Overview
CEN ISO/TR 26369:2009 (ISO/TR 26369:2009) is a Technical Report that reviews and evaluates the methods currently used to assess the photoprotection provided by sun protection products applied to the human body. It is informative in nature and intended as a scientific/technical framework to identify the most suitable methods for standardization by ISO/TC 217. The report covers both SPF (UVB) and UVA protection, and examines in vivo and in vitro approaches.
Key Topics
The report systematically compares existing test methods and lists key parameters in tabular form (Tables 1–6). Major technical topics and requirements reviewed include:
- SPF in vivo methods: volunteer selection, ethical considerations, skin phototypes, test site selection and delineation.
- SPF in vitro methods: transmittance-based approaches (evolved from Diffey proposal), newer methods using free-radical measurement or skin biopsies.
- UVA in vivo methods: protocols and measurement approaches for UVA protection.
- Instrumentation and source control: solar simulator characteristics, spectral distribution, irradiance uniformity, filters (e.g., WG320), and acceptance limits.
- (Spectro)radiometry: calibration and spectroradiometric checks, monitoring procedures and radiometer use.
- Product application and dosing: standardized application quantity (notably 2 mg/cm² for many SPF in vivo protocols), film formation, spreading technique, drying time and environmental control.
- Test design elements: number of sub-sites, UV dose progression, randomization, blinding, and validation practices.
Applications
This Technical Report is practical for:
- Evaluating and comparing laboratory methods for SPF testing and UVA protection assessment.
- Guiding development of standardized test protocols for product validation, regulatory submissions or self-regulation.
- Assisting laboratories in selection of appropriate in vivo vs in vitro methods and in configuring solar simulators, spectroradiometers, and test-site procedures.
- Supporting harmonization of test criteria across regions and jurisdictions.
Who Uses This Standard
- Cosmetic and sunscreen manufacturers (R&D, quality assurance)
- Third‑party test laboratories and contract research organizations (CROs)
- Regulatory authorities and conformity assessment bodies
- Standards developers and technical committees (ISO/TC 217, CEN)
Related Standards
ISO/TR 26369:2009 serves as an informative framework to support the development or revision of formal ISO/CEN standards for sun protection testing. It does not address labelling requirements in detail.
Keywords: sun protection test methods, SPF testing, UVA protection, in vivo SPF, in vitro SPF, photoprotection assessment, ISO/TR 26369, CEN ISO/TR 26369:2009.