SIST ISO 18861:2021

Cosmetics - Sun protection test methods - Percentage of water resistance

This document specifies a procedure for evaluating the water resistance retention percentage, by comparing the sun protection factor (SPF) before water immersion (hereafter referred to as the "static" SPF) and after a fixed period of water immersion (hereafter referred to as the "wet" SPF).

Cosmétiques - Méthodes d’essai de protection solaire - Pourcentage de résistance à l’eau

Le présent document spécifie un mode opératoire pour évaluer le pourcentage de rémanence ŕ l'eau en comparant le facteur de protection solaire (FPS) avant immersion dans l'eau (appelé ici « FPS statique ») et aprčs une durée fixe d'immersion dans l'eau (appelé ici « FPS humide »).

Kozmetika - Preskusne metode za zaščito pred soncem - Odstotek vodoodpornosti

General Information

• Status: Published
• Public Enquiry End Date: 04-Dec-2019
• Publication Date: 06-Dec-2020
• ICS: 71.100.70 - Cosmetics. Toiletries
• Technical Committee: KDS - Cosmetics, chemical disinfectants and surface active agents
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 23-Nov-2020
• Due Date: 28-Jan-2021
• Completion Date: 07-Dec-2020
• Ref Project: ISO 18861:2020 - Cosmetics — Sun protection test methods — Percentage of water resistance

Standards Content (Sample)

SLOVENSKI STANDARD
SIST ISO 18861:2021
01-januar-2021
Kozmetika - Preskusne metode za zaščito pred soncem - Odstotek vodoodpornosti
Cosmetics - Sun protection test methods - Percentage of water resistance
Cosmétiques - Méthodes d’essai de protection solaire - Pourcentage de résistance à
l’eau
Ta slovenski standard je istoveten z: ISO 18861:2020
ICS:
71.100.70 Kozmetika. Toaletni Cosmetics. Toiletries
pripomočki
SIST ISO 18861:2021 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST ISO 18861:2021

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SIST ISO 18861:2021
INTERNATIONAL ISO
STANDARD 18861
First edition
2020-09
Cosmetics — Sun protection test
methods — Percentage of water
resistance
Cosmétiques — Méthodes d’essai de protection solaire — Pourcentage
de résistance à l’eau
Reference number
ISO 18861:2020(E)
©
ISO 2020

---------------------- Page: 3 ----------------------
SIST ISO 18861:2021
ISO 18861:2020(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
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 2020 – All rights reserved

---------------------- Page: 4 ----------------------
SIST ISO 18861:2021
ISO 18861:2020(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Test method . 2
4.1 Outline of the method . 2
4.2 Test subject selection. 2
4.3 Test area . 2
4.4 Product application . 2
4.5 Water immersion procedure . 2
4.6 Reference water resistant sun product . 3
4.7 Determination of the minimum erythemal dose (MED) . 3
4.8 Number of test subjects . 3
4.9 Test chronology . 3
5 Calculations and data handling . 3
5.1 General . 3
5.2 SPF before immersion. 3
5.3 SPF after immersion . 4
5.4 Individual percentage of water resistance . 4
5.5 Mean percentage of water resistance . 4
5.6 Calculation of lower confidence limit on the mean percentage of water resistance . 4
5.7 Acceptance criteria for reference product P2 . 5
6 Test report . 5
Annex A (normative) Simulated swim test device design . 6
Annex B (normative) Test procedure and chronology . 7
Annex C (normative) Standard reference sunscreen .10
Bibliography .11
© ISO 2020 – All rights reserved iii

---------------------- Page: 5 ----------------------
SIST ISO 18861:2021
ISO 18861:2020(E)

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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 217, Cosmetics.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2020 – All rights reserved

---------------------- Page: 6 ----------------------
SIST ISO 18861:2021
ISO 18861:2020(E)

