This standard specifies the material requirements, specifications and dimensions, optical requirements, surface quality, and test methods for contact lenses. This standard applies to contact lenses made of water-based, non-hazardous material, having optical properties, and used for vision correction, treatment or cosmetic purposes. GB 11417.2-1989 Soft hydrophilic contact lenses GB11417.2-1989 Standard download and decompression password: www.bzxz.net

National Standard of the People's Republic of China
Soft hydrophilic contact lenses
Soft hydrophilic contact lenses1 Subject content and scope of application
GE 11417.2—89
This standard specifies contact lenses material requirements, specifications and dimensions, optical requirements, surface quality, and testing methods. This standard applies to contact lenses made of hydrophilic, non-hazardous material, with optical properties and used for vision correction, treatment or cosmetic purposes.
2 Reference Standards
GB2828 Batch-by-Batch Inspection and Count Sampling Procedures and Sampling Tables (Applicable to Continuous Batch Inspection) 3 Terms
3.1 Hydrophilic lenses hydrophilic Jens contain a certain amount of moisture, Lenses with specific optical properties and shapes. 3.2 Water content
water content
Under specified conditions, the percentage of water in the total lens volume. m alliance two m × 100 %
moisture content=
m
3.3 oxygen permeability coefficient (D)
oxygen permeability
under specified conditions and units The speed at which oxygen passes through unit area and unit thickness under the action of pressure difference. D
Oxygen amount × thickness
Area The value obtained from the thickness. 3.5 The back vertex diopter backvertexpower is the reciprocal of the distance (intercept) from the rear vertex to the focal point of the lens. The intercept is measured in meters (m-1), and the photometric unit is D. 3.6 Total diameter (p) total diameter is the maximum diameter of the lens.
3.7 edge
The connecting part between the convex surface and the concave surface of the contact lens.
3.8 edge form edge form
The edge profile of the section where the lens axis is located. State Bureau of Technical Supervision approved 180
(1)
.(2)
1990-02-01 implementation
3.9 optical zone optic zone| |tt||The area in a contact lens that has a specified optical effect. 3. 10 central optical zone central optic zone GB 11417.2--89
A central area with prescribed optical effects and one or several peripheral optical bands. 3.11 Optical center thickness optical center thickness The thickness at the optical center of the lens.
3.12 geometric center thickness geometrical center thickness Thickness at the geometric center of the lens.
3.13 The radius of curvature in the central area back central optic radius is the radius of curvature of the central optical area of ??the concave surface. 3. 14 Hyperboloid bi-curve
A surface connected by two areas with different curvatures. 3.15 Multi-curve
A surface connected by two or more areas with different curvatures. 3.16 Toric lens
The central optical zone of the convex or concave surface is a toric lens. 3.17 Lens container
Containers used for lens transportation and storage. There are usually two types: sealed and unsealed. The former can keep contact lenses sterile. 4 Product Classification
4.1 According to color, it is divided into two types: colored and uncolored. 4. 2 According to the moisture content, it is divided into three types: ≤49%; >49%～<70%; ≥70%. 4.3 According to the optical center thickness, it is divided into two types: ≤0.07mm and >0.07mm. 5 Technical Requirements
5.1 Material Requirements
5.1.1 Under normal conditions of use, materials must have good biocompatibility with human tissues and body fluids and contain no toxic or harmful substances. 5.1.2 The material should have a uniform and stable refractive index, and its deviation shall not exceed 0.5% of the specified value. 5.1.3 The tensile strength (wet body) of the material should comply with the requirements in Table 1. Table 1 | | tt | 100%. 5.2 Lens size and optical deviation
