1、BSI Standards PublicationBS EN ISO 16061:2015Instrumentation for use inassociation with non-activesurgical implants GeneralrequirementsBS EN ISO 16061:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO16061:2015. It supersedes BS EN ISO 16061:2009 which is
2、 withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/150, Implants for surgery.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract.
3、 Users are responsible for its correctapplication. The British Standards Institution 2015. Published by BSI StandardsLimited 2015ISBN 978 0 580 83439 4ICS 11.040.40; 11.040.99Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the
4、 authority of theStandards Policy and Strategy Committee on 31 May 2015.Amendments issued since publicationDate Text affectedEUROPEAN 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 associa
5、tion with non-active surgical implants - General requirements (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
6、 Anforderungen (ISO 16061:2015) This European Standard 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
7、 lists and bibliographical references concerning such 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 u
8、nder the responsibility of a CEN member into its own 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, Forme
9、r Yugoslav Republic of Macedonia, France, Germany, Greece, 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 E
10、UROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG 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 EBS EN ISO 16061:2015EN ISO 16061:2015 (E)
11、3 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 secretariat of which is held by DIN. This European Standard shall be given the status of a n
12、ational 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 to the possibility that some of the elements of this document may be the subject of
13、 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 by the European Commission and the European Free Trade Association, and supports es
14、sential 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 standards organizations of the following countries are bound to implement this Europea
15、n 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, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Sloven
16、ia, 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. BS EN ISO 16061:2015EN ISO 16061:2015 (E) 4 Annex ZA (informative) Relationship between this European Standard and the
17、Essential Requirements of EU Directive 93/42/EEC on medical devices 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/
18、EEC on medical devices. Once this standard is cited in the Official Journal of the European Union 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.1 confers, within the limits of the scop
19、e 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 International Standard and Directive 93/42/EEC Clause(s)/sub-clause(s) of this International Standard Essential Requ
20、irements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 7.3 6a 6 7.1, 1. indent 6 7.1, 2. indent 10.1 7.2 In respect of packaging only 6 7.3 5 i) 7.5 5 i) 7.6 5 b) and 6 8.1 10.2 8.3 In respect of packaging only 9.1 8.4 5 b) 8.5 10.1 8.6 9.1, 9.2, 10.2 and 11.3 i) 8.7 11.3 f) and 11.5 9.1 5 f
21、) and 7.1 9.2, 1. indent 7.1 9.2, 2. indent 11.2 10.1 11.1, 11.4 and 11.5 13.1 11.1 13.2 11.2 b) 13.3 (a) The part of ER 13.3 (a) concerning the information on the manufacturers authorizedrepresentative in the European Community is not addressed in this European Standard 11.2 c) 13.3 (b) BS EN ISO 1
22、6061:2015EN ISO 16061:2015 (E) 5 11.2 e) 13.3 (c) This European Standard is not applicable to power-driven systems, so ER 13.3 (l) is not applicable. 11.2 c) 13.3 (d) 11.2 g) and 11.1 13.3 (e) 11.2 h) 11.7 13.3 (f) ER: 13.3 (f) is only partially addressed in this European Standard. The safety issue
23、is addressed, but not the regulatory requirement that the manufacturers indication of single use must be consistent across the European community. 11.2 i) 13.3 (i) 11.2 j) 13.3 (j) 11.2 e) 13.3 (m) 11.2 d) and 11.3 d) 13.4 113 b), 11.3 c), 11.3 h), 11.3 k), 13.3 n) 13.6 (a) The part of ER 13.6 (a) c
24、oncerning the information on the manufacturers authorizedrepresentative in the European Community is not addressed in this European Standard. The part of ER 13.6 (a) concerning the regulatory requirement that the manufacturers indication of single use must be consistent across the European community
25、 is not addressed in this European Standard. 11.3 e) 13.6 (b) 11.3 f) 13.6 (c) 11.3 g) 13.6 (d) 13.3 j) 13.6 (g) 11.3 k) 13.6 (h) 11.3 m) 13.6 (i) 11.3 a) 13.6 (j) 11.3 k) 13.6 (k) 11.3 o) 13.6 (l) 11.3 r) 13.6 (m) 11.3 q) 13.6 (n) 11.3 r) 13.6(o) 11.4 13.6 (p) 11.3 s) 13.6 (q) WARNING Other require
26、ments and other EU Directives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 16061:2015ISO 16061:2015(E)Foreword iv1 Scope . 12 Normative references 13 Terms and definitions . 24 Intended performance . 25 Design attributes 26 Selection of materials 37 Design
27、 evaluation 37.1 General . 37.2 Pre-clinical evaluation 37.3 Clinical evaluation 38 Manufacture 39 Sterilization . 49.1 Products supplied sterile . 49.2 Products provided non-sterile. 410 Packaging . 410.1 Protection from damage in storage and transport. 410.2 Maintenance of sterility in transit 411
28、 Information supplied by the manufacturer . 411.1 General . 411.2 Labelling . 511.3 Instructions for use . 611.4 Instruments with measuring function 711.5 Restrictions in combinations 711.6 Marking on instruments . 711.7 Instruments intended for single use 7Annex A (informative) Examples of typical
29、instrument applications, together with materials found acceptable for instrument manufacture . 8Bibliography .17 ISO 2015 All rights reserved iiiContents PageBS EN ISO 16061:2015ISO 16061:2015(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national st
30、andards 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 o
31、rganizations, 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.The procedures used to develop this document and those intended for i
32、ts further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/d
33、irectives).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. Details of any patent rights identified during the development of the document will be in
34、the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions rela
35、ted to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT), see the following URL: Foreword Supplementary information .The committee responsible for this document is ISO/TC 150, Implants for surgery.This third edition canc
36、els and replaces the second edition (ISO 16061:2008), which has been technically revised.iv ISO 2015 All rights reservedBS EN ISO 16061:2015Instrumentation for use in association with non-active surgical implants General requirements1 ScopeThis International Standard specifies general requirements f
37、or 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
38、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, sterilization, packaging, and information supplied by the manufacturer.This Internationa
39、l 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 normatively referenced in this document and are indispensable for its application.
40、 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 interchange Representation of dates and timesISO 11135, Sterilization of health-
41、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: Requirements for development, validation and routine control of a sterilization process for
42、 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 aspectsISO 11607-1, Packaging for terminally sterilized medical devices Part 1: Requirem
43、ents 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, Clinical investigation of medical devices for human subjects Good clinical practiceI
44、SO 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 devicesISO 17665-1, Sterilization of health care products Moist heat Part 1: Requirements
45、 for the development, validation and routine control of a sterilization process for medical devicesISO 80000-1, Quantities and units Part 1: GeneralINTERNATIONAL STANDARD ISO 16061:2015(E) ISO 2015 All rights reserved 1BS EN ISO 16061:2015ISO 16061:2015(E)3 Terms and definitionsFor the purposes of t
46、his 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 during surgical procedu
47、res 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 addressing the following
48、, 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 has been achieved sha
49、ll 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 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 m
