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GB 23719-2009: Ophthalmic optics and instruments -- Optical devices for enhancing low vision
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Ophthalmic optics and instruments -- Optical devices for enhancing low vision
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GB 23719-2009
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Basic data | Standard ID | GB 23719-2009 (GB23719-2009) | | Description (Translated English) | Ophthalmic optics and instruments -- Optical devices for enhancing low vision | | Sector / Industry | National Standard | | Classification of Chinese Standard | C40 | | Classification of International Standard | 11.040.70 | | Word Count Estimation | 20,292 | | Date of Issue | 2009-05-06 | | Date of Implementation | 2010-03-01 | | Adopted Standard | ISO 15253-2000, MOD | | Regulation (derived from) | Announcement of Newly Approved National Standards No. 4, 2009 (No. 144 overall) | | Issuing agency(ies) | General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China | | Summary | This Chinese standard specifies the optical vision aids optical, mechanical requirements and test methods. This standard applies to manufacturers to provide specifically for the visually impaired, low vision optical vision aids, can also carry electrical components (eg lighting). This standard does not apply to low vision electro-optical vision aids. Note: For low vision electro-optical vision aids provided for by the other criteria. | GB 23719-2009: Ophthalmic optics and instruments -- Optical devices for enhancing low vision---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Ophthalmic optics and instruments.Optical devices for enhancing low vision
ICS 11.040.70
C40
National Standards of People's Republic of China
Optics and instruments optical visual aids
(ISO 15253.2000, MOD)
Published 2009-05-06
2010-03-01 implementation
Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China
Standardization Administration of China issued
Foreword
All technical contents of this standard is mandatory.
This modification uses the standard ISO 15253.2000 "optics and instruments optical visual aids."
This standard and ISO 15253.2000 compared with the content as follows.
--- increase the reference standard GB/T 16886.1 "Biological Evaluation of Medical Devices Guide", ISO 14490-5 "Optics and optical instruments
Detection methods for telescopic systems - Part 5. transmittance measurement method ";
--- 5.2.1 increase demand for materials;
--- Delete ISO 15253.2000 standard in Appendix B.
Appendix A of this standard is an informative annex.
This standard was proposed by the State Food and Drug Administration.
This standard by the National Standardization and optical instruments and medical optical instruments Technical Committee Standardization Technical Committee (SAC /
TC103/SC1).
Drafted. Hangzhou State Food and Drug Administration Medical Device Quality Supervision and Inspection Center.
The main drafters. He Tao, to Yan Qing, Zheng Jian.
Optics and instruments optical visual aids
Range 1
This standard specifies the optical and mechanical requirements and test method for an optical visual aids.
This standard applies to the optical low vision visual aid manufacturer to provide specially for the visually impaired can also carry electrical component (e.g.
An illumination source).
This standard does not apply to low vision electron optical visual aids.
Note. For the low vision electron optical vision aid as specified by other standards.
2 Normative references
Terms of the following documents become provisions of this standard by reference in this standard. For dated reference documents, all later
Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to agreements based on this standard
Whether the latest versions of these documents. For undated references, the latest version applies to this standard.
GB/T 14214 frames General requirements and test methods
GB/T 16886.1 medical devices Biological Evaluation Guide Part 1. Evaluation and Testing (GB/T 16886.1-2001,
idt ISO 10993-1.1997)
ISO 14889 uncut spectacle lens optics lens essential requirements
ISO 14490-5 detection method and optical instruments telescope systems - Part 5. transmittance measurement method
ISO 15004 ophthalmic instrument basic requirements and test methods
3 Terms and Definitions
The following terms and definitions apply to this standard.
3.1
Kepler telescope Kepleriantelescope
Combining optical system or the objective lens of a positive lens group and a positive eyepiece or eyepieces group consisting of, in the normal focus, the zoom can be formed inverted
Like home.
3.2
Typically assembled from two separate optical systems together, two optical means for simultaneously viewed.
3.3
Binocular optical apparatus by a single observation optical system.
3.4
Placed near the front of the telescope or the negative lens Telescopic microscope objective enables the device to observe the object distance.
3.5
Expressed in meters, equivalent to the reciprocal of the focal length measured in air.
NOTE. equivalent power is represented by the reciprocal of the diopter or meters.
3.6
The optical imaging system of the optical element group closest to the eye for observation of the image formed by the objective lens.
3.7
The main focus of the optical system (or focus) the linear distance to the reference point, shown in Figure 1.
NOTE. The selected reference point different (e.g., vertices, principal point), a focal length needs to be further defined, as defined in 3.7.1 to 3.7.3.
