GB/T 28538-2012 (English Version)

Standard No.: GB/T 28538-2012
Language: Chinese, Available in English version
Release Date: 2012
Published By: General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
Status: Be replaced 2024-10
Replace By: GB/T 28538-2023
Latest: GB/T 28538-2023

Scope: This standard specifies an in vivo test method for evaluating the intraocular safety of contact lenses and contact lens care products. This test is to evaluate the degree of irritation of the product to eye tissue under the test conditions. This test method is applicable to the rabbit eye test.

GB/T 28538-2012 Referenced Document

GB/T 16886.1 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process*， 2022-04-15 Update
GB/T 16886.10 Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization*， 2017-12-29 Update
GB/T 16886.2 Biological evaluation of medical devices.Part 2: Animal welfare requirements
GB/T 27025 General requirements for the competence of testing and calibration laboratories*， 2019-12-10 Update

2023 GB/T 28538-2023 Rabbit Eye Compatibility Research Test on Ophthalmic Optical Contact Lenses and Contact Lens Care Products
2012 GB/T 28538-2012 Ophthalmic optics.Contact lenses and contact lenses care products.Determination of biocompatibility by ocular study with rabbit eyes