5.2.1 Lens size deviation must comply with Table 2. >49 %~<70 %
4.5
kg/cm2
≥70 %
4. 0
181
5.2. 2
item
country
brightness radius in central area
total diameter
optical center thickness
GB 11417.2-89|| tt||Table 2
Moisture content two 49%
Tolerance deviation
±0.10 (dry body)
±0.20 (wet body)
± 0.10 (ten bodies)
±0.20 (wet body)
±0.01 (thousand bodies)
±0.02 (wet body)
The optical deviation of the lens must comply with the table 3 regulations. Table 3
item
posterior vertex diopter
0. 00~±0. 50 D
±0. 75~±10, 00 D
±10.25~±20.00D
Prism (measured at the geometric center of the optical zone) Cylindrical photometry
0~~ 2. 00 D
>2. 00 D~ 4. 00 D | | tt | 5.3.1
5.3.2
5.3.3
49%<moisture content<70%
permissible deviation
mm
Moisture content ≥70%
Allowable deviation
±0.25 (wet body)
±0.25 (wet body)Www.bzxZ.net
±0.02 (wet body)
49% moisture content ≥70%
allowable deviation
±0.10D
±0.18D
±0.25D
±0.50||tt| |±0.25D
±0.50D
±0.50D
±5″
The oxygen permeability of the lens (D/t) shall not be less than 20×10-9cm ·mLO2/s-mL·mmHg). The error between the nominal water content and the measured water content shall not be greater than ±2%. 5.3.4
The transmittance of non-tinted soft contact lenses should be greater than 92% (wet body). The lens storage solution should be free of bacteria, irritation and mold. 5.3.5
5.3.6
The lens should not have any mildew spots, rust spots, or any defects in the optical center area, and there should be no defects in other areas. 2.5 Impurities (such as bubbles, streaks, residual particles, foreign inclusions) visible under the magnifying glass. 5.3.7 The mixing transition area of ??the lens should be smooth and regular. 5.3.8 The edge of the lens should be smooth and there should be no inclusions. Defect. 6 Test Methods
6.1 Material Test
6.1.1 Material Toxicity Test: Subcutaneous implantation test of sterile materials on experimental animals, no obvious inflammatory reaction and no rejection reaction, and use of cells The material should be tested by the culture method and there should be no obvious toxic reaction to the cells. 6.1.2 The refractive index of the material: measured with an Abbe meter with an accuracy of not less than 3×10-4. 6.1.3 The tensile strength and elongation of the material: with an accuracy of not less than 3×10-4. Measured by a universal tensile tester below 0.05kg. 6.2 Dimensional inspection of lenses
182
GB 11417.2-89
6.2.1 Radius of curvature in the central area; use sagittal height method or Measured with a curvature meter with an accuracy of 001mm. 6.2.2 Total diameter: measured with a projector not less than 10 times. 6.2.3 Optical center thickness and edge thickness: use a non-contact thickness gauge that meets the deviation requirements or use a non-intrusive thickness gauge. Contact lens surface quality measurement.
6.3 Optical deviation inspection
Use a diopter with an aperture of not less than 4mm, and measure the physical and chemical properties and surface of the lens at room temperature of 20±5C. Quality inspection 6.4.1 Lens fatigue strength test: Keep the lens moist and bend it repeatedly with two fingers (about 90°). It should feel soft and elastic when bent, and the lens should deform until the specified number of times is reached. 6.4.2 Lens oxygen permeability: Measure the D value by polarography and then divide it by the sample thickness. 6.4.3 Lens water content: Determine by weight method (standard physiological saline). 6.4.4 Transmittance: Fix the lens in a sample chamber containing physiological saline (no bubbles are allowed in the sample chamber), and measure the average transmittance of visible light by a spectrophotometer.
