GB 11417.3-2012Ophthalmic optics - Contact lenses - Part 3: Soft contact lenses (English PDF)

3 Terms and definitions

4 Requirements

5 Test methods

6 Inspection rules

Foreword

Subclauses 4.4.3.2 and 4.7.1 of this part are recommendatory; the rest are mandatory.

Ophthalmic optics - Contact lenses, together with GB/T 28539 (Ophthalmic optics - Contact lenses and contact lens care products - Guidance for determination of preservative uptake and release) and GB/T 28538 (Ophthalmic optics - Contact lenses and contact lens care products - Rabbit eye compatibility study test), makes up the series of national standards on 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 (mandatory) (GB 11417.3);

- Part 4: 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 physicochemical 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 3.

This part replaces GB 11417.2-1989, Soft hydrophilic contact lenses, and its 1997 amendment.

The differences between this part and GB 11417.2-1989 with its 1997 amendment are as follows:

- the requirements, test methods, inspection rules and marking in 5.1, 5.2, 5.3.2, 5.3.4, 5.3.5, 5.3.6, 5.3.7 and 5.3.8 have been modified;

- 5.3.1, the packaging and storage provisions of Clause 9 and the wearing provisions of Clause 9 have been deleted;

- specific provisions have been added on: general principles, additional requirements for multifocal lenses and lenses intended to correct aberrations, prism base orientation, residual prismatic power, light transmission properties, optic zone diameter, material description, chemical properties of the material, stability requirements and biocompatibility, together with a clause on accompanying information.

This part was drafted by the redrafting method with reference to ISO 14534:2002, Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (English version), and the ISO 18369:2006 series of international standards, Ophthalmic optics - Contact lenses.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body 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 Subcommittee on Medical Optics and Instruments of the National Technical Committee on Optics and Photonics of Standardization Administration of China (SAC/TC 103/SC 1).

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

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

Previous editions of the standard replaced by this part:

- GB 11417.2-1989.