DIN EN 16128:2016-02

This standard specifies the reference method for the testing of spectacle frames, ready-to-wear spectacles, sunglasses and other items for eye and face protection for nickel release. The reference method supports the demonstration of conformity with the limit value for nickel release of 0,5 μg/cm2/week set forth by European Regulation. This document applies to those parts of metal spectacle frames and those metal parts of combination spectacle frames that are intended to come into direct and prolonged contact with the skin of the wearer. This document also applies to those relevant metal parts of ready-to-wear spectacles, sunglasses and other items for eye and face protection. This standard has been prepared under a mandate given to CEN by the European Commission in connection with the European REACH regulation. Following the publication of Technical Specification DIN CEN/TS 16677 (DIN SPEC 13450) in July 2014, the present standard is a further step in replacing the harmonized standard EN 16128:2011 that had been cited in the Official Journal of the EU. Compared to the reference method specified in the previous edition DIN EN 16128 of May 2011, the reference method has been substantially revised. It comprises the following procedural steps, whereby the procedure for simulating wear and corrosion specified in EN 12472 shall be carried out beforehand: 1) Coating test, applicable only to test parts with an organic coating, based on Electrochemical Impedance Spectroscopy (EIS). The coating test aims at demonstrating that the coating of the test sample is of sufficient quality to prevent the release of nickel, thereby ensuring that the test sample's nickel release does not exceed the regulatory limit. The coating test is, however, not sensitive only to nickel ions, so a model can pass the migration test even though it failed the coating test. 2) Migration test for nickel release; the migration test makes provision for quantitative testing for the amount of nickel released, to determine whether or not the model's nickel release exceeds the limit set in the European Regulation. The migration test comprises two steps: Release of nickel by artificial sweat solution into a test paper and the subsequent quantitative analytical detection of the nickel released into the paper. For a model that failed the coating test, either new test samples or - subject to the requirements of the person ordering the test - the original test samples may be subjected to the migration test. Metal frames that are uncoated, that is neither organic coating nor metal plating, and made of homogeneous alloys or metals do not require the simulation of wear and corrosion and shall be tested directly. Unless the manufacturer certifies that a component is homogeneous and uncoated, the component shall be assumed to be coated. With the publication of the present standard, an opportunity is given for all users involved in the testing of the nickel release of spectacle frames and sunglasses to initiate the switch to the new future reference method at an early stage and to gain practical experience in its application. The European working group involved in the development of EN 16128:2015 is expressly interested in user feedback which can benefit the further development of the reference method. CEN has granted member countries the option of leaving any national standards that conflict with the document in place until November 2018. However, that this does not imply that the use of the new reference method described in the present document is not binding until November 2018. Use of this method becomes binding once EN 16128:2015 is cited in the Official Journal of the European Union, taking any transition periods into consideration. At the time DIN EN 16128:2016 went into production, this citation in the Official Journal of the EU had not yet taken place. Users of this standard should carefully monitor the status of EN 16128 and/or its citation in the Official Journal of the EU. The document (EN 16128:2015) has been prepared by Technical Committee CEN/TC 170 "Ophthalmic Optics", the secretariat of which is held by DIN. The responsible German committee is Working Group NA 027-01-08-08 AK "Brillenfassungen" ("Spectacle frames") at DIN Standards Committee Optics and Precision Mechanics (NAFuO).