1、BSI Standards PublicationBS EN ISO 16408:2015Dentistry Oral care products Oral rinsesBS EN ISO 16408:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 16408:2015. It supersedes BS EN ISO 16408:2004 which iswithdrawn.The UK participation in its preparation
2、 was entrusted to Technical 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 necessary provisions of a contract. Users are responsible for its correct appli
3、cation. The British Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 85932 8 ICS 11.060.10; 97.170 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Stra
4、tegy Committee on 30 September 2015.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 16408 September 2015 ICS 97.170 Supersedes EN ISO 16408:2004English Version Dentistry - Oral care products - Oral rinses (ISO 16408:2
5、015) Mdecine bucco-dentaire - Produits de soins bucco-dentaire - Bains de bouche (ISO 16408:2015) Zahnheilkunde - Mundhygieneprodukte - Mundspllsungen und Mundwsser (ISO 16408:2015) This European Standard was approved by CEN on 10 July 2015. CEN members are bound to comply with the CEN/CENELEC Inter
6、nal 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 may be obtained on application to the CEN-CENELEC Management Centre or to any
7、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 notified to the CEN-CENELEC Management Centre has the same status as the official ver
8、sions. CEN members are the national 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,
9、 Poland, Portugal, Romania, Slovakia, 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 2015 CEN All rights of exploita
10、tion in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 16408:2015 EBS EN ISO 16408:2015EN ISO 16408:2015 (E) 3 European foreword This document (EN ISO 16408:2015) has been prepared by Technical Committee ISO/TC 106“Dentistry” in collaboration with Technical Co
11、mmittee CEN/TC 55 “Dentistry” the secretariat of whichis held by DIN. This European Standard shall be given the status of a national standard, either by publication of anidentical text or by endorsement, at the latest by March 2016, and conflicting national standards shallbe withdrawn at the latest
12、by March 2016. Attention is drawn to the possibility that some of the elements of this document may be the subject ofpatent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patentrights. This document supersedes EN ISO 16408:2004. According to the CEN-CENELEC
13、Internal Regulations, the national standards organizations of thefollowing 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,
14、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 16408:2015 has been approved by CEN as EN ISO 16408:2015 without any modification. BS
15、EN ISO 16408:2015ISO 16408:2015(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Classification 25 Requirements 25.1 pH value 25.2 Total fluoride concentration and maximum amount of fluoride . 25.3 Unintended heavy metals 25.4 Compatibility with oral tissues
16、 . 25.5 Microbial contamination 25.6 Stability against ageing 35.7 Container and/or dispensing system 35.8 Readily fermentable carbohydrates 36 Sampling 37 Test methods . 37.1 General . 37.2 Visual inspection . 37.3 Determination of pH value 37.4 Determination of stability against ageing 37.4.1 Test
17、 . 37.4.2 Compliance . 47.5 Pass/fail criteria . 48 Test report . 49 Accompanying information . 49.1 Manufacturers instructions for use . 49.2 Information on the primary container, and on the secondary container, if it exists . 410 Packaging . 5Annex A (normative) Determination of fluoride in oral r
18、inses containing ionic fluoride compounds 6Bibliography 9 ISO 2015 All rights reserved iiiContents PageBS EN ISO 16408:2015ISO 16408:2015(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of prepari
19、ng 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 the right to be represented on that committee. International organizations, governmental and non-governmental, in lia
20、ison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) 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 Dir
21、ectives, 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 editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).Attention is drawn to the possibility that s
22、ome 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 identified during the development of the document will be in the Introduction and/or on the ISO list of patent decla
23、rations 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 explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information ab
24、out 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 is ISO/TC 106, Dentistry, Subcommittee SC 7, Oral care products.This second edition cancels and replaces the first
25、edition (ISO 16408:2004), which has been technically revised with the following changes: “heavy metals” has been replaced by the term unintended heavy metals, which has been defined in 3.3; reference to ISO 28888 and corresponding requirement in 5.1 were added; ambient storage conditions of real tim
26、e test for determination of stability against ageing (7.4.1) was changed (23 2) C at (60 15) % relative humidity; the bibliography was updated by including latest ISO/TC 217 standards.iv ISO 2015 All rights reservedBS EN ISO 16408:2015ISO 16408:2015(E)IntroductionOral rinses are used for oral hygien
27、e purposes intended to provide health and/or cosmetic benefits.This International Standard specifies the chemical and physical properties of oral rinses. Common labelling aspects are also specified in order to enhance international understanding and trade. ISO 2015 All rights reserved vBS EN ISO 164
28、08:2015BS EN ISO 16408:2015Dentistry Oral care products Oral rinses1 ScopeThis International Standard specifies physical and chemical requirements and test methods for oral rinses. It also specifies the accompanying information such as the manufacturers instructions for use, marking, and/or labellin
