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Delivery: <= 9 days. True-PDF full-copy in English will be manually translated and delivered via email. GB/T 11417.1-2025: Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification and recommendations for labelling specifications Status: Valid GB/T 11417.1: Historical versions
Basic dataStandard ID: GB/T 11417.1-2025 (GB/T11417.1-2025)Description (Translated English): Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification and recommendations for labelling specifications Sector / Industry: National Standard (Recommended) Classification of Chinese Standard: C40 Classification of International Standard: 11.040.70 Word Count Estimation: 66,621 Date of Issue: 2025-08-01 Date of Implementation: 2027-08-01 Older Standard (superseded by this standard): GB/T 11417.1-2012 Issuing agency(ies): State Administration for Market Regulation, Standardization Administration of China GB/T 11417.1-2025: Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification and recommendations for labelling specifications---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/GBT11417.1-2025 ICS 11.040.70 CCSC40 National Standard of the People's Republic of China Replaces GB/T 11417.1-2012 Ophthalmic optical contact lenses Part 1.Vocabulary, classification and recommended identification specifications Ophthalmicoptics-Contactlenses-Part 1.Vocabulary,classificationand (ISO 18369-1.2017,Ophthalmicoptics-Contactlenses-Part 1.Vocabulary, Released on August 1, 2025 Implementation on August 1, 2027 State Administration for Market Regulation The National Standardization Administration issued Table of ContentsPreface III Introduction VI 1 Scope 1 2 Normative references 1 3 Terms, definitions and symbols 1 3.1 Terms and Definitions 1 3.1.1 Basic terminology 1 3.1.2 Contact lens parameters and design-related terms 3 3.1.3 Terminology related to aspheric contact lenses 18 3.1.4 Terms related to bifocal and multifocal contact lenses 18 3.1.5 Terminology related to scleral contact lenses and ophthalmic lenses 21 3.1.6 Terms related to contact lens material properties 22 3.1.7 Terminology related to tinted contact lenses 25 3.1.8 Terminology related to contact lens manufacturing 26 3.1.9 Terminology related to contact lens packaging and labeling 26 3.1.10 Terms related to contact lens use and wearing methods 27 3.1.11 Terms related to contact lens hygiene 28 3.1.12 Other terms 29 3.2 Symbols 31 4 Classification of contact lens materials 32 Appendix A (Informative) Specifications for Hard Contact Lenses 34 Appendix B (Informative) Specifications for Soft Contact Lenses 42 Reference 44 Index 45 Preface This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents" Drafting. GB (/T) 11417 “Ophthalmic optics contact lenses”, GB/T 28538 “Ophthalmic optics contact lenses and contact lens care products rabbit eye GB/T 28539 "Determination of uptake and release of preservatives in ophthalmic contact lenses and contact lens care products" Together they constitute the national standard for contact lenses. This document is Part 1 of GB (/T) 11417 “Contact lenses in ophthalmic optics”. GB (/T) 11417 has been published in the following parts. --- Part 1.Vocabulary, classification and recommended identification specifications; --- Part 2.Hard contact lenses; --- Part 3.Soft contact lenses; --- Part 4.Standard salt solution for testing; --- Part 5.Test methods for optical properties; --- Part 6.Mechanical properties test methods; --- Part 7.Test methods for physical and chemical properties; --- Part 8.Determination of validity period; --- Part 9.UV and visible light radiation ageing test (in vitro method). This document replaces GB/T 11417.1-2012 "Ophthalmic optics contact lenses Part 1.Vocabulary, classification and recommended labeling specifications". Compared with GB/T 11417.1-2012, in addition to structural adjustments and editorial changes, the main technical changes are as follows. --- Changed the terms "scleral contact lens", "hard contact lens", "rigid gas permeable contact lens", "soft contact lens", "composite contact lens" in "basic terminology". Contact lenses, multifocal contact lenses, and progressive focus contact lenses (see 