Introduction
The protection which cosmetic products containing organic or inorganic sunscreens provide against
sunburn is neither absolute nor permanent.
One of the many factors that can have an effect on the level of protection given by these products is
water contact. UV absorbers in the formulation can leach out or be physically removed by the washing
action in the sea or swimming pool.
In order to make the sun products more effective, manufacturers have developed formulations which
are more substantive to the skin during water immersion. These products have been variously labelled
as water resistant or very water resistant.
In order to substantiate these product efficacy claims, a number of methods has been developed and
published: including a method promulgated in the United States of America FDA monograph on OTC
sunscreen drug products (Federal Register/ Vol. 58, No 90). Standard methods have also been published
in Australia/New Zealand (AS/NZS 2640) and in the Republic of South Africa (SABS 1557).
The method for conditions required for water resistance SPF test exists as an International Standard,
i.e. ISO 16217, and requires a sun protection factor to be measured following a defined water immersion
procedure.
This document describes the procedure for water resistant percentage calculation, based on water
immersion procedure described in ISO 16217, which is the ratio between before and after bath SPF.
The SPF measurement procedure is that described by ISO 24444.
All references to the sun protection factor (SPF) test method herein, relate to ISO 24444.
The reader should ensure that the latest version of ISO 24444 sun protection factor (SPF) test method
is followed.
© ISO 2020 – All rights reserved v

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SIST ISO 18861:2021

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SIST ISO 18861:2021
INTERNATIONAL STANDARD ISO 18861:2020(E)
Cosmetics — Sun protection test methods — Percentage of
water resistance
1 Scope
This document specifies a procedure for evaluating the water resistance retention percentage, by
comparing the sun protection factor (SPF) before water immersion (hereafter referred to as the “static”
SPF) and after a fixed period of water immersion (hereafter referred to as the “wet” SPF).
2 Normative references
The following document is referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 16217:2020, Cosmetics — Sun protection test methods — Water immersion procedure for determining
water resistance
ISO 24444:2019, Cosmetics — Sun protection test methods — In vivo determination of the sun protection
factor (SPF)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
simulated swim test device
spa, whirlpool or similar device designed for water immersion
[SOURCE: ISO 16217:2020, 3.1]
3.2
standardized water
water for use in the simulated swim test device (3.1)
3.3
static sun protection factor
static SPF
SPF
is
SPF without water resistance challenge
3.4
SPF before water immersion
arithmetic mean of all valid SPF (3.3) values for the study, expressed to one decimal by truncation
is
© ISO 2020 – All rights reserved 1

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SIST ISO 18861:2021
ISO 18861:2020(E)

3.5
individual water resistance sun protection factor
individual water resistance SPF
SPF
iwr
SPF determined after the water immersion step on each subject
3.6
SPF post water immersion
arithmetic mean of all valid SPF (3.5) values for the study, expressed to one decimal by truncation
iwr
4 Test method
4.1 Outline of the method
The principle is to compare the sun protection factor (SPF) for a sunscreen product after a period of
immersion in water with the static SPF without immersion in water.
4.2 Test subject selection
Participants are enrolled for the study in accordance with the criteria described in ISO 24444. At least
10 subjects shall be selected.
[1]
The Declaration of Helsinki is relevant to testing using human subjects. Informed, written (signature)
consent shall be obtained from all test subjects. The consent should include specific consent to
participate in water resistance testing including length of time — temperature of the water — likelihood
of becoming chilled during testing.
4.3 Test area
As per the requirements of ISO 24444, the individual product test sites and the unprotected test site
shall be delineated within the region between the scapula line and the waist. Additionally, the test sites
shall be configured such that they will be fully immersed when the test subject is located comfortably
in the simulated swim test device. Test product application to test sites should be randomized on each
individual subject and over the whole test panel, as described in ISO 24444.
4.4 Product application
The product shall be applied according to the procedure set out in ISO 24444.
4.5 Water immersion procedure
The static SPF (SPF ) is determined in accordance with the ISO 24444.
is
To determine the SPF post water immersion (SPF ), ISO 24444 shall be followed to the point where
iwr
the product under
...

