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GB 17342-2009Ophthalmic instrument -- Trial case lenses (English PDF)

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Issued by

Standardization Administration of China

Level / Type

National · Mandatory

Issue date

June 12, 2009

Implementation date

July 1, 2010

Scope

GB 17342-2009 (Ophthalmic instrument -- Trial case lenses) is available as an English-translated PDF.

GB 17342-2009 — This standard specifies the basic requirements for testing the human eye refractive defects of various refraction lens. This standard applies to all types of full bore and reduced aperture trial case lenses.

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Document preview — GB 17342-2009

National Standard of the People's Republic of China

ICS
11.040.70
Classification
C 40
Replacing
GB 17342-1998

Issued by: Standardization Administration of China

Contents

  • Foreword
  • 1 Scope
  • 2 Normative references
  • 3 Terms and Definitions
  • 4 Classification and Uses
  • 4.1 Purpose
  • 4.2 Spherical lenses optometry
  • 4.3 Lenticular lens optometry
  • 4.4 Prism refraction lens
  • 4.5 Supplemental trial lenses
  • 5 Requirements
  • 5.1 General
  • 5.3 Optical Performance Requirements
  • 5.4 Structural requirements
  • 5.5 Material and surface quality
  • 6 Test method
  • 6.1 Optical performance test
  • 6.2 Material and surface quality inspection
  • 6.3 Structural testing
  • 7 Inspection rules
  • 8 Signs, packaging, transportation, storage
  • 8.1 Mark
  • 8.2 Packaging

Foreword

All technical contents of this standard is mandatory.

This revised standard adopts ISO 9801:1997 "ophthalmic instruments refraction lens." this standard and ISO 9801:1997 main technical differences are as follows.

--- The standard Chapter 4. Classification and use for the new section, the auxiliary lens description;

--- The standard 5.2. Added configuration requirements. the basic configuration of refraction of the lens, auxiliary lens configuration;

--- The standard 5.3. optical performance requirements. cylinder of ball lens tolerance; prism prism sheet, spherical degree, cylinder degree of tolerance;

The geometric center of the lens prism ball lens and the lens sub-file column and tolerance; cylinder axial binning and tolerance; prism sheet baseline Binning and tolerance; make adjustments and provisions of the cross cylinder technical requirements;

--- The standard 5.4. Structural requirements. to adjust the thickness of refraction of the lens; auxiliary lens structure to provide for;

--- The standard 6.3. added auxiliary lens configuration of test methods;

--- The standard 7.1. Added requirements for ball lens, a lenticular lens, a prism sheet single pass rate and the rate of qualified FCL; made the wrong piece Regulations;

--- The standard 8.1. double-sided lettering optometry lenses prescribed a variety of technical indicators should meet the optical performance requirements.

This standard replaces GB 17342-1998 "ophthalmic instruments refraction lens." this standard and GB 17342-1998 "ophthalmic instruments optometry lenses," compared to the main changes are as follows.

--- The standard Chapter 4. Classification and use for the new section, the auxiliary lens description;

--- The standard 5.2. Added configuration requirements. the basic configuration of refraction of the lens, auxiliary lens configuration;

--- The standard 5.3. optical performance requirements. cylinder of ball lens tolerance; prism prism sheet, spherical degree, cylinder degree of tolerance;

Ball lenses and lenticular sheet lens geometric center of the prism binning and tolerance; cylinder axial binning and tolerance; cross-cylinder Make adjustments and provisions of technical requirements;

--- The standard 5.4. Structural requirements. to make adjustments to the thickness of the refraction of the lens, the outer diameter of the frame; auxiliary lens structure made Regulations;

--- The standard 6.3. added auxiliary lens configuration of test methods;

--- The standard 7.1. adjust the requirements of the ball lens, a lenticular lens, a prism sheet single pass rate and the rate of qualified FCL; made the wrong piece Regulations;

--- The standard 7.3. Sampling checklist to make adjustments;

--- The standard 8.1. double-sided lettering optometry lenses prescribed a variety of technical indicators should meet the optical performance requirements.