3.1.1.3, 3.1.1.7~3.1.1.9, 3.1.1.11, 3.1.1.15, 3.1.1.16, 2012 edition, 2.1.1.3, 2.1.1.7–2.1.1.9, 2.1.1.11, 2.1.1.14, and 2.1.1.15); --- Added "monofocal contact lens", "spherical aberration", "contact lens accessories", "suction rod", "contact lens container", "balance" in the "basic terminology" (see 3.1.1.13, 3.1.1.17~3.1.1.21); --- Added "diopter", "front vertex", "paraxial front vertex power", and "paraxial back vertex power" to the "contact lens parameters and design-related terms" "Cylinder power", "cylindrical axis", "prismatic error", "power profile", "prescription optical prismatic power", "prismatic axis", "conic section", "conic Surface", "eccentricity", "oblate", "prolate", "ellipse", "hyperbola", "posterior optical zone", "equivalent posterior curvature radius", "critical thickness" (see 3.1.2.1.1~3.1.2.1.4, 3.1.2.1.7~3.1.2.1.12, 3.1.2.1.21~3.1.2.1.27, 3.1.2.2.1, 3.1.2.2.2, 3.1.2.4.2); --- Changed the terms "front vertex power of label", "back vertex power of label", "peripheral area", "contact lens" in "contact lens parameters and design related terms" Mirror axis”, “circumferential contact lens”, “cut edge”, “center thickness”, “axial edge thickness” (see 3.1.2.1.5, 3.1.2.1.6, 3.1.2.1.18, 2.1.2.1.12, 2.1.2.1.34, 2.1.2.1.43, 2.1.2.4.1, 2.1.2.4.5); --- Deleted the terms and definitions of "spherical surface" and "thickness" in "Contact lens parameters and design-related terms" (see the.2012 edition of 2.1.2.1.23, 2.1.2.4); --- Changed the “additional power” in the “terms related to bifocal and multifocal contact lenses” (see 3.1.4.1, 2.1.4.1 of the.2012 edition); --- Added "scleral lens height" in "terms related to scleral contact lenses and eye lenses" (see 3.1.5.14); --- Added "tensile modulus", "refractive index", "osmotic pressure" and "conductivity" in the "terms related to contact lens material properties" (see 3.1.6.1, 3.1.6.3, 3.1.6.5, 3.1.6.6); --- Changed the terms "gas permeability coefficient", "oxygen permeability coefficient", "oxygen permeability", "water content", "high water content contact lens" in the "terms related to contact lens material properties" Touch mirror", "ion type", "spectral transmittance", "light transmittance", "ultraviolet A section", "ultraviolet absorption type 1", "ultraviolet absorption type 2" (see 3.1.6.4, 3.1.6.7, 3.1.6.9, 3.1.6.10, 3.1.6.10.2, 3.1.6.11~3.1.6.13, 3.1.6.14.1, 3.1.6.14.3, 3.1.6.14.4, 2012 edition 2.1.6.2, 2.1.6.3, 2.1.6.5, 2.1.6.6, 2.1.6.6.3, 2.1.6.7, 2.1.6.9, 2.1.6.10, 2.1.6.11.1, --- Deleted the terms and definitions of "medium water content contact lens" and "non-ionic" in the "terms related to contact lens material properties" (see.2012 Version 2.1.6.6.2, 2.1.6.8); --- Changed the “Molded contact lens” in the “Terms related to contact lens manufacturing” (see 3.1.8.3, 2.1.8.3 of the.2012 edition); --- Added "Terms related to contact lens packaging and labeling" (see 3.1.9); --- Added "elastic wearing" and "orthokeratology contact lenses" in the "terms related to contact lens use and wearing methods" (see 3.1.10.4.3, 3.1.10.4.4); --- Added "Terms related to contact lens hygiene treatment" (see 3.1.11); --- Added "inter-laboratory reproducibility" and "V-meter" in "other terms" (see 3.1.12.8.2, 3.1.12.12); --- Changed “Classification of contact lens materials” (see Chapter 4, Chapter 3 of the.2012 edition). This document is modified to adopt ISO 18369-1.2017 “Ophthalmic optics — Contact lenses — Part 1.Vocabulary, classification system and recommended identification” specification". The technical differences between this document and ISO 18369-1.2017 and the reasons for them are as follows. --- Changed the "Scope" (see Chapter 1) to make its provisions clearer; --- Changed the "scleral contact lens" and "hydrogel contact lens" in the "basic terminology" (see 3.1.1.3, 3.1.1.10, ISO 18369-1.2017 3.1.1.3 and 3.1.1.10) to make the provisions clearer; --- Added "monofocal contact lens" in "basic terms" (see 3.1.1.13) to make the provisions clearer; --- Deleted "contact lens care products" in "basic terms" (see 3.1.1.18 of ISO 18369-1.2017) to adapt to my country's Technical conditions, increase operability; --- Changed the "Paraxial Anterior Vertex Power", "Paraxial Posterior Vertex