1、March 2013 Translation by DIN-Sprachendienst.English price group 12No 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).ICS
2、11.040.40!$#-“1970010www.din.deDDIN EN ISO 14630Non-active surgical implants General requirements (ISO 14630:2012);English version EN ISO 14630:2012,English translation of DIN EN ISO 14630:2013-03Nichtaktive chirurgische Implantate Allgemeine Anforderungen (ISO 14630:2012);Englische Fassung EN ISO 1
3、4630:2012,Englische bersetzung von DIN EN ISO 14630:2013-03Implants chirurgicaux non actifs Exigences gnrales (ISO 14630:2012);Version anglaise EN ISO 14630:2012,Traduction anglaise de DIN EN ISO 14630:2013-03SupersedesDIN EN ISO 14630:2009-08www.beuth.deDocument comprises 23 pagesIn case of doubt,
4、the German-language original shall be considered authoritative.03.13 DIN EN ISO 14630:2013-03 2 A comma is used as the decimal marker. National foreword This document (EN ISO 14630:2012) has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” in collaboration with Technical Commit
5、tee CEN/TC 285 “Non-active surgical implants” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Feinmechanik und Optik (Optics and Precision Mechanics Standards Committee), Working Committee NA 027-02-17 AA Chirurgische Implantate. The DIN S
6、tandards corresponding to the International Standards referred to in Clause 2 of this standard are as follows: ISO 8601 DIN ISO 8601 ISO 10993-1 DIN EN ISO 10993-1 ISO 10993-7 DIN EN ISO 10993-7 ISO 11135-1 DIN EN ISO 11135-1 ISO 11137-1 DIN EN ISO 11137-1 ISO 11137-2 DIN EN ISO 11137-2 ISO 11607-1
7、DIN EN ISO 11607-1 ISO 13408-1 DIN EN ISO 13408-1 ISO 14155 DIN EN ISO 14155 ISO 14160 DIN EN ISO 14160 ISO 14937 DIN EN ISO 14937 ISO 14971 DIN EN ISO 14971 ISO 17664 DIN EN ISO 17664 ISO 17665-1 DIN EN ISO 17665-1 ISO 22442-1 DIN EN ISO 22442-1 ISO 22442-2 DIN EN ISO 22442-2 ISO 22442-3 DIN EN ISO
8、 22442-3 ISO 80000 (all parts) DIN EN ISO 80000 (all parts) Amendments This standard differs from DIN EN ISO 14630:2009-08 as follows: a) Clause 5 “Design attributes” has been extended to include anatomical features, pathology of the host tissue and information how to reduce the risk of use error; b
9、) Subclause 7.2 “Pre-clinical evaluation” has been extended in particular with regard to the results of biophysical and modelling research; c) Subclause 11.3 “Instructions for use” has been extended to include the date of the latest revision of the instructions for use; d) Annex ZA has been brought
10、in line with the requirements of the European Commission. Previous editions DIN 58800: 1971-11 DIN 58800-1: 1980-01 DIN EN ISO 14630: 1997-12, 2005-08, 2008-04, 2009-08 DIN EN ISO 14630:2013-03 3 National Annex NA (informative) Bibliography DIN ISO 8601, Data elements and interchange formats Informa
11、tion interchange Representation of dates and times DIN EN ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management system DIN EN ISO 10993-7, Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals DIN EN ISO 11135-
12、1, Sterilization of health care products Ethylene oxide Part 1: 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 1: Requirements for development, validation and rou
13、tine 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 11607-1, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier syst
14、ems and packaging systems DIN EN ISO 13408-1, Aseptic processing of health care products Part 1: General requirements DIN EN ISO 14155, Clinical investigation of medical devices for human subjects Good clinical practice DIN EN ISO 14160, Sterilization of health care products Liquid chemical steriliz
15、ing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devices DIN EN ISO 14937, Sterilization of health care products General requirements for char
16、acterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices 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
17、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 the development, validation and routine control of a sterilization process for medical devices DIN EN ISO 22442-1, Medical devices utili
18、zing animal tissues and their derivatives Part 1: Application of risk management DIN EN ISO 22442-2, Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling DIN EN ISO 22442-3, Medical devices utilizing animal tissues and their derivatives
19、 Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents DIN EN ISO 80000 (all parts), Quantities and units DIN EN ISO 14630:2013-03 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 14630
20、 December 2012 ICS 11.040.40 Supersedes EN ISO 14630:2009 English Version Non-active surgical implants General requirements (ISO 14630:2012) Implants chirurgicaux non actifs Exigences gnrales (ISO 14630:2012) Nichtaktive chirurgische Implantate Allgemeine Anforderungen (ISO 14630:2012) This European
21、 Standard was approved by CEN on 30 November 2012. 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 conc
