GB 11417.2-2025 English PDF

GB 11417.2: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB 11417.2-2025	RFQ	ASK	3 days	Ophthalmic optics - Contact lenses - Part 2: Rigid contact lenses
GB 11417.2-2012	70	Add to Cart	Auto, < 3 mins	Ophthalmic optics -- Contact lenses -- Part 2: Rigid contact lenses specification	Valid
GB 11417.2-1989	239	Add to Cart	2 days	Soft hydrophilic contact lenses	Obsolete

Basic data

Standard ID: GB 11417.2-2025 (GB11417.2-2025)
Description (Translated English): Ophthalmic optics - Contact lenses - Part 2: Rigid contact lenses
Sector / Industry: National Standard
Classification of Chinese Standard: C40
Classification of International Standard: 11.040.70
Date of Issue: 2025-10-31
Date of Implementation: 2028-11-01
Older Standard (superseded by this standard): GB 11417.2-2012

GB 11417.2-2012: Ophthalmic optics -- Contact lenses -- Part 2: Rigid contact lenses specification

---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 - Contact lenses - Part 2. Rigid contact lenses specification ICS 11.040.70 C40 National Standards of People's Republic of China Replacing GB 11417.1-1989 Ophthalmic optics Contact lenses Part 2. rigid contact lenses Part 2. Rigidcontactlensesspecification Issued on. 2012-12-31 2013-12-01 implementation Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China Standardization Administration of China released

Foreword

This section 4.3.3.2,4.7.1 are recommended, the rest are mandatory. "Optics - Contact lenses" and GB/T 28539 "Ophthalmic optics - Contact lenses and contact lens care products preservative uptake and release Guidelines for determination of discharge "and GB/T 28538" Ophthalmic optics - Contact lenses and contact lens care products rabbit eye test compatibility of "common structure Contact lens into the national standards. "Optics - Contact lenses" is divided into nine sections. --- Part 1. Vocabulary, classification and identification of recommended specifications; (GB/T 11417.1) --- Part 2. rigid contact lenses; (GB 11417.2) --- Part 3. soft contact lenses; (GB 11417.3) --- Part 4. Test standard salt solution; (GB/T 11417.4) --- Part 5. Test methods for optical properties; (GB/T 11417.5) --- Part 6. Mechanical test methods; (GB/T 11417.6) --- Part 7. Test methods for physical and chemical properties; (GB/T 11417.7) --- Part 8. determination of validity; (GB/T 11417.8) --- Part 9. ultraviolet and visible radiation aging test (in vitro method); (GB/T 11417.9) This is Part 2. This section Press GB/T 1.1-2009 given rule drafting. This Part replaces GB 11417.1-1989 "hard contact lenses" and the 1997 No. 1 amendments. In addition to editorial changes, the technical content of this section and change GB 11417.1-1989 and 1997 No. 1 amendments as follows. --- Modified biocompatibility, refractive index, optical bias, geometry, surface impurities and defects, pores, edge shape of the material, light Transmittance spectral transmittance requirements; --- Revised test methods (Chapter 6); --- Modify the sampling and inspection rules (Chapter 7); --- Modify the content of the tag (Chapter 8); --- Remove the stress, the lens shape requirements; --- Remove the wear requirements (Chapter 9); --- Supplementary performance over the UV spectrum, oxygen content and oxygen permeability coefficient, mechanical properties, physical and chemical materials, microbiological, stability Claim. This section uses redrafted reference method ISO 14534.2002 "Ophthalmic optics - Contact lenses and contact lens care products basic requirements" ISO 18369.2006 "Ophthalmic optics - Contact lenses" and ANSIZ80.20 "ophthalmic contact lens standard terminology, tolerance, and physical measurement methods Physical and Chemical Characteristics "establishment. Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents. This part is proposed by the State Food and Drug Administration. This part of the National Optics and Photonics Standardization Technical Committee medical optical instruments and Technical Committee (SAC/TC103/SC1) Centralized. This section drafted by. State Food and Drug Administration Hangzhou Medical Device Quality Supervision and Inspection Center, Zhejiang Medical Devices Unit The inspection. The main drafters of this part. He Tao, JIA Xiao Hang, Wen Yan, Ma Li, JIANG Xiao Road, flowers Chen, Zheng, Qi Weiming, Li Jiazhong, Chen Jingyun. This part of the standard replaces the previous editions. --- GB 11417.1-1989 No. 1 of 1997 and amendments. Ophthalmic optics Contact lenses Part 2. rigid contact lenses

1 Scope

GB 11417 provisions of this part of the rigid contact lens (hereinafter referred to as. contact lens) the scope, terms and definitions, requirements, test methods, pumping Sampling and inspection rules, labeling, marking and accompanying information requirements. This section applies to rigid corneal and scleral contact lenses.

