Cosmetics - Sun protection test methods - In vivo determination of the sun protection factor (SPF) (ISO 24444:2010)

ISO 24444:2010 specifies a method for the in vivo determination of the sun protection factor (SPF) of sunscreen products. This International Standard is applicable to products that contain any component able to absorb, reflect or scatter ultraviolet (UV) rays and which are intended to be placed in contact with human skin.
ISO 24444:2010 provides a basis for the evaluation of sunscreen products for the protection of human skin against erythema induced by solar ultraviolet rays.

Kosmetik - Untersuchungsverfahren für Sonnenschutzmittel - In-vivo-Bestimmung des Sonnenschutzfaktors (SSF) (ISO 24444:2010)

Diese Internationale Norm beschreibt ein Verfahren zur In vivo Bestimmung des Lichtschutzfaktors (LSF) von Sonnenschutzmitteln. Diese internationale Norm gilt für Präparate, die in Kontakt mit menschlicher Haut gebracht werden sollen, einschließlich jeglicher Komponenten, die UV Strahlen absorbieren, reflektieren oder streuen können.
Sie dient als eine Basis für die Bewertung von Sonnenschutzmitteln zum Schutz der menschlichen Haut gegen Erytheme oder Sonnenbrand, die (der) durch ultraviolette Sonnenstrahlen induziert wurde(n).

Cosmétiques - Méthodes d'essai de protection solaire - Détermination in vivo du facteur de protection solaire (FPS) (ISO 24444:2010)

L'ISO 24444:2010 spécifie une méthode de détermination in vivo du Facteur de Protection Solaire (FPS) des produits solaires. La présente Norme internationale peut s'appliquer à des produits qui contiennent tout composant pouvant absorber, refléter ou diffuser les rayons ultraviolets (UV) et qui sont destinés à être mis en contact avec la peau humaine.
L'ISO 24444:2010 fournit une base pour l'évaluation des produits solaires destinés à la protection de la peau humaine contre un érythème ou un coup de soleil induits par les rayons ultraviolets solaires.

Kozmetika - Preskusne metode za zaščito pred soncem - Določevanje faktorja zaščite pred soncem (SPF) in vivo (ISO 24444:2010)

Ta mednarodni standard določa metodo za določevanje faktorja zaščite pred soncem (SPF) in vivo pri proizvodih za zaščito pred soncem. Ta mednarodni standard velja za proizvode, ki vsebujejo katero koli komponento, sposobno vpijati, odbijati ali razprševati ultravijolične žarke, namenjene nanosu v stiku s človeško kožo. Zagotavlja podlago za ocenjevanje proizvodov za zaščito človeške kože pred kožno rdečino, ki jo povzročajo sončni ultravijoličnimi žarki.

General Information

Status
Withdrawn
Publication Date
14-Nov-2010
Withdrawal Date
14-Jan-2020
Technical Committee
Drafting Committee
Current Stage
9960 - Withdrawal effective - Withdrawal
Completion Date
15-Jan-2020

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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Kosmetik - Untersuchungsverfahren für Sonnenschutzmittel - In-vivo-Bestimmung des Sonnenschutzfaktors (SSF) (ISO 24444:2010)Cosmétiques - Méthodes d'essai de protection solaire - Détermination in vivo du facteur de protection solaire (FPS) (ISO 24444:2010)Cosmetics - Sun protection test methods - In vivo determination of the sun protection factor (SPF) (ISO 24444:2010)71.100.70SULSRPRþNLCosmetics. ToiletriesICS:Ta slovenski standard je istoveten z:EN ISO 24444:2010SIST EN ISO 24444:2011en,de01-april-2011SIST EN ISO 24444:2011SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 24444
November 2010 ICS 71.100.70 English Version
Cosmetics - Sun protection test methods -In vivo determination of the sun protection factor (SPF) (ISO 24444:2010)
Cosmétiques - Méthodes d'essai de protection solaire - Détermination in vivo du facteur de protection solaire (FPS) (ISO 24444:2010)
Kosmetik -Untersuchungsverfahren für Sonnenschutzmittel - In-vivo- Bestimmung des LSF (Lichtschutzfaktors) (ISO 24444:2010) This European Standard was approved by CEN on 26 May 2010.
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 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 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 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.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2010 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 24444:2010: ESIST EN ISO 24444:2011

