1、May 2013 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 11
2、.100.10; 71.100.70!%$*“2010788www.din.deDDIN EN ISO 24443Determination of sunscreen UVA photoprotection in vitro(ISO 24443:2012);English version EN ISO 24443:2012,English translation of DIN EN ISO 24443:2013-05In vitro Bestimmung des UVA-Schutzes von Sonnenschutzmitteln (ISO 24443:2012);Englische Fa
3、ssung EN ISO 24443:2012,Englische bersetzung von DIN EN ISO 24443:2013-05Dtermination in vitro de la photoprotection UVA (ISO 24443:2012);Version anglaise EN ISO 24443:2012,Traduction anglaise de DIN EN ISO 24443:2013-05SupersedesDIN EN ISO 24443:2012-09 andDIN 67502:2005-02www.beuth.deIn case of do
4、ubt, the German-language original shall be considered authoritative.Document comprises 32 pages04.13 DIN EN ISO 24443:2013-05 2 A comma is used as the decimal marker. National foreword This document (EN ISO 24443:2012) has been prepared by Technical Committee ISO/TC 217 “Cosmetics” in collaboration
5、with Technical Committee CEN/TC 392 “Cosmetics” (Secretariat: AFNOR, France). The responsible 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 Kosmetis
6、che Mittel. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). It should be noted that in the original reference version EN ISO 24443:2012, Annex E, E.4.4, the unit f
7、or viscosity is missing, but has been given in this document as a National footnote. In Clause 6 and Annexes A, B and F, reference is made to a spreadsheet. The relevant Excel files are available from the Normenausschuss Lebensmittel und landwirtschaftliche Produkte (Food and Agricultural Products S
8、tandards Committee) in DIN. Amendments Compared with DIN EN ISO 24443:2012-09, the following corrections have been made to the German version only: a) DIN 67502 has been added to the superseding note; b) information about the relevant Excel files for Clause 6 and Annexes A, B and F has been included
9、 in the National foreword. Previous editions DIN 67502: 2005-02 DIN EN ISO 24443: 2012-09 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 24443 June 2012 ICS 71.100.70 English Version Determination of sunscreen UVA photoprotection in vitro Dtermination in vitro de la photoprotection UVA In
10、vitro Bestimmung des UVA-Schutzes von Sonnenschutzmitteln (ISO 24443:2012) This European Standard was approved by CEN on 24 May 2012. 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 st
11、andard 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 official versions (English, French, German). A version in
12、 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 Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech R
13、epublic, Denmark, Estonia, Finland, France, Germany, 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 STANDARDIZATION COMIT
14、 EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 24443:2012: E(ISO 24443:2012) (ISO 24443:2012) Contents Page For
15、eword . 3 1 Scope . 4 2 Terms and definitions 4 3 Principle 5 4 Apparatus 5 4.1 UV spectrophotometer specifications . 5 4.2 Calibration of the UV spectrophotometer 6 4.3 Calibration of the UV exposure source 6 4.4 Monitoring of the UV exposure source 6 4.5 Calibration of the UVA radiometer used to m
16、onitor the test sample irradiation . 7 4.6 Substrate/plate . 7 5 Test method 7 5.1 Outline of the test procedure 7 5.2 Equipment calibration and validation of test plates . 7 5.3 Absorption measurements through the plate . 8 5.4 Sample application . 8 5.5 Absorbance measurements of the product-treat
17、ed plate 8 5.6 Number of determinations 8 5.7 Determination of initial calculated SPF (SPFin vitro), “C” value, initial UVAPF(UVAPF0), and UV exposure dose. 8 5.8 UV exposure . 10 5.9 Measurement of final adjusted absorbance spectrum . 10 5.10 Calculation of UVAPF of plates after UV exposure of the
18、sample 11 6 Procedure using the spreadsheet in this International Standard . 11 7 Reference sunscreen formula S2 . 12 8 Test report . 12 Annex A (normative) Calibration of UV spectrophotometer and plate transmission test . 13 Annex B (normative) Radiometer calibration to spectroradiometric irradianc
19、e procedure 17 Annex C (normative) Computation values: PPD and erythema action spectra and UVA and UV-SSR spectral irradiances . 19 Annex D (normative) PMMA test plate surface specifications 22 Annex E (normative) UVA reference sunscreen S2 . 24 Annex F (informative) Statistical calculations 28 Bibl
