SIST ISO 16217:2020

Cosmetics - Sun protection test methods - Water immersion procedure for determining water resistance

This document specifies a procedure of water immersion for the in vivo determination of the water resistance of sunscreen products.
This document is applicable to products intended to be placed in contact with human skin including any component able to absorb, reflect or scatter UV rays and which, in addition, are designed to be less readily removed from the skin by water and/or during water immersion. It is intended to be read in conjunction with ISO 24444.

Cosmétiques - Méthodes d'essai de protection solaire - Mode opératoire d’immersion dans l’eau pour la détermination de la résistance à l'eau

Le pr�sent document sp�cifie un mode op�ratoire d'immersion dans l'eau utilis� pour la d�termination in vivo de la r�sistance � l'eau des produits solaires.
Le pr�sent document est applicable aux produits destin�s � �tre mis en contact avec la peau humaine, y compris tout composant pouvant absorber, r�fl�chir ou diffuser les rayons UV, et qui sont en outre con�us pour �tre moins faciles � �liminer de la peau sous l'action de l'eau et/ou pendant l'immersion dans l'eau. Il est destin� � �tre lu conjointement avec l'ISO 24444.

Kozmetika - Preskusne metode za zaščito pred soncem - Postopek s potopitvijo v vodo za določevanje vodoodpornosti

General Information

• Status: Published
• Public Enquiry End Date: 04-Dec-2019
• Publication Date: 11-May-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: 07-May-2020
• Due Date: 12-Jul-2020
• Completion Date: 12-May-2020
• Ref Project: ISO 16217:2020 - Cosmetics — Sun protection test methods — Water immersion procedure for determining water resistance

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 16217
First edition
2020-05
Cosmetics — Sun protection test
methods — Water immersion
procedure for determining water
resistance
Cosmétiques — Méthodes d'essai de protection solaire — Mode
opératoire d’immersion dans l’eau pour la détermination de la
résistance à l'eau
Reference number
ISO 16217:2020(E)
©
ISO 2020

---------------------- Page: 1 ----------------------
ISO 16217:2020(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]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved

---------------------- Page: 2 ----------------------
ISO 16217:2020(E)

Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle . 2
4.1 Main steps . 2
4.2 General principle . 2
5 Test criteria . 2
5.1 Selection of the test subjects . 2
5.2 Test area . 3
5.3 Product application . 3
6 Water immersion procedure . 3
6.1 Room conditions . 3
6.2 Water quality . 3
6.3 Immersion sequencing cycle . 3
6.4 Positioning of test subjects . 3
6.5 Drying after immersion . 4
6.6 Reversion to ISO 24444 procedure . 4
7 Water quality and condition . 4
8 Procedural validation . 4
8.1 General . 4
8.2 Calculation of the individual water resistance SPF (SPF ). 4
iwr
8.3 Calculation of the water resistance SPF (SPF ) . 5
wr
8.4 Statistical criterion . 5
9 Test report — post-water immersion SPF . 5
Annex A (normative) Simulated swim test device design . 6
Annex B (normative) Standardized water requirements . 7
Annex C (normative) Standard reference sunscreen . 8
Annex D (normative) Product positioning on test subjects . 9
Bibliography .10
© ISO 2020 – All rights reserved iii

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ISO 16217:2020(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 ----------------------
INTERNATIONAL STANDARD ISO 16217:2020(E)
Cosmetics — Sun protection test methods — Water
immersion procedure for determining water resistance
1 Scope
This document specifies a procedure of water immersion for the in vivo determination of the water
resistance of sunscreen products.
This document is applicable to products intended to be placed in contact with human skin including
any component able to absorb, reflect or scatter UV rays and which, in addition, are designed to be less
readily removed from the skin by water and/or during water immersion. It is intended to be read in
conjunction with ISO 24444.
2 Normative references
The following documents are 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 24444:2019, 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
Note 1 to entry: For the purposes of this document, the simulated swim test device shall be in accordance with
Annex A.
3.2
individual water resistance sun protection factor
individual water resistance SPF
SPF
iwr
SPF determined after the water immersion step on each subject
Note 1 to entry: SPF is calculated by a simple division of MED by MED .
iwr ipi iui
3.3
static sun protection factor
static SPF
SPF without water resistance challenge
Note 1 to entry: This is determined in accordance with ISO 24444.
© ISO 2020 – All rights reserved 1