INTERNATIONAL ISO
STANDARD 18861
First edition
2020-09
Cosmetics — Sun protection test
methods — Percentage of water
resistance
Cosmétiques — Méthodes d’essai de protection solaire — Pourcentage
de résistance à l’eau
Reference number
ISO 18861:2020(E)
©
ISO 2020

---------------------- Page: 1 ----------------------
ISO 18861:2020(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
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 2020 – All rights reserved

---------------------- Page: 2 ----------------------
ISO 18861:2020(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Test method . 2
4.1 Outline of the method . 2
4.2 Test subject selection. 2
4.3 Test area . 2
4.4 Product application . 2
4.5 Water immersion procedure . 2
4.6 Reference water resistant sun product . 3
4.7 Determination of the minimum erythemal dose (MED) . 3
4.8 Number of test subjects . 3
4.9 Test chronology . 3
5 Calculations and data handling . 3
5.1 General . 3
5.2 SPF before immersion. 3
5.3 SPF after immersion . 4
5.4 Individual percentage of water resistance . 4
5.5 Mean percentage of water resistance . 4
5.6 Calculation of lower confidence limit on the mean percentage of water resistance . 4
5.7 Acceptance criteria for reference product P2 . 5
6 Test report . 5
Annex A (normative) Simulated swim test device design . 6
Annex B (normative) Test procedure and chronology . 7
Annex C (normative) Standard reference sunscreen .10
Bibliography .11
© ISO 2020 – All rights reserved iii

---------------------- Page: 3 ----------------------
ISO 18861:2020(E)

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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 217, Cosmetics.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2020 – All rights reserved

---------------------- Page: 4 ----------------------
ISO 18861:2020(E)

Introduction
The protection which cosmetic products containing organic or inorganic sunscreens provide against
sunburn is neither absolute nor permanent.
One of the many factors that can have an effect on the level of protection given by these products is
water contact. UV absorbers in the formulation can leach out or be physically removed by the washing
action in the sea or swimming pool.
In order to make the sun products more effective, manufacturers have developed formulations which
are more substantive to the skin during water immersion. These products have been variously labelled
as water resistant or very water resistant.
In order to substantiate these product efficacy claims, a number of methods has been developed and
published: including a method promulgated in the United States of America FDA monograph on OTC
sunscreen drug products (Federal Register/ Vol. 58, No 90). Standard methods have also been published
in Australia/New Zealand (AS/NZS 2640) and in the Republic of South Africa (SABS 1557).
The method for conditions required for water resistance SPF test exists as an International Standard,
i.e. ISO 16217, and requires a sun protection factor to be measured following a defined water immersion
procedure.
This document describes the procedure for water resistant percentage calculation, based on water
immersion procedure described in ISO 16217, which is the ratio between before and after bath SPF.
The SPF measurement procedure is that described by ISO 24444.
All references to the sun protection factor (SPF) test method herein, relate to ISO 24444.
The reader should ensure that the latest version of ISO 24444 sun protection factor (SPF) test method
is followed.
© ISO 2020 – All rights reserved v

---------------------- Page: 5 ----------------------
INTERNATIONAL STANDARD ISO 18861:2020(E)
Cosmetics — Sun protection test methods — Percentage of
water resistance
1 Scope
This document specifies a procedure for evaluating the water resistance retention percentage, by
comparing the sun protection factor (SPF) before water immersion (hereafter referred to as the “static”
SPF) and after a fixed period of water immersion (hereafter referred to as the “wet” SPF).
2 Normative references
The following document is referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 16217:2020, Cosmetics — Sun protection test methods — Water immersion procedure for determining
water resistance
ISO 24444:2019, Cosmetics — Sun protection test methods — In vivo determination of the sun protection
factor (SPF)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
simulated swim test device
spa, whirlpool or similar device designed for water immersion
[SOURCE: ISO 16217:2020, 3.1]
3.2
standardized water
water for use in the simulated swim test device (3.1)
3.3
static sun protection factor
static SPF
SPF
is
SPF without water resistance challenge
3.4
SPF before water immersion
arithmetic mean of all valid SPF (3.3) values for the study, expressed to one decimal by truncation
is
© ISO 2020 – All rights reserved 1

---------------------- Page: 6 ----------------------
ISO 18861:2020(E)

