1、September 2015 Translation by DIN-Sprachendienst.English price group 13No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).
2、ICS 11.040.30!%F/“2351295www.din.deDDIN EN ISO 16061Instrumentation for use in association with nonactive surgicalimplants General requirements (ISO 16061:2015);English version EN ISO 16061:2015,English translation of DIN EN ISO 16061:201509Instrumente, die in Verbindung mit nichtaktiven chirurgisch
3、en Implantaten verwendetwerden Allgemeine Anforderungen (ISO 16061:2015);Englische Fassung EN ISO 16061:2015,Englische bersetzung von DIN EN ISO 16061:2015-09Instrumentation utiliser en association avec les implants chirurgicaux non actifs Exigences gnrales (ISO 16061:2015);Version anglaise EN ISO 1
4、6061:2015,Traduction anglaise de DIN EN ISO 16061:2015-09SupersedesDIN EN ISO 16061:2010-01www.beuth.deDocument comprises 28 pagesIn case of doubt, the German-language original shall be considered authoritative.08.15 DIN EN ISO 16061:2015-09 2 A comma is used as the decimal marker. National foreword
5、 This document (EN ISO 16061:2015) has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” in collaboration with Technical Committee CEN/TC 285 “Non-active surgical implants” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the DIN-Normenaus
6、schuss Feinmechanik und Optik (DIN Standards Committee Optics and Precision Mechanics), Working Committee NA 027-02-17 AA Chirurgische Implantate. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 8601 DIN EN ISO 8601 ISO 11135 DIN EN ISO
7、 11135 ISO 11137-1 DIN EN ISO 11137-1 ISO 11137-2 DIN EN ISO 11137-2 ISO 11137-3 DIN EN ISO 11137-3 ISO 11607-1 DIN EN ISO 11607-1 ISO 11607-2 DIN EN ISO 11607-2 ISO 14155 DIN EN ISO 14155 ISO 14971 DIN EN ISO 14971 ISO 17664 DIN EN ISO 17664 ISO 17665-1 DIN EN ISO 17665-1 ISO 80000-1 DIN EN ISO 800
8、00-1 Amendments This standard differs from DIN EN ISO 16061:2010-01 as follows: a) Clause 11 “Information supplied by the manufacturer” has been restructured and extended on the lines of DIN EN ISO 14630; b) further steels have been included in Tables A.1 to A.3; c) Annex ZA has been brought in line
9、 with the requirements of the European Commission; d) the standard has been editorially revised. Previous editions DIN EN 12011: 1998-03 DIN EN ISO 16061: 2010-01 DIN EN ISO 16061:2015-09 3 National Annex NA (informative) Bibliography DIN ISO 8601, Data elements and interchange formats Information i
10、nterchange Representation of dates and times DIN EN ISO 11135, Sterilization of health care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices DIN EN ISO 11137-1, Sterilization of health care products Radiation Part
11、 1: Requirements for development, validation and routine control of a sterilization process for medical devices DIN EN ISO 11137-2, Sterilization of health care products Radiation Part 2: Establishing the sterilization dose DIN EN ISO 11137-3, Sterilization of health care products Radiation Part 3:
12、Guidance on dosimetric aspects DIN EN ISO 11607-1, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems DIN EN ISO 11607-2, Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming
13、, sealing and assembly processes DIN EN ISO 14155, Clinical investigation of medical devices for human subjects Good clinical practice DIN EN ISO 14971, Medical devices Application of risk management to medical devices DIN EN ISO 17664, Sterilization of medical devices Information to be provided by
14、the manufacturer for the processing of resterilizable medical devices DIN EN ISO 17665-1, Sterilization of health care products Moist heat Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices DIN EN ISO 80000-1, Quantities and units Part
15、 1: General DIN EN ISO 16061:2015-09 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 16061 May 2015 ICS 11.040.40; 11.040.99 Supersedes EN ISO 16061:2009English Version Instrumentation for use in association with non-active surgical implants - General requ
16、irements (ISO 16061:2015) Instrumentation utiliser en association avec les implants chirurgicaux non actifs - Exigences gnrales(ISO 16061:2015) Instrumente, die in Verbindung mit nichtaktiven chirurgischen Implantaten verwendet werden - Allgemeine Anforderungen (ISO 16061:2015) This European Standar
17、d was approved by CEN on 12 March 2015. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such
18、 national standards may be obtained on application to the CEN-CENELEC 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 translation under the responsibility of a CEN member into its own
19、language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Gr
20、eece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUN
21、G CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 16061:2015 EForeword 31 Scope . 42 Normative references 43 Terms and definitions . 54 Intended performance
