1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 28399:2011Dentistry Products for external tooth bleaching (ISO 28399:2011)BS EN ISO 28399:2011 BRITISH STANDARDNational forewordThis British Standard is the UK implemen
2、tation of EN ISO 28399:2011.The UK participation in its preparation was entrusted to T e c h n i c a l Committee CH/106/7, Oral hygiene products.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the nece
3、ssaryprovisions of a contract. Users are responsible for its correctapplication. BSI 2011 ISBN 978 0 580 59603 2 ICS 71.100.70; 97.170 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of theStandards Policy and S
4、trategy Committee on 28 February 2011. Amendments issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 28399 January 2011 ICS 97.170 English Version Dentistry - Products for external tooth bleaching (ISO 28399:2011) Mdecine bucco-dentaire - Pro
5、duits dclaircissement dentaire, usage externe (ISO 28399:2011) Zahnheilkunde - Externe Zahnbleichmittel (ISO 28399:2011) This European Standard was approved by CEN on 11 September 2010. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for givin
6、g 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 Standard exists in three offic
7、ial 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 national standards bodies of
8、Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
9、EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 28399:2011: EBS EN I
10、SO 28399:2011 EN ISO 28399:2011 (E) 3 Foreword This document (EN ISO 28399:2011) 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 o
11、f a national standard, either by publication of an identical text or by endorsement, at the latest 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 pa
12、tent 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 following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, C
13、roatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The te
14、xt of ISO 28399:2011 has been approved by CEN as a EN ISO 28399:2011 without any modification. BS EN ISO 28399:2011ISO 28399:2011(E) ISO 2011 All rights reserved iiiContents Page Foreword iv Introduction.v 1 Scope1 2 Normative references1 3 Terms and definitions .1 4 Classification .2 4.1 General .2
15、 4.2 Products for professional application.2 4.3 Products for consumer application.2 5 Requirements.2 5.1 Concentration of active ingredients for bleaching 2 5.2 Surface microhardness.2 5.3 Surface erosion .2 6 Test methods .3 6.1 Preparation of tooth specimens 3 6.2 Preparation and application of t
16、ooth bleaching product 3 6.3 Surface microhardness.3 7 Packaging, marking and information to be supplied by the manufacturer.3 7.1 General .3 7.2 Packaging.3 7.3 Marking and instructions for use.3 Annex A (informative) Test method for the measurement of hydrogen peroxide concentration.5 Annex B (inf
17、ormative) Test method for the measurement of erosion of enamel and dentine caused by products for external tooth bleaching .6 Annex C (informative) Test method for laboratory assessment of tooth bleaching efficacy .10 Bibliography13 BS EN ISO 28399:2011ISO 28399:2011(E) iv ISO 2011 All rights reserv
18、edForeword ISO (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 subject for which a
19、 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 (IEC) on all matte
20、rs of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circula
21、ted to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. 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 responsibl
22、e for identifying any or all such patent rights. ISO 28399 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 7, Oral care products. BS EN ISO 28399:2011ISO 28399:2011(E) ISO 2011 All rights reserved vIntroduction Products for external tooth bleaching are used in dentistry fo
23、r 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 includes requirements and test methods for products intended for external bleaching of natural teeth by chemical means. B
24、S EN ISO 28399:2011BS EN ISO 28399:2011INTERNATIONAL STANDARD ISO 28399:2011(E) ISO 2011 All rights reserved 1Dentistry Products for external tooth bleaching 1 Scope This International Standard specifies requirements and test methods for external tooth bleaching products. These products are intended
25、 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 use. This
26、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 materials (e.g.
27、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 using ISO 1
28、0993-1 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) applies. ISO 1
29、942:2009 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 and defin
30、itions 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. BS EN ISO 28399:2011ISO
31、 28399:2011(E) 2 ISO 2011 All rights reserved3.2 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 appl
32、ication; or 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 d
33、ental professionals (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 p
34、roducts can 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 manufact
35、urers instructions 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
36、hardness (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 accordanc
37、e with Annex B or other equivalent methods. BS EN ISO 28399:2011ISO 28399:2011(E) ISO 2011 All rights reserved 36 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 %
38、solution (mass concentration) 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
39、 then polish the surface using 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 toot
40、h bleaching product The dispensing, 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. Specime
41、ns shall be stored in a 37 C artificial 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
42、 treatment. Determine the surface 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 p
43、rocedure. 7 Packaging, marking 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
44、adequately protect the contents 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)
45、Instructions shall accompany each package of the product and shall include the information appropriate to the product, as indicated in Table 1. BS EN ISO 28399:2011ISO 28399:2011(E) 4 ISO 2011 All rights reservedTable 1 Requirements for marking and instructions for use No. Information Outermost pack
46、age Container Manufacturers instructions for use 1 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
47、 accordance with ISO 8601 for the materials under 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 o
48、f active ingredient(s) M M 12 Concentration of active 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 auxiliar
49、y device only) M 16 Specific contra-indication(s) 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 information. BS EN ISO 28399:2011ISO 28399:2011(E) ISO 2011 All rights reserved 5Annex A (informative) Test method for the measurement
