DIN EN ISO 18556-2016 Dentistry - Intraoral spatulas (ISO 18556 2016) German version EN ISO 18556 2016《牙科 口腔内压舌板(ISO 18556-2016) 德文版本EN ISO 18556-2016》.pdf

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1、September 2016 English price group 8No 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 11.060.25!%$q“2560178www.din.de

2、DIN EN ISO 18556Dentistry Intraoral spatulas (ISO 18556:2016);English version EN ISO 18556:2016,English translation of DIN EN ISO 18556:2016-09Zahnheilkunde Intraoralspatel (ISO 18556:2016);Englische Fassung EN ISO 18556:2016,Englische bersetzung von DIN EN ISO 18556:2016-09Mdecine buccodentaire Spa

3、tules intraorales (ISO 18556:2016);Version anglaise EN ISO 18556:2016,Traduction anglaise de DIN EN ISO 18556:2016-09SupersedesDIN 13977:200905www.beuth.deDocument comprises 11 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.09

4、.16 DIN EN ISO 18556:2016-09 2 A comma is used as the decimal marker. National foreword This document (EN ISO 18556:2016) has been prepared by Technical Committee ISO/TC 106 “Dentistry” (Secretariat: SCC, Canada) in collaboration with Technical Committee CEN/TC 55 “Dentistry” (Secretariat: DIN, Germ

5、any). The responsible German body involved in its preparation was DIN-Normenausschuss Dental (DIN Standards Committee Dentistry), Working Committee NA 014-00-23 AA Dentalmedizinische Instrumente. The DIN Standards corresponding to the International Standards referred to in Clause 2 of this standard

6、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 17664 DIN EN ISO 17664 Amendments This standard differs from DIN 13977:2009-05 as follows: a) the previous eminence-based term “Heidemann spatula” has been replaced by the evidence-based term “intr

7、aoral spatula”; b) the scope of the standard has been extended to include non-metallic intraoral spatulas; c) the number of cycles that need to be withstood to meet the requirements for resistance to reprocessing has been increased to 100. Previous editions DIN 13977: 1972-01, 2009-05 National Annex

8、 NA (informative) Bibliography DIN EN ISO 1942, Dentistry Vocabulary DIN EN ISO 6507-1, Metallic materials Vickers hardness test Part 1: Test methods DIN EN ISO 6508-1, Metallic materials Rockwell hardness test Part 1: Test methods DIN EN ISO 17664, Sterilization of medical devices Information to be

9、 provided by the manufacturer for the processing of resterilizable medical devices EUROPEAN 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 intraorales (ISO 18556:2016) Zahnei

10、lkud Intraoralspatel (ISO 18556:2016) This European 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-t

11、o-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 version in any other language made by transla

12、tion 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, Czech Republic, Denmark, Estonia, Finland,

13、 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. EUROPEAN COMMITTEE FOR STANDARDIZATION C

14、OMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE 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 EEN ISO 18556:2016 (E) 2 Contents Pag

15、e European foreword . 3 Foreword 4 1 Scope 5 2 Normative references 5 3 Terms and definitions . 5 4 Classification . 5 5 Requirements . 6 5.1 Dimensions 6 5.2 Material . 6 5.3 Handle . 7 5.4 Spatula blade 7 5.5 Combination of handle and blade . 7 5.6 Surface . 7 5.7 Resistance to reprocessing 7 6 Te

16、st methods 7 6.1 Visual examination . 7 6.2 Dimensions 8 6.3 Test of resistance to reprocessing 8 7 Marking . 8 Bibliography 9 DIN EN ISO 18556:2016-09 EN ISO 18556:2016 (E) 3 European foreword This document (EN ISO 18556:2016) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in colla

17、boration 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 October 2016, and conflicting national standards sh

18、all 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 responsible for identifying any or all such patent rights. According to the CEN-CENELEC Internal

19、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, Irelan

20、d, 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 18556:2016 has been approved by CEN as EN ISO 18556:2016 without any modification. DIN EN

21、ISO 18556:2016-09 ForewordISO (the 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 subj

22、ect for which a technical committee 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 (IE

23、C) on all matters of electrotechnical 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 n

24、oted. This document was drafted in 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 identifyin

25、g any or all such patent rights. Details 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 o

26、f users and does not constitute an 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 - Supple

27、mentary information.The committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC 4, Dental instruments.4EN ISO 18556:2016 (E) DIN EN ISO 18556:2016-09 1 ScopeThis International Standard specifies requirements and their test methods for metallic and non-metallic intraoral spa

28、tulas 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 marking and labelling.2 Normative refe

29、rencesThe 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.IS

30、O 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 for the processing of resterilizable

31、 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 and to model the contours of the fil

32、ling 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 depending on their design and materi

33、al properties (e.g. shape, function, bending): Type 1: oval, cutting, rigid; Type 2: rectangular, flat, flexible.5 EN ISO 18556:2016 (E) DIN EN ISO 18556:2016-09 N1)N1)National footnote: In Germany, these instruments are termed “Heidemannspatel” rather than “Intraoralspatel”. 5 Requirements5.1 Dimen

34、sionsMetallic intraoral spatulas shall have the dimensions 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

35、of the manufacturer.Spatulas with dimensions other than listed 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 spatu

36、la blade2Length of shaft and spatula blade+ 2 - 5Height of 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 spa

37、tulas shall consist of martensitic and precipitation hardening 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-metal

38、lic materials are at the discretion of the manufacturer.6EN ISO 18556:2016 (E) DIN EN ISO 18556:2016-09 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

39、 hardness of 410 HV 1 to 700 HV 1, respectively.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

40、designed at the discretion of the manufacturer.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

41、 intraoral spatulas to increase lubricity 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 deter

42、ioration in performance or showing signs 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

43、cycles less than 100; this number shall 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 a

44、ny magnification.7 EN ISO 18556:2016 (E) DIN EN ISO 18556:2016-09 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 resi

45、stance to reprocessingCarry 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 shal

46、l show no signs of deterioration, 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).

47、8EN ISO 18556:2016 (E) DIN EN ISO 18556:2016-09 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)Surgical instruments Materials Part 1: Metals1) To be published.9 EN ISO 18556:2016 (E) DIN EN ISO 18556:2016-09