GB/T 28538-2023 Active National standards

GB/T 28538-2023 Ophthalmic optics—Contact lenses and contact lenses care products—Determination of biocompatibility by ocular study with rabbit eyes

GB/T 28538-2023 Ophthalmic optics—Contact lenses and contact lenses care products—Determination of biocompatibility by ocular study with rabbit eyes

Publish Date: 2023-09-07 Implement Date: 2024-10-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: GB/T 28538-2023

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical optical instruments and equipment, and endoscopes

ICS Name: Ophthalmic equipment

Publish Date: 2023-09-07

Implement Date: 2024-10-01

Pages: 16 pages

Scope

This document describes the in vivo test method for evaluating the ocular safety of contact lenses and contact lens care products. This test is used to evaluate the degree of irritation caused by the product to ocular tissues under test conditions. This document is applicable to rabbit eye tests.

Development Information

Word Count: 29 Thousand words Pages: 16 pages

Replace the following standards

GB/T 28538-2012 Ophthalmic optics—Contact lenses and contact lenses care products—Determination of biocompatibility by ocular study with rabbit eyes

Referenced Standards

GB 11417.1-1989 Hard corneal contact lenses GB/T 11417.1-2012 Ophthalmic optics—Contact lenses—Part 1:Vocabulary,classification system and recommendations for labeling specifications GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.2-2000 Biological evaluation of medical devices—Part 2:Animal welfare requirements GB/T 16886.2-2011 Biological evaluation of medical devices—Part 2:Animal welfare requirements GB/T 16886.10-2000 Biological evaluation of medical devices—Part 10:Tests for irritation and sensitization GB/T 16886.10-2005 Biological evaluation of medical devices—Part 10:Tests for irritation and delayed-type hypersensitivity GB/T 16886.10-2017 Biological evaluation of medical devices—Part 10:Tests for irritation and skin sensitization GB/T 16886.10-2024 Biological evaluation of medical devices—Part 10:Tests for skin sensitization GB/T 27025-2008 General requirements for the competence of testing and calibration laboratories GB/T 27025-2019 General requirements for the competence of testing and calibration laboratories GB/T 11417.1-2025 Ophthalmic optics—Contact lenses—Part 1:Vocabulary,classification and recommendations for labelling specifications GB/T 16886.2-2026 Biological evaluation of medical devices—Part 2:Animal welfare requirements

Adopt standards

ISO 9394:2012

Related Standards

GB 11533-1989 Replaced

GB 11533-1989 Standard logarithmic visual acuity charts

Publish Date: 1989-03-27

GB/T 14148-1993 Replaced

GB/T 14148-1993 Glass blank of ophthalmic lenses

Publish Date: 1993-02-15

GB/T 14214-1993 Replaced

GB/T 14214-1993 Spectacle frames

Publish Date: 1993-03-01

GB 10810-1996 Replaced

GB 10810-1996 Spectacles lenses

Publish Date: 1996-12-17

GB 17342-1998 Replaced

GB 17342-1998 Ophthalmic instrument—Trial case lenses

Publish Date: 1998-05-05

GB 13511-1999 Replaced

GB 13511-1999 Assembled spectacles

Publish Date: 1999-08-12