EN ISO 11953-2010 en Dentistry - Implants - Clinical performance of hand torque instruments《牙科 植入物 手持转矩仪器的临床性能》.pdf

1、BS EN ISO11953:2010ICS 11.060.15NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDDentistry Implants Clinicalperformance of handtorque instruments(ISO 11953:2010)This British Standardwas published under theauthority of the StandardsPolicy and StrategyCommittee on

2、30 June2010 BSI 2010ISBN 978 0 580 65542 5Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 11953:2010National forewordThis British Standard is the UK implementation of EN ISO 11953:2010.The UK participation in its preparation was entrusted to TechnicalCommittee CH/106/8, Dental i

3、mplants.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunity

4、from legal obligations.EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11953 June 2010 ICS 11.060.15 English Version Dentistry - Implants - Clinical performance of hand torque instruments (ISO 11953:2010) Mdecine bucco-dentaire - Implants - Performances cliniques des instruments de serrage

5、(ISO 11953:2010) This European Standard was approved by CEN on 19 May 2010. 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 biblio

6、graphical references concerning such national standards may be obtained on application to the CEN 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 o

7、f a CEN member into its own language and notified to the CEN 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, France, Germany, Greece, Hungary, Icel

8、and, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue

9、 Marnix 17, B-1000 Brussels 2010 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11953:2010: EBS EN ISO 11953:2010EN ISO 11953:2010 (E) 3 Foreword This document (EN ISO 11953:2010) has been prepared by Technical Committee ISO/T

10、C 106 “Dentistry” in collaboration with Technical Committee CEN/TC 55 “Dentistry” 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 identical text or by endorsement, at the latest by December 2010, and confli

11、cting national standards shall be withdrawn at the latest by December 2010. 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 responsible for identifying any or all such patent rights. According

12、to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, L

13、atvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 11953:2010 has been approved by CEN as a EN ISO 11953:2010 without any modification. BS EN ISO 11953:2010ISO

14、11953:2010(E) ISO 2010 All rights reserved iiiForeword ISO (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 mem

15、ber body 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 El

16、ectrotechnical 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 ado

17、pted by 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 pat

18、ent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 11953 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 8, Dental implants. BS EN ISO 11953:2010ISO 11953:2010(E) iv ISO 2010 All rights reservedIntroduction Screw-retained joint

19、s are used widely in dental implant systems and for their integrity depend on the creation and maintenance of an appropriate clamping force. Failure of such joints is a documented clinical problem that can have significant impact on the outcome of treatment. Manually operated, suitably calibrated to

20、rque wrenches or devices are widely employed in dental implant treatment to tighten screwed joints and should be capable of providing the desired torque in a consistent manner. There is, however, some evidence that this might not always be the case. This International Standard has, therefore, been d

21、eveloped to facilitate the availability of devices that meet the necessary clinical requirements and help ensure a successful clinical outcome. BS EN ISO 11953:2010INTERNATIONAL STANDARD ISO 11953:2010(E) ISO 2010 All rights reserved 1Dentistry Implants Clinical performance of hand torque instrument

22、s 1 Scope This International Standard describes a classification system for hand-held torque wrenches intended for clinical use. It specifies their performance requirements in terms of accuracy and reproducibility and resistance to reprocessing. Test methods are described, and marking and labelling

23、requirements are specified. This International Standard does not include electronically controlled devices. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references,

24、the latest edition of the referenced document (including any amendments) applies. ISO 1942, Dentistry Vocabulary ISO 17664, Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices 3 Terms and definitions For the purposes of

25、 this document the terms and definitions given in ISO 1942 and the following apply. 3.1 hand torque instrument manually operated mechanical device used for the tightening of dental implants or parts of a dental implant system by displaying or limiting the rotational force of the instrument 3.2 usage

26、 sequence of tightening and retightening operations followed by reprocessing (including disassembly, cleaning, disinfection and/or sterilization) in accordance with the manufacturers instructions 4 Classification 4.1 General Screw-retained joints are secured by a clamping force resulting from the am

27、ount of tension generated in the screw, each screw having an optimal value. Torque control using a hand torque instrument to which a screwdriver tip is attached, is the most widely used method in implant dentistry. The mechanical devices commonly employed utilize the following methods for torque con

28、trol. BS EN ISO 11953:2010ISO 11953:2010(E) 2 ISO 2010 All rights reserved4.2 Type 1 These devices have a preset “break” mechanism. The break mechanism design incorporates either a hinge, located close to the central long-axis of the screwdriver tip, or a clutch located around the long-axis of the s

29、crewdriver tip. The locking mechanism is held rigidly by a compression spring acting on a cam or a clutch, so designed that at the desired torque it is unlocked, permitting a) flexure or b) slip of the handle (“break point”), and thus indicating to the operator that the desired torque has been achie

30、ved. Therefore, the instrument provides both tactile and auditory feedback to the operator. 4.3 Type 2 These devices operate as Type 1 but have an adjustable compression spring which allows the value of the “break” torque to be selected. 4.4 Type 3 These devices have a similar configuration to Type

31、1, but incorporate a torque beam rather than a “break” mechanism. This beam is deformed linearly in relation to the applied torque, which can be measured by the operator using a scale built into the instrument. 4.5 Type 4 These devices place the torque-limiting mechanism in a casing with an output s

