EU REACH Annex XVII provides for prolonged contact with skin, nickel metal objects in the release. Recently, the EU verify that the product meets the requirements of a standard test method has been modified. Prolonged contact with skin, metal goods, including ear and body piercing in the group of ornaments, and other jewelry, tables, zippers and clothing accessories, sunglasses, etc., the release of these products may cause skin sensitive to nickel ions, nickel allergies, severe or even cause of nickel dermatitis.
Modified, the original nickel-free standard test method EN 1811:1998 + A1: 2008 is divided into:
☆ EN 1811:2011 - a long time for direct contact with the skin of all metal objects, but does not include frames and sunglasses;
☆ EN 16128:2011 - only for frames and sunglasses.
With EN 1811:1998 + A1: 2008 compared, EN 1811:2011 major changes in technology are:
☆ applies extended to all parts of the group into the body piercing ornaments;
☆ test solution changes, replacing ammonia with a solution of caustic soda solution;
☆ contrast between the light of further laboratory studies to measure the uncertainty analysis instead of 0.1 times the correction factor;
☆ increase in Annex C, regulate the release of nickel before the test preparation process of different items.
Frames and sunglasses for the EN 16128:2011 and EN 1811:1998 + A1: 2008 compared to the technically has not changed, while retaining the 0.1-fold correction factor analysis. According to the earlier comparative studies between laboratories, allowing the analysis of the results between different laboratories are different. In other words, the test results analyzed by multiplying 0.1 times the correction factor, obtained after adjusting the results (ie results of the analysis, 10%), and then compared with the nickel-release limits. In other words, 0.1 times the correction factor is adjusted analysis, the results of the analysis if the limit is 10 times or more before the test failed.
EN 1811 from the correction factor to the change in the method of measurement uncertainty, in addition to spectacle frames and sunglasses display (there are provisions in EN 16128), the type of combination of body piercing jewelry and other direct contact with the skin for a long time items such as jewelry , tables and other nickel release more restrictive. The following table assumes that the two versions of EN 1811 the same results of the analysis shows that the two nickel-release restrictions change. EN 1811 version of the results of the analysis of each different treatment may lead to the opposite or inconclusive results.
Some uncertainty is inherently present in any measurement, and real results in repeated tests, the resulting uncertainty of the results among a group of statistics out. To EN 1811:2011, the results of the analysis and limits so close, that they are a group of uncertain outcomes and limit overlap with each other, so there is no conclusion. Analysis of uncertainty must be completely within the required limits above or below, so as to arrive at the conclusion of qualified or unqualified.
Currently, REACH Annex XVII ambiguous use of the CEN test methods that have been issued for the release of nickel test, but did not specify a specific standard or version. Therefore, in March 2013 EN 1811:1998 + A1: 2008 undo ago, some overlap period. During this time, in addition to other frames and sunglasses can be used any version of the EN 1811 test, to prove that goods meet the requirements of nickel release. This is a transitional period for industry to comply with more stringent EN 1811:2011 good products and processes and other aspects of the necessary preparations.