2 Normative references

The following documents for the application of this document is essential. For cited documents with dates, only the dated edition applies to this document. For undated references, the latest edition (including any amendments) applies to this document. GB/T 2829-2002 periodic inspection Sampling procedures and tables (suitable for process stability test) GB/T 3978-2008 standard and illumination geometry GB/T 5702-2003 light color evaluation method GB/T 11417.1-2012 Ophthalmic optics - Contact lenses - Part 1. Vocabulary, classification and identification specifications recommended GB/T 16886.5 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity tests GB/T 16886.10 Biological evaluation of medical devices - Part 10. irritation and delayed-type hypersensitivity test GB/T 16886.11 Biological evaluation of medical devices - Part 11. Tests for systemic toxicity GB /sterilization Microbiological methods - Part 1 T 19973.1 medical equipment. the total number of microorganisms on the product estimate YY/T 0297 Medical Device Clinical Investigation YY/T 0316 Medical Devices Risk Management for Medical Device Applications Symbols - Part 1 YY/T 0466.1 medical equipment used with medical device labels, labeling and information. General requirements People's Republic of China Pharmacopoeia 2010 edition two

3 Terms and Definitions

Terms and definitions GB/T 11417.1-2012 defined apply to this document.

4 Requirements

4.1 General Safety and performance of contact lenses should be evaluated by preclinical and clinical evaluation, including in accordance with YY/T 0316 carried out appropriate risk analysis. In addition to the following requirements, if the manufacturer declares that there are other additional properties, it should give a detailed description and to provide requirements and test methods apply. 4.2 Optical Performance 4.2.1 General Contact lenses for special medical purposes without having optical properties, if the accompanying information and logo clearly described to the following optical properties Seeking may apply. 4.2.2 back vertex power, cylinder power and cylinder axis position Contact lenses after vertex, prescription cylinder power and cylinder axis position (if any), the nominal value should be in small containers on the label, the nominal value Tolerance should meet the requirements of Table 1. Table 1 back vertex power, cylinder power and cylinder axis position Project Name Tolerance After the vertex F'V | F'V | ≤5.00D ± 0.12D 5.00D < | F'V | ≤10.00D ± 0.18D 10.00D < | F'V | ≤15.00D ± 0.25D 15.00D < | F'V | ≤20.00D ± 0.37D | F'V | > 20.00D ± 0.50D Prescription cylinder power F'C | F'C | ≤2.00D ± 0.25D 2.00D < | F'C | ≤4.00D ± 0.37D | F'C | > 4.00D ± 0.50D Cylinder axial ± 5 ° 4.2.3 prism Design of prescription contact lenses, prisms of the nominal value should be on the label of small containers, prescription prism design values of tolerance and non-nominal The residue prism prism design tolerances shall comply with the provisions of Table 2. Table 2 prism Project Name Tolerance Prism residuals | F'V | ≤6.00D ± 0.25cm/m | F'V | > 6.00D ± 0.50cm/m Prescription prism - ± 0.25cm/m 4.2.4 The maximum deviation of the optical center Scleral contact lens, the optical center of the maximum deviation of 0.50mm. 4.2.5 light transmission properties 4.2.5.1 General Contact lens transmittance in the visible region, ultraviolet color vision requirements and requirements shall comply with the following provisions. If contact lenses are used for special medical purposes Light transmission properties have special requirements, shall be given in the accompanying detailed description of the information and provide the applicable requirements and test methods. 4.2.5.2 visible region requirements Contact lens optical transmittance and color vision should meet the requirements. Under a) the light transmittance state model eye τV should be separately measured in standard illuminant D65 and A, the result should be not less than 85%; b) After the optical zone should be wearing glasses tinted contact lenses color vision meets daily to analyze and evaluate the application. Analysis and evaluation of the impact of color vision Price may be in line with spectrum illumination and CIE illuminant D Planck blackbody radiation through the CRI down after contact lens Low volume analysis method, and to evaluate the practical application. Correlated color temperature of illumination should be selected to characterize the actual application, at least the choice of high, Medium, and low color temperature of the lighting body and record the selected correlated color temperature and illumination. Note 1. The light is transmitted through simulations using state means that the optical path through the air - Lens - salt solution interface to simulate the air - Lens - tear layer interface Reflected light loss, this time to calculate the refractive index of salt solution to take 1.336. Note 2. The color perception Impact Analysis chosen lighting body recommended GB/T 3978-2008 specified