1、October 2012 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).IC
2、S 11.040.30; 11.060.25!$“1919888www.din.deDDIN EN ISO 13504Dentistry General requirements for instruments and related accessories used indental implant placement and treatment (ISO 13504:2012);English version EN ISO 13504:2012,English translation of DIN EN ISO 13504:2012-10Zahnheilkunde Allgemeine A
3、nforderungen an bei der Implantation verwendete Instrumente und Zubehr(ISO 13504:2012);Englische Fassung EN ISO 13504:2012,Englische bersetzung von DIN EN ISO 13504:2012-10Mdecine bucco-dentaire Exigences gnrales relatives aux instruments et aux accessoires connexes utiliss enimplantologie dentaire
4、(ISO 13504:2012);Version anglaise EN ISO 13504:2012,Traduction anglaise de DIN EN ISO 13504:2012-10www.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Document comprises 23 pages10.12 DIN EN ISO 13504:2012-10 2 A comma is used as the decimal marker. National
5、foreword This standard has been prepared by Technical Committee ISO/TC 106 “Dentistry” (Secretariat: CNN, Canada) in collaboration with Technical Committee CEN/TC 55 “Dentistry” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Dental (Denti
6、stry Standards Committee), Working Committee NA 014-00-21 AA Dentalimplantate, Working Group NA 014-00-21-02 AK Instrumente fr die dentale Implantologie. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 1043-1 DIN EN ISO 1043-1 ISO 1942
7、DIN EN ISO 1942 ISO 2768-1 DIN ISO 2768-1 ISO 5832-2 DIN EN ISO 5832-2 ISO 5832-3 DIN EN ISO 5832-3 ISO 7405 DIN EN ISO 7405 ISO 10993-1 DIN EN ISO 10993-1 ISO 11135-1 DIN EN ISO 11135-1 ISO 11137-1 DIN EN ISO 11137-1 ISO 14155 DIN EN ISO 14155 ISO 14971 DIN EN ISO 14971 ISO 15223-1 DIN EN ISO 15223
8、-1 ISO 17664 DIN EN ISO 17664 ISO 17665-1 DIN EN ISO 17665-1 DIN EN ISO 13504:2012-10 3 National Annex NA (informative) Bibliography DIN EN ISO 1043-1, Plastics Symbols and abbreviated terms Part 1: Basic polymers and their special characteristics DIN EN ISO 1942, Dentistry Vocabulary DIN EN ISO 583
9、2-2, Implants for surgery Metallic materials Part 2: Unalloyed titanium DIN EN ISO 5832-3, Implants for surgery Metallic materials Part 3: Wrought titanium 6-aluminium 4-vanadium alloy DIN EN ISO 7405, Dentistry Evaluation of biocompatibility of medical devices used in dentistry DIN EN ISO 10993-1,
10、Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management system DIN EN ISO 11135-1, 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
11、 EN ISO 11137-1, Sterilization of health care products Radiation Part 1: Requirements for develop-ment, validation and routine control of a sterilization process for medical devices DIN EN ISO 14155, Clinical investigation of medical devices for human subjects Good clinical practice DIN EN ISO 14971
12、, Medical devices Application of risk management to medical devices DIN EN ISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements DIN EN ISO 17664, Sterilization of medical devices Information to be provided b
