Gap Analysis Report on EN 1811:2023 for the Release of Nickel
Article written by: Dippal Manchanda, MSc CSci CChem FRSC, Technical Director & Chief Assayer Birmingham Assay Office, UK
In February 2023, the European Committee for Standardization (CEN) published EN 1811:2023, the latest reference test method for the release of nickel from articles intended to come into direct and prolonged contact with the skin. This report aims to identify the gaps between EN 1811:2023 and the conflicting national standards and the differences between the new standard and the previous version of EN 1811.
Scope and Exclusions
EN 1811:2023 covers all post assemblies that are inserted into pierced parts of the human body and articles intended to come into direct and prolonged contact with the skin, except for spectacle frames and sunglasses, which are subject to the requirements of EN 16128. However, the scope of the standard remains the same as the previous version of EN 1811.
Major Changes and Updates
EN 1811:2023 introduces several new definitions, such as the revised definition of "homogeneous," which now excludes coated materials. It also adds a new definition for "surface finish," which characterises the appearance and texture of a surface. The new standard clarifies the procedures for handling very small samples and filtering the release solution to remove particulates before analysis. A minimum of three test samples of the same batch shall be submitted for testing wherever possible, as items in a batch can vary. Additionally, the updated standard requires a more detailed test report, including the sample area used for calculation and the volume of test solution used, among other information.
The conflicting national standards must be withdrawn by August 2023 at the latest, which will require manufacturers/ testing laboratories to adjust their testing processes to comply with EN 1811:2023. The new standard clarifies some of the previous ambiguities in the test procedures, but it may also introduce new challenges, such as the need for improved adhesion of wax and the requirement to cover cracks and fissures. The updated standard provides more specific guidance on the preparation, testing, and calculation of results, including a new flow chart for sample preparation and testing procedure for complete watches.
EN 1811:2023 represents a significant update to the previous version of the standard, introducing new definitions, clarifications, and more specific guidance on the preparation, testing, and calculation of results. Manufacturers/ testing houses must adapt their testing processes to comply with the new standard by August 2023, which may require some adjustments and improvements to their current practices.
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