29、g requirements.This International Standard is not applicable to other delivery systems (e.g. mouthsprays, foams, powders). It is not intended to describe regulatory aspects, e.g. methods of prescription.This International Standard is not applicable to oral rinses available by prescription only.2 Nor
30、mative 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)
31、 applies.ISO 1942, Dentistry VocabularyISO 3696, Water for analytical laboratory use Specification and test methodsISO 8601, Data elements and interchange formats Information interchange Representation of dates and timesISO 28888, Dentistry Screening method for erosion potential of oral rinses on de
32、ntal hard tissuesINCI, International Nomenclature for Cosmetic Ingredients3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.3.1oral rinsemouthrinsemouthwashliquid formulation used by the public for oral care purposesSOURCE:
33、ISO 1942, 2009, 2.2093.2mouthsprayliquid formulation in spray form for oral care purposes not requiring dilution with waterSOURCE: ISO 1942, 2009, 2.1853.3unintended heavy metalsheavy metal elements, which are detected in the analysis but not purposely includedINTERNATIONAL STANDARD ISO 16408:2015(E
34、) ISO 2015 All rights reserved 1BS EN ISO 16408:2015ISO 16408:2015(E)4 ClassificationOral rinses shall be classified according to their application by the user as follows: Type 1: ready-for-use solutions; Type 2: concentrated solutions for use after dilution with water; Type 3: solutions for use aft
35、er mixing.5 Requirements5.1 pH valueOral rinses shall have a pH value between 3,0 and 10,5. If the pH value of an oral rinse is below 5,5 it shall pass a screening test as specified in ISO 28888.Test the pH value in accordance with 7.1 and 7.3.NOTE At the time of development of this International St
36、andard, there is no evidence that oral rinses with pH values between 5,5 and 10,5 promote enamel erosion.5.2 Total fluoride concentration and maximum amount of fluorideThe total fluoride concentration of one container of oral rinse of Type 1 shall not exceed a mass fraction of 0,15 %.The maximum amo
37、unt of ionic fluoride per single container shall not exceed 125 mg.Test fluoride-containing oral rinses in accordance with Annex A.As an alternative one of the procedures given in ISO 11609, Annex C,3or other validated method of similar sensitivity and accuracy, may be use, for example References 13
38、 or 14.5.3 Unintended heavy metalsThe maximum total concentration of unintended heavy metals in oral rinses shall not exceed 20 mg/kg.Test in accordance with a validated method, for example References 15, 16, 17 or 22.If this is not suitable other method of similar sensitivity and accuracy shall be
39、used.NOTE There may be other potentially dangerous elements, especially arsenic, which are not covered by this International Standard as currently no analytical test methods and no effect levels are consented.5.4 Compatibility with oral tissuesOral rinses shall not cause irritation or damage to the
40、oral hard and/or soft tissue, when used in accordance with the manufacturers recommendation for frequency and duration of use and experience with known side effects.Specific qualitative and quantitative requirements for freedom from biological hazards are not included in this International Standard,
41、 but it is recommended that reference be made to ISO 7405 and ISO 10993-1 when assessing possible biological or toxicological hazards.5.5 Microbial contaminationThe microbial contamination of oral rinses shall not exceed 100 colony-forming units (CFU) per gram. Oral rinses shall be free of pathogens
42、.2 ISO 2015 All rights reservedBS EN ISO 16408:2015ISO 16408:2015(E)Testing for microbial contamination shall be carried out according to a validated method, for example References 6, 7, 8, 9, 10, 11 or 12.5.6 Stability against ageingOral rinses shall show no signs of deterioration, such as agglomer
43、ation or change in clarity, after being subjected to the determination of stability to ageing procedure specified in 7.4.5.7 Container and/or dispensing systemThe container and/or dispensing system shall neither contaminate nor permit contamination of the oral rinse inside such that it will affect i
44、ts compliance with the requirements of Clause 5 after being subjected to the determination of stability to ageing described in 7.4.5.8 Readily fermentable carbohydratesOral rinses shall not contain readily fermentable carbohydrates.Compliance shall be established by the absence of such compounds in
45、the complete formula, or by performing tests in accordance with commonly used analytical methods.6 SamplingThe oral rinses used for testing shall be representative of actual manufactured oral rinse and shall not be altered in any way.Eight containers of oral rinses from the same manufacturing tracki
46、ng code (e.g. batch code, lot number) shall be tested before the determination of stability to ageing (see 7.4).7 Test methods7.1 GeneralAll tests shall be performed before and after the stability to ageing test (7.4).7.2 Visual inspectionBefore and after agitation, examine the oral rinse under a br
47、ight light with normal visual acuity without magnification.7.3 Determination of pH valueTest the pH value of the oral rinse in its intended concentration for use.Determine the pH value of the solution using a calibrated pH-meter with an accuracy of 0,1 mV.7.4 Determination of stability against agein
48、g7.4.1 TestOne of the following two tests shall be performed.a) Accelerated testStore the oral rinse at (40 2) C for 3 months at (75 5) % relative humidity or under such conditions of time and temperature as will simulate storage at room temperature for 30 months. ISO 2015 All rights reserved 3BS EN
49、 ISO 16408:2015ISO 16408:2015(E)b) Real time testStore the oral rinse at (23 2) C at (60 15) % relative humidity for 30 months or for the period indicated by the expiry date listed on the product label see 9.2 n).7.4.2 ComplianceExamine by visual inspection (7.2) of the oral rinse if requirement 5.6 is fulfilled.7.5 Pass/fail criteriaUnless otherwise noted, if none of the samples fails, the oral rinse passes.If one sample does not meet the minimum requirement, another eight samples