20、iography 30 2DIN EN ISO 24443:2013-05 EN ISO 24443:2012 (E) Foreword This document (EN ISO 24443:2012) has been prepared by Technical Committee ISO/TC 217 in collaboration with Technical Committee CEN/TC 392 “Cosmetics” the secretariat of which is held by AFNOR. This European Standard shall be given
21、 the status of a national standard, either by publication of an identical text or by endorsement, at the latest by December 2012, and conflicting national standards shall be withdrawn at the latest by December 2012. Attention is drawn to the possibility that some of the elements of this document may
22、 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 Internal Regulations, the national standards organisations of the following countries are bound to implement this European Standard: Austria,
23、 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, Turkey and the United Kingd
24、om. Endorsement notice The text of ISO 24443:2012 has been approved by CEN as a EN ISO 24443:2012 without any modification. “Cosmetics”3DIN EN ISO 24443:2013-05EN ISO 24443:2012 (E)1 ScopeThis International Standard specifies an in vitro procedure to characterize the UVA protection of sunscreen prod
25、ucts. Specifications are given to enable determination of the spectral absorbance characteristics of UVA protection in a reproducible manner. In order to determine relevant UVA protection parameters, the method has been created to provide a UV spectral absorbance curve from which a number of calcula
26、tions and evaluations can be undertaken. Results from this measurement procedure can be used for other computations, as required by local regulatory authorities. These include calculation of the Ultraviolet-A protection factor (UVAPF) correlating with in vivo UVAPF from the persistent pigment darken
27、ing (PPD) testing procedure, critical wavelength and UVA absorbance proportionality. These computations are optional and relate to local sunscreen product labelling requirements. This method relies on the use of in vivo SPF results for scaling the UV absorbance curve.This International Standard is n
28、ot applicable to powder products such as pressed powder and loose powder products.2 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.2.1in vitro UVA protection factorUVAPFin vitro UVA protection factor of a sun protection product against UVA radiation
29、, which can be derived mathematically with in vitro spectral modelling2.2in vitro calculation of SPFSPFin vitroprotection factor of a sun protection product against erythema-inducing radiation calculated with spectral modelling2.3action spectrum for erythemaE(l)relative effects of individual spectra
30、l bands of an exposure source for an erythema responseNOTE See References 1 and 2.2.4action spectrum for PPDP(l)relative effects of individual spectral bands of an exposure source for a persistent pigment responseNOTE See References 3 and 4.2.5monochromatic absorbanceAlsunscreen absorbance at wavele
31、ngth, l, related to the sunscreen transmittance, Tl, byAl= - log (Tl)where transmittance, Tl, is the fraction of incident irradiance transmitted by the sunscreen film4DIN EN ISO 24443:2013-05 EN ISO 24443:2012 (E) 2.6irradianceIfluence rate per unit area, expressed in W/m2, for a defined range of wa
32、velengthsEXAMPLE From 290 nm to 400 nm for UVA + UVB irradiance; from 320 nm to 400 nm for UVA irradiance.2.7spectral irradiance for SPF testing or PPD testingI(l)irradiance per unit wavelength, I(l) , expressed in W/m2/nm2.8spectrophotometerinstrument that measures absorbance (or transmission) prop
33、erties of a test medium as a function of wavelength2.9spectroradiometerinstrument that measures spectral irradiance (intensity in watts per unit area per nanometre) of electromagnetic sourcesNOTE Limited to ultraviolet, visible and short infrared ranges in this International Standard.2.10radiometeri
34、nstrument that measures broad band irradiance (intensity in watts per unit area) of electromagnetic sourcesNOTE Limited to ultraviolet, visible and short infrared ranges in this International Standard.3 PrincipleThe test is based on the assessment of UV-transmittance through a thin film of sunscreen
35、 sample spread on a roughened substrate, before and after exposure to a controlled dose of radiation from a defined UV exposure source. Because of the several variables that cannot be controlled with typical thin film spectroscopic techniques, each set of sunscreen transmission data is mathematicall
