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GB 11417.2-2012: Ophthalmic optics -- Contact lenses -- Part 2: Rigid contact lenses specification Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid GB 11417.2: Historical versions
Similar standardsGB 11417.2-2012: Ophthalmic optics -- Contact lenses -- Part 2: Rigid contact lenses specification---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GB11417.2-2012 GB ICS 11.040.70 C 40 NATIONAL STANDARD GB11417.2-2012 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 Table of ContentsForeword... 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... 16ForewordSections 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 specification1 ScopeThis 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 referencesThe 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 cytotoxicity3 Terms and definitionsFor the purpose of this standard, the following terms and definitions defined in GB/T 11417.1-2012 apply to this document.4 Requirements4.1 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. 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. 4.2.3 Prism degree For the contact lens designed according to the prescription, the nominal value of prismatic power shall be marked on the labels on the small packaging container. The tolerance of the nominal value of prism designed by prescription and residual prism designed by non-prism power shall comply with the provisions in Table 2. 4.2.4 Maximum deviation of the optical center Maximum deviation of the optical center of scleral contact lenses is 0.50 mm. 4.2.5 Transmittance performance 4.2.5.1 General provisions Visible light transmittance, color vision requirements and requirements for ultraviolet region for the contact lenses shall be in compliance with the following provisions. 4.2.5.2 Requirements for visible region Light transmittance and color vision requirements for the contact lenses shall be in compliance with. 4.2.5.3 Requirements for ultraviolet region For UV absorbing contact lens, the UV absorbing class shall be set forth in the accompanying information. Its nominal value shall be in conformance with the Table 3. 4.3 Requirements of the Geometric Sizes 4.3.1 Dimension of Lens The nominal values of the base curves radius or bottom diameter’s vector height, overall diameter, and center thickness; optical zone diameter contact lenses’ base curves radius or bottom diameter’s vector height, total diameter, center thickness, and optical zone diameter shall be labeled on the small packaging container. 4.4.2 Physical properties of materials 4.4.2.1 Refractive index The nominal value of refractive index of contact lenses shall be provided in the accompanying information. The effective digit of nominal value shall be consistent with that of tolerance. The tolerance shall be ±0.002. 4.4.2.4 Contact angle The nominal value of static contact angle of contact lenses material shall be provided in the accompanying information. The tolerance shall be ± 20%. 4.4.2.5 Mechanical property Manufacturers shall provide the bending deformation and loading force of contact lenses when it breaks in the accompanying information; and the loading force when contact lenses are deformed to 30%. Furthermore, manufacturers are required to validate them by test. 4.4.3 Chemical properties of the materials 4.4.3.1 Extraction test The extraction of finished material of contact lenses as per GB/T 11417.7-2012 shall not exceed the extraction rate provided by manufacturers. 4.5 Biocompatibility evaluation 4.5.1 General provisions The manufactured goods of contact lenses shall pass the biological evaluation to prove its good biocompatibility. Biological evaluation can consider the result of biological test of 4.5.2, 4.5.3 and 4.5.4.For the new material that has never been used before, it shall conduct 4.5.5 skin sensitization test and 4.5.6 rabbit eyes biocompatibility test. 4.5.4 Cytotoxicity test It shall test the contact lenses using agar diffusion (final concentration of agar shall be less than 1.5g/L) specified in GB/T 16886.5.The tested result shall be no cytotoxicity. 4.5.5 Skin allergy test It shall prepare in accordance with per the regulations in 4.5.1; and use test methods in accordance with per the regulations in GB/T 16886.10.The tested result shall be no skin allergy. 4.6 Requirements for organisms Contact lens can adopt sterile packaging or non-sterile packaging. When the contact lens adopt non-sterile packaging, within the validity period, the biological load shall be less than 100CFU/piece. 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.5 Test methodsAll 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.6 Sampling and inspection rules6.1 Ex-factory test Ex-factory inspection rules are determined by the manufacturer.7 Label, mark and accompanying information7.1 Requirements of label and mark In addition to the labeling requirement of nominal value set out in the Chapter 4, it shall mark the following marks on the label of small packaging container. 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. 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. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of English version of GB 11417.2-2012 be delivered?Answer: The full copy PDF of English version of GB 11417.2-2012 can be downloaded in 9 seconds, and it will also be emailed to you in 9 seconds (double mechanisms to ensure the delivery reliably), with PDF-invoice.Question 2: Can I share the purchased PDF of GB 11417.2-2012_English with my colleagues?Answer: Yes. 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