1、BSI Standards PublicationBS EN ISO 18556:2016Dentistry Intraoral spatulasBS EN ISO 18556:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO18556:2016. The UK participation in its preparation was entrusted to TechnicalCommittee CH/106/4, Dental Instruments
2、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 Standards Institution 2016.Published by
3、 BSI Standards Limited 2016ISBN 978 0 580 82004 5ICS 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 April 2016.Amendments/corrigenda issued since publ
4、icationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 18556 April 2016 ICS 11.060.20 English Version Dentistry - Intraoral spatulas (ISO 18556:2016) Mdecine bucco-dentaire - Spatules bouche (ISO 18556:2016) Zahnheilkunde - Intraoralspatel (ISO 18556:2016) This E
5、uropean Standard was approved by CEN on 18 March 2016. 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
6、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 version in any other language made by translation under the responsibility of a CEN membe
7、r 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, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, Fran
8、ce, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOM
9、ITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 18556:2016 EBS EN ISO 18556:2016EN ISO 18556:2016 (E) 3 European foreword This document (EN I
10、SO 18556:2016) has been prepared by Technical Committee ISO/TC 106 “Dentistry“ 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
11、or by endorsement, at the latest by October 2016, and conflicting national standards shall be withdrawn at the latest by October 2016. 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 responsibl
12、e for identifying any 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, F
13、ormer 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 the United Kingdom. Endorsement notice The text of ISO 185
14、56:2016 has been approved by CEN as EN ISO 18556:2016 without any modification. BS EN ISO 18556:2016ISO 18556:2016(E)Foreword iv1 Scope . 12 Normative references 13 Terms and definitions . 14 Classification 15 Requirements 25.1 Dimensions . 25.2 Material . 25.3 Handle. 35.4 Spatula blade 35.5 Combin
15、ation of handle and blade . 35.6 Surface 35.7 Resistance to reprocessing . 36 Test methods . 36.1 Visual examination 36.2 Dimensions . 46.3 Test of resistance to reprocessing 47 Marking 4Bibliography 5 ISO 2016 All rights reserved iiiContents PageBS EN ISO 18556:2016ISO 18556:2016(E)ForewordISO (the
16、 International Organization 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 committe
17、e has been established has the 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 electrotechni
18、cal standardization.The procedures 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
19、 accordance with the editorial 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. D
20、etails of any patent rights 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
21、 endorsement.For an explanation 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 information.The committee
22、responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC 4, Dental instruments.iv ISO 2016 All rights reservedBS EN ISO 18556:2016INTERNATIONAL STANDARD ISO 18556:2016(E)Dentistry Intraoral spatulas1 ScopeThis International Standard specifies requirements and their test methods for me
23、tallic and non-metallic intraoral spatulas used to introduce and model filling materials into a tooth cavity, including single use disposable items.NOTE This includes instruments used for placement and contouring of non-metallic direct restorative materials.It also specifies requirements for their m
24、arking and labelling.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 edition of the referenced document
25、(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 17664, Sterilization of medical devices Information to be provided by the manufacturer
26、 for the processing of resterilizable medical devices3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.3.1intraoral spatulahand-held dental instrument with a flat blade used to introduce filling materials into tooth cavities
27、 and to model the contours of the filling surfaces, which could be made from metallic or non-metallic materials3.2non-metallic intraoral spatulaintraoral spatula (3.1) made from plastics or ceramic materials4 ClassificationSpatula blades for intraoral spatulas are classified into the following types
28、 depending on their design and material properties (e.g. shape, function, bending): Type 1: oval, cutting, rigid; Type 2: rectangular, flat, flexible. ISO 2016 All rights reserved 1BS EN ISO 18556:2016ISO 18556:2016(E)5 Requirements5.1 DimensionsMetallic intraoral spatulas shall have the dimensions
29、indicated in Figure 1 and Table 1.The width of the spatula blade, b, shall be within a range of 1,4 mm to 3,2 mm.The minimum thickness of the intraoral spatula blade shall be 0,2 mm.The degree of taper of the blade will be at the discretion of the manufacturer.Spatulas with dimensions other than lis
30、ted are acceptable provided that they meet the functional needs for placement of filling materials.Test in accordance with 6.2.Table 1 Dimensions for intraoral spatulasDimensions in millimetresOverall lengthamax.Handle length5Length of spatula blade2Length of shaft and spatula blade+ 2 - 5Height of
31、spatula blade2175 105 13,5 35 10aThus, during reprocessing, the intraoral spatula fits into a dental tray.Dimensions in millimetresKey1 handle area, used for marking2 spatula bladeFigure 1 Intraoral spatulas5.2 MaterialMetallic intraoral spatulas shall consist of martensitic and precipitation harden