3.7.1
Along the optical axis (axis of symmetry) in the optical system, measuring the distance from the rear surface to the back focus. See Figure 1.
3.7.2
Along the optical axis (axis of symmetry) in the optical system, the front surface of the front focal distance measurement. See Figure 1.
3.7.3
Along the optical axis (axis of symmetry) in the optical system, measure the distance from the focal point to the corresponding master. See Figure 1.
1 --- top front focal length;
2 --- rear top focal length;
3 --- front focus;
4 --- back focus.
1 a schematic view of a focal length
3.8
The object distance, focusing means by a user of the telephoto.
3.9
(Optical low vision) the distance between the near telescope/microscope foremost telescope portion and the object.
3.10
A positive lens or lens group and the negative ocular optical system, or a combination of the group consisting of the eyepiece, the focusing in the normal case, the formed amplified positive.
3.11
By a user's hand to locate and support means without artificial support structure.
3.12
Under conditions specified by the manufacturer, by the low-vision aids can be seen the maximum range of the target object plane.
3.13
Aid for the visually impaired vision enhancement device.
3.14
Kepler or capable of forming a Galilean telescope magnified retinal image of a target and other optical devices.
3.14.1
It is designed to be a hand-held telescope.
3.14.2
Telescope within the frame is mounted on the frame or eyeglass frames.
3.15
It means the ratio of the linear dimensions of the size of an enlarged image of the fundus as seen and the same object seen without magnification means.
3.15.1
In the reference observation point (e.g., the entrance pupil of the eye), the ratio of the imaging angle and the target angle on the side edges.
3.15.2
For magnifier, in meters from the reference line of sight (see 3.20) diopters and in the equivalent power F (see 3.5) by
Plot calculated.
Example. the reference horizon is 0.25m, the nominal magnification is given by the equation M = 0.25F.
3.15.3
M Commercial
For magnifying glass, the amplification factor is calculated by the following equation.
Commercial M = M + 1
Note. Due to many low vision textbooks mentioned commercial magnification, so the use of this definition. This term should not be adopted in the future.
3.16
Co stereomicroscope lowvision-aidmicroscope
Lens system is designed to produce an enlarged image.
Note. It may be a single lens may also be a multi-component system.
3.16.1
Glasses microscope spectaclemicroscope
Placed on the spectacle frame refers to an image or a magnifying glass eyeglasses worn close to the eye or magnifying glass support, include those containing an additional luminosity near
An optical means for correcting near vision.
3.16.2
An illumination source with a magnifying glass.
3.17
In the optical device in front of only one use.
3.18
The optical size of the central area zoneofopticaldimensions
Magnifying optical zone opticalzoneofmagnifier
Magnifier loaded into linear available sizes.
Note. in millimeters.
3.19
Placed in front of the objective lens of a positive lens telescope, the device can see the near object.
3.20
Accepted distance between the corneal vertex and the object to be observed is 250mm.
Note. Reference is first calculated line of sight with reference to the amount of magnification of an optical instrument as close observation.
3.21
Changing the image size by changing the viewing of the retina caused by the distance.
3.22
Under a given set of conditions, the minimum distance between two points that can be resolved by linear or angular value to represent the value.
3.23
Magnifier support portion is designed to be fixed or to adjust the distance between the optical system and the observation target object.
3.23.1
For the stand magnifier, the design object is placed at a position closest to the surface of the eye from the magnifying virtual image plane. See Figure 2.
1 --- vertex image distance;
2 --- image plane;
3 --- object plane.
FIG image distance of the vertex 2, a schematic view of the image plane and the object plane
3.23.2
Stand magnifier reciprocal vertex image distance (in meters) of.
Note. Units diopters.
3.24
Close Telescope near-visiontelescope
Suitable for a telescope to observe at close range the target.
3.25
Placed on an upright support system telescope.
Category 4
4.1 Magnifier
a) a hand-held;
b) vertical;
c) The head-mounted, or mounted eyewear comprising a spectacle frame.
4.2 telescope far --- formula
a) a hand-held;
b) a head mounted, or mounted eyewear comprising a spectacle frame.
4.3 --- near the telescope type/telescope microscope
a) a hand-held;
b) a head mounted, or mounted eyewear comprising a spectacle frame.
4.4 focusable telescope ---
a) a hand-held;
b) a head mounted, or mounted eyewear comprising a spectacle frame.
5 Requirements
5.1 Optical properties
5.1.1 Resolution
5.1.1.1 General
Means for measuring optical resolution, contrast optotype should not be less than 80%.
