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GB 11417.2-2012 PDF in English


GB 11417.2-2012 (GB11417.2-2012) PDF English
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GB 11417.2-2012English70 Add to Cart 0-9 seconds. Auto-delivery. Ophthalmic optics -- Contact lenses -- Part 2: Rigid contact lenses specification Valid
GB 11417.2-1989English239 Add to Cart 2 days Soft hydrophilic contact lenses Obsolete
Standards related to (historical): GB 11417.2-2012
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GB 11417.2-2012: PDF in English

GB  11417.2‐2012  GB ICS 11.040.70 C 40 NATIONAL STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA Replacing GB 11417.1-1989 Ophthalmic optics - Contact lenses - Part 2. Rigid contact lenses specification 眼科光学 接触镜 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 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  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); — 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. 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 Biological evaluation of medical devices - Part 11. Tests for systemic toxicity 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 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. 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. 7.2 Accompanying information provided by the manufacturer 7.2.1 Operation inst... ......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.