Reference numberISO 24444:2010(E)© ISO 2010
INTERNATIONAL STANDARD ISO24444First edition2010-11-15Cosmetics — Sun protection test methods — In vivo determination of the sun protection factor (SPF) Cosmétiques — Méthodes d'essai de protection solaire — Détermination in vivo du facteur de protection solaire (FPS)
ISO 24444:2010(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
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ISO 2010 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's member body in the country of the requester. ISO copyright office Case postale 56 • CH-1211 Geneva 20 Tel.
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ii © ISO 2010 – All rights reserved
ISO 24444:2010(E) © ISO 2010 – All rights reserved iii Contents Page Foreword.iv Introduction.v 1 Scope.1 2 Terms and definitions.1 3 General principle.2 4 Test subjects.3 4.1 Selection of the test subjects.3 4.2 Number of test subjects.3 4.3 Test area.4 5 Apparatus and materials.4 5.1 Source of ultraviolet radiation.4 5.2 Reference sunscreen formulations.5 6 Procedure.6 6.1 Main steps.6 6.2 Test conditions.6 6.3 Position of the test subjects.6 6.4 Procedure for product application.6 6.5 Procedure for UV exposure.8 6.6 Product removal.9 6.7 Procedure for MED assessment.9 7 Calculation of the sun protection factor and statistics.10 7.1 Calculation of the individual SPF (SPFi).10 7.2 Calculation of product SPF.10 7.3 Statistical criterion.10 7.4 Validation of the test.10 8 Test report.11 Annex A (normative)
Selection criteria for the test subjects.12 Annex B (normative)
Definition of the UV solar simulator output.15 Annex C (normative)
SPF reference sunscreen formulations.23 Annex D (normative)
Calculations and statistics.32 Annex E (informative)
Colorimetric determination of skin colour typing and prediction of the minimal erythemal dose (MED) without UV exposure.38 Bibliography.45
ISO 24444:2010(E) iv © ISO 2010 – All rights reserved Foreword 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 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 matters 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 circulated 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 responsible for identifying any or all such patent rights. ISO 24444 was prepared by Technical Committee ISO/TC 217, Cosmetics. SIST EN ISO 24444:2011

ISO 24444:2010(E) © ISO 2010 – All rights reserved v Introduction The level of sun protection provided by sunscreen products has traditionally been estimated using the sun protection factor or SPF test, which uses the erythemal response of the skin to ultraviolet (UV) radiation. The SPF is a ratio calculated from the energies required to induce a minimum erythemal response with and without sunscreen product applied to the skin of human volunteers. It uses ultraviolet radiation usually from an artificial source. Different standard methods are available and described in the technical report ISO/TR 26369[4]. These standards are similar by some parameters but different by others. Differences can lead to discrepancy of results. Harmonization is therefore necessary to get the same SPF value for a single product whatever the country in which it is tested. SIST EN ISO 24444:2011

INTERNATIONAL STANDARD ISO 24444:2010(E) © ISO 2010 – All rights reserved 1 Cosmetics — Sun protection test methods — In vivo determination of the sun protection factor (SPF) 1 Scope This International Standard specifies a method for the in vivo determination of the sun protection factor (SPF) of sunscreen products. This International standard is applicable to products that contain any component able to absorb, reflect or scatter ultraviolet (UV) rays and which are intended to be placed in contact with human skin. It provides a basis for the evaluation of sunscreen products for the protection of human skin against erythema induced by solar ultraviolet rays. 2 Terms and definitions For the purposes of this document, the following terms and definitions apply. 2.1 ultraviolet radiation UVR electromagnetic radiation in the range of 290 nm to 400 nm 2.1.1 ultraviolet B UVB electromagnetic radiation in the range of 290 nm to 320 nm 2.1.2 ultraviolet A UVA electromagnetic radiation in the range of 320 nm to 400 nm NOTE UVA II = 320 nm to 340 nm; UVA I = 340 nm to 400 nm. 2.2 erythema reddening of the skin caused by UV radiation 2.3 sunscreen products products containing any component able to absorb, reflect or scatter UV rays, which are intended to be placed in contact with human skin 2.4 minimal erythemal dose MED lowest dose of ultraviolet radiation (UVR) that produces the first perceptible unambiguous erythema with defined borders appearing over most of the field of UV exposure, 16 h to 24 h after UV exposure SIST EN ISO 24444:2011

ISO 24444:2010(E) 2 © ISO 2010 – All rights reserved 2.4.1 MEDu MED on unprotected skin 2.4.2 MEDp MED on product protected skin 2.5 individual sun protection factor SPFi ratio of the minimal erythemal dose on product protected skin (MEDp) to the minima
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