DIN EN ISO 16408-2015 Dentistry - Oral care products - Oral rinses (ISO 16408 2015) German version EN ISO 16408 2015《牙科学 口腔护理产品 口腔清洗(ISO 16408-2015) 德文版本EN ISO 16408-2015》.pdf

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1、December 2015 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 71.100.70!%IR“2389347www.din.de

2、DIN EN ISO 16408Dentistry Oral care products Oral rinses (ISO 16408:2015);English version EN ISO 16408:2015,English translation of DIN EN ISO 16408:2015-12Zahnheilkunde Mundhygieneprodukte Mundspllsungen und Mundwsser (ISO 16408:2015);Englische Fassung EN ISO 16408:2015,Englische bersetzung von DIN

3、EN ISO 16408:2015-12Mdecine bucco-dentaire Produits de soins bucco-dentaire Bains de bouche (ISO 16408:2015);Version anglaise EN ISO 16408:2015,Traduction anglaise de DIN EN ISO 16408:2015-12SupersedesDIN EN ISO 16408:2004-08www.beuth.deDTranslation by DIN-Sprachendienst.In case of doubt, the German

4、-language original shall be considered authoritative.Document comprises 15 pages11.15 DIN EN ISO 16408:2015-12 2 A comma is used as the decimal marker. National foreword This document (EN ISO 16408:2015) has been prepared by Technical Committee ISO/TC 106 “Dentistry” (Secretariat: SCC, Canada) in co

5、llaboration with Technical Committee CEN/TC 55 “Dentistry” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was DIN-Normenausschuss Dental (DIN Standards Committee Dentistry), Working Committee NA 014-00-19 AA Mundpflegeprodukte. The DIN Standards corresponding to

6、 the International Standards referred to in Clause 2 of this standard are as follows: ISO 1942 DIN EN ISO 1942 ISO 3696 DIN ISO 3696 ISO 8601 DIN ISO 8601 ISO 28888 DIN EN ISO 28888 Amendments This standard differs from DIN EN ISO 16408:2004-08 as follows: a) “heavy metals” has been replaced by the

7、term “unintended heavy metals”, which has been defined in 3.3; b) a reference to ISO 28888 and a corresponding requirement in 5.1 have been added; c) the ambient storage conditions of the real time test for determination of stability against ageing (7.4.1) have been changed to (23 2) C at (60 15) %

8、relative humidity; d) the Bibliography has been updated by including the latest ISO/TC 217 standards. Previous editions DIN EN ISO 16408: 2004-08 National Annex NA (informative) Bibliography DIN EN ISO 1942, Dentistry Vocabulary DIN EN ISO 28888, Dentistry Screening method for erosion potential of o

9、ral rinses on dental hard tissues DIN ISO 3696, Water for analytical laboratory use Specification and test methods DIN ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 16408September 201

10、5 ICS 97.170 Supersedes EN ISO 16408:2004English VersionDentistry - Oral care products - Oral rinses(ISO 16408:2015)Mdecine bucco-dentaire - Produits de soins bucco-dentaire - Bains de bouche (ISO 16408:2015)Zahnheilkunde - Mundhygieneprodukte -Mundspllsungen und Mundwsser(ISO 16408:2015)This Europe

11、an Standard was approved by CEN on 10 July 2015. 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 concer

12、ning 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 member into

13、 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, France, Ge

14、rmany, 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 STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR

15、 NORMUNGCEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 16408:2015 EContents Page Foreword .3 Introduction .4 1 Scope .5 2 Normative references5 3 Terms and

16、definitions .5 4 Classification 6 5 Requirements .6 5.1 pH value . 6 5.2 Total fluoride concentration and maximum amount of fluoride 6 5.3 Unintended heavy metals . 6 5.4 Compatibility with oral tissues . 6 5.5 Microbial contamination .7 5.6 Stability against ageing 7 5.7 Container and/or dispensing

17、 system . 7 5.8 Readily fermentable carbohydrates . 7 6 Sampling 7 7 Test methods 7 7.1 General 7 7.2 Visual inspection 7 7.3 Determination of pH value . 7 7.4 Determination of stability against ageing 7 7.4.1 Test 7 7.4.2 Compliance. 8 7.5 Pass/fail criteria . 8 8 Test report 8 9 Accompanying infor

18、mation.8 9.1 Manufacturers instructions for use . 8 9.2 Information on the primary container, and on the secondary container, if it exists . 8 10 Packaging .9 Annex A (normative) Determination of fluoride in oral rinses containing ionic fluoride compounds . 10 Bibliography . 13 2DIN EN ISO 16408:201

