1、BSI Standards PublicationBS EN ISO 16635-1:2014BS ISO 16635-1:2013Dentistry Dental rubber dam techniquePart 1: Hole punchBS EN ISO 16635-1:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 16635-1:2014. It is identical to ISO 16635-1:2013. It supersedes B
2、S ISO 16635-1:2013, which is withdrawn.The UK participation in its preparation was entrusted by Technical Committee CH/106, Dentistry to Subcommittee CH/106/4, Dental Instruments and Equipment.A list of organizations represented on this subcommittee can be obtained on request to its secretary.This p
3、ublication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2014. Published by BSI Standards Limited 2014ISBN 978 0 580 84077 7ICS 11.060.20Compliance with a British Standard cannot confer imm
4、unity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 April 2013.Amendments/corrigenda issued since publicationDate Text affected31 May 2014 This corrigendum renumbers BS ISO 16635-1:2013 as BS EN ISO 16635-1:2014EUR
5、OPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 16635-1 April 2014 ICS 11.060.20 English Version Dentistry - Dental rubber dam technique - Part 1: Hole punch (ISO 16635-1:2013) Mdecine bucco-dentaire - Technique de la digue dentaire en caoutchouc - Partie 1: Pinces percer la digue (ISO 16635-1
6、:2013) Zahnheilkunde - Kofferdamtechnik - Teil 1: Lochzangen (ISO 16635-1:2013) This European Standard was approved by CEN on 25 April 2014. 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 nati
7、onal 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 versions (English, French, German). A ver
8、sion 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, Belgium, Bulgaria, Croatia, Cyprus,
9、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, Switzerland, Turkey and United Kingdom
10、. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 16635-
11、1:2014 EBS EN ISO 16635-1:2014EN ISO 16635-1:2014 (E)EN ISO 16635-1:2014 (E) 3 Foreword The text of ISO 16635-1:2013 has been prepared by Technical Committee ISO/TC 106 “Dentistry” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 16635-1:2014 by Technical
12、 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 October 2014, and conflicting national standards shall be withdrawn at the
13、 latest by October 2014. 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 to the CEN-CENELEC Internal Regulations, the nation
14、al standards organizations of the following countries are bound to implement 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, Lithu
15、ania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 16635-1:2013 has been approved by CEN as EN ISO 16635-1:2014 without any modification. BS EN ISO 16635-1:2014ISO
16、16635-1:2013(E)BS ISO 16635-1:2013 ISO 2013 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Requirements 24.1 General . 24.2 Total length. 24.3 Distance between the forceps handles in the open passive state . 24.4 Character
17、istics of the die plate 34.5 Distances 34.6 Spring type mechanism . 34.7 Materials . 44.8 Surface profile and finish . 45 Test methods . 45.1 Visual examination 45.2 Dimensions . 46 Marking 4BS ISO 16635-1:2013ISO 16635-1:2013(E) ISO 2013 All rights reserved iiiContents PageForeword ivIntroduction v
18、1 Scope . 12 Normative references 3 Terms and definitions .4 Requirements 24.1 General . 24.2 Total length. 24.3 Distance between the forceps handles in the open passive state . 24.4 Characteristics of the die plate 34.5 Distances 34.6 Spring type mechanism . 34.7 Materials . 44.8 Surface profile an
19、d finish . 45 Test methods .5.1 Visual examination 45.2 Dimensions . 46 Marking BS EN ISO 16635-1:2014ISO 16635-1:2013(E)BS ISO 16635-1:2013ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of prepari
20、ng International Standards is normally carried out through ISO technical committees. Each member 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 lia
21、ison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical 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 te
22、chnical committees is to prepare International Standards. Draft International Standards adopted 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 dra
23、wn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.ISO 16635-1 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 4, Dental instruments.ISO 16635
24、 consists of the following parts, under the general title Dentistry Dental rubber dam technique: Part 1: Hole punch Part 2: Clamp forcepsiv ISO 2013 All rights reservedBS ISO 16635-1:2013ISO 16635-1:2013(E)Introductionn order to facilitate the use of dental rubber dam, standardization of the require
25、d instruments and materials is necessary.In dental practice hole punches do not come into direct contact with the patient, provided they are used as intended. ISO 2013 All rights reserved vDentistry Dental rubber dam technique Part 1: Hole punch1 ScopeThis part of ISO 16635 specifies requirements an
26、d test methods for hole punches for dental rubber dam.2 Normative referencesThe following documents, in whole or in 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 ed
27、ition of the referenced document (including any amendments) applies.ISO 1942, Dentistry VocabularyISO 6507-1, Metallic materials Vickers hardness test Part 1: Test methodISO 6508-1, Metallic materials Rockwell hardness test Part 1: Test methodISO 15510, Stainless steels Chemical composition3 Terms a
28、nd definitionsFor the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.3.1dental rubber damdental damrubber damsheet of elastic material used for the isolation of one tooth or several teeth from the rest of the oral cavity3.2dental rubber dam clampfixati