5.1.1.2 magnifying telescope and microscope/telescope near
7.4 by detecting, in a linear field of view 70%, visual aids should be able to distinguish no greater than 0.233mm/line pair (0.116mm/line)
Target, the target white light illumination using a standard CIE D65 illuminant, the light intensity in the range of 750lx ~ 1000lx.
5.1.1.3 telescope
7.4 by detecting, within 70%, or 10 ° linear field of view field angle range, visual aids should be able to distinguish the diagonal of 2 '(or less) of the pair
Composition, and a 1 '(or less) to the target angle if the request exceeds the diffraction limit of the visual aid, monochromatic light of 555nm should be used
Out within the predetermined area, the resolution of visual aids should be less than 50% of the diffraction limit; within the claimed range work, binoculars
It should meet the above requirements.
5.1.2 equivalent power magnifier ---
Magnifier tolerance equivalent power along the optical axis deviates from the nominal value of 5%. Optical power difference between the two principal meridian should not exceed the cross
2.5%.
The main parameters for the two principal meridian magnifier design, equivalent to the maximum deviation of the optical power of the optical power must not exceed two meridians
2.5%.
5.1.3 angular magnification telescope ---
And the maker equivalent magnification telescope along the optical axis deviates from the nominal value of 5% tolerance.
5.1.4 Zhou Bian the magnification change --- magnifiers and telescopes
7.5 When a method as described according to the linear detection instrument field of view, magnification change than 70% of the linear field of view should be in accordance with Table 1
Or Table 2 requirements.
The manufacturer shall specify test methods.
Table 1 magnifier/close Telescope
Equivalent power/D Zhou Bian magnification change /%
≤12 5
12 ~ 20 10
≥20 15
Table 2 distance telescope
Magnification Zhou Bian magnification change /%
≤3 × 2.5
3 × ~ 5 × 5
≥5 × 7.5
5.1.5 transmittance
If the manufacturer has made a claim on the transmittance measurement of the ISO 14490-5 standard shall be provided with appropriate transmittance curve.
5.2 Materials and structures
5.2.1 Materials
When used according to manufacturer's intended use, the components in direct contact with the patient's skin, the material should be non-toxic, no serious sensitization reaction, by
GB/T 16886.1 requirements for biological evaluation of medical devices.
5.2.2 Flammability
Test of visual aid in accordance with ISO 15004, should not continue to burn after the withdrawal of the test bars.
5.2.3 Anti-dip
For the claim to the anti-soaked instrument shall meet the following requirements.
Instrument in water at 40 ℃ to 45 ℃ completely immersed 5.0min ± 0.5min, and dried in air at 20 ℃ ± 5 ℃, and then into the
Row detector, the result should comply with this standard.
5.2.4 anti-sweat
If the frame containing a vision aid compliance GB/T 14214 standard range, the anti-sweat claims shall comply with the standard requirements.
5.2.5 The head-mounted (including glasses and glasses type mounted equipment) the mechanical strength of
When the vision aid containing compliance GB/T 14214 and ISO 14889 standard range of frames and lenses, which should comply with the standard mechanical strength
The relevant requirements.
5.2.6 defensive performance
The resilience of the instrument manufacturer's declaration, the declaration shall specify the manufacturer is given on the conditions under which, and to provide test methods.
6 Use of environmental conditions
In table 3 given environmental conditions, it should comply with all the requirements of this standard.
Table 3 Environmental conditions of use
Project Environmental Conditions
Temperature -25 ℃ ~ + 35 ℃
Relative humidity 30% to 85%
Atmospheric pressure 800hPa ~ 1060hPa
Vibration (unpackaged) a 10g/6ms
only for a hand-held instrument.
7 Test methods
7.1 General
All test methods are type tests. Allow selection of another equivalent method, but the manufacturer or are responsible test argument used
It is equivalent method.
--- 7.2 equivalent power magnifier
A method for detecting an optical power equivalent to be reached at 95% confidence level, the less than 0.5% relative uncertainty.
7.3 angular magnification telescope ---
A method for detecting the angular magnification should be reached at 95% confidence level, the less than 0.5% relative uncertainty.
7.4 Resolution test
7.4.1 Test principle
Following means for detecting the resolution of low-vision aids. 4 sets the resolution in different directions by the plate 90 °, 180 °, 45 °, 135 ° of Ron-
chi stripes (see Figure 3). Able to see in various directions on the fringe indicates that the resolution achieved during the test, the points to be measured
Resolution can be clearly observed in the linear field of view. The viewer's vision of at least 1.0 (logarithmic visual acuity 5.0).
