Under European Medical Device Regulation 2017/745, optical lenses and spectacle frames are considered Class 1 medical devices and subjected to dozens of lab tests and production specifications to ensure optimal lense quality, frame durability and product safety.
Like most products intended for the EU market, eyewear must carry the iconic CE marking (as per Medical Devices Regulation 2017/745). In order to obtain this marking, manufacturers or their EU Representative Agent (for non-EU businesses) must register their product with the Medicines and Healthcare products Regulatory Agency (MHRA).
The purpose of eyeglasses is to correct or improve vision for people who have near-sightedness (myopia), far-sightedness (hyperopia), presbyopia, and astigmatism. As this corrective function affects wearers’ daily life, precise lense manufacturing and mounting are important requirements to provide quality spectacles to the market.
Part of the EU’s growing concern over the presence of hazardous chemicals in daily-use products has included nickel, a metal frequently used in alloys. Nickel is a known skin allergen, even claiming the title of the American Contact Dermatitis Society’s “Contact Allergen of the Year” in 2008. The European Chemicals Agency (ECHA) has continued to strengthen restrictions on Nickel and clarified its definition of ‘prolonged contact with the skin’ in relation to consumer products.
As part of QIMA's comprehensive spectacle frame testing, nickel release in coated metal parts is tested against the ISO 12870 Standard.
ISO 12870 focuses on such aspects of eyewear quality as general frame construction (including smooth surfaces and rounded edges); stability in elevated temperatures; resistance to perspiration; resistance to ignition, and many others.
It is the belief amongst organizations like HOKLAS and the ILAC that many economies are served by authoritative bodies that can exercise oversight for laboratories tasked to carry out national and international compliance tests.
QIMA's lab test reports are issued with HOKLAS and ILAC endorsements, offering an extra layer of assurance as each lab is subjected to their own performance standards dictated by these accreditation bodies. Your exacting production standards for optical lenses and frames should be met with the same level of expertise, lab management and top-tier testing equipment.
QIMA's Quality Assurance services can also help you design your eyewear in accordance with all established national and international standards to prepare you for production in your intended market.
Our online platform and mobile application make it easy for you to schedule Eyewear tests and inspections, and receive your results at any time. Book new tests and inspections, view pending orders, and access results from your mobile device. Our online platform provides valuable supply chain insights, including a summary of your QC activity, all of your supplier’s quality stats, industry benchmarking data, and more.
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