Translated English of Chinese Standard: GB11417.2-2012 www.chinesestandard.net Email: Sales@ChineseStandard.net GB ICS 11.040.70 C 40 NATIONAL STANDARD OF THE PEOPLE S REPUBLIC OF CHINA GB 11417.2-2012 Replacing GB 11417.1-1989 Ophthalmic optics - Contact lenses - Part 2: Rigid contact lenses specification Issued on: December 31, 2012 Implemented on: December 1, 2013 Issued by: General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China; Committee of Standardization Administration of the People's Republic of China www.chinesestandard.net Page 1 of 16
Table of Contents Foreword... 3 1 Scope... 5 2 Normative references... 5 3 Terms and definitions... 6 4 Requirements... 6 5 Test methods... 13 6 Sampling and inspection rules... 13 7 Label, mark and accompanying information... 14 Appendix A... 16 www.chinesestandard.net Page 2 of 16
Foreword Sections 4.3.3.2 and 4.7.1 are recommendatory. The rest are mandatory. Ophthalmic Optics - Contact Lenses, GB/T28539 Ophthalmic Optics - Contact Lenses and Contact Lens Care Products - Guidelines for Determination of Preservative Uptake and Release and GB/T28538 Ophthalmic Optics - Contact Lenses and Contact Lens Care Products - Determination of Biocompatibility by Ocular Study with Rabbit Eyes jointly constitute the national standards of contact lenses. Ophthalmic Optics Contact lenses is divided into 9 parts as follows: Part 1: Vocabulary, Classification System and Recommendations for Labeling Specifications (GB/T 11417.1); Part 2: Rigid contact lenses (GB 11417.2); Part 3: Soft contact lenses (GB 11417.3); Part 4: Standard salt solution for test (GB/T 11417.4); Part 5: Test methods for optical properties (GB/T 11417.5); Part 6: Mechanical properties test methods (GB/T 11417.6); Part 7: Physicochemical properties test methods (GB/T 11417.7); Part 8: Determination of shelf-life (GB/T 11417.8); Part 9: Ageing by exposure to UV and visible radiation (in vitro method) (GB/T 11417.9). This Part is Part 2. This Part is drafted according to the rules specified in GB/T 1.1-2009. This Part replaces GB 11417.1-1989 Rigid corneal contact lenses and the Corrigendum No. 1 in 1997. Except editorial amendment, the change of technical content of this Part, GB 11417.1-1989 and Corrigendum No. 1 in 1997 are as follows: Amend the requirements of biological compatibility, refractive index, optical deviation, geometric dimensioning, impurities, surface defects, fenestration, limbic shape, luminous transmittance, and spectral transmittance; Modify the test methods (Chapter 6); www.chinesestandard.net Page 3 of 16
Modify the sampling and inspection rules (Chapter 7); Modify the contents of signs (Chapter 8); Delete the requirements for the stress and lens shape; Delete the wear requirements (Chapter 9); Supplement the requirements of ultraviolet spectrum performance, amount of oxygen permeability, coefficient of oxygen permeability, mechanical property, physicochemical properties of materials, microorganism, and stability. This Part is redrafted and compiled by referring to ISO 14534:2002 Ophthalmic Optics-Contact Lenses and Contact Lens Care Products - Fundamental Requirements, ISO18369:2006 Ophthalmic Optics - Contact Lenses, and ANSI Z80.20 Ophthalmic Optics - Contact Lenses - Terminology, Tolerances, Measurement Methods and Physicochemical Properties. Please note that some contents in this document may involve patents. The issuing organization of this document is not responsible to identify these patents. This Part was proposed by the China Food and Drug Administration. This Part shall be administered by Technical Subcommittee of Medical Optics and Instrument of National Optics and Photonics Technical Committee for Standardization (SAC/TC 103/SC1). The drafting organizations of the Part: China Food and Drug Administration - Hangzhou Medical Device Quality, Supervising and Testing Center, and Zhejiang Medical Device Inspection Institute. Main drafters of this Part: He Tao, Jia Xiaohang, Wen Yan, Ma Li, Jiang Xiaolu, Chen Xianhua, Zheng Jian, Qi Weiming, Li Jiazhong, and Chen Jingyun. The previous versions replaced by the Part are: GB 11417.1-1989, and Corrigendum No. 1 in 1997. www.chinesestandard.net Page 4 of 16
Ophthalmic optics - Contact lenses - Part 2: Rigid contact lenses specification 1 Scope This Part of GB 11417 specifies the scope, terminology, definition, requirements, test method, sampling, inspection regulations, label, mark, and accompanying information of rigid contact lenses (hereinafter referred to as contact lenses). This Part applies to rigid cornea and scleral contact lenses. 2 Normative references The articles contained in the following documents have become part of this document when they are quoted herein. For the dated documents so quoted, all the modifications (Including all corrections) or revisions made thereafter shall be applicable to this document. GB/T 2829-2002 Sampling procedures and tables for periodic inspection by attributes (Applicable to inspection of process stability) GB/T 3978-2008 Standard illuminants and geometric conditions GB/T 5702-2003 Methods of measuring the color of light sources GB/T 11417.1-2012 Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labeling specifications GB/T 16886.5 Biological evaluation of medical devices - Part 5: Test for in vitro cytotoxicity GB/T 16886.10 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity GB/T 16886.11 systemic toxicity Biological evaluation of medical devices - Part 11: Tests for GB/T 19973.1 Sterilization of medical devices - Microbiological methods - Part 1: Estimation of population of microorganisms on products YY/T 0297 Clinical investigation of medical devices www.chinesestandard.net Page 5 of 16