3.5
individual water resistance sun protection factor
individual water resistance SPF
SPF
iwr
SPF determined after the water immersion step on each subject
3.6
SPF post water immersion
arithmetic mean of all valid SPF (3.5) values for the study, expressed to one decimal by truncation
iwr
4 Test method
4.1 Outline of the method
The principle is to compare the sun protection factor (SPF) for a sunscreen product after a period of
immersion in water with the static SPF without immersion in water.
4.2 Test subject selection
Participants are enrolled for the study in accordance with the criteria described in ISO 24444. At least
10 subjects shall be selected.
[1]
The Declaration of Helsinki is relevant to testing using human subjects. Informed, written (signature)
consent shall be obtained from all test subjects. The consent should include specific consent to
participate in water resistance testing including length of time — temperature of the water — likelihood
of becoming chilled during testing.
4.3 Test area
As per the requirements of ISO 24444, the individual product test sites and the unprotected test site
shall be delineated within the region between the scapula line and the waist. Additionally, the test sites
shall be configured such that they will be fully immersed when the test subject is located comfortably
in the simulated swim test device. Test product application to test sites should be randomized on each
individual subject and over the whole test panel, as described in ISO 24444.
4.4 Product application
The product shall be applied according to the procedure set out in ISO 24444.
4.5 Water immersion procedure
The static SPF (SPF ) is determined in accordance with the ISO 24444.
is
To determine the SPF post water immersion (SPF ), ISO 24444 shall be followed to the point where
iwr
the product under test has been applied to the subject’s skin.
Product treated skin is then immersed in water according to the process described in ISO 16217.
The following sequence of immersion and rest period shall be followed:
— 20 min of immersion of the test subjects with water circulated for the full period;
— 5 min to 20 min drying time with no towelling permitted between immersion periods.
For 40 min water resistance, repeat this sequence
...

NORME ISO
INTERNATIONALE 18861
Première édition
2020-09
Cosmétiques — Méthodes d’essai de
protection solaire — Pourcentage de
résistance à l’eau
Cosmetics — Sun protection test methods — Percentage of water
resistance
Numéro de référence
ISO 18861:2020(F)
©
ISO 2020

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ISO 18861:2020(F)

DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2020
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
Tél.: [phone]
E-mail: [e-mail]
Web: www.iso.org
Publié en Suisse
ii © ISO 2020 – Tous droits réservés

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ISO 18861:2020(F)

Sommaire Page
Avant-propos .iv
Introduction .v
1 Domaine d’application . 1
2 Références normatives . 1
3 Termes et définitions . 1
4 Méthode d’essai . 2
4.1 Présentation de la méthode . 2
4.2 Sélection des volontaires participant à l’essai . 2
4.3 Zone d’essai . 2
4.4 Application du produit . 2
4.5 Mode opératoire d’immersion dans l’eau . 2
4.6 Produit solaire de référence résistant à l’eau . 3
4.7 Détermination de la dose érythémale minimale (DEM) . 3
4.8 Nombre de volontaires participant à l’essai . 3
4.9 Chronologie de l’essai . 3
5 Calculs et gestion des données . 4
5.1 Généralités . 4
5.2 FPS avant immersion . 4
5.3 FPS après immersion . 4
5.4 Pourcentage individuel de résistance à l’eau . 4
5.5 Pourcentage moyen de résistance à l’eau . 4
5.6 Calcul de la limite de confiance inférieure sur le pourcentage moyen de résistance à l’eau 4
5.7 Critères d’acceptation pour le produit de référence P2 . 5
6 Rapport d’essai . 5
Annexe A (normative) Conception du dispositif d’immersion . 6
Annexe B (normative) Mode opératoire d’essai et chronologie . 7
Annexe C (normative) Formulation solaire de référence standard .10
Bibliographie .11
© ISO 2020 – Tous droits réservés iii

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ISO 18861:2020(F)

