1、December 2014Translation by DIN-Sprachendienst.English price group 7No 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、 11.060.25!%k“2278872www.din.deDDIN EN ISO 16635-2Dentistry Dental rubber dam instruments Part 2: Clamp forceps (ISO 16635-2:2014);English version EN ISO 16635-2:2014,English translation of DIN EN ISO 16635-2:2014-12Zahnheilkunde Kofferdaminstrumente Teil 2: Klammerzangen (ISO 16635-2:2014);Englisch
3、e Fassung EN ISO 16635-2:2014,Englische bersetzung von DIN EN ISO 16635-2:2014-12Mdecine bucco-dentaire Instruments de digue dentaire en caoutchouc Partie 2: Pinces porte-crampons (ISO 16635-2:2014);Version anglaise EN ISO 16635-2:2014,Traduction anglaise de DIN EN ISO 16635-2:2014-12SupersedesDIN 1
4、3993-2:2010-07www.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Document comprises 10 pages12.14 DIN EN ISO 16635-2:2014-12 2 A comma is used as the decimal marker. National foreword This document (EN ISO 16635-2:2014) has been prepared by Technical Committ
5、ee ISO/TC 106 “Dentistry” in collaboration with Technical Committee CEN/TC 55 “Dentistry” (Secretariat: SCC, Canada). The responsible German body involved in its preparation was the DIN-Normenausschuss Dental (DIN Standards Committee Dentistry), Working Committee NA 014-00-23 AA Dentalmedizinische I
6、nstrumente. The DIN Standards corresponding to the International Standards referred to in Clause 2 of this standard are as follows: ISO 1942 DIN EN ISO 1942 ISO 6507-1 DIN EN ISO 6507-1 ISO 6508-1 DIN EN ISO 6508-1 ISO 16635-1 DIN EN ISO 16635-1 ISO 17664 DIN EN ISO 17664 Amendments This standard di
7、ffers from DIN 13993-2:2010-07 as follows: a) the content of DIN 13993-2:2010-07 has been adopted in ISO 16635-2:2014; b) steel designations have been specified in accordance with ISO 15510; c) the number of reprocessing cycles has been increased to 100. Previous editions DIN 13993-2: 2010-07 Nation
8、al Annex NA (informative) Bibliography DIN EN ISO 1942, Dentistry Vocabulary DIN EN ISO 6507-1, Metallic materials Vickers hardness test Part 1: Test method DIN EN ISO 6508-1, Metallic materials Rockwell hardness test Part 1: Test method (scales A, B, C, D, E, F, G, H, K, N, T) DIN EN ISO 16635-1, D
9、entistry Dental rubber dam technique Part 1: Hole punch DIN EN ISO 17664, Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices EN ISO 16635-2September 2014 ICS 11.060.20 English VersionDentistry - Dental rubber dam instr
10、uments - Part 2: Clampforceps (ISO 16635-2:2014)Mdecine bucco-dentaire - Instruments de digue dentaireen caoutchouc - Partie 2: Pinces porte-crampons(ISO 16635-2:2014)Zahnheilkunde - Kofferdaminstrumente - Teil 2: Klammerzangen (ISO 16635-2:2014) This European Standard was approved by CEN on 28 June
11、 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 national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtain
12、ed 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 its own language and notified to the CEN-
13、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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland,
14、Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom. CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CEN All rights of exploitation in any form and by any means res
15、erved worldwide for CEN national Members. Ref. No. EN ISO 16635-2:2014 EEUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMContents Page Foreword . 3 Introduction . 4 1 Scope . 5 2 Normative references. 5 3
16、 Terms and definitions 5 4 Requirements . 6 4.1 General 6 4.2 Total length . 6 4.3 Locking part 6 4.4 Distance between the forceps handles in the closed, passive state 6 4.5 Retaining pins . 6 4.6 Spring and ability to return to the original state . 7 4.7 Materials 7 4.8 Surface finish 7 4.9 Corrosi
17、on resistance and resistance to reprocessing . 7 5 Test methods 7 5.1 Visual examination . 7 5.2 Dimensions . 7 5.3 Reprocessing 7 6 Marking 8 DIN EN ISO 16635-2:2014-12 EN ISO 16635-2:2014 (E) 2ForewordThis document (EN ISO 16635-2:2014) has been prepared by Technical Committee ISO/TC 106 “Dentistr
18、y” 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 March 2015, and conflicting national sta
19、ndards shall be withdrawn at the latest by March 2015. 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 In
20、ternal 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland,
21、 Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 16635-2:2014 has been approved by CEN as EN ISO 16635-2:2014 without any modificati
22、on. DIN EN ISO 16635-2:2014-12EN ISO 16635-2:2014 (E)3IntroductionIn order to support the increasing use of dental rubber dam the application of dental rubber dam should be supported by standardization of the required instruments and materials.In dental practice and when used as intended, clamp forc
23、eps for dental rubber dam clamps come into contact with the patient.DIN EN ISO 16635-2:2014-12 EN ISO 16635-2:2014 (E) 41 ScopeThis part of ISO 16635 specifies requirements and test methods for clamp forceps intended for the application of dental rubber dam clamps to teeth.2 Normative referencesThe
24、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 edition of the referenced document (including any amendments) applies.ISO 1942, De
25、ntistry VocabularyISO 6507-1, Metallic materials Vickers hardness test Part 1: Test methodISO 6508-1, Metallic materials Rockwell hardness test Part 1: Test methodISO 16635-1, Dentistry Dental rubber dam technique Part 1: Hole punchISO 15510:2010, Stainless steels Chemical compositionISO 17664, Ster
