15.2 ANSI Z87.1 & FDA Safety Regulations

ANSI Z87.1 & FDA Safety Regulations

Ophthalmic dispensing involves not only maximizing visual acuity but also protecting the patient's eyes from environmental hazards. In the United States, protective eyewear standards and regulations are established by two primary entities: the American National Standards Institute (ANSI), which publishes the voluntary consensus standard ANSI/ISEA Z87.1-2020: Occupational and Educational Personal Eye and Face Protection Devices, and the federal Food and Drug Administration (FDA), which regulates everyday dress eyewear under 21 CFR 801.410. The Occupational Safety and Health Administration (OSHA) enforces ANSI Z87.1 compliance in the workplace.

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ANSI Z87.1-2020 Safety Eyewear Standards

The ANSI Z87.1 standard covers eye protection devices used in industrial, educational, and medical settings. It separates protectors into two performance categories: "basic impact" and "high impact." Lenses and frames must undergo rigorous testing to achieve these ratings.

Basic Impact Lenses

Basic impact safety lenses are designed to protect against low-velocity hazards, such as dust, wood shavings, or minor hand-tool debris.

• Minimum Thickness: Prescription basic impact safety lenses must have a minimum center thickness of 3.0 mm. An exception is permitted: if the lens power in the most plus meridian of the distance portion is greater than +3.00 D, the minimum thickness can be reduced to 2.5 mm.
• The Z87 Basic Impact Test: The lens is mounted in a standard test holder and subjected to a drop-ball test. A 1-inch steel ball (weighing approximately 2.4 ounces) is dropped from a height of 50 inches onto the center of the lens. The lens must not crack, chip, fracture, or dislodge from the holder.

High Impact Lenses

High impact safety lenses are designed to protect against high-velocity hazards, such as flying metal fragments, grinding sparks, or impact from power tools. High-impact lenses are typically fabricated from impact-resistant polymers such as polycarbonate or Trivex.

• Minimum Thickness: Prescription high-impact lenses must maintain a minimum thickness of 2.0 mm at their thinnest point, regardless of lens material or dioptric power. There is no power-based thickness exemption.
• The High-Mass Test: A heavy, pointed projectile weighing 17.6 ounces (1.1 pounds) is dropped through a tube from a height of 50 inches onto the lens mounted in a frame. The lens must not fracture or detach from the frame.
• The High-Velocity Test: A 1/4-inch steel ball is propelled at the lens at a speed of 150 feet per second (102 miles per hour) for spectacles, or 250 feet per second for face shields. The test is repeated at multiple angles. The lens must not break, chip, or be pushed out of the frame.

Frame Markings and Side Protection

• Safety Frame Markings: Safety frames must meet stringent structural requirements. Prescription safety frames must be marked with Z87-2 on the frame front and both temples to indicate they are rated for prescription use. If the frame is rated for high impact, it is marked with Z87-2+.
• Safety Lens Markings: Lenses must also be permanently marked. High-impact lenses are etched with the manufacturer's logo and a "+" sign (e.g., "O+"). Basic impact lenses are etched with only the manufacturer's logo.
• Side Shields: To protect the eyes from lateral hazards, safety glasses must have side shields. The Z87.1 standard allows side shields to be either permanent (built-in) or removable. If removable side shields are used, they must be specifically tested and certified for use with that exact frame model.

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FDA Regulation 21 CFR 801.410: Dress Eyewear

The FDA regulates everyday, fashion, and sun eyewear under federal regulation 21 CFR 801.410. The FDA's mandate is to ensure that all spectacles sold to the general public possess a baseline level of impact resistance.

The FDA Drop-Ball Test Protocol

Unlike the Z87.1 safety standards, the FDA does not specify a minimum thickness for dress lenses. It is a performance-based regulation. A lens of any thickness is compliant, provided it can pass the referee test:

• Test Setup: A 5/8-inch steel ball weighing approximately 0.56 ounces is dropped from a height of 50 inches onto the horizontal upper surface of the lens at its geometric center.
• Pass/Fail Criteria: A lens fails the test if it fractures (splits into two or more pieces) or if any lens material visible to the naked eye becomes detached from the ocular (inner) surface.

Testing Frequency: Glass vs. Plastic

The FDA distinguishes between lens materials regarding how frequently they must be tested:

• Prescription Glass Lenses: Glass is highly brittle. To ensure safety, 100% of prescription glass lenses must be individually drop-ball tested after being finished, surfaced, and tempered (either by heat-treating or chemical-tempering). The optician or laboratory must document this individual test.
• Plastic Lenses (CR-39, Polycarbonate, Trivex): Because plastic materials are inherently flexible and impact-resistant, the FDA permits statistical batch testing. The manufacturer or laboratory must test a statistically representative sample from each production lot.

FDA Testing Exemptions

Certain specialized lens designs are exempt from the drop-ball test because the test itself would damage the lens or because the lens cannot be manufactured to withstand the impact without destroying its utility. These lenses must still be made as impact-resistant as possible, but do not undergo testing:

1. Raised-segment multifocal lenses (e.g., executive bifocals)
2. Prism segment multifocal lenses
3. Slab-off prism lenses
4. Lenticular lenses (high-plus cataract lenses)
5. Laminated glass/plastic lenses
6. Custom-made prescription lenses of unique or delicate design

Warning Labels and Record Keeping

The FDA requires manufacturers, importers, and dispensers to maintain records of impact-resistance compliance (such as laboratory invoices and batch testing logs) for at least 3 years from the date of distribution. Furthermore, when dispensing glass lenses, opticians must ethically inform patients that while the lenses pass the FDA impact test, they are not "shatterproof" or "unbreakable."

Regulation Comparison Table