36、y adjusted so that the in vitro SPF data yield the same measured in vivo SPF value that was determined by in vivo testing. Samples are then exposed to a specific measured dose of UV radiation to account for the photostability characteristics of the test product. The resulting spectral absorbance dat
37、a have been shown to be a useful representation of both the width and height of the UVA protection characteristics of the sunscreen product being tested. The mathematical modelling procedure has been empirically derived to correlate with human in vivo (persistent pigment darkening) test results.4 Ap
38、paratus4.1 UV spectrophotometer specificationsThe UV spectrophotometer wavelength range shall span the primary waveband of 290 nm to 400 nm. The wavelength increment step shall be 1 nm.A UV spectrophotometer that does not have a monochromator after the test sample should employ a fluorescence reject
39、ion filter.The UV spectrophotometer input optics should be designed for diffuse illumination and/or diffuse collection of the transmitted irradiance through the roughened polymethylmethacrylate (PMMA) substrate, with and without the sunscreen layer spread on its surface. The size of the diameter of
40、the entrance port of the UV spectrophotometer probe shall be smaller than the size of the light spot to be measured at the sample level (in order to account for stray light). The area of each reading site should be at least 0,5 cm2in order to reduce the variability between readings and to compensate
41、 for the lack of uniformity in the product layer. The wavelength should be accurate to within 1 nm, as checked using a holmium-doped filter (see Annex A). The ability of an instrument to accurately measure absorbance is limited by the sensitivity of the instrument. The minimum 5DIN EN ISO 24443:2013
42、-05EN ISO 24443:2012 (E)required dynamic range for this methodology is 2,2 absorbance units as determined according to Annex A. The maximum measured absorbance should be within the dynamic range of the device used. If the test measurements yield absorbance curves that exceed the determined upper lim
43、it of the UV spectrophotometer, the product should be re-tested using an instrument with increased sensitivity and dynamic range.The lamp in the UV spectrophotometer that is used to measure the transmittance shall emit continuous radiation over the range of 290 nm to 400 nm, and the level of irradia
44、nce should be sufficiently low, so that the photostability of the product is not unduly challenged (a xenon flash lamp is a convenient solution). Therefore the UV dose during one measurement cycle should not exceed 0,2 J/cm2.NOTE A UV spectrophotometer is used to measure the absorbance properties of
45、 the sunscreen on the test plates. A spectroradiometer is used to measure the spectral energy distribution and intensity of the UV exposure source or the UV spectrophotometer during the absorbance measurement of the sunscreen on the test plate.4.2 Calibration of the UV spectrophotometerThe UV spectr
46、ophotometer shall be validated at regular intervals (recommended at least every month) by measurements of reference materials.A three-fold test is required, as described in Annex A: dynamic range of the UV spectrophotometer; linearity test of the UV spectrophotometer; wavelength accuracy test.4.3 Ca
47、libration of the UV exposure source The spectral irradiance at the exposure plane of the UV exposure source that is used for irradiation (to take into account any photoinstability) shall be as similar as possible to the irradiance at ground level under a standard zenith sun5as defined by COLIPA6or i
48、n DIN 675017. The UV irradiance shall be within the following acceptance limits (measured at sample distance).Table 1 UV exposure source specificationsUV exposure source specifications as measured with a spectroradiometerTotal UV irradiance (290 nm to 400 nm) 40 W/m2to 200 W/m2Irradiance ratio of UV
49、Aato UVBb8:22a320 nm to 400 nm.b290 nm to 320 nm.The UV exposure source device should have the ability to maintain samples within the range of 25 C to 35 C. It is important that the temperature of the sample itself be measured and not just the surrounding air temperature. To maintain samples at a temperature less than or equal to 35 C, a filter system that particularly reduces IR radiation should be used to achieve the specified temperature range. Cooling trays for the
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