GB 11533-1989
Replaced
GB 11417.2-2025
Pending
National standards
force_standard
GB 11417.2-2025 Ophthalmic optics—Contact lenses—Part 2:Rigid contact lenses
GB 11417.2-2025 Ophthalmic optics—Contact lenses—Part 2:Rigid contact lenses
Basic Information
Standard Code:
GB 11417.2-2025
Standard Type:
National standards
Standard Status:
Pending
is_force_gb:
yes
CCS Name:
Medical optical instruments and equipment, and endoscopes
ICS Name:
Ophthalmic equipment
Publish Date:
2025-10-31
Implement Date:
2028-11-01
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
本文件规定了硬性接触镜的要求、标签、标识和随附文件,描述了试验方法。
本文件适用于硬性接触镜。
Development Information
Same series standard
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 11417.1-2025 Ophthalmic optics—Contact lenses—Part 1:Vocabulary,classification and recommendations for labelling specifications
GB/T 11417.4-2012 Ophthalmic optics—Contact lenses—Part 4:Saline solution for contact lens testing
GB/T 11417.5-2012 Ophthalmic optics—Contact lenses—Part 5:Testing methods for optical properties
GB/T 11417.6-2012 Ophthalmic optics—Contact lenses—Part 6:Mechanical properties test methods
GB/T 11417.7-2012 Ophthalmic optics—Contact lenses—Part 7:Physicochemical properties test methods
GB/T 11417.8-2012 Ophthalmic optics—Contact lenses—Part 8:Determination of shelf-life
GB/T 11417.8-2023 Ophthalmic optics—Contact lenses—Part 8:Determination of shelf-life
GB/T 11417.9-2012 Ophthalmic optics—Contact lenses—Part 9:Ageing by exposure to UV and visible radiation(in vitro method)
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 19973.1-2005 Sterilization of medical devices—Microbiological methods—Part 1:Estimation of population of microorganisms on products
GB/T 19973.1-2015 Sterilization of medical devices—Microbiological methods—Part 1:Determination of a population of microorganisms on products
GB/T 19973.1-2023 Sterilization of health care products—Microbiological methods—Part 1:Determination of a population of microorganisms on products
GB/T 28538-2012 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
GB/T 28539-2012 Ophthalmic optics—Contact lenses and contact lens care products—Guidelines for determination of preservative uptake and release
GB/T 28539-2023 Ophthalmic optics—Contact lenses and contact lens care products—Determination of preservative uptake and release
YY/T 0466.1-2009 Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1:General requirements
YY/T 0466.1-2016 Medical devices—Symbols to be used with medical device labels,labelling and information to be supplied—Part 1:General requirements
YY/T 0466.1-2023 Medical devices—Symbols to be used with information to be supplied by the manufacturer—Part 1:General requirements
中华人民共和国药典 四部
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