SIST EN ISO 16061:2009
(Main)Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2008)
Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2008)
This International Standard specifies general requirements for instruments to be used in association with nonactive surgical implants. These requirements apply to instruments when they are manufactured and when they are resupplied after refurbishment. This International Standard also 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.
Instrumente die in Verbindung mit nichtaktiven chirurgischen Implantaten verwendet werden - Allgemeine Anforderungen (ISO 16061:2008)
Diese Internationale Norm legt allgemeine Anforderungen für Instrumente, die in Verbindung mit nichtaktiven chirurgischen Implantaten verwendet werden, fest. Diese Anforderungen gelten für Instrumente während ihrer Herstellung und wenn sie nach Aufarbeitung wiedergeliefert werden.
Diese Norm gilt auch für Instrumente, die mit Antriebseinheiten verbunden werden können, aber gilt nicht für die Antriebseinheiten selbst.
In Bezug auf die Sicherheit legt diese Internationale Norm Anforderungen für die beabsichtigte Funktion, Konstruktionsmerkmale, Werkstoffauswahl, Designprüfung, Herstellung, Sterilisation, Verpackung und Bereitstellung von Informationen durch den Hersteller fest.
Diese Norm gilt nicht für Instrumente, die in Verbindung mit Dentalimplantaten, transendodontischen und transradikulären Implantaten sowie ophthalmologischen Implantaten verwendet werden.
Instrumentation à utiliser en association avec les implants chirurgicaux non actifs - Exigences générales (ISO 16061:2008)
Instrumenti, ki se uporabljajo pri neaktivnih kirurških vsadkih (implantati) - Splošne zahteve (ISO 16061:2008)
General Information
Relations
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Instrumenti, ki se uporabljajo pri neaktivnih kirurških vsadkih (implantati) - Splošne zahteve (ISO 16061:2008)Instrumente die in Verbindung mit nichtaktiven chirurgischen Implantaten verwendet werden - Allgemeine Anforderungen (ISO 16061:2008)Instrumentation à utiliser en association avec les implants chirurgicaux non actifs - Exigences générales (ISO 16061:2008)Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2008)11.040.30Operacijski instrumenti in materialiSurgical instruments and materialsICS:Ta slovenski standard je istoveten z:EN ISO 16061:2008SIST EN ISO 16061:2009en01-marec-2009SIST EN ISO 16061:2009SLOVENSKI
STANDARDSIST EN 12011:20001DGRPHãþD
SIST EN ISO 16061:2009
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 16061December 2008ICS 11.040.40; 11.040.99Supersedes EN 12011:1998
English VersionInstrumentation for use in association with non-active surgicalimplants - General requirements (ISO 16061:2008)Instrumentation à utiliser en association avec les implantschirurgicaux non actifs - Exigences générales (ISO16061:2008)Instrumente die in Verbindung mit nichtaktivenchirurgischen Implantaten verwendet werden - AllgemeineAnforderungen (ISO 16061:2008)This European Standard was approved by CEN on 29 November 2008.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: rue de Stassart, 36
B-1050 Brussels© 2008 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 16061:2008: ESIST EN ISO 16061:2009
EN ISO 16061:2008 (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 16061:2009
EN ISO 16061:2008 (E) 3 Foreword This document (EN ISO 16061:2008) has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” in collaboration with 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 June 2009, and conflicting national standards shall be withdrawn at the latest by June 2009. 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 12011:1998. 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 16061:2008 has been approved by CEN as a EN ISO 16061:2008 without any modification. SIST EN ISO 16061:2009
EN ISO 16061:2008 (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 to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC of 14 June 1993 concerning 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 normative clauses of this standard given in Table ZA.1 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 1— Correspondence between this European Standard and Directive 93/42/EEC
Clause(s)/sub-clause(s) of this International Standard Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 4 1, 3, 2, 4, 12
5 1, 2, 3, 4, 5, 7.1, 7.2, 7.3, 7.5, 7.6, 8, 9, 10.1, 12
6 1, 2, 7.1
7 1, 2, 3, 4, 5, 6, 7, 9.1, 9.2, 12
8 1, 2, 3, 4, 5, 7, 9, 12
9 1, 2, 3, 4, 7, 8.1, 8.3 to 8.7, 13.3. c), 13.6 h)
10 1, 2, 4, 5, 7.2, 7.5, 7.6, 8.3, 8.6, 8.7
11 13
WARNING — Other requirements and other EU Directives may be applicable to the products falling within the scope of this standard.