26、ilization of medical devices Information to be provided by the device manufacturer for the processing of reusable medical devices3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 1942, ISO 16635-1 and the following apply.3.1dental rubber damrubber damde
27、ntal damsheet of elastomeric film composed of natural rubber latex or synthetic material that is used to isolate one or several teeth from the rest of the oral cavity during a dental restorative procedure3.2locking partdevice located around the parts of the forceps handles near the joint, which lock
28、s automatically when the clamp forceps opens, thus fixating the forceps after it has picked up the dental dam clamp3.3clamp receiverworking end of the clamp forceps which serves for the picking up and bringing into position of the dental rubber dam clamp and is linked with the forceps joint by means
29、 of a connecting pieceNote 1 to entry: The working ends move diametrically opposed to the forceps handles as a result of the handles being guided in the joint.DIN EN ISO 16635-2:2014-12EN ISO 16635-2:2014 (E)53.4retaining pinspin-like ends of the clamp forceps receiver which are inserted into the ho
30、les of the clamp jaws of the dental rubber dam clamps4 Requirements4.1 GeneralIn accordance with its intended use, a clamp forceps shall be designed such that it can be used to apply the dental rubber dam clamp across the row of teeth without the forceps coming into contact with the teeth.This requi
31、res that the working end with the retaining pins is angled against the handle and/or stepped.The retaining pins shall be provided with a depth-control stop to ensure that they can only be inserted to a certain depth into the hole in the clamp and that the clamp can be safely orientated in three spat
32、ial directions while the forceps is applied to the tooth.4.2 Total lengthThe total length of the clamp forceps shall be 175 mm.Test in accordance with 5.2.4.3 Locking partThe clamp forceps shall be provided with a mechanism which locks and unlocks when the forceps is used, so that the clamp forceps
33、holds the clamps in the tensioned state and releases them again following their application to the tooth.Test in accordance with 5.1.4.4 Distance between the forceps handles in the closed, passive stateThe distance between the forceps handles in the closed, passive state shall not exceed 95 mm.Test
34、in accordance with 5.2.4.5 Retaining pins4.5.1 Length of retaining pinsThe length of the retaining pins for the depth control stop shall be (3,5 0,5) mm.Test in accordance with 5.2.4.5.2 Diameter of retaining pinsThe diameter of the retaining pins shall be (1,5 0,2) mm.Test in accordance with 5.2.4.
35、5.3 Distance between the retaining pinsThe distance between the retaining pins, when the forceps is opened to the maximum degree, shall be at least 20 mm when measured at the outside.DIN EN ISO 16635-2:2014-12 EN ISO 16635-2:2014 (E) 6Test in accordance with 5.2.4.6 Spring and ability to return to t
36、he original stateThe clamp forceps shall be returned to a closed position by means of as spring.Test in accordance with 5.1.4.7 MaterialsClamp forceps shall be made of martensitic hardening corrosion-resistant stainless steel having the material numbers 4021-420-00-I (name of the steel designation:
37、X20Cr13; S42020), or 4028-420-00-I (X30Cr13; S42030), 4034-420-00-I (X46Cr13, S42040) with a hardness of 42 HRC to 55 HRC or a Vickers hardness of 500 HV1 to 700 HV1, or of austenitic corrosion-resistant steel with the material number 4301-304-00-I (X5CrNi18-10; S30408) in accordance with ISO 15510:
38、2010.Same parts can be made of austenitic corrosion resistant steel having the material numbers 4301-304-00-I (X5CrNi18-10) or 4310-301-00-I (X10CrNi18-8; S30110) according to ISO 15510:2010.Test the Rockwell hardness in accordance with ISO 6508-1, scale C, or test the Vickers hardness in accordance
39、 with ISO 6507-1.4.8 Surface finishThe manufacturer may choose between a brightened and a matted surface.All surfaces of the clamp forceps shall be free of pores, cracks and all residues, including abrasives and/or polishing agents.Test in accordance with 5.1.4.9 Corrosion resistance and resistance
40、to reprocessingThe clamp forceps shall not show any signs of corrosion.The clamp forceps shall withstand 100 reprocessing cycles, as defined by the manufacturers instructions in accordance with ISO 17664, without deterioration or showing signs of corrosion.Test in accordance with 5.3.NOTE Discolorat
41、ions due to water spots are not regarded signs of corrosion.5 Test methods5.1 Visual examinationPerform visual examination with normal visual acuity without any magnification.5.2 DimensionsThe dimensions are tested by means of appropriate length measuring devices (e.g. micrometers, callipers) with a
42、 maximum permissible error of 0,1 mm.5.3 ReprocessingCarry out 100 reprocessing cycles in accordance with the manufacturers recommended methods of cleaning, disinfection and sterilization. Visually inspect the forceps for signs of corrosion or surface deterioration.DIN EN ISO 16635-2:2014-12EN ISO 16635-2:2014 (E)76 MarkingClamp forceps shall be marked as follows:a) name of the manufacturer and/or brand;b) model number (reference number);c) lot number (batch designation).DIN EN ISO 16635-2:2014-12 EN ISO 16635-2:2014 (E) 8
