GB 11533-1989
Replaced
YY 0477-2016
Active
Industry standards-Medicine
YY 0477-2016 Rigid gas permeable contact lenses for orthokeratology
YY 0477-2016 Rigid gas permeable contact lenses for orthokeratology
Basic Information
Standard Code:
YY 0477-2016
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical optical instruments and equipment, and endoscopes
ICS Name:
Ophthalmic equipment
Publish Date:
2016-03-23
Implement Date:
2018-01-01
Pages:
8 pages
Scope
This standard specifies the terms and definitions, requirements, test methods, sampling and inspection rules, marking, labeling, and accompanying materials, packaging, and other requirements for rigid gas-permeable contact lenses used for corneal reshaping (hereinafter referred to as corneal reshaping lenses). Corneal reshaping lenses are intended to temporarily change the shape of the cornea to achieve temporary correction of refractive errors.
Development Information
Replace the following standards
Referenced Standards
GB/T 11417.1-2012 Ophthalmic optics—Contact lenses—Part 1:Vocabulary,classification system and recommendations for labeling specifications
GB 11417.2-2012 Ophthalmic optics—Contact lenses—Part 2:Rigid contact lenses specification
GB/T 2829-2002 Sampling procedures and tables for periodic inspection by attributes (Apply to inspection of process stability)
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
GB/T 2829-2025 Sampling procedures and tables for periodic inspection by attributes(Apply to inspection of process stability)
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