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GB 11417.3-2025 English PDF

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GB 11417.3-2025: Ophthalmic optics - Contact lenses - Part 3: Soft contact lenses

GB 11417.3: Evolution and historical versions

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
GB 11417.3-2025	English	279	Add to Cart	3 days [Need to translate]	Ophthalmic optics - Contact lenses - Part 3: Soft contact lenses		GB 11417.3-2025
GB 11417.3-2012	English	259	Add to Cart	3 days [Need to translate]	Ophthalmic optics -- Contact lenses -- Part 3: Soft contact lenses	Valid	GB 11417.3-2012

Basic data

Standard ID	GB 11417.3-2025 (GB11417.3-2025)
Description (Translated English)	Ophthalmic optics - Contact lenses - Part 3: Soft contact lenses
Sector / Industry	National Standard
Classification of Chinese Standard	C40
Classification of International Standard	11.040.70
Word Count Estimation	14,15
Date of Issue	2025-10-31
Date of Implementation	2028-11-01
Older Standard (superseded by this standard)	GB 11417.3-2012
Issuing agency(ies)	State Administration for Market Regulation and Standardization Administration of China

GB 11417.3-2025: Ophthalmic optics - Contact lenses - Part 3: Soft contact lenses

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 11.040.70 CCSC40 National Standards of the People's Republic of China Replaces GB 11417.3-2012 Ophthalmic contact lenses Part 3.Soft Contact Lenses Published on 2025-10-31 Implemented on 2028-11-01 State Administration for Market Regulation The State Administration for Standardization issued a statement.

Preface III Introduction IV 1.Scope 1 2 Normative References 1 3.Terms and Definitions 1 4 Requirements 1 5.Test Methods 6.Labels, markings, and accompanying documents Appendix A (Normative) List of Applicable Documents for Test Methods of Soft Contact Lenses 7 References 8

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents". Drafting. GB/T 11417 "Ophthalmic Contact Lenses" and GB/T 28538 "Ophthalmic Contact Lenses and Contact Lens Care Products - Rabbiteye Diagnosis" The standards include "Cost Compatibility Study Test" and GB/T 28539 "Determination of Preservative Intake and Release in Ophthalmic Optical Contact Lenses and Contact Lens Care Products". This constitutes a series of national standards for contact lenses. This document is Part 3 of GB (/T) 11417 "Ophthalmic Optics Contact Lenses". GB (/T) 11417 has already published the following parts. ---Part 1.Identification Guidelines for Vocabulary, Classification, and Recommendations; ---Part 2.Rigid Contact Lenses; ---Part 3.Soft Contact Lenses; ---Part 4.Standard salt solutions for testing; ---Part 5.Test methods for optical properties; ---Part 6.Test methods for mechanical properties; ---Part 7.Test methods for physical and chemical properties; ---Part 8.Determination of Validity Period; ---Part 9.Ultraviolet and Visible Radiation Aging Tests (In Vitro Method) This document supersedes GB 11417.3-2012 "Ophthalmic Optics Contact Lenses Part 3.Soft Contact Lenses", and is consistent with GB 11417.3- Compared to.2012, aside from structural adjustments and editorial changes, the main technical changes are as follows. ---The scope has been changed (see Chapter 1, Chapter 1 of the.2012 edition); ---Terminology and definitions have been revised (see Chapter 3, Chapter 3 of the.2012 edition); ---The "General Requirements" have been changed (see 4.1,.2012 version 4.1); ---The "Optical Performance" section has been changed (see 4.2,.2012 edition 4.2); ---The "geometry" has been changed (see 4.3,.2012 version 4.3); ---The "Contact Lens Material" section has been changed (see 4.4,.2012 edition of 4.4); ---The "Biocompatibility Assessment" has been revised (see 4.5,.2012 version 4.5); ---The "Microbiological Requirements" have been revised (see 4.6,.2012 edition of 4.6); ---Stable features have been changed (see 4.7,.2012 version 4.7); ---The section on "Internal quality and surface defects" has been amended (see 4.8,.2012 version 4.8); ---The "Test Methods" have been changed (see Chapter 5, Chapter 5 of the.2012 edition); ---The "Inspection Rules" section has been removed (see Chapter 6 of the.2012 edition); ---The “Labels, Identification and Accompanying Documents” have been changed (see Chapter 6, Chapter 7 of the.2012 edition). Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents. This document was proposed and is under the jurisdiction of the National Medical Products Administration. The release history of this document and the document it replaces is as follows. ---First published in 1989 as GB 11417.2-1989; ---First revised in.2012 as GB 11417.3-2012; ---This is the second revision.