Avant-propos
L’ISO (Organisation internationale de normalisation) est une fédération mondiale d’organismes
nationaux de normalisation (comités membres de l’ISO). L’élaboration des Normes internationales est
en général confiée aux comités techniques de l’ISO. Chaque comité membre intéressé par une étude
a le droit de faire partie du comité technique créé à cet effet. Les organisations internationales,
gouvernementales et non gouvernementales, en liaison avec l’ISO participent également aux travaux.
L’ISO collabore étroitement avec la Commission électrotechnique internationale (IEC) en ce qui
concerne la normalisation électrotechnique.
Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont
décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier, de prendre note des différents
critères d’approbation requis pour les différents types de documents ISO. Le présent document a été
rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2 (voir www
.iso .org/ directives).
L’attention est attirée sur le fait que certains des éléments du présent document peuvent faire l’objet de
droits de propriété intellectuelle ou de droits analogues. L’ISO ne saurait être tenue pour responsable
de ne pas avoir identifié de tels droits de propriété et averti de leur existence. Les détails concernant
les références aux droits de propriété intellectuelle ou autres droits analogues identifiés lors de
l’élaboration du document sont indiqués dans l’Introduction et/ou dans la liste des déclarations de
brevets reçues par l’ISO (voir www .iso .org/ brevets).
Les appellations commerciales éventuellement mentionnées dans le présent document sont données
pour information, par souci de commodité, à l’intention des utilisateurs et ne sauraient constituer un
engagement.
Pour une explication de la nature volontaire des normes, la signification des termes et expressions
spécifiques de l’ISO liés à l’évaluation de la conformité, ou pour toute information au sujet de l’adhésion
de l’ISO aux principes de l’Organisation mondiale du commerce (OMC) concernant les obstacles
techniques au commerce (OTC), voir le lien suivant: www .iso .org/ iso/ fr/ avant -propos.
Le présent document a été élaboré par le comité technique ISO/TC 217, Cosmétiques.
Il convient que l’utilisateur adresse tout retour d’information ou toute question concernant le présent
document à l’organisme national de normalisation de son pays. Une liste exhaustive desdits organismes
se trouve à l’adresse www .iso .org/ fr/ members .html.
iv © ISO 2020 – Tous droits réservés

---------------------- Page: 4 ----------------------
ISO 18861:2020(F)

Introduction
La protection contre les coups de soleil assurée par les produits cosmétiques qui contiennent des écrans
solaires organiques ou inorganiques n’est ni absolue ni permanente.
L’un des nombreux facteurs pouvant avoir un effet sur le niveau de protection de ces produits est
le contact avec l’eau. Les absorbeurs d’UV contenus dans la formulation peuvent être rincés ou être
éliminés physiquement par l’action de lavage dans la mer ou dans une piscine.
Afin de rendre les produits solaires plus efficaces, les fabricants ont mis au point des formulations
qui sont plus résistantes sur la peau pendant l’immersion dans l’eau. Ces produits ont été étiquetés de
diverses manières comme étant résistants ou très résistants à l’eau.
Afin de corroborer les allégations d’efficacité de ces produits, plusieurs méthodes ont été mises au point
et publiées, notamment une méthode promulguée dans la monographie de l’Agence fédérale américaine
des produits alimentaires et médicamenteux (FDA) sur les produits cosmétiques d’écrans solaires en
vente libre (Federal Register/ Vol. 58, N° 90). Des méthodes normalisées ont également été publiées en
Australie/Nouvelle-Zélande (AS/NZS 2640) et dans la République d’Afrique du Sud (SABS 1557).
La méthode portant sur les conditions requises pour l’essai de résistance à l’eau du FPS existe sous
forme de Norme internationale, à savoir l’ISO 16217, et exige de mesurer un facteur de protection
solaire selon un mode opératoire d’immersion dans l’eau défini.
Le présent document décrit le mode opératoire de calcul du pourcentage de résistance à l’eau, reposant
sur le mode opératoire d’immersion dans l’eau décrit dans l’ISO 16217, qui est le rapport entre le FPS
avant et après bain.
Le mode opératoire de mesure du FPS est celui décrit par l’ISO 24444.
Toutes les références à la méthode d’essai du facteur de protection solaire (FPS) indiquées ici renvoient
à l’ISO 24444.
Il convient que le lecteur s’assure qu’il dispose de la dernière version de l’ISO 24444 portant sur la
méthode d’essai du facteur de protection solaire (FPS).
© ISO 2020 – Tous droits réservés v

