GB 11417.2-2025Ophthalmic optics - Contact lenses - Part 2: Rigid contact lenses (English PDF)

Foreword

GB(/T) 11417 Ophthalmic optics - Contact lenses is divided into the following parts. -- Part

1.Vocabulary, classification and recommendations for labelling specifications. The purpose is to define the terms and definitions for contact lenses. -- Part

2.Rigid contact lenses. The purpose is to specify the performance requirements for rigid contact lenses. -- Part

3.Soft contact lenses. The purpose is to specify the performance requirements for soft contact lenses. -- Part

4.Saline solution for contact lens testing. The purpose is to specify the requirements for standard saline solutions used in contact lens testing. -- Part

5.Testing methods for optical properties. The purpose is to specify the test methods for the optical properties of contact lenses. -- Part

6.Mechanical properties test methods. The purpose is to specify the test methods for the mechanical properties of contact lenses. -- Part

7.Physicochemical properties test methods. The purpose is to specify the test methods for the physical and chemical properties of contact lens materials. -- Part

8.Determination of shelf-life. The purpose is to specify the testing procedures for the stability of contact lenses during storage. -- Part

9.Ageing by exposure to UV and visible radiation (in vitro method). The purpose is to specify the in vitro test method for aging contact lenses under simulated sunlight irradiation. This document and GB 11417.3 are the core product standards in the field of contact lenses, and other related standards revolve around and serve these two core standards. Although relevant contact lens standards exist internationally, their framework and requirements have not yet formed a systematic standard system. This document references ISO 14534, ISO 18369, and ANSI Z80.20.During the revision process, the key clauses of the standards underwent thorough research and technical verification, striving to ensure that the revised standards can more effectively support market supervision, guide the high-quality development of the industry, promote technological progress, and protect public safety in the use of medical devices. Ophthalmic optics - Contact lenses - Part

1 Scope

Part 2 of China's mandatory national standard for contact lenses, covering rigid lenses. A rigid gas-permeable lens is a small piece of precisely figured polymer that floats on the tear film and does not follow the shape of the cornea - which is exactly why it is prescribed: it replaces the corneal surface with its own optical surface, and so corrects astigmatism and keratoconus that no soft lens can. Its performance depends on properties that must be specified and verified: the back optic zone radius that determines how it fits, the total diameter and edge form that decide whether it is tolerable to wear, the optical power and its tolerance, and above all the oxygen permeability, since the cornea has no blood supply and takes its oxygen from the air through the tear film. A lens too impermeable produces corneal oedema. This part specifies the requirements and test methods for rigid lenses.

This document specifies the requirements, labeling, marking, and accompanying documentation for rigid contact lenses, and describes the test methods. This document applies to rigid contact lenses.

2 Normative references

The provisions of the following documents constitute the essential clauses of this document through normative references in this text. Among them, for any dated reference, only the version corresponding to that date applies to this document; for any undated reference, the latest version (including all amendments) applies to this document.

GB/T 11417.1 Ophthalmic optics - Contact lenses - Part

3 Terms and definitions

The terms and definitions defined in GB/T 11417.1 apply to this document.

4 Requirements

4.1 General requirements In addition to the requirements in 4.2~4.8, if the manufacturer expressly indicates any other special design or additional performance, a detailed description shall be provided, along with applicable requirements and test methods.

5 Testing methods for optical properties

GB/T 11417.6 Ophthalmic optics - Contact lenses - Part

6 Mechanical properties test methods

GB/T 11417.7 Ophthalmic optics - Contact lenses - Part

7 Physicochemical properties test methods

GB/T 11417.8 Ophthalmic optics - Contact lenses - Part

8 Determination of shelf- life

GB/T 11417.9 Ophthalmic optics - Contact lenses - Part

9 Ageing by exposure to UV and visible radiation (in vitro method)

GB/T 16886.1 Biological evaluation of medical devices - Part