ANSI Z80.1-2015 Ophthalmics C Prescription Ophthalmic Lenses C Recommendations (VC)《眼科学.处方眼镜镜片.建议》.pdf

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1、American National Standardfor Ophthalmics Prescription Ophthalmic Lenses RecommendationsANSI Z80.1-2015Editorially Revised January 2016ANSI Z80.1-2015ANSIZ80.1-2015Revision ofANSI Z80.1-2010American National Standardfor Ophthalmics Prescription Ophthalmic Lenses RecommendationsSecretariatThe Vision

2、CouncilApproved August 20, 2015Editorially Revised January 25, 2016American National Standards Institute, Inc.Approval of an American National Standard requires review by ANSI that therequirements for due process, consensus, and other criteria for approval havebeen met by the standards developer.Con

3、sensus is established when, in the judgement of the ANSI Board ofStandards Review, substantial agreement has been reached by directly andmaterially affected interests. Substantial agreement means much more thana simple majority, but not necessarily unanimity. Consensus requires that allviews and obj

4、ections be considered, and that a concerted effort be madetowards their resolution.The use of American National Standards is completely voluntary; theirexistence does not in any respect preclude anyone, whether he has approvedthe standards or not, from manufacturing, marketing, purchasing, or usingp

5、roducts, processes, or procedures not conforming to the standards.The American National Standards Institute does not develop standards andwill in no circumstances give an interpretation of any American NationalStandard. Moreover, no person shall have the right or authority to issue aninterpretation

6、of an American National Standard in the name of the AmericanNational Standards Institute. Requests for interpretations should beaddressed to the secretariat or sponsor whose name appears on the titlepage of this standard.CAUTION NOTICE: This American National Standard may be revised orwithdrawn at a

7、ny time. The procedures of the American National StandardsInstitute require that action be taken periodically to reaffirm, revise, orwithdraw this standard. Purchasers of American National Standards mayreceive current information on all standards by calling or writing the AmericanNational Standards

8、Institute.American National StandardPublished byThe Vision CouncilZ80 Secretariat225 Reinkers LaneAlexandria, VA 22314Copyright 2015 by The Vision CouncilAll rights reserved.No part of this publication may be reproduced in anyform, in an electronic retrieval system or otherwise,without prior written

9、 permission of the publisher.Printed in the United States of AmericaDeveloped byThe Accredited Committee Z80 for Ophthalmic Standards -The Vision CouncilZ80 Secretariat225 Reinkers LaneAlexandria, VA 22314i Contents Foreword L i 1 Scope and Purpose . 1 2 Normative References . 2 3 Definitions 3 4 Cl

10、assification . 11 5 Optical Requirements 11 6 Mechanical The definitions area was reviewed with changes and modifications; “Position of Wear“ definitions were added in a new annex E for informationalpurposes, in order to help instruct others on three terms commonly used in thisarea. These terms are

11、becoming more commonplace with growing popularity ofnewer fabrication technologies and lens designs; A further clarification of how tolerances should be applied to compensated lens-es was added in the optical requirements section; A voluntary permanent lens marking standardized character ( ) was add

12、ed asa recommendation, to be applied on lenses that contain such compensation; Other modifications to the marking guidelines were also made; Another new addition to the standard was included in the area of transmittance,where a recommendation for minimum transmittance when driving was added.The new

13、section provides guidance and is intended to harmonize with ANSIZ80.3 requirements in this area; Reference to orientation of polarization axis was added; The “FDA Impact“ guidelines were again included, with an additional sentenceadded to refer the reader to the specific authoritative source which s

14、hould bereferenced on this topic, the Federal Register; Following the recent publication of the revised Standard ANSI Z80.1-2015, a ty-pographical was identified in the formula for the calculation of UVB mean trans-mittance in subclause 8.13. The error has been corrected and the correctformula is no

15、w listed in subclause 8.13.Background and Summary of Past revisions for ANSI Z80.1 The Z80 Standards Committee for Ophthalmic Lenses was organized in 1956. Threeseparate standards were drafted, two relating to the manufacture of lenses and oneto the fabrication of ophthalmic lenses into prescription

16、 eyewear. A standard relatingmainly to lenses, but containing additional tolerances for a mounted pair, was issuedin 1964. The tolerances were based largely upon an analysis of measured parame-ters in typical single-vision, mass-produced lenses assembled into conservativelystyled and sized mountings

17、. The standard represented the state-of-the-art for suchlenses and a set of quality goals for lenses surfaced in the ophthalmic laboratory onan individual basis.At the beginning of 1970, the Standards Committee Z80 was reorganized with theOptical Society of America, its former sponsor, serving as Se

