EN 14139:2010

Overview

EN 14139:2010 is a European Standard developed by CEN that specifies the minimum requirements for ready-to-wear spectacles used primarily for near vision and reading. These spectacles incorporate single vision lenses of equal positive spherical power ranging from +1.00 to +3.50 dioptres. Unlike custom prescription eyeglasses, ready-to-wear spectacles covered under this standard are not intended for regular use without the approval and guidance of an eye-care professional.

This standard ensures the safety, optical performance, and quality of ready-to-wear spectacles according to harmonized European regulations and is aligned with the essential requirements of EU Directive 93/42/EEC on medical devices.

Key Topics

• Scope and Definitions
  Defines ready-to-wear spectacles as devices with single vision lenses pre-mounted and not customized based on a healthcare professional’s prescription.

• Performance Requirements
  Specifies tolerances for optical power and prismatic power to guarantee consistent visual quality. Lenses must meet criteria outlined in EN ISO 14889, and frames must comply with EN ISO 12870 for durability and safety.

• Optical Power Range and Tolerances
  Ready-to-wear lenses must have spherical power within +1.00 to +3.50 dioptres, with tolerances compliant with EN ISO 8980-1, ensuring reliable and safe optical correction.

• Marking and Packaging
  Spectacles must be permanently marked with manufacturer identification and declared spherical power. Packaging must include warnings that these products are intended exclusively for near vision and reading, not suitable for driving or road use, and must carry guidance for regular eye-care professional examinations.

• Safety and Usage Warnings
  Clear labeling with the standardized “not suitable for driving and road use” symbol, alongside notices emphasizing the importance of professional eye care, helps protect consumers from using these spectacles inappropriately.

• Regulatory Compliance
  The standard aligns with EU medical device regulations, providing a framework to ensure ready-to-wear spectacles meet health and safety requirements for medical devices.

Applications

• Retail Optical Products
  EN 14139:2010 facilitates the manufacturing and distribution of over-the-counter reading glasses that meet consistent quality and performance standards.

• Consumer Eye Care
  Provides guidelines for manufacturers and retailers to inform users about the safe use of ready-to-wear spectacles, limiting risks associated with self-prescribing eyewear.

• Eye-Care Professionals
  Enables eye-care practitioners to recommend or approve ready-to-wear spectacles for short-term or emergency use, emphasizing that these spectacles cannot replace full eye examinations or prescription eyewear.

• Quality Assurance
  Manufacturers utilize this standard to certify that their ready-to-wear spectacle products comply with European market requirements, reducing liability and enhancing consumer trust.

• Medical Device Compliance
  By conforming to the standard, manufacturers fulfill part of the regulatory obligations under EU Directive 93/42/EEC for medical devices, enabling market access within EU member states.

Related Standards

• EN ISO 12870:2004 - Spectacle frames, requirements and test methods, referenced for frame performance and glazing security.
• EN ISO 14889:2003 - Specifications for uncut finished lenses, framing the necessary optical quality for spectacle lenses.
• EN ISO 8980-1:2004 - Sets optical power tolerances for single vision spectacle lenses.
• EN ISO 7998, EN ISO 13666, EN ISO 8624 - Provide essential terminology and measurement systems used throughout ophthalmic optics.
• EU Directive 93/42/EEC - Regulatory framework for medical devices in the European Union to which this standard relates, ensuring safety and performance compliance.

Keywords: EN 14139, ready-to-wear spectacles, ophthalmic optics, single vision lenses, spectacle standards, eye-care professional, optical power tolerances, medical device compliance, CEN standard, reading glasses, eyewear regulations, European Standard for spectacles.