---------------------- Page: 5 ----------------------
NORME INTERNATIONALE ISO 18861:2020(F)
Cosmétiques — Méthodes d’essai de protection solaire —
Pourcentage de résistance à l’eau
1 Domaine d’application
Le présent document spécifie un mode opératoire pour évaluer le pourcentage de rémanence à l’eau en
comparant le facteur de protection solaire (FPS) avant immersion dans l’eau (appelé ici « FPS statique »)
et après une durée fixe d’immersion dans l’eau (appelé ici « FPS humide »).
2 Références normatives
Les documents suivants sont cités dans le texte de sorte qu’ils constituent, pour tout ou partie de leur
contenu, des exigences du présent document. Pour les références datées, seule l’édition citée s’applique.
Pour les références non datées, la dernière édition du document de référence s’applique (y compris les
éventuels amendements).
ISO 16217:2020, Cosmétiques — Méthodes d’essai de protection solaire — Mode opératoire d’immersion
dans l’eau pour la détermination de la résistance à l’eau
ISO 24444:2019, Cosmétiques — Méthodes d'essai de protection solaire — Détermination in vivo du facteur
de protection solaire (FPS)
3 Termes et définitions
Pour les besoins du présent document, les termes et définitions suivants s’appliquent.
L’ISO et l’IEC tiennent à jour des bases de données terminologiques destinées à être utilisées en
normalisation, consultables aux adresses suivantes:
— ISO Online browsing platform: disponible à l’adresse https:// www .iso .org/ obp
— IEC Electropedia: disponible à l’adresse http:// www .electropedia .org/
3.1
dispositif d’immersion
spa, bain à remous ou dispositif similaire conçu pour l’immersion dans l’eau
[SOURCE: ISO 16217:2020, 3.1]
3.2
eau normalisée
eau utilisée dans le dispositif d’immersion (3.1)
3.3
facteur de protection solaire statique
FPS statique
FPS
is
FPS sans épreuve de résistance à l’eau
3.4
FPS avant immersion dans l’eau
moyenne arithmétique de toutes les valeurs de FPS (3.3) valides pour l’étude, exprimée à une décimale
is
près par troncation
© ISO 2020 – Tous droits réservés 1

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ISO 18861:2020(F)

3.5
facteur de protection solaire de résistance à l’eau individuelle
FPS de résistance à l’eau individuelle
FPS
iwr
FPS déterminé après l’étape d’immersion dans l’eau sur chaque volontaire
3.6
FPS post-immersion dans l’eau
moyenne arithmétique de toutes les valeurs de FPS (3.5) valides pour l’étude, exprimée à une
iwr
décimale près par troncation
4 Méthode d’essai
4.1 Présentation de la méthode
Le principe consiste à comparer le facteur de protection solaire (FPS) d’un produit solaire après une
période d’immersion dans l’eau au FPS statique sans immersion dans l’eau.
4.2 Sélection des volontaires participant à l’essai
Les participants sont inclus dans l’étude selon les critères décrits dans l’ISO 24444. Au moins
10 volontaires doivent être sélectionnés.
[1]
La Déclaration d’Helsinki est pertinente pour les essais avec des sujets humains. Un consentement
éclairé, écrit et signé doit être obtenu de tous les volontaires participant à des essais. Il convient que ce
consentement contienne le consentement spécifique pour participer à l’essai de résistance à l’eau, avec
la durée, la température de l’eau et la possibilité que le volontaire ait froid pendant l’essai.
4.3 Zone d’essai
Selon les exigences de l’ISO 24444, les sites d’essai protégés et non protégés doivent être délimités
à l’intérieur de la région entre les omoplates et la taille. En outre, les sites d’essai doivent être
configurés de manière à être entièrement immergés lorsque le volontaire participant à l’essai est placé
confortablement dans le dispositif d’immersion. Il convient que les sites d’essai pour l’application du
produit soient choisis de manière aléatoire sur chaque volontaire individuel et sur l’ensemble du panel
de volontaires, comme décrit dans l’ISO 24444.
4.4 Application du produit
Le produit doit être appliqué selon le mode opératoire établi dans l’ISO 24444.
4.5 Mode opératoire d’immersion dans l’eau
Le FPS statique (FPS ) est déterminé conformément à l’ISO 24444.
is
Pour déterminer le FPS post-immersion dans l’eau (FPS ), il faut se conformer à l’ISO 24444 jusqu’au
iwr
moment où le produit soumis à l’essai a été appliqué sur la peau du volontaire.
Immerger alors dans l’eau la peau traitée avec le produit selon le processus décrit dans l’ISO 16217.
La séquence d’immersion et la période de repos suivantes doivent être respectées:
— 20 min d’immersion des volontaires participant à l’essai dans une eau en mouvement pendant toute
la période;
— 5 min à 20 min de temps de séchage sans utiliser de serviette entre les périodes d’immersion.
Pour une résistance à l’eau de 40 min, répéter cette séquence deux fois.
2 © ISO 2020 – Tous droits réservés

