ANSI Z80.25-1996 For Ophthalmics Instruments - Fundamental Requirements and Test Methods (VC)《眼科.仪器.基本要求和试验方法》.pdf

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1、AMERICAN NATIONAL STANDARDOLAANSI Z80.25-1996 (R2002)for Ophthalmic Istruments Fundamental Requirementsand Test MethodsANSIZ80.25-1996 (R2002)American National Standardfor Ophthalmic Instruments Fundamental Requirementsand Test MethodsSecretariatOptical Laboratories AssociationApproved December 11,

2、2001 Reaffirmed February 28, 2002American National Standards Institute, Inc.American Approval of an American National Standard requires verification by ANSI National that the requirements for due process, consensus, and other criteria for approval have been met by the standards developer. Standard C

3、onsensus is established when, in the judgment of the ANSI Board of Standards Review, substantial agreement has been reached by directly and materially affected interests. Substantial agreement means much more than a simple majority, but not necessarily unanimity. Consensus requires that all views an

4、d objections be considered, and that a concerted effort be made toward their resolution. The use of American National Standards is completely voluntary; their existence does not in any respect preclude anyone, whether he has approved the standards or not, from manufacturing, marketing, purchasing, o

5、r using products, processes, or procedures not conforming to the stan- dards. The American National Standards tnstitute does not develop standards and will in no circumstances give an interpretation of any American National Standard. Moreover, no person shall have the right or authority to issue an

6、interpretation of an American National Standard in the name of the Ameri- can National Standards Institute. Requests for interpretations should be addressed to the secretariat or sponsor whose name appears on the title page of this standard. CAUTION NOTICE: This American National Standard may be rev

7、ised or withdrawn at any time. The procedures of the American National Standards Institute require that action be taken periodically to reaffirm, revise, or withdraw this standard. Purchasers of American National Standards may receive current information on all standards by calling or writing the Am

8、eri- can National Standards Institute. Published by Optical Laboratories Association P. 0. Box 2000 Merrifield, VA 22116-2000 U.S.A. Copyright 0 1996 by Optical Laboratories Association. All rights reserved. No part of this publication may be reproduced in any form, in an electronic retrieval system

9、 or otherwise, without prior written permission of the publisher. Printed in the United States of America CPll.96.500 Contents Page Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

10、 . . . . . . . . . . . . . . . . . . . . . . . . . ii Scope . 1 Normative references . 1 Definitions 2 Fundamental requirements 3 Environmental conditions . 3 Special requirements for active ophthalmic instruments . .3 Test methods . 5 Information supplied by the manufacturer 6 Tables 1 Environmenta

11、l conditions in use 8 2 Storage conditions 8 3 Transport conditions . 8 4 Environmental tests 9 Annexes A Spectral weighting functions for retinal hazard analysis . 10 6 Radiometric measures 13 C Example of Information given by manufacturer on the avoidance of over-exposure to a potentially optical

12、radiation hazard 15 D Product related standards 16 Foreword (This foreword is not part of American National Standard 260.25-1996 This is a standard for ophthalmic instruments which specifies characteristics which are common to many such instruments, such as: safety issues, environmental use conditio

13、ns, electrical requirements, storage and transport conditions, radiation hazards, marking requirements, accompanying docu- ments and others. Since these characteristics are common to many oph- thalmic instruments it is economical to standardize them in a single horizontal standard rather than includ

14、e these characteristics in each of the individual instrument standards. In 1982, the Optical Laboratories Association (OLA) assumed the responsi- bility of the Secretariat; and in 1985 the 280 Committee became an accred- ited standards committee. The scope of the 280 committee is for the establishme

15、nt of standards that shall apply to ophthalmic lenses and to equipment, instruments and to processes used in the final fabrication level which affect their performance; to ophthalmic frames, sunglasses, and fashion eyewear; to contact lenses and accessories for their use; to intraocu- lar implant le

16、nses; to low vision aids and ophthalmic contact devices in addition to contact lenses; and to optical instrumentation used in ophthalmic procedures and vision evaluation. The current ophthalmic standards are drafted by subcommittees of the 280 committee. These subcommittees may, in turn, establish w

17、orking groups, as needed, to address detailed areas in the assigned project. Suggestions for improvement of this standard will be welcome. They should be sent to the Optical Laboratories Association, P.O. Box2000, Merrifield, VA 22116-2000, U.S.A. This standard was processed and approved for submitt

18、al to ANSI by the Accredited Standards Committee on Ophthalmic, 280. Committee approval of this standard does not necessarily imply that all committee members voted for its approval. At the time it approved this standard, the 280 Committee had the following members: David E. Eifrig, Chairman F. Dow

19、Smith, Vice Chairman Robeert Rosenberg, Secretary ii Organization Represented Name of Representative American Academy of Ophthalmology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . David E. Eifrig Edmund Thall (Alt.) Thomas C. White (Alt.) American Academy of Optometry . .

