1、May 2011 Translation by DIN-Sprachendienst.English price group 11No 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 71
2、.100.70!$pk|“1777289www.din.deDDIN EN ISO 28399Dentistry Products for external tooth bleaching (ISO 28399:2011)English translation of DIN EN ISO 28399:2011-05Zahnheilkunde Externe Zahnbleichmittel (ISO 28399:2011)Englische bersetzung von DIN EN ISO 28399:2011-05Mdecine bucco-dentaire Produits dclair
3、cissement dentaire, usage externe (ISO 28399:2011)Traduction anglaise de DIN EN ISO 28399:2011-05www.beuth.deDocument comprises pagesIn case of doubt, the German-language original shall be considered authoritative.1904.11 DIN EN ISO 28399:2011-05 A comma is used as the decimal marker. National forew
4、ord This standard has been prepared by Technical Committee ISO/TC 106 “Dentistry” (Secretariat: SCC, Canada) in collaboration with Technical Committee CEN/TC 55 “Dentistry” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Dental (Dentistry
5、Standards Committee), Working Committee NA 014-00-19 AA Mundpflegeprodukte. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 1942 DIN EN ISO 1942 ISO 6344-1 DIN ISO 6344-1 ISO 8601 DIN ISO 8601 National Annex NA (informative) Bibliograph
6、y DIN EN ISO 1942, Dentistry Vocabulary DIN ISO 6344-1, Coated abrasives Grain size analysis Part 1: Grain size distribution test DIN ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times 2 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 2
7、8399 January 2011 ICS 97.170 English Version Dentistry Products for external tooth bleaching (ISO 28399:2011) Mdecine bucco-dentaire Produits dclaircissement dentaire, usage externe (ISO 28399:2011) Zahnheilkunde Externe Zahnbleichmittel (ISO 28399:2011) This European Standard was approved by CEN on
8、 11 September 2010. 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
9、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 member into its own language and notifie
10、d 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, L
11、uxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2011 CEN All
12、rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 28399:2011: EContents PageForeword .3 Introduction.41 Scope5 2 Normative references5 3 Terms and definitions .5 4 Classification .6 4.1 General .6 4.2 Products for professional applicatio
13、n.6 4.3 Products for consumer application.6 5 Requirements.6 5.1 Concentration of active ingredients for bleaching 6 5.2 Surface microhardness.6 5.3 Surface erosion .6 6 Test methods .7 6.1 Preparation of tooth specimens 7 6.2 Preparation and application of tooth bleaching product 7 6.3 Surface micr
14、ohardness.7 7 Packaging, marking and information to be supplied by the manufacturer.7 7.1 General .7 7.2 Packaging.7 7.3 Marking and instructions for use.7 Annex A (informative) Test method for the measurement of hydrogen peroxide concentration.8 Annex B (informative) Test method for the measurement
15、 of erosion of enamel and dentine caused by products for external tooth bleaching .10 Annex C (informative) Test method for laboratory assessment of tooth bleaching efficacy .14 Bibliography17 EN ISO 28399:2011 (E) DIN EN ISO 28399:2011-05 2Foreword This document (EN ISO 28399:2011) has been prepare
16、d 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 or by endorsement, at the latest
17、 by July 2011, and conflicting national standards shall be withdrawn at the latest by July 2011. 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 pate
18、nt 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, France, Germany, Greece, Hungary, Icela
19、nd, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 28399:2011 has been approved by CEN as a EN ISO 28399:2011 without any modification. “EN
20、 ISO 28399:2011 (E) DIN EN ISO 28399:2011-05 3Introduction Products for external tooth bleaching are used in dentistry for changing the colour of natural teeth towards a lighter or whiter shade. They are applied in the oral cavity directly on the outer surfaces of teeth. This International Standard
21、includes requirements and test methods for products intended for external bleaching of natural teeth by chemical means. EN ISO 28399:2011 (E) DIN EN ISO 28399:2011-05 41 Scope This International Standard specifies requirements and test methods for external tooth bleaching products. These products ar
22、e intended for use in the oral cavity, either by professional application (in-office tooth bleaching products) or consumer application (professional or non-professional home use of tooth bleaching products), or both. It also specifies requirements for their packaging, labelling and instructions for
23、use. This International Standard is not applicable to tooth bleaching products: specified in ISO 11609; those intended to change colour perception of natural teeth by mechanical methods (e.g. stain removal) or using restorative approaches, such as veneers or crowns; auxiliary or supplementary materi
24、als (e.g. tray materials) and instruments or devices (e.g. lights) that are used in conjunction with the bleaching products. This International Standard does not specify biological safety aspects of tooth bleaching products. NOTE A tooth bleaching product can be evaluated for its biological safety u
25、sing ISO 10993-1 and ISO 7405. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) appl
26、ies. ISO 1942:2009 Dentistry Vocabulary ISO 6344-1, Coated abrasives Grain size analysis Part 1: Grain size distribution test ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times 3 Terms and definitions For the purposes of this document, the terms
27、 and definitions given in ISO 1942 and the following apply. 3.1 bleaching natural teeth removal of intrinsic or acquired discolorations of natural teeth through the use of chemicals, sometimes in combination with the application of auxiliary means NOTE Adapted from ISO 1942:2009, 2.28. EN ISO 28399:
28、2011 (E) DIN EN ISO 28399:2011-05 53.2 professional home use of a product use prescribed by a professional and for use at home under the repeated supervision of the dentist 4 Classification 4.1 General Products for external tooth bleaching can be classified for either: a) professional application; o
