GB11417.3-2012
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
GB 11417.3-2012 is a current mandatory Chinese national standard for Ophthalmic optics - Contact lenses - Part 3：Soft contact lenses. 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
This standard applies to soft contact lenses intended for the Chinese market. It establishes the terminology, requirements, and testing rules for these ophthalmic devices. Manufacturers of soft contact lenses, including multifocal and cosmetic colored lenses, must comply with this mandatory standard for market access. It does not apply to rigid contact lenses, which are covered under a separate standard.
Technical requirements
This standard specifies comprehensive requirements for finished soft contact lenses. For optical performance, it mandates tolerances for back vertex power, cylinder power, axis, and prism. It also sets strict limits on light transmittance and color vision impact, including specific requirements for UV-absorbing lenses categorized as Class 1 or Class 2. Regarding geometric dimensions, the standard defines tolerances for base curve radius, total diameter, and center thickness, with specific variations based on the lens water content. The material requirements cover physical properties such as refractive index, water content, and oxygen permeability, alongside chemical performance criteria like extraction limits and preservative uptake. Furthermore, the standard enforces rigorous biocompatibility testing. Finished lenses must undergo biological evaluation, including acute systemic toxicity, eye irritation, and cytotoxicity tests. For new materials, additional skin sensitization and rabbit eye compatibility studies are mandatory. It also sets microbial requirements, requiring a Sterility Assurance Level (SAL) of 10^-6, and mandates stability testing including radiation aging.
Testing methods
Testing procedures are primarily referenced in the appendices, utilizing related standards such as GB/T 11417.5 for optical performance and GB/T 11417.7 for physicochemical properties. Key evaluations include radiation aging tests for stability, agar diffusion tests for cytotoxicity, and specialized spectral analysis for transmittance and color vision impact. Manufacturers must ensure that test method reproducibility is better than half of the specified tolerance limit.
FAQs
What products are regulated under GB 11417.3-2012?
This standard applies specifically to soft contact lenses. It covers optical, geometric, material, and biological requirements for finished soft lens products, excluding rigid contact lenses which are covered under GB 11417.2.
Is GB 11417.3-2012 a mandatory standard?
Yes, this standard is mandatory for soft contact lenses. It replaces the older GB 11417.2-1989 and introduces updated requirements for optical performance, material characterization, stability, and biocompatibility.
How does GB 11417.3-2012 relate to ISO standards?
The standard was drafted by referencing ISO 14534:2002 and the ISO 18369:2006 series. However, manufacturers must comply with the specific GB testing methods and tolerance limits outlined in this document for market access in China, which may differ slightly from international ISO parameters.
The summary above provides a high-level overview of GB 11417.3-2012. To ensure complete compliance for your products entering the Chinese market, a precise and professional translation of the full technical specifications is essential. Purchase our high-quality English translation of GB 11417.3-2012 today to access all detailed parameters, tolerance tables, and testing procedures.
Applicability hints
- Type
- Product
- CCS
- C40
- ICS
- 11.040.70
- Competent department
- National Medical Products Administration
- Technical committee
- National Medical Products Administration