The European norm for evaluating the nickel content risk in metal spectacle frames has been changed. CEN, the European Union's committee that establishes the technical guidelines for this sort of things, adopted a new procedure largely based on the test method developed by the Italian certification institute, Certottica, at a meeting on Dec. 13-14. The vote was almost unanimous, with 91.4 percent in favor and only the the Swedes voting against.
As previously reported, the test measures the quantity of nickel residue from metal frames deposited on the skin. Above a certain level, the effect is considered harmful to the wearer, and the sale of the frames is banned from sale in accordance with the terms of EU Directive Nr. 27. The previous norm, EN 12472.198, used a highly abrasive substance containing corundum, simulating conditions that are remote from those of normal wear, while destroying the tested frames. The new norm uses an abrasive paste which simulates a situation much closer to the reality of normal spectacle wear. The details of the new test procedure will be published on Jan. 24, 2001.
The new regulations will also the spell out the details of the first minimum European guidelines for pre-mounted spectacles, which are generally sold over the counter in drugstores and supermarkets. The idea is to eliminate potential health risks on products which come within the scope of EU Directive 93/42 on ?medical devices.?