standard illuminant A, illuminant D50 and D75. Note 3. The color rendering index calculation can be found in GB/T 5702-2003. If the area claimed that the optical spectral transmission colored contact lenses have a special application purposes, not for the light transmittance and (or) color vision Requirements, manufacturers respond after wearing glasses, as the brightness and (or) depending on the color vision in the application of safety and efficacy evaluation, including follow Risk analysis YY/T 0316, and suitable for clinical evaluation conducted in accordance with the relevant provisions of YY/T 0297 carried out. 4.2.5.3 ultraviolet requirements For UV absorption type contact lens, the UV absorbing category shall be given in the accompanying data, the nominal value shall conform to Table 3. Note. Nominal ultraviolet absorbing contact lenses should be marked belong "UV absorption type 1" or "UV absorption type 2." Table 3 transmittance requirements Project Title Requirements UV spectrum The average transmittance τUVR UV-A segment transmittance τUVA Wavelength range 316nm ~ 380nm UV-B segment transmittance τUVB Wavelength range 280nm ~ 315nm Class 1 UV absorbing contact lens τUVA < 0.10τ (λV) Class 2 UV absorbing contact lens τUVA < 0.50τ (λV) Class 1 UV absorbing contact lens τUVB < 0.01τ (λV) Class 2 UV absorbing contact lens τUVB < 0.05τ (λV) 4.3 geometry requirements 4.3.1 Lens Size Vector-based arc radius or diameter of the bottom is high, the total sagittal diameter, center thickness and optical zone diameter of the contact lens base curve radius or diameter of the bottom is high, the total direct Diameter, center thickness and optical zone diameter nominal value shall be marked on the label of small containers; labeling method should be consistent with the geometric parameters GB/T 11417.1-2012 requirements, tolerances should meet the requirements of Table 4. Table 4 millimeters geometry requirements Geometric parameters of the project name Tolerance Contact Lens PMMA breathable material Scleral contact lenses Base curve radius (BC) ± 0.025 ± 0.05 ± 0.10 After the ring surface optics The radius of curvature of the region a, b 0 < Δr≤0.2 ± 0.025 ± 0.05 ± 0.12 0.2 < Δr≤0.4 ± 0.035 ± 0.06 ± 0.13 0.4 < Δr≤0.6 ± 0.055 ± 0.07 ± 0.15 Δr > 0.6 ± 0.075 ± 0.09 ± 0.17 Table 4 (Continued) millimeters Geometric parameters of the project name Tolerance Contact Lens PMMA breathable material Scleral contact lenses Optical zone diameter c ± 0.20 ± 0.20 ± 0.20 Posterior radius of curvature (Only preformed lens) - - ± 0.10 The basic optical zone diameter - - ± 0.20 Front or rear arc radius of curvature c (When measurable) ± 0.10 ± 0.10 ± 0.10 Behind the arc diameter c ± 0.20 ± 0.20 ± 0.20 (Only preformed lens) The total diameter b ± 0.10 ± 0.10 ± 0.25 Front optical zone diameter c ± 0.20 ± 0.20 ± 0.20 Bifocal high vector -0.10 0.20 -0.10 0.20 -0.10 0.20 Central thickness ± 0.02 ± 0.02 ± 0.10 Vertex gap (only molded scleral lens) - - ± 0.02 aΔr as the difference between the radius of curvature of the two principal meridian. b tolerance applies to each principal meridian. c tolerance only applies to spherical lenses and curved obvious, does not apply to the measurement difficulties finished lenses and contact lens having a mixed transition region. 4.3.2 porous, trimming, displacement size If porous, trimming, displacement, its geometry should be indicated on the label of small containers, and actual measured value and the nominal value shall not be greater than 10% of the nominal value. 4.4 Material 4.4.1 presentation material The manufacturer shall indicate the contact lens material according to GB/T 11417.1-2012 classification and labeling requirements, and gives the name and the main material of Learn molecular structure. For beauty class color or darker colored contact lenses shall indicate the name of the class of dye used, and the ratio of the category, but also gives its application security and reliability Basis. 4.4.2 The physical properties of materials 4.4.2.1 refractive index The nominal value of the refractive index of the contact lens in the accompanying information should be given, the nominal value of the valid bit effective number of bits should be consistent with tolerance, tolerance of ± 0.002. 4.4.2.2 oxygen permeability Contact lens oxygen permeability coefficient and the back vertex power of -3.00D lenses or typical applications the amount of oxygen in the nominal value shall be given in the accompanying profile. Oxygen permeability coefficient relative tolerance should be ± 20%, the amount of oxygen should not be less than 20% of the nominal value. 4.4.2.3 Hardness The nominal value of the contact lens material hardness should be Shore hardness (ShoreD) are given in the accompanying information, tolerance should be ± 5. 4.4.2.4 Contact Angle Contact lens material static contact angle of the nominal value should be given in the accompanying information, tolerance should be ± 20%. 