Colson Bertrand, Vollhardt Jürgen, Cole Curtis, Kolbe Ludger, Matts Paul, Muller Benoit, Nogueira Luciano, Oliveira Sergio, Pissavini Marc, Pouradier Florence, Renner Gerald, Rohr Mathias, Ruvolo Eduardo, Tricaud Caroline, Uhlig Steffen
QuoData GmbH, Dresden, Germany.
DSM-Firmenich, Kaiseraugst, Switzerland.
Int J Cosmet Sci. 2025 Sep;47 Suppl 1:2-24. doi: 10.1111/ics.70019.
This paper presents the experimental design, the statistical model, performance criteria and results of a method performance study conducted in order to characterize the performance of alternative methods for SPF and UVA-PF testing. The performance of alternative methods is characterized against the performance of the ISO 24444 and ISO 24443 methods.
A factorial experimental design was implemented. For a given method, such a design allows good statistical reliability of precision estimates with as few as four participating laboratories. To cover the wide range of sunscreen products on the market, 32 sunscreens were tested. These 32 products were classified into eight product groups. The product groups differ in terms of SPF level, application viscosity and type of UV filters and matrix. In co-operation with a WG7 ISO ad hoc group performance criteria for the alternative methods were developed for reproducibility precision, between-laboratory variation, bias and the variation of bias across products and across product groups.
Performance characteristics for the reference method along with reproducibility and repeatability limits are provided. The results for the participating alternative methods will be presented in separate articles, following this paper.
The precision of ISO 24444 and ISO 24443 was characterized for each of the eight product groups. The main sources of variation were identified for each of the two reference methods. Reproducibility and repeatability limits were derived and are provided.
本文介绍了一项方法性能研究的实验设计、统计模型、性能标准和结果，该研究旨在描述用于SPF和UVA-PF测试的替代方法的性能。将替代方法的性能与ISO 24444和ISO 24443方法的性能进行了对比。
采用析因实验设计。对于给定方法，这种设计只需四个参与实验室就能实现精度估计的良好统计可靠性。为涵盖市场上种类繁多的防晒产品，测试了32种防晒霜。这32种产品被分为八个产品组。这些产品组在SPF水平、涂抹粘度、紫外线过滤剂类型和基质方面存在差异。与ISO第7工作组特设小组合作，针对替代方法制定了关于再现性精度、实验室间差异、偏差以及产品间和产品组间偏差变化的性能标准。
提供了参考方法的性能特征以及再现性和重复性限度。参与研究的替代方法的结果将在本文之后的单独文章中呈现。
针对八个产品组中的每一组，对ISO 24444和ISO 24443的精度进行了描述。确定了两种参考方法各自的主要变异来源。得出并提供了再现性和重复性限度。
