1.2 Standards for Ophthalmic Lenses

What are the 5 groups that control standards and regulation for ophthalmic prescriptions and lenses?

FDA

FTC

OSHA

ANSI

OLA

What does OSHA stand for?

Occupational Safety and Health Administration

What does ANSI stand for?

American National Standards Institute (ANSI)

What does OLA stand for?

optical laboratory association

What organization made the duty to warn program?

OLA

What is the duty to warn program?

all patients should be informed of the impact resistance of polycarbonate and trivex and be given the option to get it

What did the FDA do in 1972?

Requires spec lenses to be impact resistant

What did the FDA say about crown glass?

It is an avoidable hazard and all crown glass must now be tempered

How does the FDA require lenses be tested fro impact resistance?

drop ball test

What is the drop ball test for normal spec lenses?

0.56oz steel ball dropped from 50 inches

What is true of the drop ball test?

All lenses must be tested individually (unless lens can be damaged)

What is the drop ball test for safety eyewear?

2.4oz steel ball dropped from 50 inches

Does the FDA have a minimum thickness requirement for lenses?

None for dress eyewear (must just be impact resistant/pass drop ball)

they do have minimum for safety lenses

What are the two ways to temper glass lenses and which one is superior?

thermal tempering

chemical tempering (superior impact resistance)

Which of the 5 agencies can make rules and regulations?

FDA

FTC

OSHA

What did Eyeglasses 1 from the FTC say?

each patient must be given their spec Rx immediately after their exam, no mayor what

requires the sph/cyl, prism, and signature of prescribing doctor

prohibits disclaimers

What did Eyeglasses II from the FTC say?

removed the minimum info requirement on spec rx

suggests expiration date

still prohibits disclaimers

What rules did the OSHA put into place in regards to safety eyewear?

requires use of ANSI approved safety eyewear in hazardous work environment

What does ANSI do?

non-profit that assigns committees for standards (not rules, just guidelines)

What is ANSI Z80? What does it cover

standards for ophthalmic lenses

covers everything from spec lenses, rigid and soft CL, IOLs, Dress frames, etc

What is ANSI Z80.1?

lens quality criteria

lenses must be impact resistant

describes tolerance for power being off

What is ANSI Z80.3?

minimum UV-protection requirements for non-prescription sunglasses

impact resistance requirements

What is ANSI Z80.5?

standards for dress eyewear frames

What is ANSI Z87.1?

standards for safety eye wear:

-normal safety lenses must be 3.0mm thick (2.5 if >+3.00D)

-must pass drop ball test

-high impact lenses must be 2.0mm thick

-if high impact, must have 1/4 inch steel ball @150 feet