SIST EN ISO 16061:2009
Reference numberISO 16061:2008(E)© ISO 2008
INTERNATIONAL STANDARD ISO16061Second edition2008-12-01Instrumentation for use in association with non-active surgical implants — General requirements Instrumentation à utiliser en association avec les implants chirurgicaux non actifs — Exigences générales
SIST EN ISO 16061:2009
ISO 16061:2008(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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SIST EN ISO 16061:2009
ISO 16061:2008(E) © ISO 2008 – All rights reserved iiiContents Page Foreword.iv 1 Scope.1 2 Normative references.1 3 Terms and definitions.2 4 Intended performance.2 5 Design attributes.3 6 Selection of materials.3 7 Design evaluation.3 7.1 General.3 7.2 Pre-clinical evaluation.4 7.3 Clinical evaluation.4 8 Manufacture.4 9 Sterilization.4 9.1 Products supplied sterile.4 9.2 Products provided non-sterile.4 10 Packaging.4 10.1 Protection from damage in storage and transport.4 10.2 Maintenance of sterility in transit.5 11 Information to be supplied by the manufacturer.5 11.1 General.5 11.2 Instruments with measuring function.5 11.3 Restrictions in combinations.5 11.4 Marking on instruments.5 11.5 Instructions for use.5 11.6 Instruments intended for single use.6 Annex A (informative)
Examples of typical instrument applications, together with materials found acceptable for instrument manufacture.7 Bibliography.18
SIST EN ISO 16061:2009
ISO 16061:2008(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 16061 was prepared by Technical Committee ISO/TC 150, Implants for surgery. This second edition cancels and replaces the first edition (ISO 16061:2000), which has been technically revised.
SIST EN ISO 16061:2009
INTERNATIONAL STANDARD ISO 16061:2008(E) © ISO 2008 – All rights reserved 1Instrumentation for use in association with non-active surgical implants — General requirements 1 Scope 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 also 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. 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 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 11137-3, Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems ISO 11607-2, Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes 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 ISO 14971, Medical devices — Application of risk management to medical devices SIST EN ISO 16061:2009
ISO 16061:2008(E) 2 © ISO 2008 – All rights reserved ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements 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 EN 556-1, Sterilization of medical devices — Requirements for medical devices to be designated “STERILE” — Part 1: Requirements for terminally sterilized medical devices EN 556-2, Sterilization of medical devices — Requirements for medical devices to be designated “STERILE” — Part 2: Requirements for aseptically processed medical devices EN 1041:2008, Information supplied by the manufacturer of medical devices 3 Terms and definitions For the purposes of this document, 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 re-issued 4 Intended performance The intended performance of an instrument shall be described and documented by addressing the following: a) functional characteristics; b) intended conditions of use. NOTE Account 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). SIST EN ISO 16061:2009
ISO 16061:2008(E) © ISO 2008 – All rights reserved 35 Design 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); 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 interconnection of 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). 6 Selection 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) selection from the materials found suitable by proven clinical use in similar applications. NOTE Annex A lists some of the materials that have been found acceptable in certain applications. 7 Design evaluation 7.1 General 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. NOTE In certain circumstances, a clinical evaluation can also be required. SIST EN ISO 16061:2009
ISO 16061:2008(E) 4 © ISO 2008 – All rights reserved 7.2 Pre-clinical evaluation If pre-clinical testing of instruments is required, the testing shall simulate conditions of intended use. 7.3 Clinical 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 14155-1 and ISO 14155-2. 8 Manufacture Instruments shall be manufactured to specifications in accordance with the required design attributes (see Clause 5). NOTE 1 The application of quality systems as described in ISO 13485 might be appropriate. NOTE 2 The 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. 9 Sterilization 9.1 Products supplied sterile Instruments which are labelled “STERILE” shall comply with EN 556-1 and EN 556-2. Sterilization processes shall be validated and routinely controlled. If instruments are to be sterilized by ethylene oxide, ISO 11135-1 applies. If instruments are to be sterilized by irradiation, ISO 11137-1, ISO 11137-2 and ISO 11137-3 apply. If instruments are to be sterilized by steam, ISO 17665-1 applies. 9.2 Products provided non-steri
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