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 は現行の中国強制国家規格です：Ophthalmic optics - Contact lenses - Part 3：Soft contact lenses。業界：食品。テーマ：製品安全。施行日：2013年12月1日。

適用可否は製品範囲、認証ルート、所管当局の通知、移行規定によって異なります。コンプライアンス判断に使う前に、翻訳をご依頼いただくか公式情報源をご確認ください。

コンプライアンス概要

この概要は現在英語のみで提供しています。

適用範囲

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.

技術要求

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.

試験方法

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.

よくある質問

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.

適用のヒント

種別: 製品
CCS: C40
ICS: 11.040.70
所管部門: National Medical Products Administration
技術委員会: National Medical Products Administration