BS EN ISO 13504-2012 Dentistry General requirements for instruments and related accessories used in dental implant placement and treatment《牙科学 牙科植体位置和治疗使用仪器和相关配件的通用要求 n n》.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 13504:2012Dentistry Generalrequirements for instrumentsand related accessories used indental implant placement andtreatment (ISO 13504:2012)BS EN ISO 13504:2012 BRITISH

2、 STANDARDNational forewordThis British Standard is the UK implementation of EN ISO13504:2012.The UK participation in its preparation was entrusted to TechnicalCommittee CH/106/4, Dental Instruments and Equipment.A list of organizations represented on this committee can beobtained on request to its s

3、ecretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2012. Published by BSI StandardsLimited 2012ISBN 978 0 580 69614 5ICS 11.060.25Compliance with a British Standard canno

4、t confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 July 2012.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 13504 July 2012 ICS 11.060.25 En

5、glish Version Dentistry - General requirements for instruments 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) Z

6、ahnheilkunde - Allgemeine Anforderungen an bei der Implantation verwendete Instrumente und Zubehr (ISO 13504:2012) This 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 Euro

7、pean Standard the status of a national standard without any alteration. Up-to-date 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 version

8、s (English, French, German). A version in any other language made by translation 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, Be

9、lgium, 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, Slovenia, Spain, Sweden, Swit

10、zerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE 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.

11、Ref. No. EN ISO 13504:2012: EBS EN ISO 13504:2012EN ISO 13504:2012 (E) 3 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 DIN. This European S

12、tandard 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 some of the elements

13、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 implement this Europea

14、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

15、ia, 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. BS EN ISO 13504:2012ISO 13504:2012(E) ISO 2012 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope 1

16、2 Normative references . 13 Terms and definitions . 23.2 Instruments . 23.3 Stainless steel 24 Classification 34.1 Intended usage (application) 34.2 Tissue contact 34.3 Reprocessing . 35 Intended performance 36 Performance attributes 37 Material selection 48 Performance evaluation . 48.1 General . 4

17、8.2 Pre-clinical evaluation 48.3 Clinical evaluation . 49 Manufacturing 59.1 General . 59.2 Technical documentation 510 Reprocessing . 510.1 Products supplied sterile 510.2 Products provided non-sterile . 510.3 Reprocessing information 511 Information to be supplied by the manufacturer 511.1 General

18、 . 511.2 Marking on instruments . 511.3 Labelling on the package 611.4 Instructions for use . 6Annex A (normative) Materials found acceptable for instrument manufacture. 7Annex B (informative) Cross-referencing of steel grades specified in international, regional or national standards 13Bibliography

19、 .15BS EN ISO 13504:2012ISO 13504:2012(E)ForewordISO (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 bo

20、dy 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 Electrot

21、echnical 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

22、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 right

23、s. ISO shall not be held responsible for identifying any or all such patent rights.ISO 13504 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 4, Dental instruments.iv ISO 2012 All rights reservedBS EN ISO 13504:2012ISO 13504:2012(E)IntroductionThe use of dental implants is

24、increasing throughout the world. Due to improved and new applications of dental implants, the need for better instruments and related accessories to be used in the placement of dental implants and the further manipulation of connecting parts in the craniofacial area is also growing. Dental implants

25、need to be approved by local authorities.However, instruments used in the placement of dental implants are different and need a different approval procedure. This International Standard is intended to harmonize the approval procedures and to reduce the costs caused by repeated approval and test proc

26、edures in different countries.Materials present in instruments used in dental implant procedures have proven to be well tolerated. Potential adverse reactions cannot be totally ruled out but such reactions are to be mitigated.However, long-term clinical experience of the use of the materials referre

27、d to in this International Standard has shown that an acceptable level of biological response can be expected when they are used in appropriate applications and when instruments are manufactured under appropriate design considerations and processes.Due to different stainless steel standards, Annex B

28、 has been added. This gives cross-references to designations of stainless steels which are listed in other international, regional or national standards designation systems. ISO 2012 All rights reserved vBS EN ISO 13504:2012BS EN ISO 13504:2012Dentistry General requirements for instruments and relat

29、ed accessories used in dental implant placement and treatment1 ScopeThis International Standard specifies general requirements for the manufacture of instruments and related accessories used in the placement of dental implants and further manipulations of connecting parts in the craniofacial area.It

