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American National Standard for Intraocular Lenses
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Ame rican National Standard for Intraocular Lenses A First for American Ophthalmology ARTHUR H. KEENEY, MD In April 1984, the American National Standards Institute, New York City, issued Standard Z80.7-1984 covering Optical and Physical Requirements for intraocular lenses. This 15-page document was prepared under the auspices of the American Academy of Ophthalmology committee on Ophthalmic Instruments and Devices. The initial drafting committee was chaired by Norman Jaffe and subsequently by Robert Drews. This standard represents a consensus of manufacturers, raw material producers, polymer chemists, other technical experts, and 14 ophthalmologists involved in its development. As stated in its scope, it "applies to the optical and mechanical properties and performance and biocompatibility of first quality intraocular lenses in the assembled or final form." A particularly derived glossary defines technical terms used in the description and performance of intraocular lenses. A critical test procedure for resolving power now hinges on the U.S. Air Force 1951 resolution targets which have been more familiar to photographic than ophthalmic scholars. Both apparatus and procedures are suggested for evaluation of intraocular lenses. Appropriate formulae and equations are evolved for resolution efficiency, conversion of back focal length in air to actual focal length in air, and measuring luminous transmission. An appendix covers recommended standard practices for acute toxicity evaluation of intraocular lenses. This standard becomes one of a series of eight ophthalmic standards currently in print and others which are in development. Comparable standards institutes in German, the United Kingdom, and France have From the Department of Ophthalmology, University of Louisville School of Medicine, Louisville, Kentucky.
44A
developed many more individual standards than are now available as American National Standards. These documents, through the American National Standards Institute, become the basis for the development of international standards through the International Organization for Standardization in Geneva. ISO documents are designed to facilitate international exchange of technical knowledge and trade in products. The American Academy of Ophthalmology has been a participating organizational member of the American National Standards Institute since 1956 and has continuously provided from its membership the chairman of the Z80 committee on ophthalmic standards or its predecessors. This standard, as all American national standards, is on an obligatory cycle of review, endorsement, or updating every five years. Technical needs and the action of the appropriate committee however, may generate revisions or new standards at any time prior to the five-year period. Individual copies of the document are available from the American National Standards Institute, 1430 Broadway, New York, New York 10018, at the single copy price of $6.00 plus $2.00 handling charge. Discounts of 10 to 40% are available on larger orders. Academy Fellows assisting Doctor Drews in the development of this standard are: Oliver Dabezies, Miles Galin, Henry Hirschman, Kenneth Hoffer, Norman Jaffe, Herbert Kaufman, and Richard Keates. Academy members serving as consultants to the Z80.7 committee include: Jorge Buxton, Robert Crossen, Edward Norton, Thomas Pettit, Walter Stark, and David Worthen. Other ANSI Z80 ophthalmic standards cover ophthalmic lenses, contact lenses, sunglasses, solutions used with contact lenses, ophthalmic frames, and low vision aids.
Ame rican National Standard for Intraocular Lenses A First for American Ophthalmology ARTHUR H. KEENEY, MD In April 1984, the American National Standards Institute, New York City, issued Standard Z80.7-1984 covering Optical and Physical Requirements for intraocular lenses. This 15-page document was prepared under the auspices of the American Academy of Ophthalmology committee on Ophthalmic Instruments and Devices. The initial drafting committee was chaired by Norman Jaffe and subsequently by Robert Drews. This standard represents a consensus of manufacturers, raw material producers, polymer chemists, other technical experts, and 14 ophthalmologists involved in its development. As stated in its scope, it "applies to the optical and mechanical properties and performance and biocompatibility of first quality intraocular lenses in the assembled or final form." A particularly derived glossary defines technical terms used in the description and performance of intraocular lenses. A critical test procedure for resolving power now hinges on the U.S. Air Force 1951 resolution targets which have been more familiar to photographic than ophthalmic scholars. Both apparatus and procedures are suggested for evaluation of intraocular lenses. Appropriate formulae and equations are evolved for resolution efficiency, conversion of back focal length in air to actual focal length in air, and measuring luminous transmission. An appendix covers recommended standard practices for acute toxicity evaluation of intraocular lenses. This standard becomes one of a series of eight ophthalmic standards currently in print and others which are in development. Comparable standards institutes in German, the United Kingdom, and France have From the Department of Ophthalmology, University of Louisville School of Medicine, Louisville, Kentucky.
44A
developed many more individual standards than are now available as American National Standards. These documents, through the American National Standards Institute, become the basis for the development of international standards through the International Organization for Standardization in Geneva. ISO documents are designed to facilitate international exchange of technical knowledge and trade in products. The American Academy of Ophthalmology has been a participating organizational member of the American National Standards Institute since 1956 and has continuously provided from its membership the chairman of the Z80 committee on ophthalmic standards or its predecessors. This standard, as all American national standards, is on an obligatory cycle of review, endorsement, or updating every five years. Technical needs and the action of the appropriate committee however, may generate revisions or new standards at any time prior to the five-year period. Individual copies of the document are available from the American National Standards Institute, 1430 Broadway, New York, New York 10018, at the single copy price of $6.00 plus $2.00 handling charge. Discounts of 10 to 40% are available on larger orders. Academy Fellows assisting Doctor Drews in the development of this standard are: Oliver Dabezies, Miles Galin, Henry Hirschman, Kenneth Hoffer, Norman Jaffe, Herbert Kaufman, and Richard Keates. Academy members serving as consultants to the Z80.7 committee include: Jorge Buxton, Robert Crossen, Edward Norton, Thomas Pettit, Walter Stark, and David Worthen. Other ANSI Z80 ophthalmic standards cover ophthalmic lenses, contact lenses, sunglasses, solutions used with contact lenses, ophthalmic frames, and low vision aids.