GB/T 45808-2025 English PDF

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GB/T 45808-2025: Ophthalmic optics - Contact lenses and contact lens care products - Cytotoxicity testing of contact lenses in combination with lens care solution to evaluate lens/solution interactions
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/T 45808-2025	294	Add to Cart	3 days	Ophthalmic optics - Contact lenses and contact lens care products - Cytotoxicity testing of contact lenses in combination with lens care solution to evaluate lens/solution interactions	Valid

Similar standards

GB/T 40177   GB/T 11417.4   GB 11417.2   GB/T 11239.1   GB/T 11417.8   

Basic data

Standard ID: GB/T 45808-2025 (GB/T45808-2025)
Description (Translated English): Ophthalmic optics - Contact lenses and contact lens care products - Cytotoxicity testing of contact lenses in combination with lens care solution to evaluate lens/solution interactions
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: C40
Classification of International Standard: 11.040.70
Word Count Estimation: 14,116
Date of Issue: 2025-05-30
Date of Implementation: 2026-06-01
Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration

GB/T 45808-2025: Ophthalmic optics - Contact lenses and contact lens care products - Cytotoxicity testing of contact lenses in combination with lens care solution to evaluate lens/solution interactions

---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 Standard of the People's Republic of China Ophthalmic optics contact lenses and contact lens care products Evaluation of contact lenses combined with contact lens care solutions Interaction cytotoxicity assay (ISO 18189.2016, IDT) Released on 2025-05-30 2026-06-01 implementation State Administration for Market Regulation The National Standardization Administration issued

Table of contents

Preface III 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Principle 1 5 Direct contact cytotoxicity test of contact lenses combined with contact lens care solutions 1 6 Results Evaluation 5 7 Test Report 5 Appendix A (normative) Measurement of cell lysis area in direct contact cytotoxicity test of contact lenses combined with contact lens care solutions 6 References 8

Foreword

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. This document is equivalent to ISO 18189.2016 “Ophthalmic optics contact lenses and contact lens care products based on contact lenses combined with contact lenses” Cytotoxicity test of nursing solutions to evaluate their interactions. The following minimal editorial changes were made to this document. --- For the convenience of users of this document, "Cell Bank of the Chinese Academy of Sciences" has been added (see 5.2.2.1). 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 on Optics and Photonics Standardization (SAC/TC103). This document was drafted by. Zhejiang Medical Device Inspection Institute and Haichang Contact Lens Co., Ltd. The main drafters of this document. Fang Li, He Xian, Weng Xu, Chen Xianhua, Xia Zhongcheng, Lin Xinyi, Zhang Ziyang, Chen Ping, Zhou Xianjun. Ophthalmic optics contact lenses and contact lens care products Evaluation of contact lenses combined with contact lens care solutions Interaction cytotoxicity assay

1 Scope

This document describes an in vitro test for evaluating the potential cytotoxic effects of interactions between contact lenses and contact lens care solutions. Test method. This document applies to contact lenses and contact lens care solution products. NOTE. The potential cytotoxicity caused by contact lenses or contact lens care solutions themselves is evaluated in accordance with ISO 10993-5.

2 Normative references

The contents of the following documents constitute essential clauses of this document through normative references in this document. For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to This document. ISO 18369-1 Ophthalmic optics — Contact lenses — Part 1.Vocabulary, classification system and recommended labelling practices specifications) Note. GB/T 11417.1-2012 Ophthalmic optics Contact lenses Part 1.Vocabulary, classification and recommended labeling specifications (ISO 18369-1.2006, MOD)

3 Terms and definitions

For the purposes of this document, the terms and definitions defined in ISO 18369-1 and the following apply. 3.1 roomtemperature Defined as 18℃~25℃.

4 Principle

Chemicals in contact lens solutions may cause cytotoxic reactions in ocular tissues either directly or indirectly through contact lenses. Absorption of preservatives or other solution components of contact lenses and subsequent release of these chemicals into the ocular environment may Potential interactions between contact lens care products and various contact lens materials should be considered when designing studies. To comprehensively evaluate the cytotoxic potential of a new or modified contact lens material or contact lens care product.

5 Direct contact cytotoxicity test of contact lenses combined with contact lens care solutions

5.1 General The following protocol describes a test method for evaluating the potential cytotoxicity of contact lenses immersed in contact lens care solutions. ......

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