GB11417.3-2025

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 11417.3-2025 ist eine kommende verbindliche chinesische Nationalnorm: Ophthalmic optics—Contact lenses—Part 3:Soft contact lenses. Branchencluster: Lebensmittel. Schwerpunkt: Produktsicherheit. Inkrafttreten: 1. Nov. 2028.

Die Anwendbarkeit hängt vom Produktumfang, dem Zertifizierungsweg, Bekanntmachungen der Behörden und Übergangsregeln ab. Fordern Sie eine Übersetzung an oder prüfen Sie die Quelle, bevor Sie diesen Eintrag für Compliance-Entscheidungen nutzen.

Compliance-Überblick

Dieser Überblick ist derzeit nur auf Englisch verfügbar.

Geltungsbereich und Anwendbarkeit

This standard specifies the requirements, labeling, and testing methods for soft contact lenses. It is mandatory for all manufacturers producing soft contact lenses intended for the Chinese market. The standard applies to various types of soft contact lenses, including those with special optical designs or UV absorption features, but excludes rigid contact lenses which are covered under GB 11417.2.

Technische Anforderungen

The standard outlines comprehensive technical requirements across several critical categories. For optical performance, it specifies tolerances for back vertex power, cylinder power, prism, and light transmission properties, including visible light transmittance and UV absorption categories. Manufacturers must ensure strict adherence to these optical tolerances to guarantee product safety. Regarding geometric dimensions, the standard sets limits for base curve radius, total diameter, center thickness, and optic zone diameter. It also details requirements for contact lens materials, encompassing physical properties like refractive index, oxygen permeability, and water content, as well as chemical properties such as extraction limits and preservative uptake/release, referencing GB/T 28539. Furthermore, the standard mandates rigorous biocompatibility evaluation and microbial requirements. Soft contact lenses must be supplied in sterile packaging with a Sterility Assurance Level (SAL) not exceeding 10^-6. Stability testing, including radiation aging, and assessments for intrinsic quality and surface defects are also strictly specified.

Prüfverfahren

Testing methods are primarily referenced in Appendix A of the standard, which lists applicable documents such as GB/T 11417.5 for optical performance, GB/T 11417.6 for mechanical properties, and GB/T 11417.7 for physicochemical properties. Manufacturers must use these specified test methods or provide alternative methods that simulate actual human eye application with sufficient repeatability and reproducibility. Biological evaluation tests are conducted in accordance with GB/T 16886.1.

Häufige Fragen

What products are regulated under GB 11417.3-2025?

GB 11417.3-2025 regulates soft contact lenses, including those with special medical purposes, colored lenses, and UV-absorbing lenses. It does not apply to rigid contact lenses.

Are there any updates from the previous version of GB 11417.3?

Yes, GB 11417.3-2025 replaces GB 11417.3-2012. Key changes include updates to terms, optical performance, geometric dimensions, material requirements, and the deletion of inspection rules.

How does GB 11417.3-2025 relate to ISO standards?

The standard references ISO 14534 and ISO 18369 during its revision. However, it forms a systematic national standard framework specific to the Chinese market, working in conjunction with other parts of the GB 11417 series.

The summary above provides a high-level overview of GB 11417.3-2025. To ensure complete compliance for your soft 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 11417.3-2025 today to access all detailed parameters, tables, and testing procedures.

Hinweise zur Anwendbarkeit

Normtyp: Produkt
CCS: C40
ICS: 11.040.70
Zuständige Behörde: National Medical Products Administration
Technisches Komitee: National Technical Committee on Optics and Photonics of Standardization Administration of China

Normbeziehungen

Ersetzt:GB 11417.3-2012 (Gültig)