Power" and "Label Anterior Vertex Power" in the "Contact Lens Parameters and Design-Related Terms" "Label back vertex power" and "back optical zone curvature radius" (see 3.1.2.1.3~3.1.2.1.6, 3.1.2.2.3, ISO 18369-1.2017) 3.1.2.1.3~3.1.2.1.6, 3.1.2.2.3) to make the provisions clearer; --- Changed the terms "osmotic pressure", "oxygen permeability coefficient", "oxygen permeability" and "water content" in the "terms related to contact lens material properties" (see 3.1.6.5, 3.1.6.7, 3.1.6.9, 3.1.6.10, 3.1.6.5, 3.1.6.6, 3.1.6.8, 3.1.6.10, 3.1.6.11 of ISO 18369-1.2017) Its provisions are clearer; --- Added "light transmittance" in the "terms related to contact lens material properties" (see 3.1.6.13) to make its provisions clearer; --- Deleted "multiple-measurement solution", "single-measurement solution" and "tamper-evident packaging" in "terms related to contact lens packaging and labeling" (see 3.1.9.3, 3.1.9.4, and 3.1.9.6 of ISO 18369-1.2017) to adapt to my country's technical conditions and increase operability; --- Deleted "active ingredient", "antimicrobial activity", "antimicrobial agent" and "neutralization" from the "terms related to contact lens hygiene" "Neutralizer", "Surfactant", "Standard", "Sanitization", "Contact Lens Cleaning", "Contact Lens Care Procedure", "Contact Lens Disinfection", "Contact Lens Removal" Contact lens disinfectant ingredients, contact lens disinfectant care products, contact lens system disinfectant care products, rubbing cleansing fluids, and enzyme cleaners "Rinse", "soak", "conditioning solution", "wetting solution", "eye drops", "multi-purpose solution" (see 3.1.11.1~ of ISO 18369-1.2017) 3.1.11.6, 3.1.11.8, 3.1.11.12~3.1.11.19, 3.1.11.21~3.1.11.24), to adapt to my country's technical conditions, increase operability; --- Deleted "inoculum" in "other terms" (see 3.1.12.7 of ISO 18369-1.2017) to adapt to my country's technical conditions. Increased operability; --- Changed the "Classification of contact lens materials" (see Chapter 4, Chapter 4 of ISO 18369-1.2017) to adapt to my country's technical conditions. Increase operability. The following editorial changes have been made to this document. --- To coordinate with the Chinese standard, the name of the standard was changed to "Ophthalmic optics - Contact lenses - Part 1.Vocabulary, classification and recommended identification" specification". Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents. This document is proposed by the State Food and Drug Administration. This document is under the jurisdiction of the National Technical Committee for Standardization of Optics and Photonics (SAC/TC103). This document was drafted by. Zhejiang Medical Device Inspection Institute, Shanghai Weikang Optical Glasses Co., Ltd., Haichang Contact Lens Co., Ltd. Co., Ltd., Alcon (China) Ophthalmic Products Co., Ltd., Johnson & Johnson Vision Care Trading (Shanghai) Co., Ltd., Wenzhou Medical University Eye and Optometry Hospital, Euclid (Suzhou) Medical Technology Co., Ltd., Beijing Bausch and Lomb Eye Care Products Co., Ltd., Shanghai Aikonte Medical Technology Co., Ltd. company. The main drafters of this document are. Luo Yongjie, Zhen Hui, Yan Qinglai, Zhang Li, Tang Yao, Zhao Jie, Xu Pinghua, Wen Yan, Chen Ping, Yang Zhifang, Kong Weiping, Jiang Jun, Zhang Wei, Lu Canlong, and Yuan Lingzhi. The previous versions of this document and the documents it replaces are as follows. ---First published in.2012 as GB/T 11417.1-2012; ---This is the first revision.introductionGB (/T) 11417 “Contact lenses in ophthalmic optics” is intended to be divided into the following parts. --- Part 1.Vocabulary, classification and recommended labeling specifications. The purpose is to specify the terms and definitions of contact lenses. --- Part 2.Hard contact lenses. The purpose is to specify the performance requirements of hard contact lenses. --- Part 3.Soft contact lenses. The purpose is to specify the performance requirements of soft contact lenses. --- Part 4.Standard saline solution for testing. The purpose is to specify the specifications of standard saline solution for contact lens testing. --- Part 5.Test methods for optical properties. The purpose is to specify the test methods