30、 is applicable to single-use and reusable instruments, regardless of whether they are manually driven or connected to a power-driven system.It is not applicable to the power-driven system itself, nor to the dental implant or to parts intended to be connected to the dental implant.With regard to safe

31、ty, this International Standard gives requirements for classification, intended performance, performance attributes, material selection, performance evaluation, manufacture, sterilization and information to be supplied by the manufacturer.2 Normative referencesThe following documents, in whole or in

32、 part, are normatively 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 1043-1, Plastics Symbols and abbreviated te

33、rms Part 1: Basic polymers and their special characteristicsISO 1942, Dentistry VocabularyISO 2768-1, General tolerances Part 1: Tolerances for linear and angular dimensions without individual tolerance indicationsISO 5832-2, Implants for surgery Metallic materials Part 2: Unalloyed titaniumISO 5832

34、-3, Implants for surgery Metallic materials Part 3: Wrought titanium 6-aluminium 4-vanadium alloyISO 7405, Dentistry 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 proces

35、sISO 11135-1, Sterilization of health care products Ethylene oxide Part 1: Requirements for 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 rout

36、ine control of a sterilization process for medical devicesISO 14155, Clinical investigation of medical devices for human subjects Good clinical practiceISO 14971, Medical devices Application of risk management to medical devicesISO 15223-1, Medical devices Symbols to be used with medical device labe

37、ls, labelling and information to be supplied Part 1: General requirementsISO 17664, Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devicesINTERNATIONAL STANDARD ISO 13504:2012(E) ISO 2012 All rights reserved 1BS EN ISO 135

38、04:2012ISO 13504:2012(E)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 devices3 Terms and definitionsFor the purposes of this document, the terms and definitions given in IS

39、O 1942 and the following apply.3.1transient usageusage for less than 60 min in any one clinical procedure3.2 Instruments3.2.1surgically invasive devicedevice which penetrates into the human body through the surface of the body, with the aid or in the context of a surgical operation3.2.2instrument us

40、ed in dental implant placement and treatmentsurgically invasive device, used with a transient usage for the preparation of bone and tissue in the craniofacial region, to be used in the placement of dental implants and the further manipulation of connecting parts3.2.3accessory used in dental implant

41、placement and treatmentnon-surgically invasive device, used with a transient usage in direct or indirect contact with the human body, to be used in the placement of dental implants and the further manipulation of connecting parts3.3 Stainless steel3.3.1stainless steelsteel, the main alloying element

42、 of which is chromium, of at least 10,5 % (mass fraction) Cr and maximum 1,2 % (mass fraction) C, and the primary importance of which is its resistance to corrosion3.3.2austenitic stainless steelcorrosion-resistant steel, typically with composition of less than 0,2 % (mass fraction) C, at least 16%

43、(mass fraction) Cr, typically about 18 % (mass fraction) Cr and over 8 % (mass fraction) Ni, which cannot be hardened by heat treatment3.3.3martensitic stainless steelcorrosion-resistant steel with low to medium carbon, with at least 0,1 % (mass fraction) C and between 12 % (mass fraction) and 19 %

44、(mass fraction) Cr, which can be hardened by quenching and tempering3.3.4precipitation-hardening stainless steelcorrosion-resistant steel with a high strength resulting from the precipitation of intermetallic compounds (the formation of very fine intermetallic phases, carbides and Laves phases in th

45、e structure) by a final heat treatment at relatively low temperature2 ISO 2012 All rights reservedBS EN ISO 13504:2012ISO 13504:2012(E)4 Classification4.1 Intended usage (application)For the purposes of this International Standard, instruments used in dental implant placement and treatment are class

46、ified as follows, according to their intended usage (application), as stated by the manufacturer. Type 1: energized or motor driven instruments. Type 2: instruments for manual use (hand instruments).4.2 Tissue contactFor the purposes of this International Standard, instruments used in dental implant

47、 placement and treatment are classified as follows, according to their intended main tissue contact within the working environment. Class 1: hard tissue. Class 2: soft tissue. Class 3: without tissue contact.4.3 ReprocessingFor the purposes of this International Standard, instruments used in dental

48、implant placement and treatment are classified as follows, according to their intended use determined by reprocessing requirements. Group 1: multiple use. Group 2: single use.5 Intended performanceThe intended performance of an instrument used in dental implant placement and treatment shall be descr

49、ibed and documented by addressing the following:a) functional characteristics;b) intended conditions of use, according to Clause 4.NOTE The following should be taken into account: 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 8).6 Performance attributesThe development of the performance attributes of an instrument used in dental implant placement and t