DIN EN ISO 27020-2011 Dentistry - Brackets and tubes for use in orthodontics (ISO 27020 2010) German version EN ISO 27020 2010《牙科 畸齿矫正用托架和管(ISO 27020-2010) 德文版本EN ISO 27020-2010》.pdf

1、April 2011 Translation by DIN-Sprachendienst.English price group 11No 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、11.060.15!$nws“1758480www.din.deDDIN EN ISO 27020Dentistry Brackets and tubes for use in orthodontics (ISO 27020:2010)English translation of DIN EN ISO 27020:2011-04Zahnheilkunde Brackets und Rhrchen fr die Kieferorthopdie (ISO 27020:2010)Englische bersetzung von DIN EN ISO 27020:2011-04Mdecine bucc

3、o-dentaire Consoles et tubes utiliss en orthodontie (ISO 27020:2010)Traduction anglaise de DIN EN ISO 27020:2011-04SupersedesDIN 13971-2:2000-01www.beuth.deDocument comprises pagesIn case of doubt, the German-language original shall be considered authoritative.1703.11 DIN EN ISO 27020:2011-04 A comm

4、a 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 German body involved in its prepara

5、tion was the Normenausschuss Dental (Dentistry Standards Committee), Working Committee NA 014-00-18 AA Kieferorthopdische Produkte. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 1942 DIN EN ISO 1942 ISO 7405 DIN EN ISO 7405 ISO 10993-

6、1 DIN EN ISO 10993-1 ISO 15841 DIN EN ISO 15841 Amendments This standard differs from DIN 13971-2:2000-01 as follows: a) limit deviations of dimensions have been deleted; rather, a tolerance range has now been specified; b) the test methods have been harmonized with international specifications; c)

7、item f) in Subclause 6.3 “Labelling” has been updated: products containing hazardous elements (e.g. nickel) shall be marked with a warning symbol. Previous editions DIN 13971-2: 2000-01 National Annex NA (informative) Bibliography DIN EN ISO 1942, Dentistry Terminology DIN EN ISO 7405, Dentistry Eva

8、luation of biocompatibility of medical devices used in dentistry DIN EN ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management system DIN EN ISO 15841, Dentistry Wires for use in orthodontics 2 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM E

9、N ISO 27020 December 2010 ICS 11.060.10 English Version Dentistry Brackets and tubes for use in orthodontics (ISO 27020:2010) Mdecine bucco-dentaire Consoles et tubes utiliss en orthodontie (ISO 27020:2010) Zahnheilkunde Brackets und Rhrchen fr die Kieferorthopdie (ISO 27020:2010) This European Stan

10、dard was approved by CEN on 14 December 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 bibliographical references concernin

11、g 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 into it

12、s 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, France, Germany, Greece, Hungary, Iceland, Ireland, I

13、taly, 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 Marnix 17, B-10

14、00 Brussels 2010 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 27020:2010: EEN ISO 27020:2010 (E) DIN EN ISO 27020:2011-04 2Contents Page Foreword3 Introduction .4 1 Scope 5 2 Normative references 5 3 Terms and definitions5 4

15、 Requirements .7 4.1 Hazardous elements 7 4.2 Measurement of dimensions 7 5 Test methods8 5.1 Sampling .8 5.2 Dimensions.8 6 Packaging and labelling information to be provided to the user13 6.1 General requirements13 6.2 Packaging .13 6.3 Labelling .14 Bibliography 15 Foreword This document (EN ISO

16、27020:2010) has been prepared by Technical Committee ISO/TC 106 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 endorseme

17、nt, at the latest by June 2011, and conflicting national standards shall be withdrawn at the latest by June 2011. 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

18、 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 European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greec

19、e, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 27020:2010 has been approved by CEN as a EN ISO 27020:2010 without any

20、modification. “Dentistry”EN ISO 27020:2010 (E) DIN EN ISO 27020:2011-04 3Introduction This International Standard has been developed as a result of the difficulty often encountered by clinicians to make meaningful comparisons between brackets and tubes using the information currently available from