29、on aid adapted to the form of the respective tooth, usually made of spring steel and consisting of two clamp jaws closely fitting the contour of the tooth and linked with each other by means of one or two bow(s)Note 1 to entry: Usually, the clamp jaws have one hole each through which they can be gra
30、sped and fixed by means of a clamp forceps.3.3clamp forcepsforceps used for the placement and removal of dental rubber dam clampsNote 1 to entry: For this purpose, a clamp is grasped by inserting the two retaining pins of the clamp forceps into the holes of the clamp jaws; the clamp is then tensione
31、d and fitted to the tooth in the desired position.3.4hole punchforceps used to punch holes of different diameters in the dental rubber damINTERNATIONAL STANDARD BS EN ISO 16635-1:2014 ISO 16635-1:2013(E) ISO 2013 All rights reserved 13.5punch handlegripping end for grasping and operating the hole pu
32、nch3.6die platerotary plate engaging in defined positions and having holes of different sizes3.7die plate engagement mechanismmechanism at the die plate ensuring the engagement of that plate in defined positions3.8punchtapered working end of the hole punch designed to perforate the dental rubber dam
33、 by penetrating into the holes of the die plate3.9perforation pointpoint where the punch makes contact with the dental rubber dam on the die plate3.10insertion openingopening between the punch and the die plate3.11insertion depthdistance between the punch and the hinge assembly, where the dental rub
34、ber dam can be inserted into the punch forceps4 Requirements4.1 GeneralThe purpose of the hole punch for dental rubber dam is the exact punching of holes of different sizes in dental rubber dam of different types and thicknesses.A mechanical arrangement shall be provided which ensures: a) automatic
35、opening of the hole punch (e.g. by a spring); b) exact positioning of the holes of the die plate below the punch.Test in accordance with 5.1.4.2 Total lengthThe total length of the hole punch for dental rubber dam shall be (165 5) mm.Test in accordance with 5.2.4.3 Distance between the forceps handl
36、es in the open passive stateThe distance between the punch handles in the open passive state shall not exceed 95 mm.NOTE This ensures safe handling also by people with small hands.Test in accordance with 5.2.BS EN ISO 16635-1:2014 ISO 16635-1:2013(E) 2 ISO 2013 All rights reservedBS EN ISO 16635-1:2
37、014 ISO 16635-1:2013(E)4.4 Characteristics of the die plateThe die plate shall have six holes ranging in size from 0,8 mm to 2,3 mm in diameter or eight holes ranging in size from 0,5 mm to 2,6 mm in diameter, with approximately the same increments (see Table 1 and Figure 1).Test in accordance with
38、5.2.Table 1 Hole sizes for die platesDimensions in millimetresTolerances: 0,1 mmDie plate with 6 holes Die plate with 8 holes 0,50,8 0,81,1 1,11,4 1,41,7 1,72,0 2,02,3 2,3 2,6Figure 1 Die plates and hole sizes4.5 DistancesThe insertion depth shall be in the range from 20 mm to 70 mm.NOTE This allows
39、 the dental rubber dam or a special dental rubber dam frame combination to be inserted deep enough in order to punch holes at any desired position.Test in accordance with 5.2.4.6 Spring type mechanism4.6.1 Spring type mechanism for holding the hole punch openIn its passive state, the hole punch for
40、dental rubber dam shall be opened, by means of a spring type mechanism, wide enough to ensure a distance of at least 2,5 mm between the tip of the punch and the face of the die plate.Test in accordance with 5.2. ISO 2013 All rights reserved 34.6.2 Die plate mechanism for the engagement of the die pl
41、ateThe die plate shall be provided with a mechanism which ensures its engagement in defined positions in order that the punch always makes contact with the holes at their centres.NOTE This is usually achieved by means of a spring mechanism.Test in accordance with 5.1.4.7 MaterialsThe hole punch shal
42、l be made of corrosion resistant martensitic stainless steel 4021-420-00-I (X20Cr13) and 4034-420-00-I (X46Cr13) in accordance with ISO 15510.The die plate shall have a hardness of 48 HRC to 55 HRC or a Vickers hardness of 600 HV1 to 720 HV1.Test the Rockwell hardness in accordance with ISO 6508-1,
43、scale C, or test the Vickers hardness in accordance with ISO 6507-1.4.8 Surface profile and finishThe surface profile is at the discretion of the manufacturer.The surfaces of the hole punch for dental rubber dam shall be free of pores, cracks, scale residues, acidic fats and residues of abrasives an
44、d polishing agents.The surfaces of the working ends and the shafts shall be polished. A possible gloss is at the discretion of the manufacturer.Test in accordance with 5.1.5 Test methods5.1 Visual examinationPerform the examination of the hole punch with normal visual acuity without any magnificatio
45、n.5.2 DimensionsTest the dimensions with usual length measuring devices with a maximum permissible error of 0,1 mm.NOTE Usual length measuring devices include external micrometers and callipers.The applied measuring force shall not exceed 1,5 N.6 MarkingThe hole punch shall be marked as follows:a) n
46、ame of the manufacturer and/or brand;b) model number (reference number);c) lot number.BS EN ISO 16635-1:2014 ISO 16635-1:2013(E) 4 ISO 2013 All rights reservedBS EN ISO 16635-1:2014BS EN ISO 16635-1:2014 ISO 16635-1:2013(E) ISO 2013 All rights reservedICS 11.060.20Price based on 4 pagesThis page del
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