The Standards of Our Industry

An explanation of current standards, sponsored by The Vision Council Optical Lab Division

By Alex Yoho, ABOM

All of us in the eyecare profession have a responsibility to give patients the very best product to address their vision needs. To that end, standards have been developed to ensure that consumers receive eyewear that meets those needs.

The standards addressing the eyewear we sell are developed and revised periodically by meetings of industry representatives (in the form of accredited committees) who are charged with developing standards facilitated by the American National Standards Institute (ANSI).

There are currently more than 200 committees overseeing more than 10,000 standards in various industries. ANSI committees are made up of people who incorporate many viewpoints in various categories, including industry experts, manufacturers, and academics, as well as what’s referred to as public comment. A consensus that everyone can benefit from is developed by utilizing all of these viewpoints.

In our industry, that means groups representing labs, optometrists, ophthalmologists, and opticians as well as interested associations are active in creating the standards.

These standards are voluntary, so manufacturers may choose whether or not their products will be made to a standard’s requirements. There are also government groups that may create regulations that may be incorporated as part of a standard. Similarly, government agencies may adopt standards for purposes of providing measures of safety protection.

As we explain below, various aspects of ANSI standards become intertwined with FDA and OSHA requirements.

KEY OPTICAL STANDARDS

There are several ANSI standards that ECPs and labs are concerned with, notably: “ANSI Z80.1-2010 for Ophthalmics–Prescription Spectacle Lenses” (regular ophthalmic eyewear); and “ANSI/ISEA Z87.1- 2010 for Occupational and Educational Personal Eye and Face Protection Devices” (safety eyewear).

There have been a number of questions regarding these standards, and we will explore some of them in this article, which is sponsored by The Vision Council’s Optical Lab Division.

DRESS EYEWEAR

First, let’s examine the topics covered by the standards. When we in the industry think of ANSI standards, usually one of two topics comes to mind. One is impact resistance and the other is lens refractive tolerances.

Each of the standards—covering dress eyewear and regular ophthalmic eyewear—incorporates both of these topics and more. For the purposes of this article, however, we will limit our discussion to impact resistance and lens refractive tolerances.

CONSENSUS VS. REGULATION

Impact resistance is important from an ethical as well as a liability standpoint. We want patients to have the safest eyewear possible. That being said, we also have a legal responsibility.

While adhering to the standard is voluntary, there’s a federal regulation that defines a level of impact resistance. Not following that federal regulation may expose the manufacturer to liability.

The FDA has defined impact resistance and how to test for it, while lawyers and judges determine liability. The federal regulations are available online; it’s a good idea to read the rules that pertain to our industry yourself.

DROP-BALL TEST

Both the ANSI Z80 standard and the CFR (Code of Federal Regulations) require the test and method of testing for the impact resistance of dress eyewear. These “dress eyewear” lenses must be able to withstand the impact from a 5/8-inch steel ball dropped onto the lens from a distance of 50 inches. That’s a pretty good wallop if it hits your hand! It is the responsibility of the manufacturer to batch test and document that the lenses produced will meet these criteria. These records must be kept for three years.

There are exceptions to the requirements for impact resistance in the law, but for the vast majority of eyewear produced and dispensed, the lenses must be made impact resistant for the patient’s protection. It is important that we do not convey to the final consumer that our products are unbreakable or shatterproof, however. They are not. Even polycarbonate or Trivex lenses can break under the right (or wrong) circumstances.

In cases where impact-resistant lenses will not fulfill the visual requirements of a particular patient, ECPs must direct in writing the use of other lenses, and give written notification to the patient (21 CFR 801.410(c)(1)).

As an industry, we have agreed to utilize the Z80 standard for dress eyewear. Many ECPs are unaware, however, that there is a 2010 revision, and they are using older versions of the standards.

The BPI Square Shooter Drop Ball Tester

The earlier Z80.1-1995 version caused confusion on power tolerance because it used the highest power meridian as the basis. This was carried into the 2005 revision. The 2010 revision, however, returns to the practice of using both the sphere and cylinder power and also specifies “the cylinder shall be expressed in minus cylinder notation.”

The Vision Council Optical Lab Division has a quick reference guide for the ANSI Z80.1-2010 available through member laboratories.

SAFETY EYEWEAR

ANSI/ISEA Z87.1-2010 has yet to be adopted into the Code of Federal Regulations as the 2003 standard was. The 29CFR, 1910.133(b)(1) criteria for eye and face protection currently states that “protective eye and face protection devices must comply with any of the following consensus standards,” meaning the 2003, 1998, and 1989 standards. These three standards were then incorporated into the regulations and given force by reference and stated as such. This regulation is overseen by OSHA.

Employers that demonstrate devices are at least as effective as those created using these last three standards will be in compliance.

Here are some more of the specifics about Z87.1-2010:

■ ORGANIZATION BY HAZARD. The format has changed from past standards by organizing information by hazard instead of by product. This is designed to aid ECPs in helping their patients select appropriate protection based on hazard, i.e., the patient’s protective need such as impact, splash, and dust.

■ UNIT, NOT COMPONENTS. Among the more notable requirements is that instead of testing the individual components of the safety eyewear (i.e., frames, lenses, etc.), the eyewear must now be tested as a complete unit. Ensuring that protectors are tested as a complete unit should improve overall safety as in certain impact situations lenses could possibly be dislodged.

■ COMPLETE SAMPLES. As this standard is adopted, those considered manufacturers will be required to submit complete safety eyewear samples for testing of the type of hazard for which they are designed. This could be fairly expensive for small manufacturers.

■ SEPARATE TESTING. In the safety eyewear category of product that we typically sell today, there will need to be separate testing for different combinations of materials, coatings, or tints; not to mention different mounting systems such as V-bevel, T- bevel, groove, and so on. If there is any deviation from the process—such that it would cause the device not to pass the test—new testing is indicated.

Though testing is only required on the combinations of lenses, coatings, and frame retention systems you expect to sell, this could limit the offerings available.

■ MINIMUM COVERAGE SPECS. Protection may be better overall because previous standards did not specify minimum coverage. This has been addressed in the new Z87 standard, which indicates that coverage must be no smaller than 34mm wide × 28mm high. Though this seems small, the 2003 standard had no such restriction. There are also minimums on side shield size in the new standard.

■ FRAME MARKINGS. Markings for frames and lenses will also change somewhat. Lens markings will be similar to those now used. However, frames will be marked “Z87-2” for basic protective spectacles, whereas the mark “Z87-2+” will be used for impact-rated frames.

■ LENS MARKINGS. Frames that are marked with “Z87-2+” will meet the requirements for both basic and high-impact devices. The difference is and will be in the lens markings.

If basic impact is required, for example, the lenses will only have the manufacturer’s logo on them. If high impact is required, however, the lenses must have the manufacturer’s logo followed by a “+” symbol.

The Vision Council Optical Lab Division will continue to provide input and guidance to new revisions. And, as always, it will be there to assist labs in providing the best and most current information to their customers. EB