29、r b) consumer application. NOTE Products for external tooth bleaching can be used alone or in conjunction with auxiliary means of application. 4.2 Products for professional application These products are tooth bleaching products that are intended by the manufacturer to be applied only by dental prof
30、essionals (in-office tooth bleaching products). 4.3 Products for consumer application These products are tooth bleaching products that are intended by the manufacturer to be applied by the consumer (for professional home use or for non-professional home use). NOTE Such external bleaching products ca
31、n be prescribed by a dental professional or directly available to consumers. 5 Requirements 5.1 Concentration of active ingredients for bleaching The concentration of active ingredients for bleaching (equivalent to hydrogen peroxide) delivered by the unexpired product according to manufacturers inst
32、ructions for use shall be within the range of +10 % and 30 % of the original concentration stated by the manufacturer for the unopened product, when tested in accordance with Annex A or other equivalent method. 5.2 Surface microhardness The reduction in the Knoop hardness (KHN) or Vickers hardness (
33、VHN) after the treatment shall be not more than 10 %, when tested in accordance with 6.3. 5.3 Surface erosion Surface erosion of the teeth tested in accordance with B.6.1 shall be no more than three times the level which is caused by the positive control (B.6.2.1), when tested in accordance with Ann
34、ex B or other equivalent methods. EN ISO 28399:2011 (E) DIN EN ISO 28399:2011-05 66 Test methods 6.1 Preparation of tooth specimens Prepare enamel and dentine specimens taken from a consistent location on extracted human or bovine teeth that have been stored in a 0,2 % solution (mass concentration)
35、of sodium azide or other solutions of equivalent efficacy for disinfection purpose. Grind the specimen surface using a sequence starting at P400 and sequentially to a minimum of P1200 silicon carbide paper in accordance with ISO 6344-1 under a constant flow of water and then polish the surface using
36、 a slurry or paste of 0,3 m mean particle size aluminium oxide. Ensure a minimum of 1 mm thickness of enamel or dentine tissue for the test specimen. Prevent dehydration of test specimens during the specimen preparation procedure. 6.2 Preparation and application of tooth bleaching product The dispen
37、sing, processing and application of the tooth bleaching product used in tests shall follow manufacturers instructions for use. The method of bleach application shall simulate the clinical procedure relative to quantity, frequency and duration of the application. Specimens shall be stored in a 37 C a
38、rtificial saliva solution similar to the one described in the ANSI/ADA Specification No. 416between bleaching intervals and for 24 h after the last bleach application prior to testing. 6.3 Surface microhardness Evaluate enamel surface hardness before and after bleaching treatment. Determine the surf
39、ace microhardness with the KHN or VHN by applying a load of 0,49 N (equivalent to a 50 g load) for 15 s. Evaluate a minimum of 10 specimens for each group, with three indentations for each specimen. Prevent dehydration of test specimens during the specimen preparation procedure. 7 Packaging, marking
40、 and information to be supplied by the manufacturer 7.1 General Additional information may be included at the discretion of the manufacturer or as required by regulation. 7.2 Packaging The components of the material shall be supplied in properly sealed containers which adequately protect the content
41、s and do not adversely affect the quality of the product. 7.3 Marking and instructions for use For each package, the following applies. a) Information shall be clearly marked on the outermost package or containers appropriate to the product, as indicated in Table 1. b) Instructions shall accompany e
42、ach package of the product and shall include the information appropriate to the product, as indicated in Table 1. EN ISO 28399:2011 (E) DIN EN ISO 28399:2011-05 7Table 1 Requirements for marking and instructions for use No. Information Outermost package Container Manufacturers instructions for use 1
43、 Name of the product M M M 2 Identification or name of the manufacturer M M M 3 Address of the manufacturer or the agent responsible for sale M M 4 Recommended conditions of storage M M 5 Manufacturers lot or batch identification M M 6 Expiry date in accordance with ISO 8601 for the materials under
44、the storage conditions recommended by the manufacturer M M 7 Classification of the materials (Clause 4) M M 8 Clinical application of the material (Clause 4) M 9 Number of containers M 10 Net mass of product in each container M M M 11 Chemical name of active ingredient(s) M M 12 Concentration of act
45、ive ingredient(s) M M M 13 Concentration equivalent to hydrogen peroxide M M M 14 Instructions for use M 15 Recommended auxiliary device(s), exposure times and any special instructions for use of the equipment (for the materials requiring an auxiliary device only) M 16 Specific contra-indication(s)
46、and/or warning(s), such as “irritation”, “avoid contact with eyes”, as necessary. M 17 Statement equivalent to “It is recommended that you consult with your dental professional before using this product.” M Explanation of symbols: “M” indicates mandatory information. “” indicates non-mandatory infor
47、mation. EN ISO 28399:2011 (E) DIN EN ISO 28399:2011-05 8Annex A (informative) Test method for the measurement of hydrogen peroxide concentration A.1 Principle The content of hydrogen peroxide (H2O2) in tooth bleaching products is determined using a modified thiosulfate titration method. A.2 Test con
48、dition Perform the test at (23 2) C. A.3 Procedure (modified thiosulfate titration method, USP10) Equivalent methods can also be used. Use analytic grade of sulfuric acid, potassium iodide, ammonium molybdate, sodium thiosulfate, starch and hydrogen peroxide. Conduct a titration calibration curve using a series of freshly prepared H2O2solutions at concentrations that include the highest possible H2O2concentration in the test product. Add approximately 1,0 g (wei