---------------------- Page: 5 ----------------------
ISO 16217:2020(E)

3.4
post-water immersion sun protection factor
post-water immersion SPF
arithmetic mean of all valid SPF (3.2) values for the study
iwr
Note 1 to entry: It is expressed to one decimal place by truncation.
3.5
water resistance sun protection factor
water resistance SPF
SPF
wr
arithmetic mean of all valid SPF (3.2) values
iwr
4 Principle
4.1 Main steps
All of the test steps set out in ISO 24444 apply. Clause 5 provides an additional step to be inserted in the
test sequence described in ISO 24444:2019, 9.4. This water immersion step commences after the test
products have been applied, following the dry-down period given in ISO 24444:2019, 9.4.10, and prior
to the exposure to simulated sunlight given in ISO 24444:2019, 9.4.11 to 9.4.15. In all other respects, the
principles and procedures of ISO 24444 apply. A tabulation of steps is set out in Table 1.
Table 1 — Main steps
Test requirements ISO 24444 This document
Terms and definitions applicable applicable
General principle applicable applicable
Test subjects applicable not applicable
Apparatus and materia
...

SLOVENSKI STANDARD
SIST ISO 16217:2020
01-junij-2020
Kozmetika - Preskusne metode za zaščito pred soncem - Postopek s potopitvijo v
vodo za določevanje vodoodpornosti
Cosmetics - Sun protection test methods - Water immersion procedure for determining
water resistance
Cosmétiques - Méthodes d'essai de protection solaire - Mode opératoire d’immersion
dans l’eau pour la détermination de la résistance à l'eau
Ta slovenski standard je istoveten z: ISO 16217:2020
ICS:
71.100.70 Kozmetika. Toaletni Cosmetics. Toiletries
pripomočki
SIST ISO 16217:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST ISO 16217:2020

---------------------- Page: 2 ----------------------
SIST ISO 16217:2020
INTERNATIONAL ISO
STANDARD 16217
First edition
2020-05
Cosmetics — Sun protection test
methods — Water immersion
procedure for determining water
resistance
Cosmétiques — Méthodes d'essai de protection solaire — Mode
opératoire d’immersion dans l’eau pour la détermination de la
résistance à l'eau
Reference number
ISO 16217:2020(E)
©
ISO 2020

---------------------- Page: 3 ----------------------
SIST ISO 16217:2020
ISO 16217:2020(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]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved

---------------------- Page: 4 ----------------------
SIST ISO 16217:2020
ISO 16217:2020(E)

Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle . 2
4.1 Main steps . 2
4.2 General principle . 2
5 Test criteria . 2
5.1 Selection of the test subjects . 2
5.2 Test area . 3
5.3 Product application . 3
6 Water immersion procedure . 3
6.1 Room conditions . 3
6.2 Water quality . 3
6.3 Immersion sequencing cycle . 3
6.4 Positioning of test subjects . 3
6.5 Drying after immersion . 4
6.6 Reversion to ISO 24444 procedure . 4
7 Water quality and condition . 4
8 Procedural validation . 4
8.1 General . 4
8.2 Calculation of the individual water resistance SPF (SPF ). 4
iwr
8.3 Calculation of the water resistance SPF (SPF ) . 5
wr
8.4 Statistical criterion . 5
9 Test report — post-water immersion SPF . 5
Annex A (normative) Simulated swim test device design . 6
Annex B (normative) Standardized water requirements . 7
Annex C (normative) Standard reference sunscreen . 8
Annex D (normative) Product positioning on test subjects . 9
Bibliography .10
© ISO 2020 – All rights reserved iii

