EU – CEN Approves EN 16128:2015 Nickel Release Standard for Spectacle Frames and Sunglasses

EN 16128:2015

EN 16128:2011

Title

Ophthalmic optics. Reference method for the testing of spectacle frames and sunglasses for nickel release

Reference test method for release of nickel from those parts of spectacle frames and sunglasses intended to come into close and prolonged contact with the skin

Scope

Parts of metal spectacle frames, combination spectacle frames, ready-to-wear spectacles, sunglasses and other items for eye and face protection that are intended to come into direct and prolonged contact with the skin of the wearer

Parts of spectacle frames and sunglasses intended to come into direct and prolonged contact with the skin

Principle

Test parts with organic coating

• Coating test based on Electrochemical Impedance Spectroscopy (EIS) to ensure the organic coating can prevent the nickel release from the parts exceed the regulatory limit.
• Impedance ≥ 3.0 x 105 Ω.cm² is deemed compliant
• Or the non-compliant parts may be subject to the migration test below

Test parts without organic coating or test parts not requiring the simulation of wear and corrosion specified in EN 12472.

• 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
• < 0.76 μg/cm²/week is deemed compliant

Test parts are placed in an artificial sweat solution for one week, and then the concentration of dissolved nickel in the solution is determined by appropriate analytical method.

The analytical result is adjusted with the 0.1 times correction factor and the adjusted test result should be lower than the regulatory limit to deem compliant.

Artificial sweat solution

Deionized water containing:

• Sodium hydroxide solution
• Sodium chloride
• Lactic acid
• Urea

Deionized water containing:

• Ammonium solution
• Sodium chloride
• Lactic acid
• Urea