1、March 2012 Translation by DIN-Sprachendienst.English price group 15No 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
2、71.100.70!$za“1876291www.din.deDDIN EN ISO 24442Cosmetics Sun protection test methods In vivo determination of sunscreen UVA protection (ISO 24442:2011)English translation of DIN EN ISO 24442:2012-03Kosmetik Prfverfahren fr Sonnenschutzmittel In-vivo-Bestimmung des UVA-Sonnenschutzes (ISO 24442:2011
3、)Englische bersetzung von DIN EN ISO 24442:2012-03Cosmtiques Mthodes dvaluation de la protection solaire Dtermination in vivo de la protection UVA (ISO 24442:2011)Traduction anglaise de DIN EN ISO 24442:2012-03www.beuth.deIn case of doubt, the German-language original shall be considered authoritati
4、ve.Document comprises 31 pages02.12 DIN EN ISO 24442:2012-03 2 A comma is used as the decimal marker. National foreword This standard has been prepared by Technical Committee ISO/TC 217 “Cosmetics” in collaboration with Technical Committee CEN/TC 392 “Cosmetics” (Secretariat: AFNOR, France). The res
5、ponsible German body involved in its preparation was the Normenausschuss Lebensmittel und landwirtschaftliche Produkte (Food and Agricultural Products Standards Committee), Working Committee NA 057-07-01 AA Kosmetische Mittel. This document has been prepared under a mandate given to CEN by the Europ
6、ean Commission and the European Free Trade Association, and supports essential requirements of EU Directives. EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 24442 December 2011 ICS 71.100.70 English Version Cosmetics - Sun protection test methods - In vivo determination of sunscreen UVA pr
7、otection (ISO 24442:2011) Cosmtique - Mthodes dvaluation de la protection solaire - Dtermination in vivo de la protection UVA Kosmetik - Prfverfahren fr Sonnenschutzmittel - In-vivo-Bestimmung des UVA-Sonnenschutzes (ISO 24442:2011)This European Standard was approved by CEN on 14 December 2011. CEN
8、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 may be obtained on appli
9、cation 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 notified to the CEN-CENELEC Man
10、agement 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, Luxembourg, Malta, Nethe
11、rlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. 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 24442:2011:
12、 EEUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG (ISO 24442:2011) 2Contents Page Foreword . 3 Introduction 4 1 Scope . 5 2 Terms and definitions . 5 3 Principle 6 4 Test subjects . 6 4.1 Selection of test subjects . 6 4.2 Number of subjects 7 5 R
13、eference sunscreen formulae 7 6 UVA source . 7 6.1 Spectral characteristics 7 6.2 Maintenance and monitoring the UV solar simulator output . 8 6.3 Beam size and uniformity . 8 6.4 Total irradiance (UV, visible and near-infrared rays). 8 7 Product application quantity and procedure 9 7.1 General 9 7.
14、2 Position of the subject . 9 7.3 Defining test sites 9 7.4 Application procedure . 10 8 Determination of minimal persistent pigment darkening doses (MPPDD) 10 8.1 UV exposure timing and subject position . 10 8.2 Determination of the minimal pigmenting dose on the unprotected test sites (MPPDDu) usi
15、ng a multiple-beam solar simulator 10 8.3 Determination of the MPPDDu using a single-beam output solar simulator . 11 8.4 Determination of the MPPDDp using a multiple-beam solar simulator 11 8.5 Determination of the MPPDDp on the protected test site with a single-beam solar simulator 12 9 Product re
16、moval . 12 10 MPPDD assessment procedure 13 10.1 Observation time for responses of MPPDDs 13 10.2 Position of subjects for MPPDD observations 13 10.3 MPPDD evaluation . 13 11 Calculations of the UVAPF and statistics 14 11.1 Calculation of the individual UVAPF (UVAPFi) for each test product for each
17、subject . 14 11.2 Calculation of the mean UVAPF . 14 11.3 Statistical test . 14 11.4 Test rejection for failure of meeting the statistical test for the reference sunscreen . 14 12 Test report . 14 Annex A (normative) Selection criteria for the test subjects 15 Annex B (normative) Definition of the s
18、ource of UVA radiation . 17 Annex C (normative) UVAPF reference sunscreen S1 . 19 Annex D (normative) Statistics and calculations . 26 Bibliography 29 DIN EN ISO 24442:2012-03 EN ISO 24442:2011 (E) Foreword This document (EN ISO 24442:2011) has been prepared by Technical Committee ISO/TC 217 “Cosmet
19、ics“ in collaboration with Technical Committee CEN/TC 392 “Cosmetics” the secretariat of which is held by AFNOR. 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 June 2012, and conflicting national
20、 standards shall be withdrawn at the latest by June 2012. 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
21、 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, Iceland, Ireland, Italy, Latvia, Lithuania,
22、Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 24442:2011 has been approved by CEN as a EN ISO 24442:2011 without any modification. 3DIN EN ISO 24442:2012-03 EN ISO 24442:201
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