21、manufacturers and suppliers. EN ISO 27020:2010 (E) DIN EN ISO 27020:2011-04 41 Scope This International Standard is applicable to brackets and tubes for use in fixed orthodontic appliances. This International Standard gives details of methods to compare the functional dimensions of orthodontic brack

22、ets and tubes, the test methods by which they can be determined, as well as packaging and labelling information. This International Standard does not specify specific qualitative and quantitative requirements for freedom from biological hazards; which are covered in ISO 10993-1 and ISO 7405. 2 Norma

23、tive references The following 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 3

24、Terms and definitions For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply. 3.1 angle of torque occlusal-gingival angle formed between the intersection of the line perpendicular to the tangent to the tooth side surface of the base and the line bisect

25、ing the slot in the occlusal-gingival direction, when viewed along the mesial-distal long-axis of the slot NOTE If the angle is oriented toward the occlusal (gingival), it is designated as positive (negative). See Figure 1. 3.2 angulation angle between the line perpendicular to the mesial-distal lon

26、g-axis of the slot and the central occlusal-gingival axis of the bracket/tube, when viewed from the buccal/labial NOTE The angulation is positive (negative) when the gingival part of the central occlusal-gingival axis is inclined toward the distal (mesial) relative to the line perpendicular to the m

27、esial-distal long-axis of the slot. See Figure 2. EN ISO 27020:2010 (E) DIN EN ISO 27020:2011-04 53.3 archwire wire that is formed approximately to the shape of the dental arch 3.4 auxiliary slot additional opening in the bracket or tube for insertion of auxiliary elements 3.5 auxiliary slot dimensi

28、ons diameter/cross-sectional dimensions of the largest wire that passes through an auxiliary slot 3.6 band structural annular component affixed to the outer circumference of the crown of a tooth and to which a bracket or tube can be attached 3.7 base part of the bracket or the tube that is attached

29、to the enamel or band 3.8 descriptor code to identify the nominal slot height in thousandths of an inch without unit designation, in accordance with accepted orthodontic practice (e.g. 18 or 22) 3.9 bracket tube structural unit attached to a band or base that is capable of retaining an archwire 3.10

30、 in-out 3.10.1 bracket in-out lidistance between the floor of the slot and the tooth side surface of the base along the intersection of the plane perpendicular to mesial-distal long-axis of the slot in the centre of the bracket slot and the plane bisecting the slot in the occlusal-gingival direction

31、, when viewed along the mesial-distal long-axis of the slot See Figure 3 a). 3.10.2 tube in-out lidistance between the floor of the slot and the tooth side surface of the base, at the mesial end of the tube and in the midplane of the slot in the occlusal-gingival direction; for tubes with a mesial c

32、hamfer, the in-out is the distance at the mesial end of the tube between that part of the floor of the slot in contact with the largest dimension of an archwire (round wire for a round tube and a rectangular wire for a rectangular tube) able to pass the entire tube, and the tooth side surface of the

33、 base in the midplane of the slot in the occlusal-gingival direction, when viewed from the gingival See Figure 3 b). EN ISO 27020:2010 (E) DIN EN ISO 27020:2011-04 63.11 rotational offset angle between a line parallel to the floor of the slot and the line connecting the points of intersection of the

34、 lines along the mesial and distal end-faces of the slot at the tooth side surface of the base, when viewed from the occlusal NOTE When the distal (mesial) part of the floor of the slot is furthest from the tooth it is known as a distal (mesial) offset. See Figure 4. 3.12 slot mesial-distal oriented

35、 opening in a bracket or tube primarily to contain an archwire 3.13 slot depth d minimum buccal-lingual dimension of a rectangle where the projection of its buccal/labial side is tangent to the shorter side of the intended slot, when viewed along the mesial-distal axis of the slot See Figure 5. 3.14

36、 slot height h maximum occlusal-gingival dimension of a rectangle that is fully engaged in the slot, when viewed along the mesial-distal long-axis of the slot See Figure 5. 3.15 slot length lssmallest mesial-distal dimension of the slot between the mesial and distal ends of the slot 4 Requirements 4