20、. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . David S. Loshin American Ceramic Society ,.,.,.,. John R. Hansen Jackson S. Stroud (Alt.) Herbert Hoover (Alt.) Clifton Wheeler (Alt.) American Optometric Association . . . . . . . . . . . . . . . . . . . . . . . . .

21、 . . . . . . . . . . . . . . . . . . . Robert Rosenberg William Benjamin (Ah.) Donald Pitts (Alt.) Gregory L. Stephens (Alt.) American Society of Cataract Class II - Basic insulation plus reinforced or double insulation; Type B: Equipment that has a degree of protection against electric shock, e.g.,

22、 resulting from a low enclosure leakage current require- ment and a patient leakage current limit of 100 CIA; Type BF: Type B requirement which in- cludes an insulated (floating) applied part; NOTE 2 - The conventional methods used in all electrical equipment for protection in case of a first insula

23、tion fault can be applied on oph- thalmic instruments; NOTE 3 - Accessible parts which even in the event of a failure cannot become live, for ex- ample double insulated from live, need not be connected to the protective (earth) conductor. 6.1.2 Addition to clause 16 e of the IEC 601- 1:1988 For the

24、replacement of lamps in ophthalmic instruments having no conductive path to the patient and containing lamps with a nominal supply voltage of not more than 24 V, and producing no open circuit voltage exceeding 30 V, it shall be permitted to open the access covers without the use of a tool. 3 ANSI 28

25、0.25-l 996 6.1.3 Addition to clause 16 f of IEC 601- thalmic instruments used to illuminate, view or 1:1966 photograph the human eye with light from 400 The diameter of the earth conductor shall be not less than the smallest diameter of the supply leads. Accessible conductive parts without precautio

26、n to become secondary volt- age in the event of a failure of the basic insulation may have a resistance to the protec- tive earth terminal exceeding 0,l ohm. The maximum permitted resistance of the protec- tive connection shall be determined by the following formula: . . . where: R, is the resistanc

27、e of protective earth con- nection in ohms (exceeding 0,l ohm); I, is the maximum continuous single fault cur- rent in amperes; I ENCL is the allowable value of the enclosure leakage current in single fault condition in milliamperes; R, is the test resistance in kilo-ohms. 6.1.4 Addition to clause 5

28、7.10 of IEC 601-l : 1988 If applicable, the reference voltage for B-d shall be at least mains voltage. 6.2 Optical radiation hazard This clause replaces clause 32, 33 and 34 of IEC 601-1:1988. The possibility of an optical radiation hazard is only present for some types of ophthalmic instruments wit

29、h very high level of radiation output which causes high irradiance on the retina. The limit values given below are con- sidered acceptable with respect to the risks when weighted against the performances in- tended. Each instrument standard shall expressly state that the requirements in 6.2.1 to 6.2

30、.3 apply, where appropriate. 6.2.1 Limit values nm to 700 nm. Short wavelength limit: The amount of radiant power exiting such an instrument in the portion of the spectrum from 305 nm to 400 nm shall have an irradiance no greater than .050 mW/ cm2 as measured at the intended cornea1 plane when the i

31、nstrument is operating at maximum brightness* and, where the aperture can be varied, at maximum aperture. Long wavelength limit: The amount of energy exiting such an instrument in the wavelength range from 700 nm to 1100 shall be no greater than the amount of energy exiting the instru- ment between

32、400 nm and 700 nm, nor shall the irradiance in the spectral range 700 nm to 1100 nm exceed 100 mW/cm2 as measured in the cornea1 plane when the instrument is oper- ating at maximum brightness and maximum aperture. NOTE 1 - instruments with beam diameter of less than 8 mm in pupil plane; If, due to s

33、tops or other obstructions of the beam, less than an 8mm circular pupil is illumi- nated, the limit values may be increased by the ratio of the area of an 8 mm pupil divided by the true area illuminated; NOTE 2 - It is recommended that the energy in the range of the spectrum below 420 nm be attenuat

34、ed as much as is practical; NOTE 3 - For instruments with an illuminating solid angle (Q) other than 0.031sr the limit val- ues may be changed by the ratio of the true solid angle, expressed in steradians, divded by 0.031 (e.g., instruments such as fundus cameras); NOTE 4 - For instruments with non-