The standard proposed by China Institute of Metrology.

This standard by the National Standardization Technical Committee Optics and optical instruments - Optical glasses Technical Committee (SAC/TC103/SC3) Centralized.

This standard is mainly drafted by. China Institute of Metrology, Shandong Institute of Metrology, Lianyungang days Connaught Optical Instrument Co., Division Shanghai Instrument Co., Ltd. ASE.

1 Scope

This standard specifies the basic requirements for testing the human eye refractive defects of various refraction lens.

This standard applies to all types of full bore and reduced aperture trial case lenses.

2 Normative references

The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard.

GB/T 2828.1 Sampling procedures for inspection - Part 1. by acceptance quality limit (AQL) retrieval batch inspection sampling plan (GB/T 2828.1-2003, ISO 2859-1:1999, IDT) GB/T 10050 Optics and optical instruments - Reference wavelengths (eqvGB/T 10050-1988, ISO 7944. 1984) JJG580 focimeter

3 Terms and Definitions

The following terms and definitions apply to this standard.

Lens in meters measured paraxial vertex length of the countdown. A lens contains two vertex.

After the lens near the axis in meters measured at the top of the reciprocal of the focal length. 1, from the rear of the lens to focus the vertex axis is called after nearly FIG.

Name diopters.

Under normal circumstances, the vertex of the lens mean a subsequent vertex. Refraction lens vertex power and wavelength. This standard specifies the use of wave Long green mercury line, lambdae = 546.07nm, see GB/T 10050.

F --- the object focus;

F '--- the image side focal point;

H --- object side principal point;

H '--- the image side principal point;

Figure 1 a schematic top focal length lens

Measure the light deviated by a predetermined point on the lens produced (usually the center of the lens) later. Figure 2, the prism is in centimeters Per meter (cm/m), the name of the unit prism diopters.

Figure 2 a schematic view of a prism

Mosaic in the box, for the determination of the refractive defects of the human eye lens.

With 1mm wall thickness of the protective frame and has a maximum limit aperture lenses.

Aperture is significantly smaller than the outer diameter of the frame thickness significantly thinner lenses.

Ball lens, a lenticular lens or ball - column joint optometry lenses chain. In its last time measured back vertex power equal in the frame of the United have a nominal value of refraction of the lens in the meridian.

Paraxial parallel beam converge at a point of refraction lenses.

Paraxial parallel light beam to two separate, mutually orthogonal cross line contains two main vertex of the refraction lens.

Lenticular lens optometry wherein a vertex principal meridian zero. Lenticular refers to the degree of its top vertex is not zero and that a principal meridian Power.

4 Classification and Uses

4.1 Purpose

In practice, a combination of all kinds of refraction of the lens is called a trial lens. Hospital of the trial lens, glasses shops for inspection an ophthalmic measuring instruments to check the human eye's refractive state and strabismus, amblyopia and other visual features of the human eye.

Optometry lenses mainly composed of positive and negative refraction spherical lenses, positive and negative cylinder lenses optometry, prism lenses, refraction lenses and other auxiliary components.

4.2 Spherical lenses optometry

By the positive and negative refraction spherical lens elements. Positive spherical lenses for the human eye optometry hyperopia and presbyopia inspection; negative refraction spherical lenses for people Myopic eye examination.

4.3 Lenticular lens optometry

By the positive and negative refraction lens cylinder components. N lenticular lens of the human eye optometry hyperopia and astigmatism, presbyopia check for. negative cylinder lenses optometry the human eye myopic astigmatism check.

4.4 Prism refraction lens

Check for the human eye strabismus and heterophoria.

4.5 Supplemental trial lenses

4.5.1 Cross-cylinder lens

Cross-cylinder lens is a special lenticular lens, on its two mutually perpendicular orientations, respectively, they have the same value but opposite sign Positive and negative cylinder vertex. Used to check the cylinder axial and cylinder degrees.

