ANSI Z80.36-2016 Ophthalmics C Light Hazard Protection for Ophthalmic Instruments (VC).pdf

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1、American National Standardfor Ophthalmics Light Hazard Protectionfor Ophthalmic InstrumentsANSI Z80.36-2016ANSIZ80.36-2016ANSIZ80.36-2016American National Standardfor Ophthalmics Light Hazard Protectionfor Ophthalmic InstrumentsSecretariatThe Vision CouncilApproved March 17, 2016Editorially revised

2、August 1, 2016Editorially revised September 19, 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.Consensus is estab

3、lished 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 objections be cons

4、idered, 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 usingproducts, proces

5、ses, 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 of an American

6、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 any time. The pr

7、ocedures 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 Institute.Ameri

8、can National StandardPublished byThe Vision Council1700 Diagonal RoadSuite 500Alexandria, VA 22314Copyright 2016 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 permission of the p

9、ublisher.Printed in the United States of AmericaDeveloped byThe Accredited Committee Z80 for Ophthalmic Standards -The Vision CouncilZ80 Secretariat1700 Diagonal RoadSuite 500Alexandria, VA 22314iContentsPageForeword .iii1 Scope. 12 Normative References . 13 Terms, definitions, and symbols 13.1 Term

10、s and definitions. 13.2 Symbols . 54 Classification 65 Requirements. 65.1 General 65.2 Requirements for classification as a Group 1 instrument 65.2.1 Requirements for classification as Group 1 for a scanning instrument 75.3 Requirements for Group 2 instruments 75.4 Emission limits for determination

11、of Group 1 classification 85.4.1 Continuous wave instruments 85.4.2 Pulsed and time-limited instruments 105.4.3 Limit for multiple source instruments . 125.5 Emission and exposure limit values for Group 2 instruments 125.5.1 Continuous wave instruments 125.5.2 Pulsed and time-limited instruments 145

12、.5.3 Multiple source instruments . 166 Test methods . 166.1 General 166.2 Measurements made to classify instruments into Group1 or Group 2 166.3 Group 2 instruments: Measurements. 166.4 Determination of area 176.5 Group 2 instruments: Determination of time and number of pulses to reach recommended m

13、aximum exposure . 176.5.1 Determination of time to reach the recommended maximum exposure for weighted corneal and lenticularultraviolet radiation radiant exposure, HS-CL, tmax 176.5.2 Determination of time to reach the recommendedmaximum exposure for unweighted lenticular ultravioletradiation radia

14、nt exposure, HUV-L for t 1000s, tmax . 176.5.3 Determination of time to reach the recommended maximumexposure for photochemical aphakic retinal radiant exposure,tmax. 176.5.4 Determination of the number of pulses necessary to reachthe recommended maximum exposure for photochemicalaphakic retinal exp

15、osure, nmax(for pulsed instruments) 187 Information supplied by the manufacturer 18iiPageAnnexesA (normative)Spectral weighting functions 22B (informative) Product-related International standards for ophthalmicinstruments to which Z80.36 applies and that contain a specific light hazard section 28C (

16、informative)Measurement instruments. 29C.1 General . 29C.2 Method for finding the spectral radiance function Lof a light source using available photometers and spectrometersor spectral power distribution information . 29D (normative)Measurement methods for radiance/irradiance. 33D.1 Measurements to

17、determine Group 1 status and to determineradiance/irradiance parameter values for Group 2 instruments 33D.2 Method to determine ES-CL, EUV-L, EIR-CL, and EVIR-AS33D.3 Method to determine EA-R. 33D.4 Method to determine HS-CL, HUV-L, HIR-CL, and HVIR-AS34D.5 Method to determine HVIR-R and HA-R 35D.6

18、Method to calculate dr . 35D.7 Example for determination of radiance from a measurementof irradiance 36E (informative) Guidance on the direct measurement of irradiance 38E.1 Measurements of irradiance in corneal or pupillary plane . 38E.2 Measurements of retinal irradiance . 38F (informative) Classi

19、fication flowchart . 41G (informative) Bibliography 42iiiForeword (This foreword is not part of American National Standard ANSI Z80.36-2016.)This American National Standard specifies fundamental requirements for optical radi-ation safety for ophthalmic instruments. It applies to all ophthalmic instr

20、uments (in-cluding current, new and emerging instruments) that direct optical radiation into or atthe eye. It also applies to those parts of therapeutic or surgical systems that directoptical radiation into or at the eye for diagnostic, illumination, measurement, imaging,or alignment purposes. It do

