Eyewear product certification is crucial for brands aiming to sell their products either domestically or globally. Our experts ensure that your products pass all necessary certifications.
PEL provides a comprehensive one-stop solution for your eyewear products entering the EU market successfully, which guarantees customers’ products complying with relevant harmonized standard requirements. Working with PEL to certify your eyewear allows you access to the market for a reasonable cost and with no hassle.
|Product type||Product Directives' Regulations||Harmonized Standards|
|Sunglasses||89/686/EEC Personal Protective Equipment Directive (PPE Directive)||EN ISO 12312-1|
|Safety spectacles||89/686/EEC Personal Protective Equipment Directive (PPE Directive)||EN 166 : 2001|
|Ski googles||89/686/EEC Personal Protective Equipment Directive (PPE Directive)||EN 174 : 2001|
|Optical frames||93/42/EEC Medical Devices Directive (MODD Directive)||EN ISO 12870|
|Reading glasses||93/42/EEC Medical Devices Directive (MODD Directive)||EN 14139|
|Opthalmic lenses||93/42/EEC Medical Devices Directive (MODD Directive)||EN ISO 14889|
|Spectacle frames*||REACH Annex 17 (Nickle release Directive)||EN 12472 EN 16128|
* spectacle frames (apply to metal frames/frames with metal parts, prolonged contact with skin)
Eyewear products for general use, such as reading glasses, ophthalmic lenses and non-prescription sunglasses, are classified as medical devices Class I, that are regulated by U.S. Food and Drug Administration. PEL ensures that your eyewear becomes USA FDA certified and that you’re able to access the American market.
In accordance with 21 CFR 801.410, all eyewear products imported to the US market should be mounted impact-resistant lenses, requiring a test of a statistically significant sample from each production batch. All importers must provide an impact resistance declaration with FDA compliance requirements. FDA accepts the Acceptable Quality (AQL) of 6.5, General Inspection Level II.
|Lot/Batch Size (pcs of lenses)||Sampling Size (pcs of lenses)||Ac/Re||Lot/Batch Size (pcs of lenses)||Sampling Size (pcs of lenses)||Ac/Re|
|2 to 8||2||0/1||281 to 500||50||7/8|
|9 to 15||3||0/1||501 to 1200||80||10/11|
|16 to 25||5||1/2||1201 to 3200||125||14/15|
|25 to 50||8||1/2||3201 to 10,000||200||21/22|
|51 to 90||13||2/3||10,001 to 35,000||315||21/22|
|91 to 150||20||3/4||35,001 to 150,000||500||21/22|
|151 to 280||32||5/6||150,001 to 500,000||800||21/22|