1、BSI Standards PublicationBS EN ISO 16635-2:2014Dentistry Dental rubber daminstrumentsPart 2: Clamp forcepsBS EN ISO 16635-2:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO16635-2:2014.The UK participation in its preparation was entrusted to TechnicalCom
2、mittee CH/106/4, Dental Instruments and Equipment.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Sta
3、ndards Institution 2014. Published by BSI StandardsLimited 2014ISBN 978 0 580 75169 1ICS 11.060.20Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 September 2014
4、.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 16635-2 September 2014 ICS 11.060.20 English Version Dentistry - Dental rubber dam instruments - Part 2: Clamp forceps(ISO 16635-2:2014) Mdecine bucco-dentaire - Instruments de digue dentai
5、re en 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 2014. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate
6、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 on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standa
7、rd 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-CENELEC Management Centre has the same status as the official versions. CEN members are the natio
8、nal standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, 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, Slov
9、akia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. 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 mean
10、s reserved worldwide for CEN national Members. Ref. No. EN ISO 16635-2:2014 EBS EN ISO 16635-2:2014EN ISO 16635-2:2014 (E) 3 Foreword This document (EN ISO 16635-2:2014) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaboration with Technical Committee CEN/TC 55 “Dentistry” th
11、e 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 standards shall be withdrawn at the latest by March 2015. Attention is d
12、rawn 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 follo
13、wing 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, Lithuania, Luxembourg, Malta, Netherlands, N
14、orway, 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 modification. BS EN ISO 16635-2:2014ISO 16635-2:2014(E) ISO 2014 All rights res
15、erved iiiContents PageForeword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Requirements 24.1 General . 24.2 Total length. 24.3 Locking part . 24.4 Distance between the forceps handles in the closed, passive state . 24.5 Retaining pins 24.6 Spring and ability to re
16、turn to the original state . 34.7 Materials . 34.8 Surface finish 34.9 Corrosion resistance and resistance to reprocessing 35 Test methods . 35.1 Visual examination 35.2 Dimensions . 35.3 Reprocessing . 36 Marking 4BS EN ISO 16635-2:2014ISO 16635-2:2014(E)ForewordISO (the International Organization
17、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 member body interested in a subject for which a technical committee has been established has t
18、he 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 Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The proc
19、edures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editori
20、al rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).Attention is drawn 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. Details of any patent rights
21、identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanat
22、ion on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document
23、 is ISO/TC 106, Dentistry, Subcommittee SC 4, Dental instruments.ISO 16635 consists of the following parts, under the general title Dentistry Dental rubber dam instruments: Part 1: Hole punch Part 2: Clamp forcepsiv ISO 2014 All rights reservedBS EN ISO 16635-2:2014ISO 16635-2:2014(E)IntroductionIn
24、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 forceps for dental rubber dam clamps come into contact with the patient.
25、ISO 2014 All rights reserved vBS EN ISO 16635-2:2014BS EN ISO 16635-2:2014Dentistry Dental rubber dam instruments Part 2: Clamp forceps1 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
26、 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 edition of the referenced document (including any amendments) appli
27、es.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 16635-1, Dentistry Dental rubber dam technique Part 1: Hole punchISO 15510:2010, Stainless steels Chemical composition
28、ISO 17664, Sterilization 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
29、damrubber damdental 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 jo
30、int, which locks 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
31、 joint by means 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.INTERNATIONAL STANDARD ISO 16635-2:2014(E) ISO 2014 All rights reserved 1BS EN ISO 16635-2:2014ISO 16635-2:2014(E)3.4retaining
32、 pinspin-like ends of the clamp forceps receiver which are inserted into the holes 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
33、 row of teeth without the forceps coming into contact with the teeth.This requires 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
34、the hole in the clamp and that the clamp can be safely orientated in three spatial 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 mechani
35、sm which locks and unlocks when the forceps is used, so that the clamp forceps 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 betwee
36、n the forceps handles in the closed, passive state shall not exceed 95 mm.Test 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 diam
37、eter of the retaining pins shall be (1,5 0,2) mm.Test in accordance with 5.2.4.5.3 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.2 ISO 2014 All rights reservedBS EN IS
38、O 16635-2:2014ISO 16635-2:2014(E)Test in accordance with 5.2.4.6 Spring and ability to return to the 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-re
39、sistant stainless steel having the material numbers 4021-420-00-I (name of the steel designation: 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-resistan
40、t steel with the material number 4301-304-00-I (X5CrNi18-10; S30408) in accordance with ISO 15510:2010.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 Ro
41、ckwell hardness in accordance with ISO 6508-1, scale C, or test the Vickers hardness in accordance 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 abra
42、sives and/or polishing agents.Test in accordance with 5.1.4.9 Corrosion resistance and resistance 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 1766
43、4, without deterioration or showing signs of corrosion.Test in accordance with 5.3.NOTE Discolorations 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 dimension
44、s are tested by means of appropriate length measuring devices (e.g. micrometers, callipers) with a 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 insp
45、ect the forceps for signs of corrosion or surface deterioration. ISO 2014 All rights reserved 3BS EN ISO 16635-2:2014ISO 16635-2:2014(E)6 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).4 IS
46、O 2014 All rights reservedBS EN ISO 16635-2:2014This page deliberately left blankThis page deliberately left blankBSI is the national body responsible for preparing British Standards and other standards-related publications, information and services.BSI is incorporated by Royal Charter. British Stan
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