Example 3 Resolution of the plate of FIG.
7.4.2 Test device
7.4.2.1 General
Platform structures on the optical test device. A plate mounted on the resolution can be adjusted to a black and white on the optical bench to 90 °. Adjustable
Section at least equal to the range of low vision aids horizontal field of view to be detected.
Striped illumination light source and the screen D65 standard light source, the light intensity on the plate plane resolution 750lx ~ 1000lx. Resolution Board
Chou linewidth = 0.116mm, at least 80% contrast (see FIG. 3).
NOTE. The most suitable resolution on a glass plate in the plate is metal plated.
7.4.2.2 magnifying telescope and microscope/telescope near
Typoscope plate is mounted in front of the resolution. The distance between the visual aid and the resolution of the plate should be adjusted.
Before placing a vision aid angular magnification observation telescope interposed between the 3-fold to 8-fold, and is focused on the image plane resolution panel.
The measurement process is not allowed to re-focus.
Figure 4 shows an example of a test device. Before measurement, adjusted in advance means that the resolution test plate X, Y direction, low vision aids
And a position matching each observation telescope.
The predetermined distance between the eyes of the user with instructions for use in low vision fixation device, adjust the near vision fixation and low observation
The distance between the telescopes.
According to the manufacturer's instructions provided to adjust the distance between the near vision aid and resolution panel.
1 --- observation telescope;
2 --- near vision aid;
3 --- screen illumination light source;
4 --- fitted with a screen resolution panel.
4 near vision aid detection apparatus of the example of FIG.
7.4.2.3 telescopic vision aid
A front plate discharge resolution collimator lens, that the resolution of the focal plane of the lens plate is positioned, in which case the resolution in the non-imaged by the lens plate
Infinity.
In order to ensure a predetermined angle of view it does not change, when the resolution of the plate when the line width is Chou = 0.116mm, the focal length of the collimator lens should be equivalent
Equal to 400mm.
Where.
Chou --- line width in millimeters (mm); Chou = 0.116mm;
[alpha] --- viewing angle, in degrees (°); α = 1 '= 0.0166 °.
Field of view of the telescope system should not be limited to the collimator lens, and the resolution should also not affect the collimating lens, but only by the system under test must
set. To this end, the collimator lens should be at least the diameter of the telescopic vision aid 1.2 times the diameter of the entrance pupil.
Figure 5 shows an example of the test apparatus. Before measurement, the test means that the resolution adjusting panel X, Y direction, and the observation telescope vision aid
Position of the mirror match.
It should be as small as possible distance between the measured telescopic vision aid and the collimator lens, to ensure that the field is not limited by a collimator lens.
For focusable telescopic vision aid, adjusting the distance between the collimator and the resolution of the plate, to equal the equivalent focal length of the collimator.
For non-focusing telescopic vision aid, adjusting the distance between the collimator and the resolution of the plate, so that the resolution of the image clear plate visual aid.
1 --- telescopic vision aid;
2 --- collimator lens;
3 --- screen illumination light source;
4 --- fitted with a screen resolution panel.
Example 5 telescopic vision aid detection apparatus of FIG.
7.4.3 Test Procedure
7.4.3.1 magnifying telescope and microscope/close Telescope
After detecting means precisely adjusted, the measurement field of view visual aid available. The plate is moved to a fixed resolution low vision aids
The edge of the visible range of the holder, the measurement resolution of the plate. Horizontal and vertical movement, respectively, may want to observe the process moves to a new telescope
position. They were measured each of the horizontal and vertical field of view. Obtained two values.
Ahor = linear field of view in the horizontal direction, in millimeters;
Avert = linear vertical field of view in millimeters.
Then the process is repeated, the resolution moved toward the edges of the field plate, in one direction until the Ronchi fringes can not be clearly identified.
Read the scale reading to obtain horizontal and vertical directions of the field of view can be distinguished. Again reading from the scale, to obtain the horizontal and vertical field of view
Range of directions, which is not observed during the telescope refocus. Obtained two values.
Ahor = distinguished horizontal linear field of view, in millimeters;
Avert = linear vertical field of view can be distinguished, in millimeters.
When the vertical movement of the difficulties that may arise, to rotate the vision aid around 90 °, the measurement range in the vertical direction.
7.4.3.2 telescopic vision aid for
Detecting means precisely adjusted after the measurement field of view of low vision aids available. The plate is moved to a fixed low resolution view
Typoscope edge holder force, the measuring range of the visible resolution of the plate. Each respectively horizontal and vertical movement of the horizontal and vertical field of view of the test
range. Obtained two values.
