Sunglasses, slit-lamps among ophthalmic standards revisions
Several ophthalmic standards that dictate the tolerances and measurements behind everyday eye care products are getting a facelift following recent national standards body meetings.
The American National Standards Institute—Accredited Standards Committee for Ophthalmic Optics, referred to as the ANSI ASC Z80, oversees the voluntary consensus standards writing activity for ophthalmic optics, equipment and devices used by eye care professionals and industry.
Standards derived from ANSI ASC Z80 influence regulations domestically—and abroad as ANSI ASC Z80 experts also participate in the International Organization for Standardization (ISO)—that govern the ophthalmic industry, making it vital that AOA representation delivers optometry's perspective and input.
Karl Citek, O.D., Ph.D., AOA Commission on Ophthalmic Standards (CmOS) chair and ANSI ASC Z80 "Nonprescription Sunglasses and Fashion Eyewear" subcommittee chair, says all the instruments that doctors of optometry work with—from the medical devices prescribed or recommended—and the procedures doctors perform or refer out, are covered by national and international standards.
"Knowledge of standards allows us to communicate with and understand not only each other but also other health care professionals, as well as manufacturers and suppliers," Dr. Citek says. "Having input in the creation and updating of standards allows us to maintain patient safety and doctor efficiency."
Sunglasses, fashion eyewear get standards tweak
When ANSI ASC Z80 convened in February 2018 for its spring meeting, the standard for nonprescription sunglass and fashion eyewear requirements (Z80.3) came up for revision. The Z80.3 guideline is intended to establish guidelines for plano sunglass lenses, as well as the compliance information for the flammability, durability, cosmetic, refractive and transmittance properties of sunglasses that manufacturers use.
In this most recent revision (Z80.3-2018), the committee approved a change to the standard that clarifies testing of photosensitive lenses. This revision brings ANSI's guideline into more agreement with international standards. These changes are available for review through ANSI's webstore.
8 national standards revised, reaffirmed in 2017
Also during the February meeting, the body discussed subcommittee reports that reviewed the revision or reaffirmation of standards in 2017, among other points. In total, eight national ophthalmic standards were approved in 2017. Below are the standards approved for revision:
- Z80.31-2017: Ophthalmic Optics - Specifications for Ready-to-Wear Near-Vision Spectacles. This standard establishes the minimum requirements for "readers" that are available directly to the public without a prescription, as well as the requirements for the flammability and durability of frames and lenses.
- Z80.37-2017: Ophthalmics - Slit-Lamp Microscopes. This standard specifies requirements and test methods for slit-lamp microscopes to provide slit illumination and observation under magnification of the eye and its adnexa.
- Z80.38-2017: Ophthalmics - Light Hazard from Operation Microscopes Used in Ocular Surgery. This standard specifies requirements and test methods for optical radiation hazards from operation microscopes used during ocular surgery.
- Z80.28-2017: Ophthalmics - Methods of Reporting Optical Aberrations of Eyes. This standard specifies standardized methods for reporting optical aberrations of eyes.
Below are the standards reaffirmed by ANSI ASC Z80 without any adjustments:
- Z80.11-2012 (R2017): Ophthalmics - Laser Systems for Corneal Reshaping. This standard applies to any laser system whose primary intended use is to alter the shape of the cornea through the removal of corneal tissue, resulting in the improvement of visual performance.
- Z80.12-2012 (R2017): Ophthalmics - Multifocal Intraocular Lenses. This standard applies to any ocular implant whose primary indication is the correction of aphakia and whose optic is designed to provide simultaneous distance and near vision.
- Z80.13-2012 (R2017): Ophthalmics - Phakic Intraocular Lenses (IOL). This standard applies to any IOL whose primary indication is the modification of the refractive power of a phakic eye.
- Z80.24-2012 (R2017): Ophthalmics - Information Interchange for Ophthalmic Optical Equipment. This standard establishes a method by which machines and computer software systems used in the fabrication of ophthalmic lenses can exchange information.
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