35、pulsed radia- tion, the assumptions used to set the limit value for radiation shorter in wavelength than 400 nm are based on considerations of the typical spec- tral distribution of a 3000K standard black body source, an illuminating solid angle at the cornea1 plane of O.O31sr, a maximum use time of

36、 5 min. and the weighting factors for L (annex A ). The limit is set to insure that the fraction of photo- chemical hazard dose due to radiation shorter in wavelength than 400 nm is no greater than l/8 of the total photochemical hazard dose over all wavelengths when that total dose is at the thresh-

37、 old limit for an 8 mm pupil; Using the ACGIH (American Conference of Governmental Industrial Hygienists) guidelines, that threshold limit is 14 JlcmVsr. To convert from photochemical hazard weighted radiance to radiance, over the designated spectral range These limit values apply to radiation from

38、oph- 4 ANSI 280.25-l 996 (305 nm to 400 nm), the conversion factor 0.276 is used. The limit is then found by the formula: (14 J/cm*/sr) x (0.031 sr) x (0.276/300/8) = 0.050 mW/cm* NOTE 5 - For instruments with pulsed radiation, the limit is a total dose expressed in J/cm*, and is found by the formul

39、a: (14 J/cm*/sr) x (0.031 sr) x (0.276/8) = 15 mJ/ cm* For multiple pulses, the limit per pulse is then 15 mJ/cm* divided by the number of pulses. *Maximum brightness is the highest intensity the instrument is capable of delivering and where overvoltage is provided relates to that bright- ness. 6.2.

40、2 Variable light brightness For instruments where provision is made to vary the brightness, the manufacturer shall provide indications of the proportions of the maximum intensity. 6.2.3 Particular information The manufacturer shall provide the user with a graph showing the relative spectral output o

41、f the instrument between 305 nm and 1100 nm when the instrument is operating at maximum light intensity and maximum aperture. The spectrum shall be taken in the beam after it exits the instrument. The manufacturer shall provide the user with the values for the spectrally-weighted photo- chemical sou

42、rce radiance, both phakic (L,) and aphakic CL.,), measured in the beam exit- ing from the instrument when operating at maximum intensity* and maximum aperture and determined by using the spectral weight- ing values given in annex A. The manufacturer shall provide information on the meaning of L, and

43、 L, to the user. NOTE - An example of such information is given in annex C. *Maximum intensity is the highest intensity the instrument is capable of delivering and where overvoltage is provided relates to that inten- sity. 7 Test methods All tests described in this standard are type tests. 7.1 Flamm

44、ability 7.1 .l Apparatus The test device consists of: a) a steel rod 300 mm +- 3 mm long and 6 mm nominal diameter with end faces which are flat and perpendicular to its longitudinal axis; b) a heat source; c) a thermocouple with temperature-indicating device. 7.1.2 Procedure One end of the steel ro

45、d is heated over a length of at least 50 mm to a temperature of (650 f 10) C”. The temperature of the rod is measured by means of the thermocouple attached at a dis- tance of 20 mm from the heated end of the rod. With the rod positioned vertically, the heated face of the rod is pressed against the s

46、urface of the test sample (the contact force being equal to the weight of the rod) for a period of 5 s, and then removed. This test is repeated on every component of the instrument made from different organic material. Then a visual in- spection following each stage is carried out to establish wheth

47、er combustion continues after removal of the rod from the test sample. 7.2 Surface temperatures The requirements in clause 4.7 shall be veri- fied at the given highest ambient temperature specified in table 1. 7.3 Checking of the environmental condi- tions The requirements according to clause 5 are

48、checked with the tests according to IS0 9022 given in table 4, page 9. NOTE 1 -The environmental test code reads as follows: IS0 9022 - X,X - X,X - x, Environmental IS0 Standard- r 1 Conditioning method- - - - - - -a -. - J I I I Degree of severity- _ _ _ _ _ _ - -i t State of operation of the instr

49、ument- - - -. - NOTE 2 - The figures in the conditioning meth- ods listed above have the following meaning: 10: cold; 11: dry heat; 12: damp heat; 14: slow temperature change; 30: mechanical stress - shock; 31: mechanical stress - bump; 36: mechanical stress - sinusoidal vibration. 5 ANSI 280.25-l 998 NOTE 3 -Severity grades are given in IS0 9022; NOTE 4 - The figures of the state of operation mean: 0: Specimen in its normal transport and/or storage container as provided by the manufac- turer; 1: Specimen unprotected, ready for operation, power supply not connected; 2: Sp