ANSI Z80.20, Ophthalmics – Contact Lenses – Standard Terminology, Tolerances, Measurements And Physicochemical Properties, has just been updated. The new 2016 Edition is available from Document Center Inc. It replaces the 2010 Edition which is now obsolete.
First, how can a 2016 Edition just be released in the spring of 2017? It’s not uncommon for a standard that has been approved to take some time prior to actual public release. So while the ANSI Z80.20 was approved on December 6, 2016, it wasn’t actually published until March 20, 2017.
What exactly does the ANSI Z80.20 cover? While first of all, the document replaces the previous ANSI Z80.2 for rigid contacts and the ANSI Z80.8 for soft contact lenses. So this standard covers tolerances for all contact lenses. It also gives you the measurement methods to use for the parameters and properties needed for proper functioning and manufacture of contact lenses. And it lays out the various conformance criteria you’ll need to meet during product tests.
That’s a lot of ground to cover and this standard is 109 pages of detailed information. You’ll find the usual scope, referenced documents and definitions sections. Then specific information for contact lenses are reviewed. These include nomenclature and classification, tolerances, physicochemical properties, measurement methods, and the test report. The Annexes cover conformance criteria, measurement systems, gauging consistency, determination of label back vertex power, and a 10-item bibliography.
Who develops the ANSI Z80.20? The oversight for this standard is provided by The Vision Council (formerly the Optical Laboratories Association). They convened a committee composed of government experts (FDA and VA), folks from related associations (like the American Academy of Optometry), and industry (the folks that design, manufacture and sell contact lenses). Even though the standard is a U.S.-based ANSI standard, participants also represent links to the international level and ISO. So this standard is broadly consensus-based.
If you’re part of this industry, you’ll need your copy now. Use Document Center Inc. for your purchase. We are an authorized distributor of many ANSI standards including those published by The Vision Council. You can search for and order these publications at our webstore, www.document-center.com. Here’s a direct link to the order page for ANSI Z80.20 for your convenience.
If you have additional standards questions or requirements, just get in touch with us. You can reach us by phone (650-591-7600) or email (info@document-center.com). You’ll find us to be knowledgeable and available to work with you to provide your company with outstanding compliance documentation support. Make us your Standards Experts!