4.5.2 Ma pole piece

Ma pole piece consists of a row of equal diameter, smooth translucent cylindrical components. Check for strabismus and phoria.

4.5.3 Black sheet

Also known as black sheet covering sheet, it is a totally opaque cover sheet. For covering is not checked monocular.

4.5.4 Pinhole film

Pinhole film is at the center of a black piece of a through aperture. Mainly used to identify the vision loss caused by refractive error was cited by the eye disease Onwards. Light through the hole should be round and smooth, and the rest opaque.

4.5.5 Fractured pieces

There is a light transmissive slit on the light shielding sheet for checking astigmatism.

4.5.6 Scrub films

Frosted translucent sheet, for children or outdoor instead of black film.

4.5.7 Plain sheet

Plano lens is opaque to check simulated blindness and so on.

4.5.8 Cross sheet

On plain piece engraved with "ten" shaped groove, it is mainly used to determine the center of the eye and the eye position determination when checking strabismus.

4.5.9 Filter

It should be plain lenses. Usually red, green lens, check for color vision.

Red and green sheet with the use of tablets for binocular stereo vision inspection, refractive media opacity visual function; red-chip can also be used for amblyopia Treatment, color vision examination; there are brown films such as photophobia eye for visual inspection of lenses.

4.5.10 Polarizer

So that natural light into a plane polarized lens for examining the implicit vision, strabismus, unequal vision, stereoscopic vision and other visual functions.

5 Requirements

5.1 General

Refraction lens FCL factory should meet the requirements of 5.2,5.3,5.4 and 5.5, according to the requirements of Chapter 6 of the inspection.

FCL 5.2 Configuration Requirements

5.2.1 Refraction spherical lens

The same size balls trial case lenses should be about two.

a) must include a + lens measuring range 0.12m-1 and -0.12m-1, at least in -12.00m-1 ~ + 12.00m-1;

b) In -0.25m-1 ~ -4.00m-1 and + 0.25m-1 lens values within the range of ~ + 4.00m-1 intervals not greater than 0.25m-1;

c) In the + 4.00m-1 ~ + 8.00m-1 lens value within the range of intervals not greater at 0.50m-1;

d) In the + 8.00m-1 lens values within ~ + 12.00m-1, the interval can not be Greater than 1.00m-1.

5.2.2 Lenticular lens optometry

The same specifications lenticular lens optometry should be about two.

a) must include a + lens measuring range 0.12m-1 and -0.12m-1, at least in -4.00m-1 ~ + 4.00m-1;

b) In -0.25m-1 ~ -3.00m-1 and + 0.25m-1 lens values within the range of ~ + 3.00m-1 intervals not greater than 0.25m-1;

c) In the + 3.00m-1 ~ + 4.00m-1 lens value within the range of intervals not greater at 0.50m-1.

5.2.3 Prism refraction lens

Prismatic refraction lens should meet the following requirements.

a) measuring prism refraction lens range to at least 8.0cm/m, where 0.5cm/m, 1.0cm/m, 2.0cm/m shall have two;

b) within 3.0cm/m ~ 8.0cm/m range lenses magnitude intervals not greater than 1.0cm/m.

5.2.4 Auxiliary lenses optometry

Auxiliary lens should include cross-cylinder lenses, maddox rod lenses, pinhole film, black film, fractured pieces, plain film, scrub films, red and green filters and the like.

5.3 Optical Performance Requirements

5.3.1 Plano lens vertex tolerance

Vertex plain lens tolerance should be consistent with the requirements of Table 1.

Table 1 plano lens vertex tolerance

Vertex nominal value m-1 Tolerance (MPE) Spherical degree m-1 Lenticular degree m-1 Prism cm/m 0 ± 0.03 ± 0.03 0.06

5.3.2 Refraction spherical lens vertex tolerance

Refraction spherical lens vertex tolerance shall comply with the requirements of Table 2.

