause 7); p) the ability to visualize the position and orientation of the implant by radiological or other imaging procedures; q) microbiological and particulate contamination levels (see Clauses 8, 9 and 10); r) the 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. SIST EN ISO 14630:2009



ISO 14630:2008(E) © ISO 2008 – All rights reserved 56 Materials Implant materials shall be selected with regard to the properties required for the intended purpose, also taking into account the effects of manufacture, handling, sterilization and storage, as well as any treatment (chemical, electro-chemical, thermal, mechanical, etc.) applied to the surface or a part of the surface of the implant material in order to modify its properties. Possible reactions of implant materials with human tissues and body fluids, other materials, other implants, substances and gases shall be considered. Possible effects of radiation, magnetic and electromagnetic 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. NOTE 1 For the assessment of the safety, quality and usefulness of the medicinal product incorporated as an integral part of an implant, appropriate methods might be specified in national or regional regulations (e.g. European Directive 2001/83/EC). Materials, including biological materials, used for implants and coatings shall be acceptably compatible with the biological tissues, cells and body fluids with which they are in contact in their implantable state. The compatibility of possible wear and degradation products shall also be acceptable. The acceptability in the particular application shall be demonstrated either a) by documented assessment in accordance with ISO 10993-1, or b) by selection from the materials found suitable by proven clinical use in similar applications. NOTE 2 Some of the level 2 standards include lists of materials which have been found acceptable in certain applications. For implants utilizing materials of animal origin that are non-viable or have been rendered non-viable either in the implant or in its manufacture, these materials shall be evaluated and their safety with respect to viruses and other transmissible agents shall be in accordance with the requirements of ISO 22442-1, ISO 22442-2 and ISO 22442-3. NOTE 3 See ISO 22442-1 for the definition of the terms “animal” and “tissue”. 7 Design evaluation 7.1 General Implants shall be evaluated to demonstrate that the intended performance (see Clause 4) is achieved. The extent to which the intended performance has been achieved shall be determined and documented. Safety and intended performance shall be demonstrated by pre-clinical evaluation, clinical evaluation and post-market surveillance, including appropriate risk management at all stages of the life cycle of the implant, in accordance with the requirements of ISO 14971. 7.2 Pre-clinical evaluation Implants shall undergo pre-clinical evaluation based on a) the relevant scientific literature relating to the safety, performance, the design characteristics, and the intended use of the implant, b) analysis of available predictive and outcome data from sources such as national and other registries, and c) analysis of data obtained from testing including bench-testing and, when available, data from validated techniques for evaluating implant safety and
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