EN ISO 24442:2022

Cosmetics - Sun protection test methods - In vivo determination of sunscreen UVA protection (ISO 24442:2022)

This document specifies a method for the in vivo determination of UVA protection factor (UVAPF) 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 UVA radiation induced by solar ultraviolet rays.

Kosmetische Mittel - Untersuchungsverfahren für Sonnenschutzmittel - In-vivo-Bestimmung des UVA Sonnenschutzes (ISO 24442:2022)

Dieses Dokument legt ein Verfahren zur In-vivo-Bestimmung des UVA-Schutzfaktors (UVASF) von Sonnen¬schutzmitteln fest. Es gilt für Erzeugnisse, welche jegliche Komponenten enthalten, 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 ultravioletten Sonnenstrahlen, die durch UVA-Strahlung induziert werden.

Cosmétiques - Méthodes d’essai de protection solaire - Détermination in vivo de la protection UVA d’un produit de protection solaire (ISO 24442:2022)

Le présent document spécifie une méthode de détermination in vivo du facteur de protection contre les UVA (FPUVA) des produits de protection solaire. Il 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.
Le présent document fournit une base pour l’évaluation des produits de protection solaire destinés à la protection de la peau humaine contre les rayonnements UVA induits par les rayons ultraviolets solaires.

Kozmetika - Metode za preskušanje zaščite pred soncem - Določevanje zaščitnega faktorja UVA in vivo (ISO 24442:2022)

Ta dokument določa metodo za določevanje faktorja zaščite pred soncem (UVAPF) 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 ki so namenjeni nanosu na človeško kožo.
Ta dokument zagotavlja podlago za vrednotenje izdelkov za zaščito človeške kože pred sevanjem UVA, ki ga povzročijo ultravijolični sončni žarki.

General Information

• Status: Published
• Publication Date: 21-Jun-2022
• Withdrawal Date: 30-Dec-2022
• 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: 22-Jun-2022
• Completion Date: 22-Jun-2022
• Ref Project: SIST EN ISO 24442:2022 - Cosmetics - Sun protection test methods - In vivo determination of sunscreen UVA protection (ISO 24442:2022)

Relations

• Replaces: EN ISO 24442:2011 - Cosmetics - Sun protection test methods - In vivo determination of sunscreen UVA protection (ISO 24442:2011)
• Effective Date: 29-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2022
Nadomešča:
SIST EN ISO 24442:2012
Kozmetika - Metode za preskušanje zaščite pred soncem - Določevanje zaščitnega
faktorja UVA in vivo (ISO 24442:2022)
Cosmetics - Sun protection test methods - In vivo determination of sunscreen UVA
protection (ISO 24442:2022)
Kosmetik - Prüfverfahren für Sonnenschutzmittel - In-vivo-Bestimmung des UVA-
Sonnenschutzes (ISO 24442:2022)
Cosmétiques - Méthodes d’essai de protection solaire - Détermination in vivo de la
protection UVA d’un produit de protection solaire (ISO 24442:2022)
Ta slovenski standard je istoveten z: EN ISO 24442:2022
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 24442
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2022
EUROPÄISCHE NORM
ICS 71.100.70 Supersedes EN ISO 24442:2011
English Version
Cosmetics - Sun protection test methods - In vivo
determination of sunscreen UVA protection (ISO
24442:2022)
Cosmétiques - Méthodes d'essai de protection solaire - Kosmetik - Prüfverfahren für Sonnenschutzmittel - In-
Détermination in vivo de la protection UVA d'un vivo-Bestimmung des UVA-Sonnenschutzes (ISO
produit de protection solaire (ISO 24442:2022) 24442:2022)
This European Standard was approved by CEN on 3 June 2022.

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
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 24442:2022 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 24442:2022) 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 December 2022, and conflicting national standards
shall be withdrawn at the latest by December 2022.
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 24442:2011.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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 24442:2022 has been approved by CEN as EN ISO 24442:2022 without any modification.

INTERNATIONAL ISO
STANDARD 24442
Second edition
2022-06
Cosmetics — Sun protection test
methods — In vivo determination of
sunscreen UVA protection
Cosmétiques — Méthodes d’essai de protection solaire —
Détermination in vivo de la protection UVA d’un produit de protection
solaire
Reference number
ISO 24442:2022(E)
ISO 24442:2022(E)
© ISO 2022
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]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 24442:2022(E)
Contents Page
Foreword .v
Introduction . vi
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 . 4
6.1 General . 4
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 . 5
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 .8
8.1 General . 8
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
9.4.1 Overview . 10
9.4.2 General . 10
9.4.3 Amount of product applied . 10
9.4.4 Mode of delivery . 11
9.4.5 Evaluation of application uniformity . 13
9.4.6 Drying time between application and UV exposure . .13
9.4.7 Exposure sub-sites . 13
9.5 UV exposure . 13
9.5.1 Provisional MPPDD . 13
iu
9.5.2 Estimated MPPDD .
...