GB 11533-1989
Replaced
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
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
Publisher:
国家市场监督管理总局、国家标准化管理委员会
Technical Committee:
国家药品监督管理局
Pages:
16 pages
Scope
本文件描述了评价接触镜和接触镜护理产品眼内安全性的体内试验方法。本试验是评价产品在试验条件下对眼组织产生刺激的程度。本文件适用于兔眼试验。
Development Information
Drafting Units:
浙江省医疗器械检验研究院
Drafting Persons:
陈献花、方丽、奚晓青、李婧、周森婷、周绮梦
Replace the following standards
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/T 14148-1993
Replaced
GB/T 14148-1993 Glass blank of ophthalmic lenses
GB/T 14214-1993
Replaced
GB/T 14214-1993 Spectacle frames
GB 10810-1996
Replaced
GB 10810-1996 Spectacles lenses
GB 17342-1998
Replaced
GB 17342-1998 Ophthalmic instrument—Trial case lenses
GB 13511-1999
Replaced