GB 11417.2-2025 Ophthalmic optics—Contact lenses—Part 2: Rigid contact lenses English, Anglais, Englisch, Inglés, えいご
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ICS 13.220.01
CCS C 81
National Standard of the People's Republic of China
GB 11417.2-2025
Replaces GB 11417.2-2012
Ophthalmic optics - Contact lenses - Part 2: Rigid contact lenses
眼科光学 接触镜 第2部分：硬性接触镜
Issue date: 2025-10-31 Implementation date: 2026-11-01
Issued by the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China
the Standardization Administration of the People's Republic of China
Contents
Foreword
Introduction
1 Scope
2 Normative References
3 Terms and Definitions
4 Requirements
5 Test Methods
6 Labels, Markings, and Accompanying Documents
Appendix A (Normative) List of Test Method Applicable Documents for Rigid Contact Lenses
References
1 Scope
This document specifies the requirements, labeling, marking, and accompanying documents for rigid contact lenses, and describes the test methods.
This document applies to rigid contact lenses.
2 Normative References
The contents of the following documents constitute essential provisions of this document. For normative references with a specified date, only the version corresponding to that date applies to this document; for normative references without a specified date, the latest version (including all amendments) applies to this document.
GB/T 11417.1: Ophthalmic Optics — Contact Lenses — Part 1: Vocabulary, Classification, and Recommended Marking Specifications
GB/T 11417.4: Ophthalmic Optics — Contact Lenses — Part 4: Standard Salt Solution for Testing
GB/T 11417.5: Ophthalmic Optics — Contact Lenses — Part 5: Optical Performance Test Methods
GB/T 11417.6: Ophthalmic Optics — Contact Lenses — Part 6: Mechanical Performance Test Methods
GB/T 11417.7: Ophthalmic Optics — Contact Lenses — Part 7: Physical and Chemical Performance Test Methods
GB/T 11417.8: Ophthalmic Optics — Contact Lenses — Part 8: Determination of Shelf Life
GB/T 11417.9: Ophthalmic Optics — Contact Lenses — Part 9: In Vitro Test for Ultraviolet and Visible Light Radiation Aging
GB/T 16886.1: Biological Evaluation of Medical Devices — Part 1: Evaluation and Testing Within a Risk Management Process
GB/T 19973.1: Sterilization of Healthcare Products — Microbiological Methods — Part 1: Determination of Total Microbial Count on Products
GB/T 28538: Ophthalmic Optics — Contact Lenses and Contact Lens Care Products — Rabbit Eye Compatibility Study Test
GB/T 28539: Ophthalmic Optics — Contact Lenses and Contact Lens Care Products — Determination of Preservative Intake and Release
YY/T 0466.1: Medical Devices — Symbols for Information Provided by Manufacturers — Part 1: General Requirements
Pharmacopoeia of the People’s Republic of China, Part Four
3 Terms and Definitions
The terms and definitions defined in GB/T 11417.1 apply to this document.
4 Requirements
4.1 General Requirements
In addition to the requirements of 4.2 to 4.8, if the manufacturer explicitly states that there are other special designs or additional performance features, detailed descriptions should be provided, along with applicable requirements and test methods.
4.2 Optical Performance
4.2.1 General Provisions
For contact lenses that do not have optical performance for special medical purposes, if there are clear descriptions in the accompanying documents and markings, the requirements of
4.2.2 to 4.2.4 for optical performance may not apply.
4.2.2 Posterior Vertex Power, Cylinder Power, and Cylinder Axis
The nominal values of the posterior vertex power, cylinder power, and cylinder axis (if any) of the contact lens should be marked on the small - package container. The tolerance of the nominal values should comply with the provisions of Table 1.
Table 1 Requirements for Posterior Vertex Power, Cylinder Power, and Cylinder Axis
4.3 Dimensional Requirements
4.3.2 Microholes, Bevels, and Displacement Dimensions
If there are microholes, bevels, or displacement, their geometric dimensions should be marked on the small - package container. The relative deviation between the measured value and the nominal value should not exceed 10%.
4.3.3 Maximum Deviation of Optical Center
The maximum deviation of the optical center for scleral contact lenses is 0.50 mm.
4.4 Contact Lens Materials
4.4.1 Material Description
The manufacturer should indicate that the contact lens material is classified and marked in accordance with the requirements of GB/T 11417.1, and provide the main chemical molecular structure of the material.
For colored contact lenses, the name, category, and ratio of the dyes or pigments used should be indicated, along with the basis for their safe and reliable application.
4.4.2 Material Physical Performance
4.4.2.1 Refractive Index
The nominal value of the refractive index of the contact lens material should be given in the accompanying documents, with a tolerance of ±0.002.
4.4.2.2 Oxygen Permeability
The nominal value of the oxygen permeability coefficient and the nominal value of the oxygen permeability of typical application contact lenses should be given in the accompanying documents. The relative tolerance of the nominal value of the oxygen permeability coefficient should be ±20%, and the relative tolerance of the nominal value of the oxygen permeability should be -20% (the upper limit is not counted).
4.4.2.3 Material Hardness
The nominal value of the hardness of the contact lens material should be given in the accompanying documents in terms of Shore D hardness, with a tolerance of ±5.
4.4.2.4 Contact Angle
The nominal value of the static contact angle of the contact lens material should be given in the accompanying documents, with a relative tolerance of ±20%.
4.4.2.5 Mechanical Performance
The bending deformation and load at the time of contact lens fracture (if not fractured, the load at 70% deformation can be given), the load at 30% deformation, and the corresponding experimental standard deviation should be given in the accompanying documents, and verified in accordance with the test methods specified in Chapter 5.
4.4.3 Material Chemical Performance
4.4.3.1 Extraction
