According to European regulations, which are incorporated into national law:

  • eyeglass frames are considered medical devices
  • sunglasses are considered personal protective equipment.

Standards are technical documents that facilitate the CE conformity assessment of these products. For more information on eyewear regulations, visit the website of the ALUTEC laboratory.

CE marking

This is the passport allowing products to freely circulate throughout the European Union territory and be placed on the market. The CE marking attests to the conformity of the products with the essential health and safety requirements of the European directive. The control procedures are described in the specific European standard(s) for each product. The test reports established after the tests make up the technical file which assumes the CE conformity of the product and authorizes the CE marking.

The main legislative and normative references.

The European Directive 94/27/EC

The European Directive 94/27/EC on dangerous substances, known as the “Nickel Directive,” came into force on 1 February 1995 and was transposed into national law by the decree of 18 July 2000. European Union Member States have implemented this regulation differently. In France, the nickel release control applied to eyeglass frames or sunglasses is restricted to parts intended to come into direct and prolonged contact with the skin. Supporting standards: EN 12472:2005 + EN 1811:1998.

The “Medical Devices” Directive 93/42/EEC

The “Medical Devices” Directive 93/42/EEC, which came into force on 14 June 1998, was transposed into national law (Decree n°95-292 of 16 March 1995). Supporting “product” standards for the “Medical Devices” Directive include: optical frames – NF EN ISO 12870:2005 (ISO 12870:2004 + corrigendum Nov04); corrective lenses – NF EN ISO 8980 -1 and -2: 2004; -3 and -5:2005;-4:2000 NF EN ISO 14889:2003; magnifying glasses or pre-assembled glasses – ISO 16034:2002 NF EN 14139:2003.

The “Personal Protective Equipment” Directive 89/686/EEC

The “Personal Protective Equipment” Directive 89/686/EEC, which came into force on 1 July 1995, was transposed into national law (Decree n° 94-689 of 5 August 2004, modified by the sports code). Supporting “product” standards for the “P.P.E.” Directive include: lenses and sunglasses – NF EN 1836:2007 (or EN 1836:2005+A1 2007); ski masks – NF EN 174:2001.

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