13、y 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 ISO 2768-1, General tolerances Part
14、 1: Tolerances for linear and angular dimensions without individual tolerance indications DIN EN ISO 13504:2012-10 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 13504 July 2012 ICS 11.060.25 English Version Dentistry - General requirements for instrument
15、s and related accessories used in dental implant placement and treatment (ISO 13504:2012) Mdecine bucco-dentaire - Exigences gnrales relatives aux instruments et aux accessoires connexes utiliss en implantologie dentaire (ISO 13504:2012) Zahnheilkunde - Allgemeine Anforderungen an bei der Implantati
16、on verwendete Instrumente und ZubehrThis European Standard was approved by CEN on 14 July 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-d
17、ate 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 translatio
18、n under 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, Fo
19、rmer 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. Management Centre: Avenue Marnix 17, B-1000
20、 Brussels 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 13504:2012: EEUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG (ISO 13504:2012) Contents Page Foreword . 3 Introd
21、uction . 4 1 Scope . 5 2 Normative references 5 3 Terms and definitions 6 3.2 Instruments . 6 3.3 Stainless steel 6 4 Classification 7 4.1 Intended usage (application) 7 4.2 Tissue contact 7 4.3 Reprocessing 7 5 Intended performance . 7 6 Performance attributes 7 7 Material selection . 8 8 Performan
22、ce evaluation 8 8.1 General 8 8.2 Pre-clinical evaluation . 8 8.3 Clinical evaluation 8 9 Manufacturing . 9 9.1 General 9 9.2 Technical documentation 9 10 Reprocessing 9 10.1 Products supplied sterile 9 10.2 Products provided non-sterile 9 10.3 Reprocessing information . 9 11 Information to be suppl
23、ied by the manufacturer 9 11.1 General 9 11.2 Marking on instruments 9 11.3 Labelling on the package 10 11.4 Instructions for use 10 Annex A (normative) Materials found acceptable for instrument manufacture 11 Annex B (informative) Cross-referencing of steel grades specified in international, region
24、al or national standards 17 Bibliography 19 2DIN EN ISO 13504:2012-10 EN ISO 13504:2012 (E) Foreword This document (EN ISO 13504:2012) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which is held by D
25、IN. 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 January 2013, and conflicting national standards shall be withdrawn at the latest by January 2013. Attention is drawn to the possibility that so
26、me 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. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to imp
27、lement 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, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romani
28、a, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 13504:2012 has been approved by CEN as a EN ISO 13504:2012 without any modification. 3DIN EN ISO 13504:2012-10 EN ISO 13504:2012 (E) Introduction7KHXVHRIGHQWDOLPSODQWVLVLQFUHDVLQJWKUR