22、erning 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 under the responsibility of a CEN member in
23、to 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, Former Yugoslav Republic of Macedonia, France,
24、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 EUROPEN DE NORMALISATION EUROPISCHES KOMITE
25、E FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 14630:2012: E Contents PageForeword 3Introduction 41 Scope 52 Normative references . 53 Terms and definition
26、s . 64 Intended performance 75 Design attributes . 76 Materials . 87 Design evaluation 97.1 General . 97.2 Pre-clinical evaluation 97.3 Clinical evaluation .107.4 Post-market surveillance .108 Manufacture 109 Sterilization .109.1 General .109.2 Products supplied sterile 109.3 Sterilization by the us
27、er .119.4 Sterilization residuals .1110 Packaging 1110.1 Protection from damage in storage and transport .1110.2 Maintenance of sterility in transit .1111 Information supplied by the manufacturer .1211.1 General .1211.2 Labelling 1211.3 Instructions for use .1311.4 Restrictions on combinations 1411.
28、5 Marking on implants .1411.6 Marking for special purposes 15Bibliography . 182DIN EN ISO 14630:2013-03 EN ISO 14630:2012 (E) . 16Relationship between this European Standard and Annex Z ZA (informative) theEssentialRequirements of EU Directive 93/42/EEC Foreword This document (EN ISO 14630:2012) has
29、 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 id
30、entical text or by endorsement, at the latest by June 2013, and conflicting national standards shall be withdrawn at the latest by June 2013. 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 res
31、ponsible for identifying any or all such patent rights. This document supersedes EN ISO 14630:2009. 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 EU Directive(s). For relationshi
32、p 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 organisations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus,
33、 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, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Ki
34、ngdom. Endorsement notice The text of ISO 14630:2012 has been approved by CEN as a EN ISO 14630:2012 without any modification. 3DIN EN ISO 14630:2013-03 EN ISO 14630:2012 (E) IntroductionThis International Standard provides a method of addressing the fundamental principles outlined in ISO/TR 14283 a
35、s they apply to non-active surgical implants. It also provides a method for demonstrating compliance with the relevant essential requirements as outlined in the 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
36、 surgical implants, hereafter referred to as implants. It might also help manufacturers 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, they are as follows,
37、 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 Stand
38、ard and Reference 4, 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 (see References 5, 6, 7, 8 and 9) apply to a more restricted set or family of non-active surgic
39、al implants, such as those designed for use in neurosurgery, cardiovascular surgery, or joint replacement.Level 3 standards (see References 10, 11, 12 and 13) apply to specific types of implants within a family of non-active surgical implants, such as hip joints or arterial stents.To address all req
40、uirements 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.4DIN
41、 EN ISO 14630:2013-03 EN ISO 14630:2012 (E) 1 ScopeThis 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 trans
42、radicular implants, intra-ocular lenses and implants utilizing viable animal tissue.With regard to safety, this International Standard specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by t
43、he 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 qua
44、lity management system, such as that described in ISO 13485, might be appropriate to help ensure that the implant achieves its intended performance.2 Normative referencesThe following referenced documents are indispensable for the application of this document. For dated references, only the edition
45、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 10993-1, Biological evaluation of medical devices Part 1: Evaluation an
46、d testing within a risk management processISO 10993-7, Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residualsISO 11135-1, Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization proc
47、ess 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 medical devicesISO 11137-2, Sterilization of health care products Radiation Part 2: Establishing the sterilization d
48、oseISO 11607-1, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systemsISO 13408-1, Aseptic processing of health care products Part 1: General requirementsISO 14155, Clinical investigation of medical devices for human subjects Good clinical practiceISO 14160, Sterilization of health care products Liquid chemical sterilizing agents for single-use medic