Ahor = linear field of view in the horizontal direction, in millimeters;
Avert = linear vertical field of view in millimeters.
Then the process is repeated, the resolution moved toward the edges of the field plate, in one direction until the Ronchi fringes can not be clearly identified.
Repeated once, read the scale reading to obtain the horizontal and vertical field of view can be distinguished.
Ahor = distinguished horizontal linear field of view, in millimeters;
Avert = linear vertical field of view can be distinguished, in millimeters.
When the vertical movement of the difficulties that may arise, to rotate the vision aid around 90 °, the measurement range in the vertical direction.
7.4.4 evaluation test
(3) can be obtained using the formula percentage distinguished linear field of view.
(A × 100)/A (3)
7.5 determine the magnification Zhou Bian changes
Measuring the change in Zhou Bian magnification should be used under the conditions specified in the manufacturer's specification. For detecting a lateral magnification of the distortion
Instrument at 95% confidence level, the uncertainty has less than 0.5%.
NOTE. shows an example of a method of measuring the Appendix A.
8 and use the information tag
8.1 mark
Each visual aids should be clearly marked with the following.
a) manufacturer and product name;
b) equivalent power magnifier nominal value given by the manufacturer;
Except customized for each type of visual aids should be clear at least the following additional information.
c) the angular magnification telescope nominal value given by the manufacturer;
d) given by the manufacturer telephoto microscope/nominal power of magnification equivalent or near the nominal value of the telescope.
8.2 Information provided by the manufacturer
8.1 in addition to the content, the manufacturer should also provide at least the following information for each of the vision aid.
Vertical a) given by the manufacturer of the magnifier from the nominal value of the dispersion of the image;
Free working b) Telescopic distance microscope;
c) to avoid direct sunlight magnifying glass placed described focusing fire;
d) visual aids maintenance and cleaning instructions;
e) any of the characteristics stated in 5.2.
If desired, the manufacturer should disclose the following information. the weight, the material of the lens, the optical magnifier dimensions (in millimeters).
Appendix A
(Informative)
Determine the magnification change of Zhou Bian
A. Rationale
Using a set of charts to evaluate Zhou Bian barrel distortion change magnification. Under specified conditions, or observed through a magnifying telescope aptamer
Grid size, can be compensated by the most magnifier to evaluate the degree of distortion of the grid when the pincushion distortion.
NOTE. mainly visual aid for pincushion distortion; this test is only valid for the form of distortion.
A. 2 means
A. 2.1 handheld and stand magnifier
A. 2.1.1 Evaluation of distortion which depicts a method of computer programs, respectively, fixed and hand-held magnifiers 0%, 5%, 10%,
15% and 20% of the pincushion distortion. The dimensions according to FIG. 6 are arranged in descending rows. See Figure A. 1.
A. 2.1.2 In order to evaluate the position of the normalized distortion magnifier, forehead support is designed in the form of a cross support rod adjustment.
A. 2.2 and far focusing telescope
FIG distortion evaluation, shown by the process computer programs, respectively telescope distance 0%, 2.5%, 5%, 7.5% and 10% of the pincushion
distortion. FIG size of the magnifying glass is 4 times the corresponding FIG. As the working distance is shorter, more effective for some of these figures near the telescope.
A. 3 steps
A. 3.1 magnifying glass position
For magnifier object distance determined by the fixed frame or stent, FIG flat on the table, so that the magnifying glass is placed in the center point of a grid suitable
Alignment of the optical axis of the magnifying glass. Hand magnifier should be mounted on a height-adjustable fixing means so that a detected between the magnifier and FIGS.
Distance in line with the manufacturer's instructions for use. Suitable fixing means so that the center point of the mobile grid magnifying optical axis alignment.
A forehead support fixed distance distortion evaluation. The distance between the magnifying glass eye and evaluators should be in line with the manufacturer's instructions
Book provisions. Evaluators should magnifying glass eye on the optical axis.
NOTE. The row of FIG. 6, in decreasing size [see A. 1b), shown in the left column of the figure]. Each row from left to right in this figure represent a lattice
0%, 5%, 10%, 15%, 20% barrel distortion [see A. 1c), draw a line in this figure].
a) Overall layout view, wherein a lattice become empty simplified block
Figure A. Example 1 Series distortion EVALUATION
Left column b) evaluation map, showing the dimensional change of the lattice sequence
Figure A. 1 (cont.)
Line 4 c) evaluation map, showing the degree of lattice distortion sequence
Figure A. 1 (cont.)
A. Nearly 3.2 telescope viewing position
Telescope near viewing distance ...
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