Table 2 refraction spherical lens vertex tolerance in meters -1

Vertex nominal value (absolute value) Tolerance (MPE) Spherical degree of cylinder 0.12 ± 0.03 ± 0.03 > 0.12 ~ 6.00 ± 0.06 ± 0.03 > 6.00 ~ 12.00 ± 0.09 ± 0.03 > 12.00 ± 0.12 ± 0.05

5.3.3 Optometry lenticular lens vertex tolerance

Cylinder vertex optometry degree lenticular lens tolerance should be consistent with the requirements of Table 3; its spherical degree of tolerance are not allowed to exceed ± 0.06m-1, its solid There are no larger than the prism 0.12cm/m.

Table 3 lenticular lens optometry lenticular vertex tolerance in meters -1

Cylinder of the nominal value (absolute value) Tolerance (MPE) 0.12 ± 0.03 > 0.12 ~ 1.00 ± 0.06 > 1.00 ~ 4.00 ± 0.09 > 4.00 ~ 6.00 ± 0.12 > 6.00 ± 0.18

5.3.4 Prism refraction lens tolerance

Prismatic refraction prism lens tolerance should be consistent with the requirements of Table 4, in 0cm/m ~ prism within 5.0cm/m range optometry lenses Spherical degree, cylinder degree shall not exceed ± 0.05m-1.

Table 4 prism sheet prism tolerance in centimeters per meter

Prism nominal value tolerance (MPE) > 0 ~ 3.0 ± 0.10 > 3.0 ~ 6.0 ± 0.12 > 6.0 ± 0.25

5.3.5 Optical center displacement tolerance

Spherical lenses optometry, optical center displacement lenticular lens is represented by the prism lens at the geometric center of the circle, which allows the displacement of the optical center the difference shall be in accordance with Table 5.

Table 5 optical center displacement tolerance

Vertex nominal value (absolute value) m-1 Prism tolerance (MPE) cm/m >=0.12 ~ 1.00 ± 0.12 > 1.00 ~ 4.00 ± 0.25 > 4.00 ~ 7.00 ± 0.35 > 7.00 ~ 10.00 ± 0.50 > 10.00 ~ 12.00 ± 0.60 > 12.00 ± 0.80

5.3.6 Lenticular lens optometry axial tolerance

Lenticular lens optometry axial line is defined as 0 ° ~ 180 ° direction, marked with the axial deviation of the lens diameter at both ends with the angle between the He said its value should be in accordance with Table 6.

Table 6 cylinder lens axial tolerance

Cylinder of the nominal value (absolute value) m-1 Axial tolerance (MPE) >=0.12 ~ 0.50 ± 3 ° > 0.50 ± 2 °

5.3.7 Prism sheet baseline tolerance

Axial positioning prism sheet substrate by the prism baseline represented, the deviation should be in accordance with Table 7.

Table 7 prism baseline tolerance

Prism nominal value

cm/m

Tolerance (MPE)

> 0 ~ 0.50 ± 5 °

> 0.50 ~ 1.00 ± 4 °

> 1.00 ~ 2.00 ± 3 °

> 2.00 ~ 10.00 ± 2 ° > 10.00 ± 1 °

5.3.8 Cross-cylinder lens optical performance requirements

Cross-cylinder spherical degree of tolerance shown in Table 2, the cylinder of the tolerance shown in Table 3, the displacement of the optical center of the tolerance shown in Table 5, Table 6 axial tolerance.

Note. The axial cross-cylinder lens negative cylinder applications marked in red, positive cylinder axis bit application blue (or black) mark. Mark in two different colors, different Measurement mode, the optical performance requirements should meet those requirements.

5.4 Structural requirements

This requirement applies to all frames and lenses installed.

5.4.1 Size

Optometry lenses with some frame edges are rounded, the radius of the arc is not greater than 1.4mm. Installed outside diameter of the lens frame to 38 0-0.2mm.

Refraction lens together with its frame, including the overall thickness of not more than 2.8mm. Optometry lenses should fit into the interval for each piece of 3mm Audition holder. Which is greater than and equal to the absolute value of the full aperture ball lens thickness 4.00m-1 allows more than 2.8mm, greater than and equal to 3cm/full aperture and narrow aperture prism sheet thickness close to the object side, the side of the m allowed to exceed 2.8mm.

