Updated ISO Standards Encourage Best Practices in the Optical Industry

By Evra Taylor

legalangleThe proliferation of eyeglass frames, contact lenses, and ophthalmic equipment and devices comes with the potential hazards of poor workmanship and compromised safety. It is a comfort, therefore, to know that the Standards Council of Canada (SCC) has developed criteria that promote product reliability and best practices in the optical and ophthalmic industries.

The SCC is a member of the International Standards Organization (ISO), an umbrella group made up of more than 160 member countries worldwide. ISO standards encompass everything from agriculture to medical devices and the ISO designation signifies a global consensus on the state of the art in the technology or good practice concerned. To ensure high quality in the eyeglass industry, the ISO has developed a standard outlining fundamental manufacturing requirements.

The standards document known as ISO 12870 applies to eyeglass frames for all prescription lenses and includes such items as protection against low-quality production and hazardous materials. ISO 12870 states: “This International Standard specifies fundamental requirements for unglazed spectacle frames designed for use with all prescription lenses. It is applicable to frames at the point of sale by the manufacturer or supplier to the retailer. This International Standard applies to all spectacle frame types, including rimless mounts, semi-rimless mounts and folding spectacle frames, as well as spectacle frames made from natural organic materials.” The standardization process involves in-depth product testing and evaluation of such elements as construction, clinical evaluation, tolerance on screw threads, mechanical stability and resistance to perspiration.

Dr. Ralph Chou is an optometrist and associate professor at the School of Optometry and Vision Sciences at University of Waterloo and a member of the SCC Mirror Committee for ISO, a group that has active input into the development of these criteria. He explained that the 12870 standard is relatively old and that the recently announced document is a revamping of the guidelines to reflect technology changes. “The standards system helps protect consumers because it provides common specifications that help ensure the quality of imported and exported products,” Dr. Chou said.

He also serves on ISO technical working groups that study the requirements for tints in ophthalmic lenses and the technical requirements for lensometers.

ISO standards updates are not the result of a manufacturing  problem; rather, they are a matter of process. Most standards undergo a technical review every three to 10 years, depending on the industry. With ophthalmic goods and materials, the review interval is roughly five years. Some stipulations are mandatory, others are optional. Certain items,  like quality of construction that prevents rough surfaces or sharp edges that might cause injury, are mandatory. An example of the new provisions is a section pertaining to nickel release in eyeglass frames, which can cause health problems in some individuals. This standard, which is mandatory, stipulates a maximum level of nickel that can be leached out of the frame.

Other standards organizations are at work in the optical sector elsewhere in the world. The CE Mark, abbreviated from Conformité Européenne, or “European Conformity,” indicates that a product conforms to European Union (EU) legal requirements, including safety standards. While not all products are required to bear the CE mark, medical devices, some types of machinery, toys and PCs are subject to CE standardization. Numerous Mutual Recognition of Conformity Assessment Agreements exist between the EU and countries including Canada, the U.S., Japan, Australia, New Zealand and Israel. As a result, the CE mark is now found on many products from these countries.

As an OD who is conversant with standardization in the optical industry, Dr. Chou is not certain that Canadian opticians have a high degree of awareness of ISO standards. “I mention them to optometrists and sometimes discuss them with my students. Like many things, this is an aspect of the industry that is not touched upon much in the education process,” he stated. “In the case of nickel release, for example, dispensers need to be more conversant and aware that the ISO standard exists as a safeguard.”

Dr. Chou views ISO standardization as “relatively effective. The ISO world is eventually going to become the way in which the ophthalmic market will be governed internationally. They have an entire system of standards that deal with eyeglass frames, contact lenses, aberrometers and other items. ISO standards are also becoming extremely important in intraocular lenses and dry eye implants.”

In Dr. Chou’s opinion, raising awareness is paramount. He emphasized that ophthalmic dispensers should ask sales representatives if their products conform to ISO standards as a way of ensuring product durability and safety for the end user. “Regardless of the price point, the product needs to perform to expectations. It’s important that Canadian professionals support the development of ISO standards and keep up to date with changes over time,” he noted.