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ISO 18861:2020(F)

Pour une résistance à l’eau de 80 min, répéter cette séquence quatre fois.
Pour des durées étendues de résistance à l’eau, répéter ce processus comme il convient.
À la fin de la période d’immersion finale, laisser les volontaires participant à l’essai sécher à l’air libre
(sans utiliser de serviette sur les sites d’essai) pendant au moins 15 min.
Aucune gouttelette d’eau
...

SLOVENSKI STANDARD
oSIST ISO/DIS 18861:2019
01-november-2019
Kozmetika - Preskusne metode za zaščito pred soncem - Vodoodpornost -
Odstotek vodoodpornosti
Cosmetics - Sun protection test methods - Water resistance - Percentage of water
resistance
Cosmétiques - Méthodes d’essai de protection solaire - Résistance à l'eau - Pourcentage
de résistance à l’eau
Ta slovenski standard je istoveten z: ISO/DIS 18861:2019
ICS:
71.100.70 Kozmetika. Toaletni Cosmetics. Toiletries
pripomočki
oSIST ISO/DIS 18861:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST ISO/DIS 18861:2019

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oSIST ISO/DIS 18861:2019
DRAFT INTERNATIONAL STANDARD
ISO/DIS 18861
ISO/TC 217 Secretariat: ISIRI
Voting begins on: Voting terminates on:
2019-07-31 2019-10-23
Cosmetics — Sun protection test methods — Water
resistance — Percentage of water resistance
Cosmétiques — Méthodes d’essai de protection solaire — Détermination du pourcentage de résistance à l’eau
ICS: 71.100.70
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
This document is circulated as received from the committee secretariat.
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 18861:2019(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2019

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oSIST ISO/DIS 18861:2019
ISO/DIS 18861:2019(E)

COPYRIGHT PROTECTED DOCUMENT
© 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

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oSIST ISO/DIS 18861:2019
ISO/DIS 18861:2019(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Test method . 2
4.1 Outline of the method . 2
4.2 Test subject selection. 2
4.3 Test area . 2
4.4 Product application . 2
4.5 Water immersion procedure . 2
4.6 Reference water resistant sun product . 3
4.7 Determination of the minimum erythemal dose (MED) . 3
4.8 Number of test subjects . 3
4.9 Test Chronology . 3
5 Calculations and data handling . 3
5.1 General . 3
5.2 SPF before immersion. 4
5.3 SPF after immersion . 4
5.4 Individual percentage of water resistance . 4
5.5 Mean percentage of water resistance . 4
5.6 Calculation of lower confidence limit on the mean percentage of water resistance . 4
5.7 Acceptance criteria for reference product P2 . 5
6 Test report . 5
Annex A (normative) Simulated swim test device design . 6
Annex B (normative) Test procedure and chronology . 7
Annex C (normative) Standard reference sunscreen . 9
Bibliography .10
© ISO 2019 – All rights reserved iii

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ISO/DIS 18861:2019(E)