---------------------- Page: 5 ----------------------
SIST ISO 16217:2020
ISO 16217:2020(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 16217:2020
INTERNATIONAL STANDARD ISO 16217:2020(E)
Cosmetics — Sun protection test methods — Water
immersion procedure for determining water resistance
1 Scope
This document specifies a procedure of water immersion for the in vivo determination of the water
resistance of sunscreen products.
This document is applicable to products intended to be placed in contact with human skin including
any component able to absorb, reflect or scatter UV rays and which, in addition, are designed to be less
readily removed from the skin by water and/or during water immersion. It is intended to be read in
conjunction with ISO 24444.
2 Normative references
The following documents are 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 24444:2019, 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
Note 1 to entry: For the purposes of this document, the simulated swim test device shall be in accordance with
Annex A.
3.2
individual water resistance sun protection factor
individual water resistance SPF
SPF
iwr
SPF determined after the water immersion step on each subject
Note 1 to entry: SPF is calculated by a simple division of MED by MED .
iwr ipi iui
3.3
static sun protection factor
static SPF
SPF without water resistance challenge
Note 1 to entry: This is determined in accordance with ISO 24444.
© ISO 2020 – All rights reserved 1

---------------------- Page: 7 ----------------------
SIST ISO 16217:2020
ISO 16217:2020(E)

3.4
post-water immersion sun protection factor
post-water immersion SPF
arithmetic mean of all valid SPF (3.2) values for the study
iwr
Note 1 to entry: It is expressed to one decimal place by truncation.
3.5
water resistance sun protection factor
water resistance SPF
SPF
wr
arithmetic mean of all valid SPF (3.2) values
iwr
4 Principle
4.1 Main steps
All of the test steps set out in ISO 24444 apply. Clause 5 provides an additional step to be inserted in the
test sequence described in ISO 24444:2019, 9.4. This water immersion step commences after the test
products have been applied, following the dry-down peri
...

NORME ISO
INTERNATIONALE 16217
Première édition
2020-05
Cosmétiques — Méthodes d'essai de
protection solaire — Mode opératoire
d’immersion dans l’eau pour la
détermination de la résistance à l'eau
Cosmetics — Sun protection test methods — Water immersion
procedure for determining water resistance
Numéro de référence
ISO 16217:2020(F)
©
ISO 2020

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ISO 16217:2020(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]
Fax: [phone]
E-mail: [e-mail]
Web: www.iso.org
Publié en Suisse
ii © ISO 2020 – Tous droits réservés

---------------------- Page: 2 ----------------------
ISO 16217:2020(F)

Sommaire Page
Avant-propos .iv
1 Domaine d’application . 1
2 Références normatives . 1
3 Termes et définitions . 1
4 Principe . 2
4.1 Principales étapes . 2
4.2 Principe général . 2
5 Critères d’essai . 3
5.1 Sélection des volontaires participant à l’essai . 3
5.2 Zone d’essai . 3
5.3 Application du produit . 3
6 Mode opératoire d’immersion dans l’eau . 3
6.1 Conditions ambiantes . 3
6.2 Qualité de l’eau . 3
6.3 Cycle d’immersion . 3
6.4 Positionnement des volontaires participant à l’essai . 4
6.5 Séchage après immersion . 4
6.6 Retour au mode opératoire de l’ISO 24444 . 4
7 Qualité et état de l’eau . 4
8 Validation du mode opératoire . 4
8.1 Généralités . 4
8.2 Calcul du FPS pour la résistance à l’eau individuelle (FPS ) . 5
iwr
8.3 Calcul du FPS pour la résistance à l’eau (FPS ) . 5
wr
8.4 Critère statistique . 5
9 Rapport d’essai — FPS post-immersion dans l’eau . 5
Annexe A (normative) Conception du dispositif d’immersion . 7
Annexe B (normative) Exigences relatives à l’eau normalisée . 8
Annexe C (normative) Formulation solaire de référence standard . 9
Annexe D (normative) Positionnement du produit sur les volontaires participant à l’essai .10
Bibliographie .11
© ISO 2020 – Tous droits réservés iii

