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 comply 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 | EU Regulation 2016/425 | EN ISO 12312-1 |
Safety spectacles | EU Regulation 2016/425 | EN 166 & EN ISO 16321-1 |
Ski googles | EU Regulation 2016/425 | EN 174 & EN ISO 18527-1 |
Optical frames | EU Regulation 2017/745 | EN ISO 12870 |
Reading glasses | EU Regulation 2017/745 | EN 14139 |
Ophthalmic lenses | EU Regulation 2017/745 | 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.
This table outlines the sampling plan based on the ANSI/ASQ Standard Z1.4-2003, which provides guidelines for quality inspection through sampling. It details the relationship between the size of a lot or batch of lenses and the corresponding number of samples to be inspected. The "Ac/Re" column specifies the acceptance and rejection criteria, determining the number of defects allowed to maintain quality standards. This structured approach helps ensure product quality and consistency in compliance with established statistical quality control methodologies.
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 |
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