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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso
.org/iso/foreword .html.
This document was prepared by Technical Committee ISO/TC 217, Cosmetics.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/members .html.
iv © ISO 2019 – All rights reserved

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oSIST ISO/DIS 18861:2019
ISO/DIS 18861:2019(E)

Introduction
The protection which cosmetic products containing organic or inorganic sunscreens provide against
sunburn is neither absolute nor permanent.
One of the many factors that can have an effect on the level of protection given by these products is
water contact. UV absorbers in the formulation can leach out or be physically removed by the washing
action in the sea or swimming pool.
In order to make the sun products more effective; manufacturers have developed formulations which
are more substantive to the skin during water immersion. These products have been variously labelled
as water resistant, very water resistant.
In order to substantiate these product efficacy claims, a number of methods has been developed and
published: including a method promulgated in the United States of America FDA monograph on OTC
sunscreen drug products (Federal Register/ Vol. 58, No 90). Standard methods have also been published
in Australia/New Zealand (AS/NZS 2640) and in the Republic of South Africa (SABS1557).
The method for conditions required for water resistance SPF test exists as an international standard,
ISO 16217 and requires a sun protection factor to be measured following a defined water immersion
procedure. With the use of a spa-pool, a Jacuzzi® or a bathtub, each of which may vary in design but
must comply with the norm.
This norm describes the procedure for water resistant percentage calculation, based on water
immersion procedure described in ISO 16217, which is the ratio between before and after bath SPF.
The SPF measurement procedure is that described by ISO.
All references to the Sun Protection Factor (SPF) Test Method herein, relate to that document or to later
versions as may be published from time to time.
The reader should ensure that the current version of the ISO 24444 standard Sun Protection Factor
(SPF) test method is followed.
© ISO 2019 – All rights reserved v

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oSIST ISO/DIS 18861:2019
DRAFT INTERNATIONAL STANDARD ISO/DIS 18861:2019(E)
Cosmetics — Sun protection test methods — Water
resistance — Percentage of water resistance
1 Scope
This document intends to evaluate the Water Resistance Retention percentage, by comparing the Sun
Protection Factor (SPF) before water immersion (hereafter referred to as the "static" SPF) and after a
fixed period of water immersion (hereafter referred to as the "wet" SPF).
2 Normative references
The following document is referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 24444:2010, Cosmetics — Sun protection test methods — In vivo determination of the sun protection
factor (SPF)
ISO 16217, Cosmetics - Sun protection test methods - Water resistance - Water immersion procedure
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https: //www .iso .org/obp
— IEC Electropedia: available at http: //www .electropedia .org/
3.1
Simulated swim test device
spa, whirlpool or similar device which is designed for water immersion and which fits the requirements
of ISO 16217 in Annex A
3.2
standardised water
Water for use in the Simulated Swim Test Device shall comply with the requirements of ISO 16217
in Annex B
3.3
SPF
is
static SPF, determined without water immersion step on each subject as described in ISO 24444
[SOURCE: ISO 24444-2010, Cosmetics - Sun protection test methods - In vivo determination of the sun
protection factor (SPF)]
3.4
SPF before water immersion
arithmetic mean of all valid SPF values for the study, expressed to one decimal by truncation
is
© ISO 2019 – All rights reserved 1

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3.5
SPF
iwr
SPF determined after water immersion step on each subject as described in ISO 24444
[SOURCE: ISO 24444-2010, Cosmetics - Sun protection test methods - In vivo determination of the sun
protection factor (SPF)]
3.6
SPF post water immersion
arithmetic mean of all valid SPF values for the study, expressed to one decimal by truncation
iwr
4 Test method
4.1 Outline of the method
The principle is to compare the Sun Protection Factor for a sunscreen product after a period of
immersion in water with the static SPF without immersion in water.
4.2 Test subject selection
Participants are enrolled for the study according to the criteria described in ISO 24444. At least 10
subjects shall be selected.
[1]
All testing shall be done in accordance with the Declaration of Helsinki and national regulations, if
any, regarding human studies. Informed, written (signature) consent shall be obtained from all test
subjects. The consent should include specific consent to participate in water resistance testing including
length of time – temperature of the
...