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ISO 16217:2020(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 www .iso .org/ 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 ----------------------
NORME INTERNATIONALE ISO 16217:2020(F)
Cosmétiques — Méthodes d'essai de protection solaire
— Mode opératoire d’immersion dans l’eau pour la
détermination de la résistance à l'eau
1 Domaine d’application
Le présent document spécifie un mode opératoire d’immersion dans l’eau utilisé pour la détermination
in vivo de la résistance à l’eau des produits solaires.
Le présent document est applicable aux produits destinés à être mis en contact avec la peau humaine,
y compris tout composant pouvant absorber, réfléchir ou diffuser les rayons UV, et qui sont en outre
conçus pour être moins faciles à éliminer de la peau sous l’action de l’eau et/ou pendant l’immersion
dans l’eau. Il est destiné à être lu conjointement avec l’ISO 24444.
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 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
Note 1 à l'article: Pour les besoins du présent document, le dispositif d’immersion doit être conforme à l’Annexe A.
3.2
facteur de protection solaire pour la résistance à l’eau individuelle
FPS pour la résistance à l’eau individuelle
FPS
iwr
FPS déterminé après l’étape d’immersion dans l’eau sur chaque volontaire
Note 1 à l'article: Le FPS est calculé en divisant simplement la DEM par la DEM .
iwr ipi iui
© ISO 2020 – Tous droits réservés 1

---------------------- Page: 5 ----------------------
ISO 16217:2020(F)

3.3
facteur de protection solaire statique
FPS statique
FPS sans épreuve de résistance à l’eau
Note 1 à l'article: Il est déterminé conformément à l’ISO 24444.
3.4
facteur de protection solaire post-immersion dans l’eau
FPS post-immersion dans l’eau
moyenne arithmétique de toutes les valeurs de FPS (3.2) valides pour l’étude
iwr
Note 1 à l'article: Il est exprimé à une décimale près par troncation.
3.5
facteur de protection solaire pour la résistance à l’eau
FPS pour la résistance à l’eau
FPS
wr
moyenne arithmétique de toutes les valeurs de FPS (3.2) valides
iwr
4 Principe
4.1 Principales étapes
Toutes les étapes d’essai établies dans l’ISO 24444 s’appliquent. L’Article 5 fournit une étape
supplémentaire à ajouter à la séquence d’essai décrite dans l’ISO 24444:2019, 9.4. Cette étape
d’immersion dans l’eau commence une fois que les produits d’essai ont été appliqués, après la période
de séchage mentionnée dans l’ISO 24444:2019, 9.4.10 et avant l’exposition au simulateur solaire
mentionnée dans l’ISO 24444:2019, 9.4.11 à 9.4.15. Pour tous les autres aspects, les principes et modes
opératoires de l’ISO 24444 s’appliquent. Les différentes étapes sont résumées dans le Tableau 1.
Tableau 1 — Principales étapes
Exigences d’essai ISO 24444 Le présent document
Termes et définitions applicable applicable
Principe général applicable applicable
Volontaires participant à l’essai applicable non applicable
Appareillage et matériels applicable non applicable
Formulations solaires de référence applicable applicable
Conditions d’essai applicable applicable
Mode opératoire d’immersion dans
l’eau > > > > > > > > > applicable
Retour à l’ISO 24444 < < < < < < < < < <
Mode opératoire d’exposition aux UV applicable non applicable
Mode opératoire ultérieur applicable non applicable
4.2 Principe général
Une quantité contrôlée de produit(s) solaire(s)
...