21、es not apply to radiation that is intended for treatment ofocular tissues.ANSI Z80.36-2016 was adapted by a group of experts within the ANSI ASC Z80 In-struments and Low Vision Devices Subcommittee under the chair of William L.Brown, O.D., Ph.D. It is a performance standard. This document was develo

22、ped in 2016 when changes were made to ISO 15004-2Light hazard protection that resulted in recommendations for levels of radiant expo-sure for retinal photochemical hazard that were unacceptable to the US delegation tothe ISO.Suggestions for improvement of this standard are welcome. They should be se

23、nt tothe Vision Council, 1700 Diagonal Road, Suite 500, Alexandria, VA 22314.This standard was processed and approved for submittal to ANSI by the AccreditedStandards Committee on Ophthalmic Optics, Z80. Committee approval of this stan-dard does not necessarily imply that all committee members voted

24、 for its approval. Atthe time of approval of this standard, the Z80 Committee consisted of the followingmembers:Thomas C. White, M.D., Chair Quido Cappelli, Vice-ChairWilliam Benjamin, O.D., Secretary Michael Vitale, SecretariatOrganization Represented Name of RepresentativeAbbott Medical Optics. Le

25、onard BorrmannMark Gordon (Alt.)Advance Medical Technologies Michael PflegerRichard Courtney (Alt.)American Academy of Ophthalmology . Thomas WhiteCarl Tubbs (Alt.)Pradeep Ramulu (Alt.)Scott Haber (Alt.)American Academy of Optometry. David LoshinAmerican Ceramic Society . Lyle RubinAmerica Glaucoma

26、Society Steven GeddeDouglas Rhee (Alt.)American Optometric Association Karl CitekRobert Rosenberg (Alt.)William Benjamin (Alt.)American Society of Cataract and Refractive Surgery (ASCRS) Stephen KlyceJack Holladay (Alt.)Contact Lens Institute. Stan RogaskiPeter Mathers (Alt.)Contact Lens Manufacture

27、rs Association . Quido CappelliTroy Miller (Alt.)Department of Veterans Affairs John TownsendMichael White (Alt.)ivOrganization Represented Name of RepresentativeFederated Cornea Societies. Michael BelinDavid Glasser (Alt.)Kathy Colby (Alt.)Elmer Tu (Alt.)Food dA is the area of a section of that bea

28、m containing the given point; is the angle between the normal to that section and the direction of the beam. Note 1 to entry: The same definition holds for the time-integrated radiance Liif, in the equation for L, the radiant power d is replaced by the radiant energy dQ. Note 2 to entry: Radiance is

29、 expressed in watts per steradian square centimeter, W/(srcm2); time-integrated radiance is expressed in Joules per steradian square centimeter, J/(srcm2). ANSI Z80.36-2016 4 3.1.17 radiant exposure H at a point of a surface, for a given duration quotient of the radiant energy, dQ, incident on an el

30、ement of a surface containing the point over the given duration by unit area dA of that element dAdQH = (3) Equivalently, the radiant exposure is defined as the integral of the irradiance, E, at a given point over a given duration, t (4) Note 1 to entry: Radiant exposure is expressed in Joules per s

31、quare centimeter, J/cm2. 3.1.18 scanning instrument instrument that emits radiation having a time-varying direction, origin or pattern of propagation with regard to a stationary frame of reference. 3.1.19 spectral irradiance Equotient of the spectral radiant power d () in a wavelength interval d, in

32、cident on an element of a surface, by the area dA of that element and by the wavelength interval d ( )ddAdE= (5) Note 1 to entry: Spectral irradiance is expressed in watts per square centimeter nanometer, W/(cm2.nm). 3.1.20 spectral radiance Lfor a wavelength interval d, in a given direction at a gi

33、ven point ratio of the spectral radiant power d () passing through that point and propagating within the solid angle d in the given direction, to the product of the wavelength interval d and the areas of a section of that beam on a plane perpendicular to this direction (cos dA) containing the given

34、point and to the solid angle d ( )dddAdL=cos(6) Note 1 to entry: Spectral radiance is expressed in watts per steradian square centimeter nanometer, W/(sr.cm2.nm). 3.1.21 time-limited instrument ophthalmic device for which the maximum exposure duration is limited and known. ANSI Z80.36-2016 5 3.2 Sym

