ISO 24444:2010
Cosmetics — Sun protection test methods — In vivo determination of the sun protection factor (SPF)
ISO 24444:2010 specifies a method for the in vivo determination of the sun protection factor (SPF) of sunscreen products. This International Standard 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.
ISO 24444:2010 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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1 Scope
2 Terms and definitions
3 General principle
4 Test subjects
4.1 Selection of the test subjects
4.1.1 General
4.1.2 Skin phototype of the test subjects
4.1.3 Age restriction
4.1.4 Frequency of participation in tests
4.1.5 Ethics and consent
4.2 Number of test subjects
4.3 Test area
5 Apparatus and materials
5.1 Source of ultraviolet radiation
5.1.1 General
5.1.2 Quality of ultraviolet radiation
5.1.3 Total irradiance (UV, visible and near infrared rays)
5.1.4 Uniformity of beam
5.1.5 Maintenance and monitoring the UV solar simulator output
5.1.5.1 Radiometry
5.1.5.2 Spectroradiometry
5.2 Reference sunscreen formulations
5.2.1 General
5.2.2 Expected SPF ( SPF 20
5.2.3 Expected SPF W SPF 20
5.2.4 Acceptance SPF limits for the reference sunscreen formulations
5.2.5 Formulae and preparation of the reference sunscreen formulations
6 Procedure
6.1 Main steps
6.2 Test conditions
6.3 Position of the test subjects
6.4 Procedure for product application
6.4.1 General
6.4.2 Test sites and product application
6.4.3 Amount of product applied
6.4.4 Mode of delivery
6.4.4.1 General
6.4.4.2 Liquid type products (e.g. lotions, liquids, milks, creams, sprays and sticks)
6.4.4.3 Powders
6.4.5 Drying time between application and UV exposure
6.5 Procedure for UV exposure
6.5.1 Exposure sub-sites or skin exposed spots
6.5.2 Provisional MEDu
6.5.3 Estimated/anticipated MEDu
6.5.4 MEDu
6.5.5 Incremental progression of UV dose
6.6 Product removal
6.7 Procedure for MED assessment
6.7.1 General
6.7.2 Time of assessment of MED
6.7.3 MED assessment
6.7.4 Data rejection criteria
6.7.5 Expression of MEDs
7 Calculation of the sun protection factor and statistics
7.1 Calculation of the individual SPF (SPFi)
7.2 Calculation of product SPF
7.3 Statistical criterion
7.4 Validation of the test
8 Test report
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1 Scope
2 Terms and definitions
3 General principle
4 Test subjects
4.1 Selection of the test subjects
4.1.1 General
4.1.2 Skin phototype of the test subjects
4.1.3 Age restriction
4.1.4 Frequency of participation in tests
4.1.5 Ethics and consent
4.2 Number of test subjects
4.3 Test area
5 Apparatus and materials
5.1 Source of ultraviolet radiation
5.1.1 General
5.1.2 Quality of ultraviolet radiation
5.1.3 Total irradiance (UV, visible and near infrared rays)
5.1.4 Uniformity of beam
5.1.5 Maintenance and monitoring the UV solar simulator output
5.1.5.1 Radiometry
5.1.5.2 Spectroradiometry
5.2 Reference sunscreen formulations
5.2.1 General
5.2.2 Expected SPF ( SPF 20
5.2.3 Expected SPF W SPF 20
5.2.4 Acceptance SPF limits for the reference sunscreen formulations
5.2.5 Formulae and preparation of the reference sunscreen formulations
6 Procedure
6.1 Main steps
6.2 Test conditions
6.3 Position of the test subjects
6.4 Procedure for product application
6.4.1 General
6.4.2 Test sites and product application
6.4.3 Amount of product applied
6.4.4 Mode of delivery
6.4.4.1 General
6.4.4.2 Liquid type products (e.g. lotions, liquids, milks, creams, sprays and sticks)
6.4.4.3 Powders
6.4.5 Drying time between application and UV exposure
6.5 Procedure for UV exposure
6.5.1 Exposure sub-sites or skin exposed spots
6.5.2 Provisional MEDu
6.5.3 Estimated/anticipated MEDu
6.5.4 MEDu
6.5.5 Incremental progression of UV dose
6.6 Product removal
6.7 Procedure for MED assessment
6.7.1 General
6.7.2 Time of assessment of MED
6.7.3 MED assessment
6.7.4 Data rejection criteria
6.7.5 Expression of MEDs
7 Calculation of the sun protection factor and statistics
7.1 Calculation of the individual SPF (SPFi)
7.2 Calculation of product SPF
7.3 Statistical criterion
7.4 Validation of the test
8 Test report