18、cretariat. In 1972, thecommittees scope was broadened to include lenses other than prescription glassophthalmic lenses in recognition of the importance of plastic ophthalmic materialsiiiand the increased use of sunglasses and fashion eyewear. In the 1972 revision, cer-tain tolerances for plastic and

19、 heat-treated lenses were relaxed in response to Feder-ally mandated impact-resistant requirements for all ophthalmic lenses.The 1979 revision reflected a shift in utilization from mass-produced lenses to a basicdependence upon custom-processed lenses at the laboratory level. It was an attemptto def

20、ine the state-of-the-art in the manufacturing laboratory by recognizing the factthat, while individual tolerances may be reliably met, it is often not possible to achieveall requirements simultaneously. The Standard expressed desirable technical con-cepts that provide a framework for safety and effe

21、ctiveness. The title was changedfrom a “requirement“ to a “recommendation“ to reflect the committees intent.In 1982, the Optical Laboratories Association assumed the responsibilities of theSecretariat. In 1985, the Z80 Committee became an Accredited Standards Commit-tee.The 1995 revision attempted t

22、o write the Z80.1 standard in a fashion consistent withISO standards. This change included the practice of applying a tolerance to both me-ridional powers rather than sphere and cylinder as had been common practice. It wassubsequently found that applying the ISO power tolerance method to custom fabr

23、i-cated eyewear resulted in unacceptably high rejection rates.The 2005 revision recognized the need for change in the power tolerance methodolo-gy. This standard maintained the ISO approach to power tolerance, but used thehighest meridian only rather than both meridians. For the first time since 197

24、9, themounted cylinder axis tolerance was adjusted based upon detailed scientific studiesand a recognition of process capability and wearer needs. The difference in refractivepower tolerance between progressive addition lenses and single vision and multifocallenses reflects the fact that the toleran

25、ce on allowable cylinder in the semi-finishedblank curvature for progressive addition lenses in ISO standards is looser than thetolerance on single vision and standard multifocals. The tolerance for cylinder axisuses as its basis the amount of axis error that would be needed to result in an error of

26、0.13 D (the tolerance for cylinder refractive power). Additionally, the section on thelens measurement method has been rewritten to include automatic focimeters andbetter describe the method for measuring prism.In January 2009 the Vision Council assumed responsibility for Secretariat.The 2010 revisi

27、on included several important areas of revision. The first change re-lated to a transmission power tolerance, where the practice of using the sphere andcylinder (when expressed in minus notation) was again utilized. Two durability re-quirements for this revision were adapted from published ISO stand

28、ards: Specifica-tions and test methods for anti-reflective coatings and Minimum requirements forspectacle lens surfaces claimed to be abrasion resistant.The standard remains a recommendation. Therefore, it is the specific intent of theZ80 Committee that this standard not be used as a regulatory inst

29、rument.This standard contains six informative annexes, which are not considered part of thestandard.Suggestions for improvement of this standard will be welcome. Suggestions shouldbe sent to The Vision Council, 225 Reinekers Lane, Suite 700, Alexandria, VA22314.ivThis standard was processed and appr

30、oved for submittal to ANSI by the AccreditedStandards Committee Z80 (ASC Z80). Committee approval of this standard does notnecessarily imply that all committee members voted for its approval. At the time it ap-proved this standard, ASC Z80 had the following members:Thomas C. White, M.D., ChairQuido

31、Cappelli, Vice-ChairWilliam J. Benjamin, O.D., SecretaryOrganization Represented Name of RepresentativeAbbott Medical Optics (AMO) . Leonard BorrmannMark Gordon (Alt.)Advance Medical Technologies Association. Michael PflegerDr. Richard Courtney (Alt.)American Academy of Ophthalmology . Dr. Thomas Wh

32、iteDr. Carl Tubbs (Alt.)Dr. Pradeep Ramulu (Alt.)Scott Haber (Alt.)American Academy of Optometry. Dr. David LoshinAmerican Ceramic Society . Lyle RubinAmerican Glaucoma Society Dr. Steven GeddeDouglas Rhee (Alt.)American Optometric Association. Karl CitekDr. Robert Rosenberg (Alt.)Dr. William Benjam

33、in (Alt.)American Society of Cataract and Refractive Surgery (ASCRS) Dr. Stephen KlyceDr. Jack Holladay (Alt.)Contact Lens Institute. Stan RogaskiPeter Mathers (Alt.)Contact Lens Manufacturers Association . Quido CappelliTroy Miller (Alt.)Department of Veterans Affairs Dr. John TownsendMichael White