32、haft designed to couple with a customized contra-angle dental handpiece. A suitable screwdriver tip is placed in the handpiece and torque applied by rotating the casing of the torque applicator until the drive is decoupled by the torque-limiting mechanism. Both tactile and auditory feedback is provi

33、ded. 5 Requirements Accuracy and reproducibility The accuracy and reproducibility of the torque at “break” or the indicated torque, when tested in accordance with 6.2, shall lie within the manufacturers stated specification. For compliance, all values, both initial and after reprocessing, shall lie

34、in that stated range. The number of usages before the device needs recalibrating or discarding shall be stated by the manufacturer. See 7 d). 6 Test methods 6.1 Apparatus 6.1.1 Test rig Examples of test rigs suitable for this purpose are shown in Figures 1 and 2. For devices incorporating a hinge br

35、eak mechanism, it is necessary to impart freedom so that a break may occur. BS EN ISO 11953:2010ISO 11953:2010(E) ISO 2010 All rights reserved 3Key 1 drive shaft 2 prosthetic screw 3 screwdriver tip 4 tightening device 5 support beam 6 support shaft 7 torque measuring device 8 supports 9 clamp NOTE

36、1 and 2 can be a single unit if desired. Figure 1 Test rig: Type 1, 2 and 3 devices BS EN ISO 11953:2010ISO 11953:2010(E) 4 ISO 2010 All rights reservedKey 1 drive shaft 2 prosthetic screw 3 screwdriver tip 4 contra-angle handpiece 5 support beam 6 support shaft 7 torque measuring device 8 handpiece

37、 supports 9 handpiece clamp 10 torque applicator support 11 torque applicator clamp 12 torque applicator Figure 2 Test rig: Type 4 devices The two principal components are: a) a horizontal support beam (5) secured on a vertical support shaft (6) which is free to rotate around its central vertical ax

38、is. The bearings in which the shaft rotates shall be capable of withstanding vertical loads of 20 N; b) a torque measuring device (7) mounted on the support shaft, which imparts a rotational stiffness to the assembly similar to that of an integrated dental implant. This device shall be capable of me

39、asuring the torque with an accuracy of 0,1 Ncm 5 %. The test rig shall be calibrated and the accuracy of the assembly validated both before and after each test series. BS EN ISO 11953:2010ISO 11953:2010(E) ISO 2010 All rights reserved 5The tightening device (4) is secured horizontally to the support

40、 beam by means of supports (8) and a clamp (9) so that with a screwdriver tip (3) in place it shall be aligned vertically upwards and concentric with the central long axis of the support shaft (6). For Type 4 devices the drive sleeve of the torque limiting mechanism shall be secured so as to prevent

41、 its rotation relative to the handpiece. A vertical (drive) shaft (1) is arranged so that its central long axis is concentric with that of the support shaft and is capable of rotation up to 0,25 s1(15 r/min) to simulate clinical use. This shaft has a mechanism for holding a prosthetic screw (2) conc

42、entric with its long axis. The mounting for the vertical shaft may be moved vertically so that its central long axis remains concentric with that of the support shaft. The screwdriver tip shall be subjected in function to a downward force of 10 1 N. The test rig shall be equipped with a mechanism to

43、 stop the rotation of the drive shaft at a torque in excess of the target torque level. This torque is dependent on the design of the tightening device and shall be set as follows: Type 1: at a minimum level so as to consistently cease rotation of the drive shaft immediately after the break action;

44、Type 2: at a level in accordance with the manufacturers instructions, using hand-held magnification (2) to read the scale; Type 3: at a level in accordance with the manufacturers instructions, using an electrical contact to provide control of the tightening system by detection of the indicated torqu

45、e; Type 4: at a minimum level so as to consistently cease rotation of the drive shaft immediately after the break action. 6.1.2 Prosthetic screw The prosthetic screw shall be as supplied by the manufacturer for use with the screwdriver tip employed in the test rig. Where the screw and drive shaft ar

46、e a single unit, the features that are designed to engage with the screwdriver tip shall be of the same dimensions as those of the prosthetic screw as supplied by the manufacturer. 6.1.3 Screwdriver tip The screwdriver tip shall be as supplied by the manufacturer for use with the hand torque instrum

47、ent being tested. 6.2 Test procedure 6.2.1 Mechanical test 6.2.1.1 Type 1 and Type 4 devices Fit the tightening device and apply it to the prosthetic screw. Rotate it until the desired torque has been reached. Counter-rotate the drive shaft until the instrument is unloaded and then re-tighten. Repea

48、t the tightening/torque-releasing sequence twenty times (or as deemed appropriate) and record the torque achieved at the break point at the end of each sequence. Repeat in accordance with 6.2.2. 6.2.1.2 Type 2 and Type 3 devices Carry out the procedure as for Type 1 devices at the minimum and the ma

49、ximum torque settings as stated by the manufacturer. In the case of Type 3 (torque beam) devices this is the point at which the scale indicates the desired torque, as derived from the closing of the electrical contact. BS EN ISO 11953:2010ISO 11953:2010(E) 6 ISO 2010 All rights reserved6.2.2 Reprocessing Carry out reprocessing of the tightening device in accordance with the manufacturers instructions, which shall comply with the requirements of ISO 17664, then repeat the procedure described in 6.2.1. The cycle shou