22、. 55 Design attributes 56 Selection of materials 67 Design evaluation 67.1 General . 67.2 Pre-clinical evaluation 67.3 Clinical evaluation 68 Manufacture 69 Sterilization . 79.1 Products supplied sterile . 79.2 Products provided non-sterile. 710 Packaging . 710.1 Protection from damage in storage an
23、d transport. 710.2 Maintenance of sterility in transit 711 Information supplied by the manufacturer . 711.1 General . 711.2 Labelling . 811.3 Instructions for use . 911.4 Instruments with measuring function . 1011.5 Restrictions in combinations . 1011.6 Marking on instruments 1011.7 Instruments inte
24、nded for single use . 10Annex A (informative) Examples of typical instrument applications, together with materials found acceptable for instrument manufacture 11Bibliography 22Contents PageAnnex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directi
25、ve 93/42/EEC on medical devices . 20 DIN EN ISO 16061:2015-09 EN ISO 16061:2015 (E) 2 Foreword This document (EN ISO 16061:2015) 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 secretar
26、iat 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 2015, and conflicting national standards shall be withdrawn at the latest by November 2015. Attention is drawn
27、 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 16061:2009. This document has been prepared under a mandate given to CEN
28、 by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. According to the CEN-CENELEC Internal Regulations, the national st
29、andards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
30、 Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 16061:2015 has been approved by CEN as EN ISO 16061:2015 without any modification. DIN EN ISO 16061:2015-09 EN ISO 160
31、61:2015 (E) 3 1 ScopeThis 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
32、 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, materials, design evaluation, manufacture, sterili
33、zation, packaging, and information 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 referencesThe following documents, in whole or in part, are n
34、ormatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 8601, Data elements and interchange formats Information
35、 interchange Representation of dates and timesISO 11135, Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devicesISO 11137-1, Sterilization of health care products Radiation Part 1: Requiremen
36、ts for development, validation and routine control of a sterilization process for medical devicesISO 11137-2, Sterilization of health care products Radiation Part 2: Establishing the sterilization doseISO 11137-3, Sterilization of health care products Radiation Part 3: Guidance on dosimetric aspects
37、ISO 11607-1, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systemsISO 11607-2, Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processesISO 14155, Cli
38、nical investigation of medical devices for human subjects Good clinical practiceISO 14971, Medical devices Application of risk management to medical devicesISO 17664, Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devicesI
39、SO 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 devicesISO 80000-1, Quantities and units Part 1: GeneralDIN EN ISO 16061:2015-09 EN ISO 16061:2015 (E) 4 3 Terms and definition
40、sFor the purposes of this document, the following terms and definitions apply.3.1associated implantspecific non-active surgical implant in association with which a specific surgical instrument is intended to be used during a surgical procedure3.2instrumentnon-active medical device intended for use d
41、uring surgical procedures related to a specific non-active surgical implant3.3resupplied instrumentinstrument or set of instruments that has been returned to the manufacturer and has been re-issued4 Intended performanceThe intended performance of an instrument shall be described and documented by ad
42、dressing the following, with particular regard to safety:a) functional characteristics; andb) intended conditions of use.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
43、 has been achieved shall be determined (see Clause 7).5 Design attributesThe 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 ma
44、terials (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 o
45、f 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
46、body (see Clauses 6 and 7);h) insertion, removal, and interconnection of parts (see Clause 7);DIN EN ISO 16061:2015-09 EN ISO 16061:2015 (E) 5 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 me
47、asuring 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 11.3 p); andl) compatibility with any medicinal substances incorporated into or used with the instrument.6 Selection of materialsMaterials for the manufacture of instruments shall be selected with regard to the properties required for the intended purpose, taking into account the effects of manuf