5.4.2 Effective aperture

Absolute value of the vertex is less than the nominal value of the refraction lens 12m-1 through effective aperture of not less than 18mm; the nominal value of the absolute vertex Values greater than the refraction lens 12m-1 through the effective aperture of not less than 16mm.

5.4.3 Structure
5.4.3.1 Frame structural requirements

Refraction lens frame surface should be smooth, without having any tip can cause injury to the patient or optometrist edges, sharp corners or rough surface, and no significant deformation and cracks. Optometry lens and frame should be firmly fixed, no loose, mosaic should be neat. Frame identification shall be in accordance with Table 9 Claim.

5.4.3.2 Prism sheet structure requirements

Prism sheet should be installed in the side of the eye so close to the surface of the frame parallel to the mounting surface. Standard nominal values on the vertical frame should be light Incident on the near side eye when prism, and consistent with the measured values focimeter.

Ma pole piece structure 5.4.3.3 requirements Difference in thickness between the pole pieces Markov semi-cylindrical ends of the axial direction of the plane should not exceed 0.08mm.

5.4.3.4 Pinhole film structure requirements

Diameter through-aperture pinhole film should be within the range of 0.5mm ~ 2.0mm.

5.4.3.5 Structure requirements fractured pieces

Fractured pieces of the light transmissive slit width should be within the range of 0.5mm ~ 2.0mm.

5.5 Material and surface quality

5.5.1 Materials

Frame materials used should not contain any corrosive elements.

5.5.2 Surface quality

Optometry in the effective lens aperture not have bubbles, defects, impurities, scratches and any visually observe an irregular surface defect. Optometry translucent lens should be good, without mildew.

6 Test method

6.1 Optical performance test

6.1.1 Test Method vertex

When vertex inspection of the lens, the lens should be measured imaging centers coincides with the reticle crosshairs and prism Indication minimum or Zero.

6.1.2 Optical center displacement test methods

Inspection spherical lenses optometry, lenticular lens, the optical center of the cross cylinder displacement may first focimeter prism measurement mode Adjust to polar coordinate display (such as "P-B" mode, etc.), the geometric center of the test lens is located at the geometric center of the lens holder, measured at this time Prismatic indication is obtained by displacement of the test optical center of the lens.

6.1.3 Axial marker test method

When axial test lenticular lens optometry mark, three points should be labeled with axial connection focimeter printing mechanism of the lens ring at both ends coincide, that is, Readable axial deviation of the test lens.

6.1.4 Prism test method

When the test prism refraction prism lens to the imaging of the horizontal axis and the reticle crosshair horizontal axis coincide. Obtained at this time Prism lens under test, the degree spherical and cylinder readings.

6.1.5 The prism sheet baseline test methods when the test prism refraction lens prism baseline, following the step 6.1.4, then fine rotating the subject lens, lens ring so that the baseline marks the end and three connection focimeter printing mechanism coincide. Baseline readings were obtained at this time deviation detection lens.

6.1.6 Test Equipment

Optical performance testing should be used in accordance with the test procedures certified by JJG580 primary standard focimeter. In the subject of optometry lenses Before test, a standard focimeter indoors holding time is not less than 2h, while maintaining a temperature of 20 °C ± 5 °C, relative humidity less than it tested 85% of environmental conditions.

When refraction lens inspection, should first be a standard focimeter indexing, select Settings 0.01m-1 division, the Abbe number 58 attached Near the standard wavelength selection e line, while focusing lens mount meter inspection, detection can be carried out after removal of dust.

When refraction lens inspection shall be placed on the upper face of the test lens logo focimeter lens holder, if the lens needs double-sided lettering Identification of the two sides were tested.

