EN ISO 24444:2020

Cosmetics - Sun protection test methods - In vivo determination of the sun protection factor (SPF) (ISO 24444:2019)

This document specifies a method for the in vivo determination of the sun protection factor (SPF) of sunscreen products. It 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.
This document provides a basis for the evaluation of sunscreen products for the protection of human skin against erythema induced by solar ultraviolet rays.

Kosmetische Mittel - Untersuchungsverfahren für Sonnenschutzmittel - In-vivo-Bestimmung des Sonnenschutzfaktors (SSF) (ISO 24444:2019)

Dieses Dokument legt ein Verfahren zur In vivo Bestimmung des Sonnenschutzfaktors (SSF) von Sonnen-schutzmitteln fest. Es gilt für Erzeugnisse, welche jegliche Komponenten beinhalten, die ultraviolette (UV )Strahlen absorbieren, reflektieren oder streuen können und dazu bestimmt sind, mit der menschlichen Haut in Kontakt gebracht zu werden.
Dieses Dokument dient als Basis für die Bewertung von Sonnenschutzmitteln zum Schutz der menschlichen Haut vor einem Erythem, das durch ultraviolette Sonnenstrahlen induziert wird.

Cosmétiques - Méthodes d'essai de protection solaire - Détermination in vivo du facteur de protection solaire (FPS) (ISO 24444:2019)

Le présent document spécifie une méthode de détermination in vivo du Facteur de Protection Solaire (FPS) des produits solaires. Il peut s'appliquer à des produits qui contiennent tout composant pouvant absorber, réfléchir ou diffuser les rayons ultraviolets (UV) et qui sont destinés à être mis en contact avec la peau humaine.
Le présent document 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 24444:2019)

Ta standard določa metodo za določevanje faktorja zaščite pred soncem (SPF) in vivo sredstev za zaščito kože pred soncem. Uporablja se za izdelke, ki vsebujejo katero koli sestavino za vpijanje, odbijanje ali razpršitev ultravijoličnih žarkov in so namenjeni nanosu na človeško kožo. Ta dokument zagotavlja podlago za vrednotenje sredstev za zaščito pred soncem, ki ščitijo človeško kožo pred pordelostjo zaradi ultravijoličnih sončnih žarkov.

General Information

• Status: Published
• Publication Date: 14-Jan-2020
• Withdrawal Date: 30-Jul-2020
• ICS: 71.100.70 - Cosmetics. Toiletries
• Technical Committee: CEN/TC 392 - Cosmetics
• Drafting Committee: CEN/TC 392 - Cosmetics
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 15-Jan-2020
• Completion Date: 15-Jan-2020
• Mandate: M/389 - Standardisation mandate assigned to CEN concerning methods for testing efficacy of suncreen products
• Ref Project: SIST EN ISO 24444:2020 - Cosmetics - Sun protection test methods - In vivo determination of the sun protection factor (SPF) (ISO 24444:2019)

Relations

• Replaces: EN ISO 24444:2010 - Cosmetics - Sun protection test methods - In vivo determination of the sun protection factor (SPF) (ISO 24444:2010)
• Effective Date: 21-Jan-2020
• Amended By: EN ISO 24444:2020/A1:2022 - Cosmetics - Sun protection test methods - In vivo determination of the sun protection factor (SPF) - Amendment 1 (ISO 24444:2019/Amd 1:2022)
• Effective Date: 23-Dec-2020

Standards Content (Sample)

SLOVENSKI STANDARD
01-marec-2020
Nadomešča:
SIST EN ISO 24444:2011
Kozmetika - Preskusne metode za zaščito pred soncem - Določevanje faktorja
zaščite pred soncem (SPF) in vivo (ISO 24444:2019)
Cosmetics - Sun protection test methods - In vivo determination of the sun protection
factor (SPF) (ISO 24444:2019)
Kosmetik - Untersuchungsverfahren für Sonnenschutzmittel - In-vivo-Bestimmung des
Sonnenschutzfaktors (SSF) (ISO 24444:2019)
Cosmétiques - Méthodes d'essai de protection solaire - Détermination in vivo du facteur
de protection solaire (FPS (ISO 24444:2019)
Ta slovenski standard je istoveten z: EN ISO 24444:2020
ICS:
71.100.70 Kozmetika. Toaletni Cosmetics. Toiletries
pripomočki
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 24444
EUROPEAN STANDARD
NORME EUROPÉENNE
January 2020
EUROPÄISCHE NORM
ICS 71.100.70 Supersedes EN ISO 24444:2010
English Version
Cosmetics - Sun protection test methods - In vivo
determination of the sun protection factor (SPF) (ISO
24444:2019)
Cosmétiques - Méthodes d'essai de protection solaire - Kosmetik - Untersuchungsverfahren für
Détermination in vivo du facteur de protection solaire Sonnenschutzmittel - In-vivo-Bestimmung des
(FPS) (ISO 24444:2019) Sonnenschutzfaktors (SSF) (ISO 24444:2019)
This European Standard was approved by CEN on 9 December 2019.

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, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 24444:2020 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 24444:2020) has been prepared by Technical Committee ISO/TC 217
"Cosmetics" 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 July 2020, and conflicting national standards shall be
withdrawn at the latest by July 2020.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 24444:2010.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association.
According to the CEN-CENELEC 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, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 24444:2019 has been approved by CEN as EN ISO 24444:2020 without any modification.

INTERNATIONAL ISO
STANDARD 24444
Second edition
2019-12
Cosmetics — 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)
Reference number
ISO 24444:2019(E)
©
ISO 2019
ISO 24444:2019(E)
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved

ISO 24444:2019(E)
Contents Page
Foreword .v
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General principle . 3
5 Test subjects . 3
5.1 Selection of the test subjects . 3
5.1.1 General. 3
5.1.2 Skin colour of the test subjects . 4
5.1.3 Age restriction. 4
5.1.4 Frequency of participation in tests . 4
5.1.5 Ethics and consent. 4
5.2 Number of test subjects . 4
6 Apparatus and materials — Source of ultraviolet radiation . 5
6.1 General . 5
6.2 Quality of ultraviolet radiation . 5
6.3 Total irradiance (UV, visible and near infrared rays) . 5
6.4 Uniformity of beam . 5
6.4.1 General. 5
6.4.2 Film densitometry . 6
6.4.3 UV sensor . 6
6.4.4 Large beam source . 6
6.4.5 Small beam source. 6
7 Maintenance and monitoring the UV solar simulator output . 7
7.1 Spectroradiometry . 7
7.2 Radiometry . 8
8 Reference sunscreen formulations . 9
8.1 General . 9
8.2 Reference standard to be used . 9
9 Procedure. 9
9.1 Main steps . 9
9.2 Test conditions .10
9.3 Position of the test subjects .10
9.4 Product application .10
9.5 Procedure for MED assessment . .14
9.5.1 General.14
9.5.2 Time of assessment of MED .14
9.5.3 Data rejection criteria . .15
9.5.4 Test failure criteria .16
9.5.5 Expression of MEDs . .16
10 Calculation of the sun protection factor and statistics .16
10.1 Calculation of the individual SPF (SPF ) .16
i
10.2 Calculation of product SPF .16
10.3 Statistical criterion .16
10.4 Valida
...