DIN EN ISO 11953-2010 Dentistry - Implants - Clinical performance of hand torque instruments (ISO 11953 2010) German version EN ISO 11953 2010《牙科 植入物 手持扳牙器械的临床性能(ISO 11953-2010) 德文.pdf

1、November 2010 Translation by DIN-Sprachendienst.English price group 9No 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 11.060.25!$l1o“1731476www.din.deDDIN EN ISO 11953Dentistry Implants Clinical performance of hand torque instruments (ISO 11953:2010),English translation of DIN EN ISO 11953:2010-11Zahnheilkunde Implantate Klinisches Verhalten manuell angewandter Drehmomentschlssel (ISO 11953:2010)Englische bersetz

3、ung von DIN EN ISO 11953:2010-11Mdecine bucco-dentaire Implants Performances cliniques des instruments de serrage (ISO 11953:2010)Traduction anglaise de DIN EN ISO 11953:2010-11www.beuth.deDocument comprises pagesIn case of doubt, the German-language original shall be considered authoritative.1311.1

4、0 DIN EN ISO 11953:2010-11 2 A comma is used as the decimal marker. National foreword This standard has been prepared by Technical Committee ISO/TC 106 “Dentistry” (Secretariat: SCC, Canada) in collaboration with Technical Committee CEN/TC 55 “Dentistry” (Secretariat: DIN, Germany). The responsible

5、German body involved in its preparation was the Normenausschuss Dental (Dentistry Standards Committee), Working Committee NA 014-00-21 AA Dentalimplantate. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 1942 DIN EN ISO 1942 ISO 17664 D

6、IN EN ISO 17664 National Annex NA (informative) Bibliography DIN EN ISO 1942, Dentistry Terminology DIN EN ISO 17664, Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM

7、 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 (ISO 11953:2010) This European Standard was approved by CEN on 19 May 20

8、10. 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 concerning such national standards may be obtained

9、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 of a CEN member into its own language and notified to the CEN Management

10、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, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands,

11、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 Marnix 17, B-1000 Brussels 2010 CEN All rights of exploitation in any f

12、orm and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11953:2010: EZahnheilkunde - Implantate - Klinisches Verhalten manuell angewandter Drehmomentschlssel (ISO 11953:2010) Contents DIN EN ISO 11953:2010-11 EN ISO 11953:2010 (E) 2 Page Foreword3 Introduction .4 1 Scope 5

13、2 Normative references 5 3 Terms and definitions .5 4 Classification5 4.1 General5 4.2 Type 16 4.3 Type 26 4.4 Type 36 4.5 Type 46 5 Requirements Accuracy and reproducibility .6 6 Test methods6 6.1 Apparatus .6 6.1.1 Test rig 6 6.1.2 Prosthetic screw 9 6.1.3 Screwdriver tip.9 6.2 Test procedure.9 6.

14、2.1 Mechanical test 9 6.2.2 Reprocessing .10 7 Marking, labelling and manufacturers instructions for use .10 Bibliography 11 Foreword This document (EN ISO 11953:2010) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaboration with Technical Committee CEN/TC 55 “Dentistry” the

15、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 conflicting national standards shall be withdrawn at the latest by December 2010. Attention

16、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 to the CEN/CENELEC Internal Regulations, the national standards organizations of the f

17、ollowing 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, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, S

18、lovakia, 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. DIN EN ISO 11953:2010-11 EN ISO 11953:2010 (E) 3 Introduction Screw-retained joints are used widely in dental

19、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 torque wrenches or devices are

20、 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 developed to facilitate the a

21、vailability of devices that meet the necessary clinical requirements and help ensure a successful clinical outcome. DIN EN ISO 11953:2010-11 EN ISO 11953:2010 (E) 4 1 Scope This International Standard describes a classification system for hand-held torque wrenches intended for clinical use. It speci

22、fies their performance requirements in terms of accuracy and reproducibility and resistance to reprocessing. Test methods are described, and marking and labelling requirements are specified. This International Standard does not include electronically controlled devices. 2 Normative references The fo