Introduction

GB (/T)11417 "Ophthalmic Optical Contact Lenses" is divided into the following parts. ---Part 1.Vocabulary, Classification, and Recommended Labelling Standards. The aim is to define the terminology and definitions for contact lenses. ---Part 2.Rigid Contact Lenses. The purpose is to specify the performance requirements for rigid contact lenses. ---Part 3.Soft Contact Lenses. The purpose is to specify the performance requirements for soft contact lenses. ---Part 4.Standard Salt Solutions for Testing. The purpose is to specify the requirements for standard salt solutions used in contact lens testing. ---Part 5.Test Methods for Optical Performance. The purpose is to specify the test methods for the optical performance of contact lenses. ---Part 6.Test methods for mechanical properties. 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 mirror materials. ---Part 8.Determination of Shelf Life. The purpose is to specify the testing procedures for the stability of contact lenses during storage. ---Part 9.Ultraviolet and Visible Radiation Aging Test (In Vitro Method). The purpose is to determine the aging performance of contact lenses under simulated sunlight exposure. In vitro testing methods for chemicalization. This document and GB 11417.2 are the core product standards in the field of contact lenses. Other related standards revolve around and serve these two core standards. While international standards exist for contact lenses, their framework and requirements have not yet formed a systematic standard framework. This document refers to... Based on ISO 14534 and ISO 18369, the key clauses of the standards underwent thorough research and technical verification during the revision process, striving to ensure the revision... The new standards will be able to more effectively support market regulation, guide the high-quality development of the industry, promote technological progress, and ensure public safety in the use of medical devices. Ophthalmic contact lenses Part 3.Soft Contact Lenses

1 Scope

This document specifies the requirements, labeling, marking, and accompanying documentation for soft contact lenses, and describes the test methods. This document applies to soft contact lenses.

2 Normative references

The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included. For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies. This document. GB/T 11417.1 Ophthalmic contact lenses – Part 1.Vocabulary, classification and recommended labeling specifications GB/T 11417.4 Ophthalmic contact lenses - Part 4.Standard saline solutions for testing GB/T 11417.5 Ophthalmic Contact Lenses - Part 5.Test Methods for Optical Performance GB/T 11417.6 Ophthalmic Contact Lenses - Part 6.Test Methods for Mechanical Properties GB/T 11417.7 Ophthalmic optical contact lenses – Part 7.Test methods for physical and chemical properties GB/T 11417.8 Ophthalmic Contact Lenses - Part 8.Determination of Shelf Life GB/T 11417.9 Ophthalmic contact lenses - Part 9.Ultraviolet and visible light radiation aging test (in vitro method) GB/T 16886.1 Biological evaluation of medical devices – Part 1.Evaluation and testing in the risk management process GB/T 28538 Ophthalmic optical contact lenses and contact lens care products rabbit eye compatibility study GB/T 28539 Determination of preservative intake and release in ophthalmic contact lenses and contact lens care products Pharmacopoeia of the People's Republic of China, Part IV

3 Terms and Definitions

The terms and definitions defined in GB/T 11417.1 apply to this document.

4 Requirements

4.1 General Requirements In addition to the requirements in 4.2 to 4.8, if the manufacturer expressly indicates any other special designs or additional performance features, a detailed description shall be provided, along with applicable requirements. Summation test method. 4.2 Optical Performance 4.2.1 General Rules For contact lenses intended for special medical purposes and lacking optical properties, if clearly described in the accompanying documentation and labeling, 4.2.2 to 4.2.4 Optical performance requirements may not apply.

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