19、5-12 EN ISO 16408:2015 (E) European foreword This document (EN ISO 16408:2015) 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

20、a national standard, either by publication of an identical text or by endorsement, at the latest by March 2016, and conflicting national standards shall be withdrawn at the latest by March 2016. Attention is drawn to the possibility that some of the elements of this document may be the subject of pa

21、tent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 16408:2004. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this Euro

22、pean Standard: 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, Poland, Portugal, Romania, Slovakia, Slo

23、venia, 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. 3DIN EN ISO 16408:2015-12EN ISO 16408:2015 (E)IntroductionOral rinses are used for oral hygiene purposes intended to

24、 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.4DIN EN ISO 16408:2015-12 EN ISO 16408:2015 (E) 1 ScopeThis Intern

25、ational 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 labelling requirements.This International Standard is not applicable to other delivery system

26、s (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 Normative referencesThe following documents, in whole or in part, are normatively refere

27、nced 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.ISO 1942, Dentistry VocabularyISO 3696, Water for analytical laboratory use

28、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 dental hard tissuesINCI, International Nomenclature for Cosmetic Ingredients3 Terms and

29、 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: ISO 1942, 2009, 2.2093.2mouthsprayliquid formulation in spray form for oral care purp

30、oses not requiring dilution with waterSOURCE: ISO 1942, 2009, 2.1853.3unintended heavy metalsheavy metal elements, which are detected in the analysis but not purposely included5DIN EN ISO 16408:2015-12EN ISO 16408:2015 (E)4 ClassificationOral rinses shall be classified according to their application

31、 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 after 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

32、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 Standard, 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 maxim

33、um 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 amount of ionic fluoride per single container shall not exceed 125 mg.Test fluoride-containing oral rinses in accordance with Annex A.As an alternativ

34、e 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 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 accor

35、dance 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 used.NOTE There may be other potentially dangerous elements, especially arsenic, which are not covered by this International Standard as currently

36、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 oral hard and/or soft tissue, when used in accordance with the manufacturers recommendation for frequency and duration of use and experience with k

37、nown side effects.Specific qualitative and quantitative requirements for freedom from biological hazards are not included in this International Standard, but it is recommended that reference be made to ISO 7405 and ISO 10993-1 when assessing possible biological or toxicological hazards.6DIN EN ISO 1

38、6408:2015-12 EN ISO 16408:2015 (E) N1) National footnote: In Germany, ready-for-use solutions (type 1) are designated as “Mundspllsungen” and concentrated solutions (type 2) as “Mundwsser”. N1)Testing for microbial contamination shall be carried out according to a validated method, for example Refer

39、ences 6, 7, 8, 9, 10, 11 or 12.5.6 Stability against ageingOral rinses shall show no signs of deterioration, such as agglomeration 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 an

40、d/or dispensing system shall neither contaminate nor permit contamination of the oral rinse inside such that it will affect its 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 ri

41、nses shall not contain readily fermentable carbohydrates.Compliance shall be established by the absence of such compounds in 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 m

42、anufactured oral rinse and shall not be altered in any way.Eight containers of oral rinses from the same manufacturing tracking 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 an

43、d after the stability to ageing test (7.4).7.2 Visual inspectionBefore and after agitation, examine the oral rinse under a bright 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

44、 pH value of the solution using a calibrated pH-meter with an accuracy of 0,1 mV.7.4 Determination of stability against ageing7.4.1 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 condi

45、tions of time and temperature as will simulate storage at room temperature for 30 months.7DIN EN ISO 16408:2015-12EN ISO 16408:2015 (E)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 pathogen

46、s.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 cr

47、iteriaUnless otherwise noted, if none of the samples fails, the oral rinse passes.If one sample does not meet the minimum requirement, another eight samples shall be tested. If no more samples fail, the oral rinse passes. If a total of two or more samples of the 16 samples fail, the oral rinse fails

48、.8 Test reportThe test report shall include at least the following information:a) the name and address of the organization responsible for the test report;b) a reference to this International Standard, i.e. ISO 16408;c) the manufacturers tracking code (e.g. batch code, lot number);d) the test result

49、s and the method of determination used;e) any unusual features noted during the determination;f) if the oral rinse passed or failed the test.9 Accompanying information9.1 Manufacturers instructions for useThe manufacturers or suppliers instructions for use accompanying the oral rinse shall contain at least the following information:a) information specified in 9.2, with the exception of d), f), and n), and