23、llowing referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 1942, Dentistry Vocabulary ISO 17664, Sterilization

24、 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 this document the terms and definitions given in ISO 1942 and the following apply. 3.1 hand torque instrument manually operated mechanic

25、al 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 sequence of tightening and retightening operations followed by reprocessing (including disassembly, cleaning, disinfection and/or steril

26、ization) in accordance with the manufacturers instructions 4 Classification 4.1 General Screw-retained joints are secured by a clamping force resulting from the amount of tension generated in the screw, each screw having an optimal value. Torque control using a hand torque instrument to which a scre

27、wdriver tip is attached, is the most widely used method in implant dentistry. The mechanical devices commonly employed utilize the following methods for torque control. DIN EN ISO 11953:2010-11 EN ISO 11953:2010 (E) 5 4.2 Type 1 These devices have a preset “break” mechanism. The break mechanism desi

28、gn 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 screwdriver 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 unlo

29、cked, permitting a) flexure or b) slip of the handle (“break point”), and thus indicating to the operator that the desired torque has been achieved. 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 adjustabl

30、e 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 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

31、 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 shaft designed to couple with a customized contra-angle dental handpiece. A suitable screwdriver tip is placed in the handpiece and torque applied by rotatin

32、g the casing of the torque applicator until the drive is decoupled by the torque-limiting mechanism. Both tactile and auditory feedback is provided. 5 Requirements Accuracy and reproducibility The accuracy and reproducibility of the torque at “break” or the indicated torque, when tested in accordanc

33、e with 6.2, shall lie within the manufacturers stated specification. For compliance, all values, both initial and after reprocessing, shall lie 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

34、 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 break mechanism, it is necessary to impart freedom so that a break may occur. DIN EN ISO 11953:2010-11 EN ISO 11953:2010 (E) 6 Key 1 drive shaft 2 prosthetic

35、screw 3 screwdriver tip 4 tightening device 5 support beam 6 support shaft 7 torque measuring device 8 supports 9 clamp NOTE 1 and 2 can be a single unit if desired. Figure 1 Test rig: Type 1, 2 and 3 devices DIN EN ISO 11953:2010-11 EN ISO 11953:2010 (E) 7 Key 1 drive shaft 2 prosthetic screw 3 scr

36、ewdriver tip 4 contra-angle handpiece 5 support beam 6 support shaft 7 torque measuring device 8 handpiece 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 suppo

37、rt beam (5) secured on a vertical support shaft (6) which is free to rotate around its central vertical axis. 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 sti

38、ffness to the assembly similar to that of an integrated dental implant. This device shall be capable of measuring 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. DIN EN ISO 11953:2010-11 E

39、N ISO 11953:2010 (E) 8 The tightening device (4) is secured horizontally to the support 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 devi

40、ces the drive sleeve of the torque limiting mechanism shall be secured so as to prevent 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 si

41、mulate clinical use. This shaft has a mechanism for holding a prosthetic screw (2) concentric 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 fun

42、ction to a downward force of 10 1 N. The test rig shall be equipped with a mechanism to 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

43、 to consistently cease rotation of the drive shaft immediately after the break action; 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

44、contact to provide control of the tightening system by detection of the indicated torque; 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 us

45、e with the screwdriver tip employed in the test rig. Where the screw and drive shaft are 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 screwd

46、river tip shall be as supplied by the manufacturer for use with the hand torque instrument 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. Cou

47、nter-rotate the drive shaft until the instrument is unloaded and then re-tighten. Repeat 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

48、 Type 3 devices Carry out the procedure as for Type 1 devices at the minimum and the maximum 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. DIN EN ISO 11953:2010-11 EN ISO 11953:2010 (E) 9 6.2.2 Reprocessing Carry out reprocessing of the tightening device in accordance with the manufacturers instructions, which shall comply with the requirements of ISO