SLOVENSKI STANDARD
oSIST ISO/DIS 16217:2019
01-november-2019
Kozmetika - Preskusne metode za zaščito pred soncem - Vodoodpornost -
Postopek s potopitvijo v vodo
Cosmetics - Sun protection test methods - Water resistance - Water immersion
procedure
Cosmétiques - Méthodes d'essai de protection solaire - Résistance à l'eau - Mode
opératoire d’immersion dans l’eau
Ta slovenski standard je istoveten z: ISO/DIS 16217:2018
ICS:
71.100.70 Kozmetika. Toaletni Cosmetics. Toiletries
pripomočki
oSIST ISO/DIS 16217:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST ISO/DIS 16217:2019

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oSIST ISO/DIS 16217:2019
DRAFT INTERNATIONAL STANDARD
ISO/DIS 16217
ISO/TC 217 Secretariat: ISIRI
Voting begins on: Voting terminates on:
2018-10-23 2019-01-15
Cosmetics — Sun protection test methods — Water
resistance — Water immersion procedure
Cosmétiques — Méthodes d'essai de protection solaire — 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 16217:2018(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 2018

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oSIST ISO/DIS 16217:2019
ISO/DIS 16217:2018(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2018
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.
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Published in Switzerland
ii © ISO 2018 – All rights reserved

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oSIST ISO/DIS 16217:2019
ISO/DIS 16217:2018(E)

Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and Definitions . 1
4 Principle . 2
4.1 Main steps . 2
4.2 General principle . 2
5 Test Criteria . 3
5.1 Selection of the test subjects . 3
5.2 Test area . 3
5.3 Product Application . 3
6 Water Immersion Procedure . 3
6.1 Room conditions . 3
6.2 Water Quality. 3
6.3 Immersion Sequencing Cycle . 3
6.4 Positioning of Test Subjects . 3
6.5 Drying after Immersion . 4
6.6 Reversion to ISO 24444 procedure . 4
7 Water Quality and Condition . 4
8 Procedural Validation. . 4
9 Calculation of the Water Resistance Sun Protection factor and statistics .4
9.1 Calculation of the individual Water Resistance SPF (SPFiwr) . 4
9.2 Calculation of the Mean Water Resistance SPF (SPFwr) . 4
9.3 Statistical criterion . 5
10 Test report – Sun Protection Factor Post Immersion . 5
Annex A (normative) Simulated Swim Test Device Design . 6
Annex B (Normative) Standardised Water Requirements . 7
Annex C (Normative) Standard Reference Sunscreen . 8
Annex D (Normative) Product Positioning on Test Subjects . 9
Bibliography .10
© ISO 2018 – All rights reserved iii

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oSIST ISO/DIS 16217:2019
ISO/DIS 16217:2018(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 2018 – All rights reserved

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oSIST ISO/DIS 16217:2019
DRAFT INTERNATIONAL STANDARD ISO/DIS 16217:2018(E)
Cosmetics — Sun protection test methods — Water
resistance — Water immersion procedure
1 Scope
This International Standard describes a procedure of water immersion for the in vivo determination of
water resistance of sunscreen products using a water immersion procedure.
This standard is applicable to products intended to be placed in contact with human skin including
any component able to absorb, reflect or scatter UV rays and which, in addition, are designed to be less
readily removed from the skin by water and/or during water immersion. It shall be read in conjunction
with ISO 24444, Cosmetics — Sun protection test methods — in vivo determination of Sun Protection
Factor (SPF).
2 Normative references
The following documents are 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 17025:2017, General requirements for the competence of testing and calibration laboratories
ISO 24444, Cosmetics — Sun protection test methods — In vivo determination of the sun protection
factor (SPF)
ISO 18883, Cosmetics — Sun protection test methods — Determination of percentage of water resistance
3 Terms and Definitions
For the purposes of this document, the following terms and definitions apply.
3.1
simulated swim test device
A spa, whirlpool or similar device which is designed for water immersion and which fits the
requirements of this standard as defined in Annex A.
3.2
standardised water
Water for use in the Simulated Swim Test Device shall comply with the requirements of Annex B of this
Standard.
3.3
MEDiui
MEDiui is the individual MED value for the unprotected site.
3.4
MEDipi
MEDipi is the individual MED value for the sunscreen protected site after immersion.
3.5
individual SPFiwr
SPF determined after water immersion step on each subject. SPF iwr= MEDipi protected skin / MEDiui
unprotected skin determined after water immersion.
© ISO 2018 – All rights reserved 1

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