GB 11417.3-2025 Ophthalmic optics—Contact lenses—Part 3:Soft 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 11417.3-2025
Replaces GB 11417.3-2012
Ophthalmic optics - Contact lenses - Part 3: Soft contact lenses
眼科光学 接触镜 第3部分：软性接触镜
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 soft contact lenses, and describes the test methods.
This document applies to soft 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 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
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 in the air state should be marked on the sterile - 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 Optical Zone Diameter
The optical zone diameter of the contact lens should not be less than 7.0 mm. If this requirement is not met, the manufacturer should explain in the accompanying documents and provide corresponding risk warnings.
Note: This clause only applies to contact lenses that are visibly colored or uncolored.
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.
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 should be given in the accompanying documents, with a tolerance of ±0.005.
If the refractive index tolerance does not apply, the manufacturer should provide evidence of the safety and effectiveness of the contact lens application, including risk assessment.
4.4.2.2 Oxygen Permeability
The nominal value of the oxygen permeability coefficient and the oxygen permeability of the contact lens with a posterior vertex power of -3.00D or 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 Fading Test
For enhanced - colored contact lenses, a fading test should be conducted, and there should be no fading of the lens before and after the test.
4.4.2.4 Water Content
The nominal value of the water content of the contact lens should be marked on the minimum sales unit, with an absolute tolerance of ±2%.
4.4.3 Material Chemical Performance
4.4.3.1 Extraction
An extraction test should be conducted on the contact lens, and the result should not exceed the extraction rate given by the manufacturer.
Note: The extraction rate given by the manufacturer is determined by materials that have passed biological evaluation.