34、 (Alt.)Federated Cornea Societies. Dr. Michael BelinDr. David Glasser (Alt.)Kathy Colby (Alt.)Elmer Tu (Alt.)Food dis the index of refraction for radiation of wavelength 587.5618 nm (helium d-line); Fis the index of refraction for radiation of wavelength 486.1327 nm (hydrogen F-line); Cis the index

35、of refraction for radiation of wavelength 656.2725 nm (hydrogen C-line) In the US, the reference wavelength used is 587.5618 nm. 3.11 Distortion An aberration that results in straight lines being imaged as curves. 3.12 Focimeter An instrument for determining vertex power, cylinder axis location, opt

36、ical center and prism reference point location and prism power at a given point on an ophthalmic lens. 3.13 Index of Refraction The ratio of the velocity of light of a given wavelength in air to that in a medium. This ratio expresses the ability of a lens material to refract or bend a ray of light.

37、The index of refraction is given for a specified reference wavelength (see 3.25). 3.14 Intermediate That area in a Trifocal Lens or Progressive Power Lens that has been designated to correct vision at ranges intermediate to distant and near objects. 3.15 Interpupillary Distance 3.15.1 Distance, Bino

38、cular The separation between the visual axes of the eyes in their primary position, as the subject fixates on an infinitely distant object. This distance is measured from pupil to pupil. ddF C=1ANSI Z80.1-2015 5 3.15.2 Near, Binocular The separation between the visual axes of the eyes, at the plane

39、of the spectacle lenses, as the subject fixates on a near object at the intended working distance. NOTE This distance is conventionally 40 cm from the spectacle plane for add powers equal to or less than 2.50 D. For higher adds, this distance (expressed in meters) is the reciprocal of the add power.

40、 3.15.3 Monocular The separation between the center of the bridge of the nose and the visual axis of the designated eye (i.e., right or left) for either distance or near fixation. The right and left interpupillary distances may not necessarily be equal. Their sum is equal to the binocular interpupil

41、lary distance. When the monocular interpupillary distance is not specified, it is assumed to be one half of the binocular interpupillary distance. 3.16 Lens(es) 3.16.1 Aspheric Lens A lens in which one or both surfaces are aspheric (see 3.27.1) 3.16.2 Assembled Lens A lens (or lenses) that has (have

42、) been combined with a frame or mounting. 3.16.3 Bifocal Lens A lens designed to provide correction for two discrete viewing distances. 3.16.4 Edged Lens A lens whose periphery has been ground (flat, rimless, grooved, or beveled) to a specified size and shape. 3.16.5 Finished Lens A lens with both s

43、urfaces optically finished and produced to a desired power and thickness. 3.16.6 Impact-Resistant Lenses for Dress Eyewear Lenses that conform to the detailed requirements for impact resistance in 6.1.1. Dress (or street-wear) lenses are not to be confused with nor used in place of special-purpose o

44、ccupational, educational, or recreational protective lenses. 3.16.7 Impact-Resistant Lenses for Occupational and Educational Protection Lenses that conform to the requirements of the most recent edition of ANSI Z87.1. 3.16.8 Iseikonic Lens A type of lens made with special thickness, surface curvatur

45、es, and bevel edge location to control the magnification of an image while maintaining the prescribed refractive power. 3.16.9 Laminated Lens A lens constructed as a sandwich of multiple layers of glass, plastic, or both, bonded together as a single unit. 3.16.10 Lenticular Lens A lens, usually of s

46、trong refractive power, in which the prescribed power is provided over only a limited central region of the lens, called the lenticular portion. The remainder of the lens is ANSI Z80.1-2015 6 called the carrier and provides no refractive correction but gives dimension to the lens for mounting. 3.16.

47、11 Minus Lens A lens having negative refractive power that causes the divergence of a parallel beam of light. 3.16.12 Mounted Pair Two finished lenses of any type mounted in a frame to create complete spectacles. 3.16.13 Multifocal Lens A lens designed to provide correction for two or more discrete

48、viewing distances. 3.16.14 Ophthalmic Lens A lens intended to be used for purposes of measurement, correction, and/or protection of the eye, or for changing its appearance. 3.16.15 Plano Lens A lens having essentially zero refractive power. 3.16.16 Plus Lens A lens having positive refractive power t

49、hat causes the convergence of a parallel beam of light. 3.16.17 Progressive Power Lens A lens designed to provide correction simultaneously for more than one viewing distance in which the power changes continuously rather than discretely. Examples: Progressive Addition Lens, Degressive Lens, and Near Variable Focus Lens. 3.16.18 Semi-finished Lens A lens having only one surface finished to a specific curve. 3.16.19 Single Vision Lens A lens designed to provide correction for a single viewing distance. 3.16.20 Spectacle Lens An ophthalmic lens worn in front of