35、bols Symbols, quantities and units are listed in table 1. Table 1 Symbols, quantities and units Symbol Quantity Unit E irradiance (at a point on a surface) W/cm2Espectral irradiance W/(cm2nm) L radiance (in a given direction at a given point of a real or imaginary surface) W/(srcm2) Lspectral radian

36、ce (for a wavelength interval d, in a given direction at a given point) W/(sr.cm2.nm) Litime-integrated radiance J/(srcm2) H radiant exposure (at a point of a surface, for a given duration) J/cm2Hspectral radiant exposure J/(cm2nm) ES-CLS() weighted corneal and lenticular ultraviolet radiation irrad

37、iance W/cm2EUV-Lunweighted lenticular ultraviolet radiation irradiance W/cm2EA-RA() weighted retinal irradiance W/cm2EIR-CLunweighted corneal and lenticular infrared radiation irradiance W/cm2EVIR-ASunweighted anterior segment visible and infrared radiation irradiance W/cm2EVIR-RR() weighted retinal

38、 visible and infrared radiation thermal irradiance W/cm2LA-RA() weighted retinal radiance W/(srcm2) Li,A-RA() weighted retinal time-integrated radiance J/(srcm2) Li,VIR-RR() weighted, retinal visible and infrared radiation time-integrated radiance J/(srcm2) LVIR-RR() weighted retinal visible and inf

39、rared radiation radiance W/(srcm2) HVIR-RR() weighted retinal visible and infrared radiation radiant exposure J/cm2HIR-CLunweighted corneal and lenticular infrared radiation radiant exposure J/cm2HVIR-ASunweighted anterior segment visible and infrared radiation radiant exposure J/cm2HS-CLS() weighte

40、d corneal and lenticular ultraviolet radiation radiant exposure J/cm2HUV-Lunweighted lenticular ultraviolet radiation radiant exposure J/cm2HA-RA() weighted retinal radiant exposure J/cm2S() ultraviolet radiation hazard weighting function (see Annex A) A() aphakic photochemical hazard weighting func

41、tion (see Annex A) B() blue-light hazard function (see Annex A) R() visible and infrared radiation thermal hazard weighting function (see Annex A) summation interval nm t exposure time; also: energy integration time; for pulsed instruments: the time to deliver a full pulse width for an individual pu

42、lse, and for multiple pulses, the time that includes each individual pulse and combination of pulses s t pulse width up to a time of 0.25 s s E.t spectral radiant exposure J/(cm2.nm) (E.t) spectral radiant exposure at time t J/(cm2.nm) ANSI Z80.36-2016 6 4 Classification For the purposes of this sta

43、ndard, ophthalmic instruments are classified into two groups in order to separate those instruments that are capable of presenting a potential hazard from those which are not. The two groups are named Group 1 and Group 2. They are defined as follows: a) Group 1 instruments: Ophthalmic instruments fo

44、r which no potential light hazard exists. Ophthalmic instruments that can be shown to fulfil the requirements of 5.2. b) Group 2 instruments: Ophthalmic instruments for which a potential light hazard exists. Those ophthalmic instruments that do not fulfil the requirements of 5.2 but do fulfil those

45、of 5.3. NOTE The classification process is outlined in the classification flowchart (see annex F). 5 Requirements 5.1 General Ophthalmic instruments shall be so designed that the energy in all wavelengths be attenuated as much as possible in keeping with the intended use of the instrument. If anothe

46、r device is used in combination with an ophthalmic instrument, the connecting system shall not degrade the optical radiation safety of either instrument, nor shall the optical radiation hazards of the combined system exceed the levels that are given in this standard. 5.2 Requirements for classificat

47、ion as a Group 1 instrument An ophthalmic instrument shall be classified in Group 1 if any or all of the following criteria apply. a) An International Standard exists for the instrument type but no light hazard requirements are included in that International Standard; b) Its components, e.g., lamps,

48、 light-emitting diodes, non-removable filters, lenses, fibres, etc., prevent emissions in excess of the limits specified for instruments in Group 1 and certification of this exists. Such instruments shall be classified as Group 1 by virtue of the test certification by the manufacturer of the compone

49、nts themselves without the need for further measurements. If such components prevent some, but not all emissions to exceed the limits specified for Group 1, then measurements shall be required only for those parameters in tables 2 and 3 where the components do not prevent the limits from being exceeded; c) Its emission values are equal to or less than the limit values given in 5.4. The test methods used for determination of compliance shall be in accordance with 6.2; d) It is a dose-limited instrument by