ISO 18861

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

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

Cosmétiques — Méthodes d’essai de protection solaire — Détermination du pourcentage de résistance à l’eau

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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

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The protection which cosmetic products containing organic or inorganic sunscreens provide against

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

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

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

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.

All references to the Sun Protection Factor (SPF) Test Method herein, relate to that document or to later

The reader should ensure that the current version of the ISO 24444 standard Sun Protection Factor

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

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

ISO 16217, Cosmetics - Sun protection test methods - Water resistance - Water immersion procedure

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

spa, whirlpool or similar device which is designed for water immersion and which fits the requirements

Water for use in the Simulated Swim Test Device shall comply with the requirements of ISO 16217

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

arithmetic mean of all valid SPF values for the study, expressed to one decimal by truncation

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

arithmetic mean of all valid SPF values for the study, expressed to one decimal by truncation

The principle is to compare the Sun Protection Factor for a sunscreen product after a period of

Participants are enrolled for the study according to the criteria described in ISO 24444. At least 10

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