ISO-16061-2000.pdf

Reference number ISO 16061:2000(E) ©ISO 2000 INTERNATIONAL STANDARD ISO 16061 First edition 2000-03-15 Instrumentation for use in association with non-active surgical implants General requirements Instrumentation à utiliser en association avec les implants chirurgicaux non actifs Exigences générales Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 00:25:41 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 16061:2000(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. ©ISO 2000 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. + 41 22 749 01 11 Fax + 41 22 734 10 79 E-mail copyrightiso.ch Web www.iso.ch Printed in Switzerland ii© ISO 2000 All rights reserved Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 00:25:41 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 16061:2000(E) © ISO 2000 All rights reservediii ContentsPage Foreword.iv 1Scope 1 2Normative references1 3Terms and definitions .2 4Intended performance.2 5Design attributes2 6Selection of materials3 7Design evaluation3 7.1General3 7.2Pre-clinical evaluation.3 7.3Clinical evaluation .3 8Manufacture3 9Sterilization.4 9.1Products supplied sterile4 9.2Products provided non-sterile4 10Packaging.4 10.1Protection from damage in storage and transport.4 10.2Maintenance of sterility in transit.4 11Information to be supplied by the manufacturer4 11.1General4 11.2Instruments with measuring function4 11.3Restrictions in combinations .5 11.4Marking on instruments5 11.5Instructions for use .5 11.6Instruments intended for single use5 Annex A (informative) Examples of typical instrument applications, together with materials found acceptable for instrument manufacture6 Bibliography18 Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 00:25:41 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 16061:2000(E) iv© ISO 2000 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 3. 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 International Standard may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. International Standard ISO 16061 was prepared by Technical Committee ISO/TC 150,Implants for surgery. Annex A of this International Standard is for information only. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 00:25:41 MDTNo reproduction or networking permitted without license from IHS -,-,- INTERNATIONAL STANDARDISO 16061:2000(E) © ISO 2000 All rights reserved1 Instrumentation for use in association with non-active surgical implants General requirements 1Scope This International Standard specifies general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are resupplied after refurbishment. This International Standard applies to instruments which may be connected to power-driven systems, but does not apply to the power-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 Standard is not applicable to instruments associated with dental implants, transendodontic and transradicular implants and ophthalmic implants. NOTEReferences to standards for non-active surgical implants are listed in the Bibliography. 2Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards. ISO 11134,Sterilization of health care products Requirements for validation and routine control Industrial moist heat sterilization. ISO 11135,Medical devices Validation and routine control of ethylene oxide sterilization. ISO 11137,Sterilization of health care products Requirements for validation and routine control Radiation sterilization. ISO 11607,Packaging for terminally sterilized medical devices. ISO 14155,Clinical investigation of medical devices. ISO 14971-1,Medical devices Risk management Part 1: Application of risk analysis. ISO 15223,Medical devices Symbols to be used with medical device labels, labelling and information to be supplied. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 00:25:41 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 16061:2000(E) 2© ISO 2000 All rights reserved EN 556:1994 + A1:1998,Sterilization of medical devices Requirements for terminally-sterilized medical devices to be labelled “Sterile”. EN 1041:1998,Information supplied by the manufacturer with medical devices. 3Terms and definitions For the purposes of this International Standard, the following terms and definitions apply. 3.1 associated instrument instrument non-active medical device intended for use during surgical procedures related to a specific non-active surgical implant 3.2 resupplied instrument instrument or set of instruments that has been returned to the manufacturer and has been reissued 4Intended performance The intended performance of an instrument shall be described and documented by addressing the following: a)functional characteristics; b)intended conditions of use. NOTEAccount should be taken of: ? published standards; ? published clinical and scientific literature; ? validated test results. The extent to which the intended performance of an instrument has been achieved shall be determined (see clause 7). 