GB11417.2-2025

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

GB 11417.2-2025 est une norme nationale chinoise obligatoire à venir : Ophthalmic optics—Contact lenses—Part 2: Rigid contact lenses. Secteur : Alimentation. Thème principal : Sécurité des produits. Entrée en vigueur : 1 nov. 2028.

L’applicabilité dépend du périmètre du produit, de la voie de certification, des avis des autorités et des règles de transition. Demandez une traduction ou vérifiez la source avant d’utiliser cette fiche pour une décision de conformité.

Aperçu de conformité

Cet aperçu n’est actuellement disponible qu’en anglais.

Champ d’application

This standard applies to rigid contact lenses used in ophthalmic optics, including corneal and scleral lenses made of materials like PMMA and gas-permeable materials. It is mandatory for all manufacturers producing rigid contact lenses for the Chinese market. It does not apply to soft contact lenses, which are covered under a separate standard.

Exigences techniques

The standard specifies comprehensive optical performance requirements, including tolerances for back vertex power, cylinder power, and prism. It also regulates light transmission properties, setting limits for visible light transmittance and ultraviolet (UV) absorption categories. Manufacturers must clearly label nominal values on the primary packaging. Geometric dimensions such as base curve radius, total diameter, and center thickness are strictly regulated with specific tolerances for different lens types. The standard also outlines requirements for material properties, including refractive index, oxygen permeability, hardness, and mechanical performance under stress. Furthermore, the standard mandates biocompatibility evaluation and microbial requirements. For sterile packaging, a Sterility Assurance Level (SAL) must be maintained, while non-sterile lenses have bioburden limits. Stability testing, including radiation aging, is required to determine the expiration date.

Méthodes d’essai

Testing methods are referenced from the GB/T 11417 series, including GB/T 11417.5 for optical performance, GB/T 11417.6 for mechanical properties, and GB/T 11417.7 for physicochemical properties. Biocompatibility tests follow GB/T 16886.1, and sterility tests are conducted according to GB/T 19973.1. Visual inspection for surface defects requires a 7x to 10x magnifier.

Questions fréquentes

What products are regulated under GB 11417.2-2025?

GB 11417.2-2025 regulates rigid contact lenses, including corneal and scleral lenses made of PMMA or gas-permeable materials. It does not apply to soft contact lenses.

Are there any updates from the previous version of GB 11417.2?

Yes, this version replaces GB 11417.2-2012. Key updates include changes to optical performance, geometric dimensions, and the deletion of sampling and inspection rules. Manufacturers must review the updated tolerances and labeling requirements.

How does GB 11417.2-2025 differ from ISO standards?

While the standard references ISO 14534 and ISO 18369, it forms a systematic framework specific to the Chinese market. Compliance with GB 11417.2-2025 is mandatory for market access in China.

The summary above provides a high-level overview of GB 11417.2-2025. 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 11417.2-2025 today to access all detailed parameters, tables, and testing procedures.

Indications d’applicabilité

Type: Produit
CCS: C40
ICS: 11.040.70
Autorité compétente: National Medical Products Administration
Comité technique: National Technical Committee on Optics and Photonics of Standardization Administration of China

Relations

Remplace:GB 11417.2-2012 (En vigueur)