4.4.2.5 Mechanical Properties Manufacturers should be given in the accompanying information contact lenses and curved variable load force at break, strength and deformation load of 30%, and through Verified through testing. 4.4.3 chemical properties of materials 4.4.3.1 extraction test Results finished contact lens material according to GB/T 11417.7-2012 extracted extraction rate should not exceed the manufacturer's. Note. The extraction rate is given by the manufacturer have been evaluated by the biological material determined. 4.4.3.2 preservative uptake and release For new materials never used, the test should be measured preservative uptake and release. Contact lenses containing preservative and applicable Contact lens preservative uptake and release test results of care products, are described in the accompanying profile. 4.4.3.3 fade test For beauty class color class or enhanced coloring contact lenses should fade test. 4.5 Biocompatibility 4.5.1 General Contact lenses should be finished by the biological evaluation to demonstrate that it has good biocompatibility. Biological Evaluation consideration 4.5.2,4.5.3, Biological test results 4.5.4. Never used for new materials, skin sensitization test should be carried out 4.5.5 and 4.5.6 compatibility rabbit eyes Research trials. Note. The above new materials specifically refers to a contact lens host material. 4.5.2 acute systemic toxicity test Preparation of test solution. Press 6cm2/mL (sample surface area to extraction medium volume ratio) ratio of extraction, extraction medium was 0.9% Vegetable oil and sodium chloride injection, extraction temperature and time is preferably (37 ± 1) ℃, 72h. Test method according to GB/T 16886.11 specified, the result shall be no acute systemic toxicity. 4.5.3 acute eye irritation test 4.5.2 Preparation of test solution in accordance with the provisions in accordance with the test method GB/T 16886.10 specified, the result shall be no eye sting Shock resistance. 4.5.4 Cytotoxicity test Contact lens according to the agar diffusion test method GB/T 16886.5 specified in (final agar concentration of not more than 1.5g/L), the results should be No cytotoxicity. 4.5.5 Skin sensitization test 4.5.1 Preparation of test solution in accordance with the provisions of the method according to GB/T 16886.10 specified in test results should be no skin sensitization reaction. 4.5.6 Compatibility of the rabbit eye test Rabbit eyes and contact lens compatibility should be good. 4.6 Microbiological requirements Contact lenses can be sterile and non-sterile packaging supply packaging supply. Contact lens use non-sterile packaging supply, bioburden within the validity period should be less than 100CFU/piece. When the supply of contact lenses using aseptic packaging, sterility assurance level (SAL) should be less than 10-6. Aseptic packaging should have adequate protection in the positive Under storage, transport and handling of normal, before aseptic packaging opened or damaged, you should be able to maintain sterility. The above requirements may be tested in accordance with GB/T 19973.1 method and the "two People's Republic of China Pharmacopoeia 2010 Edition" requirements. 4.7 Stability 4.7.1 radiation aging test Finished contact lens material after being subjected to ultraviolet and visible radiation aging test, should be able to maintain a stable performance, to meet the requirements of 4.1,4.3. 4.7.2 Validity Contact lens manufacturer shall perform stability tests to determine the storage period and should be identified in a small package. 4.8 inherent quality and surface defects 4.8.1 impurities and surface flaws By 7 to 10 times lower magnifying glass, contact lenses should be no internal flaws and surface impurities affect the normal use. Interior miscellaneous materials There are quality. bubbles, stripes, residue; Surface defects. cracks, scratches and edge gaps, roughened. 4.8.2 micropores By 7 to 10 times lower magnifying glass, pore former, the latter edge shape should be consistent with the manufacturer's description. 4.8.3 edge profile By 7 to 10 times under a magnifying glass, the edge of the contact lens should be smooth and clean, its shape should be described by the manufacturer's quality characteristics Match.

5 Test methods

Chapter 4 of this standard to all the requirements of the criteria listed in A test can be performed to detect or appendix. Appendix A suitable method marked No Time, the manufacturer shall provide a suitable method. Detection or test methods provided should be considered as an analog of the human eye practical applications, including treatment (E.g. in a standard balanced salt solution). Reproducibility of detection methods, should be better than half the prescribed tolerance limits.

6 sampling and inspection rules

6.1 factory inspection Factory inspection rules determined by the manufacturer. 6.2 Type tests Type test type test is divided into general and special type testing, see Table 5. Table 5 Type Test Category Classification applicable test conditions reg General Type tests Continuous production......

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