ISO 24444:2019
Cosmetics — Sun protection test methods — In vivo determination of the sun protection factor (SPF)
This document specifies a method for the in vivo determination of the sun protection factor (SPF) of sunscreen products. It is applicable to products that contain any component able to absorb, reflect or scatter ultraviolet (UV) rays and which are intended to be placed in contact with human skin.
This document provides a basis for the evaluation of sunscreen products for the protection of human skin against erythema induced by solar ultraviolet rays.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General principle
5 Test subjects
5.1 Selection of the test subjects
5.1.1 General
5.1.2 Skin colour of the test subjects
5.1.3 Age restriction
5.1.4 Frequency of participation in tests
5.1.5 Ethics and consent
5.2 Number of test subjects
6 Apparatus and materials — Source of ultraviolet radiation
6.1 General
6.2 Quality of ultraviolet radiation
6.3 Total irradiance (UV, visible and near infrared rays)
6.4 Uniformity of beam
6.4.1 General
6.4.2 Film densitometry
6.4.3 UV sensor
6.4.4 Large beam source
6.4.5 Small beam source
7 Maintenance and monitoring the UV solar simulator output
7.1 Spectroradiometry
7.2 Radiometry
8 Reference sunscreen formulations
8.1 General
8.2 Reference standard to be used
9 Procedure
9.1 Main steps
9.2 Test conditions
9.3 Position of the test subjects
9.4 Product application
9.5 Procedure for MED assessment
9.5.1 General
9.5.2 Time of assessment of MED
9.5.3 Data rejection criteria
9.5.4 Test failure criteria
9.5.5 Expression of MEDs
10 Calculation of the sun protection factor and statistics
10.1 Calculation of the individual SPF (SPFi)
10.2 Calculation of product SPF
10.3 Statistical criterion
10.4 Validation of the test
11 Test report
11.1 Overview
11.2 General information
11.3 Data in tabular form for each test subject
11.4 Statistics for the test products
Annex A (normative) Selection criteria for the test subjects
Annex B (normative) Definition of the UV solar simulator output
Annex C (normative) SPF reference sunscreen formulations
Annex D (normative) Calculations and statistics
Annex E (normative) Colourimetric determination of skin colour typing and prediction of the minimal erythemal dose (MED) without UV exposure
Annex F (informative) Visual guidance for erythema grading
Annex G (Normative) Sample report form
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General principle
5 Test subjects
5.1 Selection of the test subjects
5.1.1 General
5.1.2 Skin colour of the test subjects
5.1.3 Age restriction
5.1.4 Frequency of participation in tests
5.1.5 Ethics and consent
5.2 Number of test subjects
6 Apparatus and materials — Source of ultraviolet radiation
6.1 General
6.2 Quality of ultraviolet radiation
6.3 Total irradiance (UV, visible and near infrared rays)
6.4 Uniformity of beam
6.4.1 General
6.4.2 Film densitometry
6.4.3 UV sensor
6.4.4 Large beam source
6.4.5 Small beam source
7 Maintenance and monitoring the UV solar simulator output
7.1 Spectroradiometry
7.2 Radiometry
8 Reference sunscreen formulations
8.1 General
8.2 Reference standard to be used
9 Procedure
9.1 Main steps
9.2 Test conditions
9.3 Position of the test subjects
9.4 Product application
9.5 Procedure for MED assessment
9.5.1 General
9.5.2 Time of assessment of MED
9.5.3 Data rejection criteria
9.5.4 Test failure criteria
9.5.5 Expression of MEDs
10 Calculation of the sun protection factor and statistics
10.1 Calculation of the individual SPF (SPFi)
10.2 Calculation of product SPF
10.3 Statistical criterion
10.4 Validation of the test
11 Test report
11.1 Overview
11.2 General information
11.3 Data in tabular form for each test subject
11.4 Statistics for the test products
Annex A (normative) Selection criteria for the test subjects
Annex B (normative) Definition of the UV solar simulator output
Annex C (normative) SPF reference sunscreen formulations
Annex D (normative) Calculations and statistics
Annex E (normative) Colourimetric determination of skin colour typing and prediction of the minimal erythemal dose (MED) without UV exposure
Annex F (informative) Visual guidance for erythema grading
Annex G (Normative) Sample report form
Bibliography