5Design attributes The development of the design attributes of an instrument to meet the performance intended by the manufacturer shall take into account at least the following: a)physical, mechanical and chemical properties of the instrument materials (see clauses 6 and 7); b)microbiological and particulate contamination levels (see clauses 7, 9 and 10); c)ease of use, cleaning and maintenance (see clause 7); d)potential deterioration of the material characteristics due to sterilization and storage (see clauses 6, 7 and 8); e)effects of contact between the instrument and body, the implant and other instruments (see clause 7); f)shape and dimensions of the instrument, including their possible effects on the body (see clause 7); Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 00:25:41 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 16061:2000(E) © ISO 2000 All rights reserved3 g)wear characteristics of materials and the effect of wear and wear products on the instrument and the body (see clauses 6 and 7); h)insertion, removal and interconnecting parts (see clause 7); i)extent of fluid leakage and/or diffusion of substances into or out of instruments (see clauses 6 and 7); j)accuracy and stability of instruments with a measuring function (see clauses 7 and 8); k)ability of the instrument or fragment of instrument to be located by means of an external imaging device (see 11.5). 6Selection of materials Materials for the manufacture of instruments shall be selected with regard to the properties required for the intended purpose, taking into account the effects of manufacture, handling, sterilization and storage (see clause 7). The suitability of a given material for a particular application shall be demonstrated by either: a)evaluating in accordance with clause 7; or b)by selection from the materials found suitable by proven clinical use in similar applications. NOTEAnnex A lists some of the materials that have been found acceptable in certain applications. 7Design evaluation 7.1General Instruments shall be evaluated in association with the implant they are designed for, in order to demonstrate that the intended performance (see clause 4) is achieved. Safety shall be demonstrated by pre-clinical evaluation and by carrying out a risk analysis in accordance with ISO 14971-1. NOTEIn certain circumstances a clinical evaluation can also be required. 7.2Pre-clinical evaluation If pre-clinical testing of instruments is required, the testing shall simulate conditions of intended use. 7.3Clinical evaluation If a clinical evaluation is required, it shall be conducted using the associated implant under the intended conditions of use. Where a clinical investigation is carried out, it shall be managed in accordance with ISO 14155. 8Manufacture Instruments shall be manufactured to specifications in accordance with the required design attributes (see clause 5). NOTE 1The application of quality systems as described in EN 46001 and EN 46002 may be appropriate. NOTE 2The design specification for re-supplied instruments need not necessarily be the same as the original, provided that the requirements of this International Standard are met. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 00:25:41 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 16061:2000(E) 4© ISO 2000 All rights reserved 9Sterilization 9.1Products supplied sterile Instruments which are labelled “STERILE“ shall comply with EN 556. Sterilization processes shall be validated and routinely controlled. If instruments are to be sterilized by ethylene oxide, ISO 11135 applies, If instruments are to be sterilized by irradiation, ISO 11137 applies, If instruments are to be sterilized by steam, ISO 11134 applies. 9.2Products provided non-sterile For instruments which are supplied non-sterile, the manufacturer shall specify at least one appropriate sterilization method such that the functional safety of the product is not adversely affected. If multiple sterilizations are not allowed, this shall be stated (see 11.6). 10 Packaging 10.1 Protection from damage in storage and transport For each instrument, the packaging shall be designed so that, under conditions specified by the manufacturer for storage, transport and handling (including control of temperature, humidity and ambient pressure, if applicable), it protects against damage and deterioration and does not adversely affect the intended performance of the instrument. NOTEPossible test methods are specified in IEC 60068-2-27, IEC 60068-2-32, IEC 60068-2-32 AMD 2and/or IEC 104/49/CDV. 10.2 Maintenance of sterility in transit Instruments labelled “STERILE“ shall be packed such that they remain sterile under normal storage, transport and handling conditions, unless the protective package is damaged or opened. The packaging shall conform to ISO 11607. 11 Information to be supplied by the manufacturer 11.1 General Information supplied with instruments by manufacturers shall be in accordance with EN 1041:1998, with the exception of 4.3. All packages shall bear a label which indicates the full contents. If the label does not list the full contents of the package, a contents list shall be enclosed. If symbols are to be used, they shall be in accordance with ISO 15223. 11.2 Instruments with measuring function The limits of accuracy of instruments having a measuring function shall be indicated by a marking on the device and/or label, instruction leaflet or manual. NOTEThis requirement does not apply to gauges used for component size selection and GO/ NO GO determination. Copyright International Orga