for the optical properties of contact lenses. --- Part 6.Mechanical properties test methods. The purpose is to specify the test methods for the mechanical properties of contact lenses. --- Part 7.Test methods for physical and chemical properties. The purpose is to specify the test methods for the physical and chemical properties of contact lens materials. --- Part 8.Determination of shelf life. The purpose is to specify the test procedures for the stability of contact lenses during storage. --- Part 9.UV and visible light radiation aging test (in vitro method). The purpose is to specify the aging of contact lenses under simulated sunlight. In vitro test methods. GB (/T) 11417 (all parts) applies to contact lenses, i.e. devices that are worn on the front surface of the eye and come into contact with the tear film in front of the eye. Covers hard corneal contact lenses, hard scleral contact lenses, and soft contact lenses. Hard contact lenses maintain their shape. Soft contact lenses It is easy to deform and needs support to maintain its normal shape. Contact lenses are mainly used to correct refractive errors, and can also be used for treatment and cosmetic purposes. The materials used are mainly divided into two categories. hard materials and soft materials. The former mainly includes corneal lenses and less commonly scleral lenses, both of which are made of gas permeable or non-gas permeable materials. Soft lenses are mainly made of hydrogel materials. A few lenses contain both hard and soft materials. In terms of vision correction, contact lenses are divided into single-focus lenses, bifocal lenses, multifocal lenses and progressive lenses. surface, aspheric surface, toric surface or free-form surface, etc. Wearing methods may be daily wear, flexible wear or continuous wear. Generally speaking, the replacement cycle of soft lenses is daily, two weeks or monthly. Replace once, etc. Hard lenses and some soft lenses are replaced less frequently, for example once a year. Ophthalmic optical contact lenses Part 1.Vocabulary, classification and recommended identification specifications1 ScopeThis document defines the terminology applicable to the physical, chemical, and optical properties, manufacture, and use of contact lenses. This document provides a glossary of contact lens terminology and some internationally accepted symbols and abbreviations associated with specific terms. This document also provides a classification of contact lens materials and recommended contact lens labeling specifications. This document applies to contact lenses.2 Normative referencesThis document has no normative references.3 Terms, definitions and symbols3.1 Terms and Definitions 3.1.1 Basic terminology 3.1.1.1 contact lenses An ophthalmic lens designed to be worn on the front surface of the eye. NOTE. This term includes plano contact lenses. 3.1.1.2 Contact lenses with an overall diameter smaller than the diameter of the visible iris and designed to be worn integrally on the cornea (3.1.1.1). 3.1.1.3 scleral contact lens Contact lens (3.1.1.1) with the scleral zone (3.1.5.12) supported on the bulbar conjunctiva and the optic zone (3.1.2.1.17) covering the entire cornea. NOTE 1 In some cases, the posterior optical zone (3.1.2.2.1) is in minimal contact with the cornea. NOTE 2 The terms microsclera, macrosclera, hemisclera, and corneosclera can be found in the contact lens literature to describe lenses of varying parameters. NOTE 3 For terminology specific to scleral contact lenses, see 3.1.5. 3.1.1.4 Contact lenses (3.1.1.1) with an anterior optic zone (3.1.2.1.17) with a diameter smaller than the overall diameter. NOTE This structure is usually used to reduce the center thickness (3.1.2.4.1) of a plus-power contact lens (3.1.2.1.13) or to reduce the edge thickness of a minus-power contact lens (3.1.2.1.14) (3.1.2.1.34)Thickness. 3.1.1.5 contact lenses Non-corrective contact lenses (3.1.1.1). ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB/T 11417.1-2025_English be delivered?Answer: Upon your order, we will start to translate GB/T 11417.1-2025_English as soon as possible, and keep you informed of the progress. 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