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GB 23719-2009 English PDF

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US$459.00 · In stock
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GB 23719-2009: Ophthalmic optics and instruments -- Optical devices for enhancing low vision
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB 23719-2009	459	Add to Cart	4 days	Ophthalmic optics and instruments -- Optical devices for enhancing low vision	Valid

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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 respectiv......

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