GB 11533-1989
Replaced
GB 11417.2-2012
Active
National standards
force_standard
GB 11417.2-2012 Ophthalmic optics—Contact lenses—Part 2:Rigid contact lenses specification
GB 11417.2-2012 Ophthalmic optics—Contact lenses—Part 2:Rigid contact lenses specification
Basic Information
Standard Code:
GB 11417.2-2012
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
yes
CCS Name:
Medical optical instruments and equipment, and endoscopes
ICS Name:
Ophthalmic equipment
Publish Date:
2012-12-31
Implement Date:
2013-12-01
Pages:
12 pages
Scope
This part of GB 11417 specifies the scope of application, terms and definitions, requirements, test methods, sampling and inspection rules, labeling, marking, and accompanying documentation for rigid contact lenses (hereinafter referred to as "contact lenses").
This part applies to rigid corneal and scleral contact lenses.
Development Information
Same series standard
GB/T 11417.1-2012 Ophthalmic optics—Contact lenses—Part 1:Vocabulary,classification system and recommendations for labeling specifications
GB 11417.3-2012 Ophthalmic optics—Contact lenses—Part 3:Soft contact lenses
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 11417.9-2012 Ophthalmic optics—Contact lenses—Part 9:Ageing by exposure to UV and visible radiation(in vitro method)
Replace the following standards
Referenced Standards
GB/T 2829-2002 Sampling procedures and tables for periodic inspection by attributes (Apply to inspection of process stability)
GB/T 3978-2008 Standard illuminants and geometric conditions
GB/T 5702-2003 Methods of measuring the color of light sources
GB/T 11417.1-2012 Ophthalmic optics—Contact lenses—Part 1:Vocabulary,classification system and recommendations for labeling specifications
中华人民共和国药典 2010年版二部
GB/T 16886.5-2003 Biological evaluation of medical devices—Part 5:Test for in vitro cytotoxicity
GB/T 16886.5-2017 Biological evaluation of medical devices—Part 5:Tests for in vitro cytotoxicity
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 16886.11-1997 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity
GB/T 16886.11-2011 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity
GB/T 16886.11-2021 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity
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
YY/T 0297-1997 Clinical investigation of medical devices
YY/T 0316-2003 Medical devices—Application of risk management to medical devices
YY/T 0316-2008 Medical devices—Application of risk management to medical devices
YY/T 0316-2016 Medical devices—Application of risk management to medical devices
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
YY/T 0316-2000 YY/T 0316-2000 Medical devices - Risk analysis - Part 1: Application of risk analysis
YY/T 0297-2026 General requirements for clinical investigation of medical devices
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