37、.1 Hazardous elements For the purposes of this International Standard, cadmium, beryllium, lead and nickel are designated to be hazardous elements and the manufacturer shall state the concentrations as a mass fraction expressed as a percentage. 4.2 Measurement of dimensions 4.2.1 The following dimen

38、sions shall be recorded to the nearest 0,01 mm. When determined in accordance with Clause 5, the following dimensions of the product shall comply with the ranges stated by the manufacturer: a) in-out lib) slot depth d c) slot height h d) slot length lse) dimensions of each auxiliary slot. EN ISO 270

39、20:2010 (E) DIN EN ISO 27020:2011-04 74.2.2 The following angles shall be recorded to the nearest 1. When determined according to Clause 5, the following angles of the product shall comply with the ranges stated by the manufacturer: a) angle of torque b) angulation c) the rotational offset 5 Test me

40、thods 5.1 Sampling Six specimens of a single product from one batch shall be procured for each test. Measurements shall be made on each dimension listed in 4.2 of each sample. 5.2 Dimensions 5.2.1 Apparatus Measurements shall be taken with callipers, micrometers, optical comparators, or other device

41、s with an accuracy of 0,005 mm or 0,5. 5.2.2 Measurement procedures 5.2.2.1 Angle of torque (see Figure 1) 5.2.2.1.1 When viewed from the labial/buccal, perform the following. a) Construct a line along the mesial-distal long-axis of the slot (X-axis). b) Construct plane 1 (see AA in Figure 1) perpen

42、dicular to the X-axis in the centre of the slot (depicted by the symbol ). 5.2.2.1.2 When viewed in plane 1, perform the following in plane 1. a) Construct line 2 bisecting the slot in the occlusal-gingival direction. b) At the point of intersection of the tooth side surface of the base and line 2 (

43、point 3 in Figure 1), construct line 4 tangent to the tooth side surface of the base. c) Construct line 5 perpendicular to line 4 (depicted by the symbol ) passing through point 3. d) Measure the angle of torque, , between line 5 and line 2. A suggested method is to view along the mesial-distal long

44、-axis of the slot (X-axis) of the bracket or tube and place a convex radius template in plane 1 of the bracket or tube, against the tooth side surface of the base, thus constructing the tooth side surface of the base. Then construct lines 2, 4 and 5 as defined above. EN ISO 27020:2010 (E) DIN EN ISO

45、 27020:2011-04 8a) Angle of torque in-face b) Angle of torque in-base Key X mesial-distal long-axis of the slot 1 plane perpendicular to the X-axis in the centre of the slot 2 line bisecting the slot in the occlusal-gingival direction 3 point of intersection of line 2 to the tooth side surface of th

46、e base 4 line tangent to the tooth side surface of the base passing through point 3 5 line perpendicular to line 4 passing through point 3 angle of torque Figure 1 Angle of torque of the bracket or tube EN ISO 27020:2010 (E) DIN EN ISO 27020:2011-04 95.2.2.2 Angulation (see Figure 2) Viewing from th

47、e labial/buccal, perform the following. a) Construct a line along the mesial-distal long-axis of the slot (X-axis). b) Construct line 1 (see AA in Figure 2) perpendicular to the X-axis in the centre of the slot (depicted by the symbol ). c) Construct line 2 along the central occlusal-gingival axis.

48、d) Measure the angulation, , between line 1 and line 2. Key X mesial-distal long-axis of the slot 1 line perpendicular to the X-axis in the centre of the slot 2 line along the central occlusal-gingival axis angulation Figure 2 Angulation of the bracket or tube 5.2.2.3 In-out (see Figure 3) 5.2.2.3.1 Bracket in-out see Figure 3 a) When viewed from the labial/buccal, perform the following. a) Construct a line along the mesial-distal long-axis of the slot (X-axis). b) Construct plane 1 see AA in Figure 3