29、XJKRXWWKHZRUOGXHWRLPSURYHGDQGQHZDSSOLFDWLRQVRIGHQWDOLPSODQWVWKHQHHGIRUEHWWHULQVWUXPHQWVDQGUHODWHGDFFHVVRULHVWREHXVHGLQWKHSODFHPHQWRIGHQWDOLPSODQWVDQGWKHIXUWKHUPDQLSXODWLRQRIFRQQHFWLQJSDUWVLQWKHFUDQLRIDFLDODUHDLVDOVRJURZLQJHQWDOLPSODQWVQHHGWREHDSSURYHGEORFDODXWKRULWLHV+RZHYHULQVWUXPHQWVXVHGLQWKHSODFH
30、PHQWRIGHQWDOLPSODQWVDUHGLIIHUHQWDQGQHHGDGLIIHUHQWDSSURYDOSURFHGXUH7KLV,QWHUQDWLRQDO6WDQGDUGLVLQWHQGHGWRKDUPRQLHWKHDSSURYDOSURFHGXUHVDQGWRUHGXFHWKHFRVWVFDXVHGEUHSHDWHGDSSURYDODQGWHVWSURFHGXUHVLQGLIIHUHQWFRXQWULHV0DWHULDOVSUHVHQWLQLQVWUXPHQWVXVHGLQGHQWDOLPSODQWSURFHGXUHVKDYHSURYHQWREHZHOOWROHUDWHG3RWH
31、QWLDODGYHUVHUHDFWLRQVFDQQRWEHWRWDOOUXOHGRXWEXWVXFKUHDFWLRQVDUHWREHPLWLJDWHG+RZHYHUORQJWHUPFOLQLFDOHSHULHQFHRIWKHXVHRIWKHPDWHULDOVUHIHUUHGWRLQWKLV,QWHUQDWLRQDO6WDQGDUGKDVVKRZQWKDWDQDFFHSWDEOHOHYHORIELRORJLFDOUHVSRQVHFDQE HHSHFWHGZKHQWKHDUHXVHGLQDSSURSULDWHDSSOLFDWLRQVDQGZKHQLQVWUXPHQWVDUHPDQXIDFWXUHG
32、XQGHUDSSURS ULDWHGHVLJQFRQVLGHUDWLRQVDQGSURFHVVHVXHWRGLIIHUHQWVWDLQOHVVVWHHOVWDQGDUGV$QQH%KDVEHHQDG GHG7KLVJLYHVFURVVUHIHUHQFHVWRGHVLJQDWLRQVRIVWDLQOHVVVWHHOVZKLFKDUHOLVWHGLQRWKHULQWHUQDWLRQDOUHJLRQDORUQDWLRQDOVWDQGDUGVGHVLJQDWLRQVVWHPV4DIN EN ISO 13504:2012-10 EN ISO 13504:2012 (E) 1 Scope7KLV,QWHU
33、QDWLRQDO6WDQGDUGVSHFLHVJHQHUDOUHTXLUHPHQWVIRUWKHPDQXIDFWXUHRILQVWUXPHQWVDQGUHODWHGDFFHVVRULHVXVHGLQWKHSODFHPHQWRIGHQWDOLPSODQWVDQGIXUWKHUPDQLSXODWLRQVRIFRQQHFWLQJSDUWVLQWKHFUDQLRIDFLDODUHD,WLVDSSOLFDEOHWRVLQJOHXVHDQGUHXVDEOHLQVWUXPHQWVUHJDUGOHVVRIZKHWKHUWKHDUHPDQXDOOGULYHQRUFRQQHFWHGWRDSRZHUGULYHQVV
34、WHP,WLVQRWDSSOLFDEOHWRWKHSRZHUGULYHQVVWHPLWVHOIQRUWRWKHGHQWDOLPSODQWRUWRSDUWVLQWHQGHGWREHFRQQHFWHGWRWKHGHQWDOLPSODQW:LWKUHJDUGWRVDIHWWKLV,QWHUQDWLRQDO6WDQGDUGJLYHVUHTXLUHPHQWVIRUFODVVLFDWLRQLQWHQGHGSHUIRUPDQFHSHUIRUPDQFHDWWULEXWHVPDWHULDOVHOHFWLRQSHUIRUPDQFHHYDOXDWLRQPDQXIDFWXUHVWHULOLDWLRQDQGLQIRUP
35、DWLRQWREHVXSSOLHGEWKHPDQXIDFWXUHU2 Normative references7KHIROORZLQJGRFXPHQWVLQZKROHRULQSDUWDUHQRUPDWLYHOUHIHUHQFHGLQWKLVGRFXPHQWDQGDUHLQGLVSHQVDEOHIRULWVDSSOLFDWLRQ)RUGDWHGUHIHUHQFHVRQOWKHHGLWLRQFLWHGDSSOLHV)RUXQGDWHGUHIHUHQFHVWKHODWHVWHGLWLRQRIWKHUHIHUHQFHGGRFXPHQW LQFOXGLQJDQDPHQGPHQWV DSSOLHV,62P
36、lastics Symbols and abbreviated terms Part 1: Basic polymers and their special characteristics,62Dentistry Vocabulary,62General tolerances Part 1: Tolerances for linear and angular dimensions without individual tolerance indications,62Implants for surgery Metallic materials Part 2: Unalloyed titaniu
37、m,62-3Implants for surgery Metallic materials Part 3: Wrought titanium 6-aluminium 4-vanadium alloy,62Dentistry Evaluation of biocompatibility of medical devices used in dentistryISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process,62St
38、erilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices,62Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a steriliza
39、tion process for medical devices,62Clinical investigation of medical devices for human subjects Good clinical practice,62Medical devices Application of risk management to medical devices,62Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General