6.4.5 Impurities and surface defects (including spots and dots): Check with a magnifying device of not less than 2.5 times under appropriate lighting conditions. Lens preservation solution: Use conventional culture medium culture method to check whether the preservation solution contains bacteria and bacteria. 6.4.6
6.4.7
Lens edge and mixed transition area: Check with the naked eye under appropriate lighting conditions. 7 Inspection rules
7.1 Type test
7.1.1 When designing new products and improving the design and production conditions of old products, type tests must be carried out. 7.1.2 During type inspection, appropriate products are randomly selected from new products as samples and inspected item by item according to the items in the technical requirements. All inspection items must be qualified. Type tests must be carried out when the product storage period exceeds half a year. 7.2 Factory inspection
Products leaving the factory must be inspected in accordance with the provisions of GB2828. The inspection items should comply with Table 4. Table 4
Item
Lens size
Optical deviation
Impurities and surface defects
Mixed transition area
Lens edge
8 Packaging, marking, storage
Corresponding clause
5.2.1
5.2.2
5.3.6
5.3.7
5.3.8
Sampling plan type
Once
Inspection level
AQL
2.5
1.5
8.1 The products must be cleaned and placed in a clean vial or special box (which must be sealable), filled with an appropriate amount of preservation solution and sealed, and then sterilized under high pressure and high temperature (silicone rubber inner cover is recommended). 8.2 One piece (sealed) shall be placed in each bottle (or box), and the center inner curvature radius (or series), diopter D, total diameter, optical center thickness, water content, batch number (or expiration date), factory name and inspection number shall be marked. 8.3 Each bottle (or box) shall be separated in small packages to prevent damage during transportation. 8.4 The outer packaging box shall have appropriate strength, and a box shall contain an appropriate number of items. Each box shall contain a certificate of conformity and instructions for use. 8.5 The factory name, address, product name and corresponding transportation mark shall be marked on the outer packaging box. 8.6 Store in a dry, cool environment without corrosive gases. 183
Basic requirements for wearing
9
GB 11417.2-89
Contact lens manufacturers or sellers must comply with the following five regulations when opening for wearing. If there is any violation, they shall be held accountable. 9.1 The spectacles fitting personnel must be specially trained and have a special training certificate (including mastering the indications and contraindications). 9.2 The sales unit must understand and be familiar with the performance of the product from the production unit before selling. 9.3 Explain the wearing precautions and maintenance methods to the wearer 9.4 Require the wearer to undergo regular eye examinations. 9.5 The sales unit must use a cleaning, disinfecting and preservative solution that meets the hygiene requirements. Additional notes:
This standard is proposed by the Ministry of Light Industry of the People's Republic of China. This standard is under the jurisdiction of the National Glass Pond Porcelain Product Quality Supervision, Inspection and Testing Center. This standard was drafted by the Glass Pond Porcelain Industrial Science Research Institute of the Ministry of Light Industry, Shanghai Glasses Factory No. 2, Beijing Factory No. 608, Shanghai Medical University, and Chongqing Jingyi Optical Glasses Company.
The main drafters of this standard are Zhou Wenquan, Chen Yiyihong, Xi Lijun, Cai Yukun, Zhu Renyuan, and Wang Daonan. GB11417.2-1989 "Soft Hydrophilic Contact Lenses" Amendment No. 1 This amendment has been approved by the State Administration of Technical Supervision on December 10, 1997 in the document No. [1997] 291, and will be implemented on March 1, 1998.
, Delete Article 5.1.3 and Table 1, Article 5.1.4, and Article 6.1.3. 2. Change Article 5.2.2 and the upper part of Table 3 to: 5.2.2 The optical deviation in the lens shall comply with the provisions of Table 3. Table 3
Item
Last item Luminosity
F110.00
10. 00≤IF\,1≤20. 00
F,1>20.00
181
Allowable deviation
±0.25
±0.50
±1.00
(D)
2-1989 & Soft Hydrophilic Contact Lenses" No. 1 revision sheet was approved by the State Bureau of Technical Supervision on December 10, 1997 in the form of Technical Supervision National Standard Letter [1997] No. 291. Since March 1, 1998 Implemented from date.
, delete the contents of 5.1.3 and Table 1, 5.1.4 and 6.1.3. 2. Article 5.2.2 and the upper part of Table 3 are changed to read: 5.2.2 The optical deviation in the lens shall comply with the provisions of Table 3. Table 3
item
item
post-term luminosity
F110.00
10. 00≤IF\,1≤20. 00|| tt||F,1>20.00
181
allowable deviation
±0.25
±0.50
±1.00
(D)
2-1989 & Soft Hydrophilic Contact Lenses" No. 1 revision sheet was approved by the State Bureau of Technical Supervision on December 10, 1997 in the form of Technical Supervision National Standard Letter [1997] No. 291. Since March 1, 1998 Implemented from date.
, delete the contents of 5.1.3 and Table 1, 5.1.4 and 6.1.3. 2. Article 5.2.2 and the upper part of Table 3 are changed to read: 5.2.2 The optical deviation in the lens shall comply with the provisions of Table 3. Table 3
item
item
post-term luminosity
F110.00
10. 00≤IF\,1≤20. 00|| tt||F,1>20.00
181
allowable deviation
±0.25
±0.50
±1.00
(D)
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