GB 11417.2-2012Ophthalmic optics - Contact lenses - Part 2: Rigid contact lenses specification (English PDF)

3 Terms and definitions

4 Requirements

5 Test methods

6 Sampling and inspection rules

Foreword

In this part, 4.3.3.2 and 4.7.1 are recommendatory; the rest is mandatory.

Ophthalmic optics - Contact lenses, together with GB/T 28539 Ophthalmic optics - Contact lenses and contact lens care products - Guidelines for determination of preservative uptake and release, and GB/T 28538 Ophthalmic optics - Contact lenses and contact lens care products - Study of ocular compatibility with rabbit eyes, constitutes the series of national standards for contact lenses.

Ophthalmic optics - Contact lenses is divided into the following 9 parts:

- Part 1: Vocabulary, classification system and recommendations for labelling specifications (GB/T 11417.1);

- Part 2: Rigid contact lenses (GB 11417.2);

- Part 3: Soft contact lenses (GB 11417.3);

- Part 4: Standard saline solution for testing (GB/T 11417.4);

- Part 5: Test methods for optical properties (GB/T 11417.5);

- Part 6: Test methods for mechanical properties (GB/T 11417.6);

- Part 7: Test methods for physical and chemical properties (GB/T 11417.7);

- Part 8: Determination of shelf life (GB/T 11417.8);

- Part 9: Ultraviolet and visible radiation ageing test (in vitro method) (GB/T 11417.9).

This part is Part 2.

This part is drafted in accordance with the rules given in GB/T 1.1-2009.

This part replaces GB 11417.1-1989 Rigid corneal contact lenses and its Amendment No. 1 of 1997.

Apart from editorial changes, the technical changes of this part with respect to GB 11417.1-1989 and its Amendment No. 1 of 1997 are as follows:

- the requirements for biocompatibility of the material, refractive index, optical deviation, geometrical dimensions, inclusions and surface defects, fenestrations, edge shape, and luminous transmittance and spectral transmittance have been modified;

- the test methods (Clause 6) have been modified;

- the sampling and inspection rules (Clause 7) have been modified;

- the content of the marking (Clause 8) has been modified;

- the requirements for stress and lens shape have been deleted;

- the fitting requirements (Clause 9) have been deleted;

- requirements for ultraviolet spectral transmittance, oxygen transmissibility and oxygen permeability, mechanical properties, physical and chemical properties of the material, microbiology and stability have been added.

This part has been prepared by redrafting with reference to ISO 14534:2002 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements, ISO 18369:2006 Ophthalmic optics - Contact lenses, and ANSI Z80.20 Ophthalmics - Contact lenses - Standard terminology, tolerances, measurements and physicochemical properties.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing bodies of this document shall not be held responsible for identifying any or all such patent rights.

This part was proposed by the State Food and Drug Administration.

This part is under the jurisdiction of the Medical Optics and Instruments Subcommittee of the National Technical Committee on Optics and Photonics of Standardization Administration of China (SAC/TC 103/SC 1).

Drafting organisations of this part: Hangzhou Medical Device Quality Supervision and Inspection Center of the State Food and Drug Administration; Zhejiang Institute of Medical Device Testing.

Principal drafters of this part: He Tao, Jia Xiaohang, Wen Yan, Ma Li, Jiang Xiaolu, Chen Xianhua, Zheng Jian, Qi Weiming, Li Jiazhong, Chen Jingyun.

Previous editions of the standard replaced by this part:

- GB 11417.1-1989 and its Amendment No. 1 of 1997.