Cosmetics - Sun protection test methods - Water immersion procedure for determining water resistance (ISO 16217:2020)

To be completed with the published version of ISO 16217:2020

Kosmetische Mittel - Untersuchungsverfahren für Sonnnenschutzmittel - Wasserimmersionsverfahren zur Bestimmung der Wasserbeständigkeit (ISO 16217:2020)

Dieses Dokument legt ein Verfahren für das Eintauchen in Wasser für die In-vivo-Bestimmung der Wasserbeständigkeit von Sonnenschutzmitteln fest.
Dieses Dokument ist anwendbar auf Sonnenschutzmittel, einschließlich aller Bestandteile, die UV-Strahlung absorbieren, reflektieren oder streuen können, die dafür vorgesehen sind, mit der menschlichen Haut in Kontakt zu kommen und schwerer durch Wasser und/oder während des Eintauchens in Wasser von der Haut entfernt zu werden. Es ist dafür vorgesehen, in Zusammenhang mit ISO 24444 gelesen zu werden.

Cosmétiques - Méthodes d'essai de protection solaire - Mode opératoire d’immersion dans l’eau pour la détermination de la résistance à l'eau (ISO 16217:2020)

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.

Kozmetika - Metode za preskušanje zaščite pred soncem - Postopek s potopitvijo v vodo za določanje vodoodpornosti (ISO 16217:2020)

General Information

Status
Published
Public Enquiry End Date
01-Oct-2021
Publication Date
15-Jun-2022
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
21-Apr-2022
Due Date
26-Jun-2022
Completion Date
16-Jun-2022

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SLOVENSKI STANDARD
SIST EN ISO 16217:2022
01-julij-2022
Kozmetika - Metode za preskušanje zaščite pred soncem - Postopek s potopitvijo
v vodo za določanje vodoodpornosti (ISO 16217:2020)

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

water resistance (ISO 16217:2020)
Kosmetische Mittel - Untersuchungsverfahren für Sonnnenschutzmittel -
Wasserimmersionsverfahren zur Bestimmung der Wasserbeständigkeit (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 16217:2020)
Ta slovenski standard je istoveten z: EN ISO 16217:2021
ICS:
71.100.70 Kozmetika. Toaletni Cosmetics. Toiletries
pripomočki
SIST EN ISO 16217:2022 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 16217:2022
---------------------- Page: 2 ----------------------
SIST EN ISO 16217:2022
EN ISO 16217
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2021
EUROPÄISCHE NORM
ICS 71.100.70
English Version
Cosmetics - Sun protection test methods - Water
immersion procedure for determining water resistance
(ISO 16217:2020)

Cosmétiques - Méthodes d'essai de protection solaire - Kosmetische Mittel - Untersuchungsverfahren für

Mode opératoire d'immersion dans l'eau pour la Sonnenschutzmittel - Wasserimmersionsverfahren zur

détermination de la résistance à l'eau (ISO Bestimmung der Wasserbeständigkeit (ISO

16217:2020) 16217:2020)
This European Standard was approved by CEN on 5 December 2021.

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

© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16217:2021 E

worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 16217:2022
EN ISO 16217:2021 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

---------------------- Page: 4 ----------------------
SIST EN ISO 16217:2022
EN ISO 16217:2021 (E)
European foreword

The text of ISO 16217:2020 has been prepared by Technical Committee ISO/TC 217 "Cosmetics” of the

International Organization for Standardization (ISO) and has been taken over as EN ISO 16217:2021 by

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 June 2022, and conflicting national standards shall be

withdrawn at the latest by June 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.

Any feedback and questions on this document should be directed to the users’ national standards body.

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 16217:2020 has been approved by CEN as EN ISO 16217:2021 without any modification.

---------------------- Page: 5 ----------------------
SIST EN ISO 16217:2022
---------------------- Page: 6 ----------------------
SIST EN ISO 16217:2022
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: 7 ----------------------
SIST EN ISO 16217:2022
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: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 16217:2022
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

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: 9 ----------------------
SIST EN ISO 16217:2022
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: 10 ----------------------
SIST EN ISO 16217:2022
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 i
...

SLOVENSKI STANDARD
oSIST prEN ISO 16217:2021
01-september-2021
Kozmetika - Metode za preskušanje zaščite pred soncem - Postopek s potopitvijo
v vodo za določevanje vodoodpornosti (ISO 16217:2020)

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

water resistance (ISO 16217:2020)
Kosmetische Mittel - Untersuchungsverfahren für Sonnnenschutzmittel -
Wasserimmersionsverfahren zur Bestimmung der Wasserbeständigkeit (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 16217:2020)
Ta slovenski standard je istoveten z: prEN ISO 16217
ICS:
71.100.70 Kozmetika. Toaletni Cosmetics. Toiletries
pripomočki
oSIST prEN ISO 16217:2021 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 16217:2021
---------------------- Page: 2 ----------------------
oSIST prEN ISO 16217:2021
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 ----------------------
oSIST prEN ISO 16217:2021
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: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 4 ----------------------
oSIST prEN ISO 16217:2021
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

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 ----------------------
oSIST prEN ISO 16217:2021
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 ----------------------
oSIST prEN ISO 16217:2021
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 ----------------------
oSIST prEN ISO 16217:2021
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
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
...

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