YY/T 0316 Medical devices - Application of risk management to medical devices YY/T 0466.1 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements Pharmacopoeia of the People's Republic of China, Edition II, 2010 3 Terms and definitions For the purpose of this standard, the following terms and definitions defined in GB/T 11417.1-2012 apply to this document. 4 Requirements 4.1 General provisions The contact lenses shall be under the pre-clinical and clinical evaluation in terms of its safety and property, including proper risk analysis according to YY/T 0316. In addition to the following requirements, if there are other additional properties declared by the manufacturer, it shall give detailed description, applicable requirements and test methods. 4.2 Optical property 4.2.1 General provisions If accompanying information and marks have distinct description on the contact lenses for special medical purpose instead of having optical property, the following optical property requirements may not be applicable. 4.2.2 Back vertex power, cylindrical power and cylindrical axis For back vertex power, prescription cylindrical power and cylindrical axis (if any), the nominal values shall be marked on the labels on the small packaging container. The tolerance of nominal values shall comply with the provisions in Table 1. www.chinesestandard.net Page 6 of 16
After tested on aging by ultraviolet light and visible radiation, materials of contact lenses shall be remained stable, in accordance with requirements of 4.1 and 4.3. 4.7.2 Validity period Contact lens manufacturer shall conduct stability test to determine the storage period and shall mark on the small package. 4.8 Internal quality and surface defect 4.8.1 Impurities and surface flaws When observed with a 7x-10x magnifier, contact lenses shall be free of internal impurities and surface flaws affecting the normal usage. Impurities in the materials: bubbles, stripes and residue. Surface flaws: cracks, edge gaps, scratches and roughness. 4.8.2 Fenestration When observed with a 7x-10x magnifier, the front and back limbic shape of fenestration shall be consistent with the shape described by manufacturers. 4.8.3 Edge profile When observed with a 7x-10x magnifier, the edge of contact lens shall be smooth, clean, and bright. Its shape shall be in accordance with the quality properties described by manufacturers. 5 Test methods All requirements in Chapter 4 of this standard can be carried out for detection or test according to Appendix A. If there is no suitable method and standard in Appendix A, the manufacturer shall provide suitable methods. Inspection or test methods provided shall consider the actual application of simulation eye as much as possible, including treatment (for example, keep balance in standard salt solution). The reproducibility of detection methods shall be better than half of the specified tolerance limit. 6 Sampling and inspection rules 6.1 Ex-factory test Ex-factory inspection rules are determined by the manufacturer. 6.2 Type test It shall be divided into general type test and special type test, as shown in Table 5. www.chinesestandard.net Page 13 of 16
7.2 Accompanying information provided by the manufacturer 7.2.1 Operation instructions provided by the manufacturer to patients The manufacturer shall require the supervisor to provide the operation instructions to the patients. In addition to nominal values shown in the accompanying information specified in Chapter 4, the Instructions shall include at least the documents below: a) Main property and applicable scope: product description and/or name of material, wearing manner, estimated purpose of use. For contact lenses provided in sterility, mark the word sterility and sterilization methods, or symbols as per YY/T 0466.1. b) Usage and precautions: guidance on wearing and removing lenses, recommended terms for replacement, information necessary for safe use of lenses, optometry personnel s guidance for daily usage, return-visit, and prompts of emergency procedures; c) Taboo: What type of patients cannot wear such lenses; instructions on personal use only; the adverse effect and side effect that are known or may occur; d) Methods recommended by manufacturers to clean, sterilize and store the lenses. Indicate the adequate caring methods and prohibited caring methods. Changing the lenses caring procedures needs to consult supervisor for guidance; e) Other necessary instructions. 7.2.2 Documents provided by manufacturer to optometry professionals In addition to nominal values shown in the accompanying information and Instructions for patients specified in Chapter 4, it shall cover at least the information below: a) Material of lens: Including the various nominal values that are not marked on the package, such as refractive index, transmittance, coefficient oxygen permeation or oxygen permeation amount; b) The manufacturer recommended optometry and usage method; indications (shortsightedness, farsightedness, astigmatism and other refractive errors, keratoconus); applicable scope (e.g. ±20.00D); standard adaptive state of lenses (it may use a fluorescent dye graph to indicate); precautions; cleaning methods, sterilizing, and storage. c) If the manufacturer claims that there are other additional properties, it shall give detail description; and provide the applicable requirements and test methods. www.chinesestandard.net Page 15 of 16
Appendix A (Normative) Standard directory of test methods of rigid contact lens The applicable standards of test methods of rigid contact lens are as follows: GB/T 5702-2003 Methods of measuring the color of light sources GB/T 11417.4-2012 Ophthalmic optics Contact lenses Part 4: Saline solution for contact lens testing GB/T 11417.5-2012 Ophthalmic optics Contact lenses Part 5: Testing methods for optical properties GB/T 11417.6-2012 Ophthalmic optics Contact lenses Part 6: Mechanical properties test methods GB/T 11417.8-2012 Ophthalmic optics Contact lenses Part 8: Determination of shelf-life GB/T 11417.9-2012 Ophthalmic optics Contact lenses Part 9: Ageing by exposure to UV and visible radiation (in vitro method) GB/T 16886.5 Biological evaluation of medical devices Part 5: Test for in vitro cytotoxicity (ISO 10993-5) GB/T 16886.10 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10) GB/T 16886.11 Biological evaluation of medical devices Part 11: Tests for systemic toxicity (ISO 10993-11) GB/T 19973.1 Sterilization of medical devices Microbiological methods Part 1: Estimation of population of microorganisms on products GB/T 28538-2012 Ophthalmic optics Contact lenses and contact lenses care products Determination of biocompatibility by ocular study with rabbit eyes GB/T 28539 2012 Ophthalmic optics Contact lenses and contact lens care products Guidelines for determination of preservative uptake and release END www.chinesestandard.net Page 16 of 16