GB11417.2-2012
Ophthalmic optics - Contact lenses - Part 2: Rigid contact lenses specification
眼科光学 接触镜 第2部分：硬性接触镜
GB 11417.2-2012 is a current mandatory Chinese national standard for Ophthalmic optics - Contact lenses - Part 2: Rigid contact lenses specification. It appears in the Food compliance cluster with a product safety focus and has an implementation date of Dec 1, 2013.
Applicability depends on product scope, certification route, competent authority notices and transition rules. Requst for the translation or verify source before using this record in a compliance decision.
Compliance overview
Scope and applicability
GB 11417.2-2012 applies to rigid corneal and scleral contact lenses manufactured or sold in the Chinese market. It covers optical, geometric, material, biological, and microbiological requirements for both PMMA and gas-permeable rigid lens materials. This standard is mandatory for all manufacturers of rigid contact lenses entering China. It does not apply to soft contact lenses, which are covered under GB 11417.3.
Technical requirements
The standard specifies optical performance requirements including back vertex power, cylinder power, prism, and light transmittance tolerances, with specific limits for visible light transmittance (minimum 85%) and UV absorption categories. Geometric dimensions such as base curve radius, total diameter, center thickness, and optic zone diameter must meet defined tolerances varying by material type (PMMA vs. gas-permeable) and lens type (corneal vs. scleral). Material requirements cover refractive index, oxygen permeability (Dk and Dk/t), Shore D hardness, contact angle, and mechanical properties including bending deformation and load force at break. Chemical performance requirements include extraction testing, preservative uptake/release for new materials, and fading tests for cosmetic tinted lenses. Biocompatibility evaluation is mandatory, encompassing acute systemic toxicity, eye irritation, cytotoxicity, and for new materials, skin sensitization and rabbit eye compatibility studies. Microbiological requirements specify bioburden limits for non-sterile packaging (below 100 CFU/lens) and SAL of 10⁻⁶ for sterile packaging. Stability requirements include radiation aging and shelf-life determination.
Testing methods
Testing methods reference the GB/T 11417 series (Parts 4–9) for standard saline solution preparation, optical performance, mechanical performance, physicochemical properties, shelf-life determination, and UV/visible light radiation aging. Biological evaluation tests follow GB/T 16886 series (Parts 5, 10, 11) for cytotoxicity, irritation, sensitization, and systemic toxicity. Microbiological testing follows GB/T 19973.1 and the Chinese Pharmacopoeia. Sampling for type testing follows GB/T 2829-2002 using single sampling plans at discrimination level II with RQL of 15.
FAQs
What products are regulated under GB 11417.2-2012?
GB 11417.2-2012 regulates rigid corneal and scleral contact lenses, including both PMMA and gas-permeable rigid lens materials. It covers optical, geometric, material, biological, and microbiological requirements. Soft contact lenses are covered separately under GB 11417.3.
Are there any updates from the previous version of GB 11417.2-2012?
Yes, GB 11417.2-2012 replaced GB 11417.1-1989 and its 1997 amendment. Key changes include modified requirements for biocompatibility, refractive index, optical deviations, geometric dimensions, and surface defects. Requirements for stress and lens shape were deleted, while UV spectral performance, oxygen permeability, mechanical properties, and microbiological requirements were added. A modification sheet issued in July 2022 further updated references for preservative testing, skin sensitization sample preparation, and radiation aging compliance criteria.
How does GB 11417.2-2012 relate to international standards?
GB 11417.2-2012 was drafted with reference to ISO 14534:2002 (fundamental requirements for contact lenses), ISO 18369:2006 (ophthalmic optics – contact lenses), and ANSI Z80.20. While aligned with international frameworks, it contains China-specific mandatory provisions that differ in certain tolerance limits and testing protocols.
The summary above provides a high-level overview of GB 11417.2-2012. To ensure complete compliance for your rigid contact lenses entering the Chinese market, a precise and professional translation of the full technical specifications is essential. Purchase our high-quality English translation of GB 11417.2-2012 today to access all detailed tolerance tables, testing procedures, and regulatory requirements.
Applicability hints
- Type
- Product
- CCS
- C40
- ICS
- 11.040.70
- Competent department
- National Medical Products Administration
- Technical committee
- National Medical Products Administration