6.2 Material and surface quality inspection

Without the aid of the optical amplification device, be tested in the lens bright-field, dark background. Shows the recommended quality inspection system schematic 3 FIG. Illumination around the test apparatus is about 200lx. Recommended lighting using 15W more than 60W fluorescent or incandescent, Illumination placement at the illustrated lenses should not be lower than 350lx.

Note. This observation method has certain subjectivity, requires inspectors have some practical experience.

1 --- non-reflective black background (150mm × 360mm);

2 --- light source;

3 --- visor (adjustable baffle);

4 --- movable refraction lens;

5 --- eye observation plane;

Rao --- adjustable visor distance (mm).

Refraction lens surface quality inspection apparatus of FIG. 3 schematic

6.3 Structural testing

6.3.1 Frame structure test method 6.2 visual reference to be.

6.3.2 Inspection Ma pole piece structure. Using the minimum scale of not more than 0.01mm micrometer, measuring Ma pole piece semi-cylindrical axial the thickness difference between both ends of the planar direction.

6.3.3 Structural testing of fractured pieces and pinholes tablets. Using the minimum scale of 0.01mm of digital calipers.

7 Inspection rules

7.1 FCL refraction lens factory, such as the following occurs. refraction spherical lenses, lenticular lenses optometry, cross between a prism lens of the three Assembly phase error; spherical lenses optometry, lenticular lens, the positive and negative error between the lens assembly; all kinds of refraction lens interrupted, missing pieces; spherical Optometry degree spherical lenses, cylinder lenses optometry degree cylinder, prism index of refraction of the lens prism of more than 2 times the respective tolerance; that is deemed "Wrong piece." 7.2 manufactured products according to the requirements of this standard, according to the case overall acceptance. Each box requires spherical refraction lenses, lenticular lenses and optometry Single pass rate prism refraction lenses shall not be less than 90%; FCL pass rate of not less than 90%. FCL when the factory, and one appears a More wrong piece, FCL is considered substandard.

7.3 batch manufactured products according to GB/T 2828.1 special inspection level of S-4, AQL 4.0 sampling requirements for the inspection, see

Table 8.

Table 8

Bulk products range

Sampling Sample size Acceptance number Ac Failed to determine the number of Re 2 ~ 90301 91 ~ 5001312 7.4 pairs of special specifications of the products according to the requirements of both supply and demand agreement separately.

8 Signs, packaging, transportation, storage

8.1 Mark

8.1.1 all kinds of vertex or prismatic refraction lens nominal value shall be marked on the frame that the opposite side of the eye, if the nominal value of the standard

Note on the frame of the double-sided, lens should ensure that the various technical indicators meet the tolerance requirements.

8.1.2 lenticular lens optometry lenses and prisms should be marked axial or baseline, respectively, on the frame or lens. If it does not prevent the lenses Measures box rotation should be marked cylinder axial or baseline prism directly on the lenses.

8.1.3 color flag of the frame helps to identify specific lens types and categories; and spherical degree, cylinder degree and prism can be directly Read from the indication mark.

8.1.4 prism refraction lens mounting base surface should prism surface side optometry eye lens adjacent parallel. Marked on the name of the frame Value usually refers to the incident light perpendicular to the prismatic refraction prism lens mounting base surface when.

8.1.5 various types of lenses in accordance with the requirements of Table 9 distinguish between different colors of the frame and (or) flags of different colors.

Table 9 Lens identification mark

Lens color Frame Type letters or symbols or identification mark Ball column refraction lens vertex nominal value -Positive + Black Negative - Red delta refraction prism sheet white/gray

Table 9 (continued)

Lens color Frame Type letters or symbols or identification mark Horse type lever piece MR -I fractured pieces or SS -Pinhole film * PH or white/black/gray - black sheet or BL -Matte film FL -Cross sheet or CL -Red filter RF -Green filter GF -Polarizer PF -

8.2 Packaging

8.2.1 refraction lens category shall be packed in boxes.

8.2.2 Instructions shall be attached to the box, packing slips and box configuration specification must be consistent with the actual configuration, the description should include the following content.

a) the manufacturer's name and address;

b) intro...

......
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