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Eyewear Product Certification

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Obtain the Necessary Optical Certifications with PEL’s Eyewear Testing Experts

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.

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EU Certification

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)

USA FDA Certification

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.

Impact Resistance Declaration

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.

FDA Registration Workflow

  1. Sign FDA registration contract with PEL
  2. Establish the company account in FDA and obtain Personal Identification Number (PIN) from FDA.
  3. Pay the official fee to FDA and obtain Payment Confirmation Number (PCN) from FDA.
  4. FDA agent and official representative are responsible for all communication and feedback with FDA, Owner Number is obtained.
  5. Completion of Registration, Registration Number posted in FDA official website.

Sampling Plan Form: ANSI/ASQ Standard Z1 .4-2003.

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

Benefits

  1. Comply with Global Regulations
    Achieving optical certifications ensures that eyewear products meet international safety and quality standards, enabling companies to operate confidently in global markets and avoid legal complications.

  2. Safety Assurance
    Certifications confirm that eyewear has been thoroughly tested for safety. This protects consumers and enhances the brand's reputation by ensuring product reliability and reducing the risk of liability.

  3. Enhance Marketability
    Optical certifications make products more attractive to retailers and distributors, facilitating easier access to new markets and ensuring compliance with trade regulations that many commercial partners require.
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Get Started with Eyewear Product Certification Here

Learn more about how PEL can help your company improve the quality of your eyewear production and prevent problems before they reach your suppliers.
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