32、ing corrosion-resistant steel with the material numbers 4021-420-00-1 (X20Cr13; 1.4021), 4034-420-00-1 (X46Cr13; 1.4034) or 4040-420-00-1 (X68Cr17, 1.4040).Examples of additional suitable stainless steels can be found in ISO 7153-1.Non-metallic materials are at the discretion of the manufacturer.2 I
33、SO 2016 All rights reservedBS EN ISO 18556:2016ISO 18556:2016(E)5.3 HandleThe shape of the handle (e.g. circular, octagonal) is left to the discretion of the manufacturer.5.4 Spatula bladeThe spatula blade shall have a hardness of 42 HRC to 60 HRC or a Vickers hardness of 410 HV 1 to 700 HV 1, respe
34、ctively.Test in accordance with ISO 6508-1, scale C, or ISO 6507-1.5.5 Combination of handle and bladeRemovable blades shall be securely fixed to the handle. The extraction force shall be 10 N.5.6 SurfaceThe surface and shape of the cross sectional profile is designed at the discretion of the manufa
35、cturer.The surfaces of the intraoral spatula shall be free of defects and residues.The surfaces of the working ends and of the shafts shall be smooth. No remaining signs of machined surface finish shall be seen.Coatings may be added to the working tip of metal intraoral spatulas to increase lubricit
36、y and provide contrast in the oral cavity.Test in accordance with 6.1.5.7 Resistance to reprocessingThe metallic intraoral spatula shall withstand 100 reprocessing cycles, as defined by the manufacturers instructions, in accordance with ISO 17664 without deterioration in performance or showing signs
37、 of corrosion.Non-metallic intraoral spatulas shall withstand the same reprocessing procedures as metallic intraoral spatulas, unlessa) the intraoral spatula is designated as single-use disposable item, andb) the manufacturer has specified a maximum number of cycles less than 100; this number shall
38、be used for the test.The reprocessing cycle shall include the recommended methods of cleaning, disinfection and sterilization.Test in accordance with 6.3.6 Test methods6.1 Visual examinationPerform the visual examination with normal visual acuity and without any magnification. ISO 2016 All rights re
39、served 3BS EN ISO 18556:2016ISO 18556:2016(E)6.2 DimensionsMeasure the dimensions using a device that is accurate to 1/10 of the tolerance to be measured.NOTE Examples of suitable measuring devices are vernier calipers and micrometers in accordance with ISO 3611.6.3 Test of resistance to reprocessin
40、gCarry out 100 reprocessing cycles with the intraoral spatula, as defined by the manufacturers instructions, in accordance with ISO 17664.If the manufacturer has specified a maximum number of cycles less than 100, this number shall be used for the test.The intraoral spatula shall show no signs of de
41、terioration, distortion or corrosion.NOTE Discolorations due to water stains are no signs of corrosion.7 MarkingIntraoral spatulas shall be marked as follows:a) the name of the manufacturer and/or mark;b) the model number (reference number);c) the lot number (batch designation).4 ISO 2016 All rights
42、 reservedBS EN ISO 18556:2016ISO 18556:2016(E)Bibliography1 ISO 3611, Geometrical product specifications (GPS) Dimensional measuring equipment: Micrometers for external measurements Design and metrological characteristics2 ISO 4049, Dentistry Polymer-based restorative materials3 ISO 7153-1,1)Surgica
43、l instruments Materials Part 1: Metals1) To be published. ISO 2016 All rights reserved 5This 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 inc
44、orporated by Royal Charter. British Standards and other standardization products are published by BSI Standards Limited.British Standards Institution (BSI)BSI Group Headquarters389 Chiswick High Road London W4 4AL UKAbout usWe bring together business, industry, government, consumers, innovators and
45、others to shape their combined experience and expertise into standards -based solutions.The knowledge embodied in our standards has been carefully assembled in a dependable format and refined through our open consultation process. Organizations of all sizes and across all sectors choose standards to
46、 help them achieve their goals.Information on standardsWe can provide you with the knowledge that your organization needs to succeed. Find out more about British Standards by visiting our website at or contacting our Customer Services team or Knowledge Centre.Buying standardsYou can buy and downloa
47、d PDF versions of BSI publications, including British and adopted European and international standards, through our website at where hard copies can also be purchased. If you need international and foreign standards from other Standards Development Organizations, hard copies can be ordered from our
48、 Customer Services team.SubscriptionsOur range of subscription services are designed to make using standards easier for you. For further information on our subscription products go to British Standards Online (BSOL) youll have instant access to over 55,000 British and adopted European and internati
49、onal standards from your desktop. Its available 24/7 and is refreshed daily so youll always be up to date. You can keep in touch with standards developments and receive substantial discounts on the purchase price of standards, both in single copy and subscription format, by becoming a BSI Subscribing Member. PLUS is an updating service exclusive to BSI Subscribing Members. You will automatically receive the latest hard copy of your standard
