YY 0290.8-2008 Ophthalmic implants—Intraocular lenses—Part 8:Fundamental requirement

YY/T 0290.1-2008 Ophthalmic implants—Intraocular lenses—Part 1:Terminology YY 0290.3-2008 Ophthalmic implants—Intraocular lenses—Part 3:Mechanical properties and test methods YY/T 0290.4-2008 Ophthalmic implants—Intraocular lenses—Part 4:Labeling and information YY/T 0290.5-2008 Ophthalmic implants—Intraocular lenses—Part 5:Biocompatibility

YY 0290.8-1997 Intraocular lenses—Part 8:Fundampental requirements

YY 0290.8-2022 Ophthalmic optics—Intraocular lenses—Part 8:Fundamental requirement

GB/T 16886.7-2001 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals GB 18278-2000 Sterilization of health care products—Requirements for validation and routine control—Industrial moist heat sterilization GB 18279-2000 Medical devices—Validation and routine control of ethylene oxide sterilization GB 18280-2000 Sterilization of health care products—Requirement for validation and routine control—Radiation sterilization YY/T 0640-2008 Non-active surgical implants—General requirements 中华人民共和国药典(2005)二部 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 19000-2000 Quality management systems—Fundamentals and vocabulary GB/T 19000-2008 Quality management systems—Fundamentals and vocabulary GB/T 19000-2016 Quality management systems—Fundamentals and vocabulary GB/T 19000.2-1998 Quality management and quality assurance standards—Part 2:Generic guidelines for the application of GB/T 19001、GB/T 19002 and GB/T 19003 GB/T 19000.3-2001 Quality management and quality assurance standards—Part 3:Guidelines for the application of GB/T 19001-1994 to the development, supply, installation and maintenance of computer software GB/T 19000.4-1995 Quality management and quality assurance standards—Part 4:Cuide to dependability programme management YY/T 0287-2003 Medical devices—Quality management systems—Requirements for regulatory purposes YY/T 0287-2017 Medical devices—Quality management systems—Requirements for regulatory purposes YY 0290.1-1997 Intraocular lenses—Part 1:Terminology YY/T 0290.1-2008 Ophthalmic implants—Intraocular lenses—Part 1:Terminology YY/T 0290.1-2021 Ophthalmic optics—Intraocular lenses—Part 1:Terminology YY 0290.2-1997 Intraocular lenses—Part 2:Optical properties and their test methods YY 0290.2-2009 Ophthalmic implants—Intraocular lenses—Part 2:Optical properties and test methods YY 0290.2-2021 Ophthalmic optics—Intraocular lenses—Part 2:Optical properties and test methods YY 0290.3-1997 Intraocular lenses—Part 3:Mechanical properties and their test methods YY 0290.3-2008 Ophthalmic implants—Intraocular lenses—Part 3:Mechanical properties and test methods YY 0290.3-2018 Ophthalmic optics—Intraocular lenses—Part 3:Mechanical properties and test methods YY 0290.4-1997 Intraocular lenses—Part 4:Labeling and information YY/T 0290.4-2008 Ophthalmic implants—Intraocular lenses—Part 4:Labeling and information YY/T 0290.4-2022 Ophthalmic optics—Intraocular lenses—Part 4:Labeling and information YY 0290.5-1997 Intraocular lenses—Part 5:Biocompatibility YY/T 0290.5-2008 Ophthalmic implants—Intraocular lenses—Part 5:Biocompatibility YY/T 0290.5-2023 Ophthalmic optics—Intraocular lenses—Part 5:Biocompatibility YY 0290.6-1997 Intraocular lenses—Part 6:Shelf-life and shipping testing YY/T 0290.6-2009 Intraocular lenses—Part 6:Shelf-life and transport stability YY/T 0290.6-2021 Ophthalmic optics—Intraocular lenses—Part 6:Shelf-life and transport stability YY 0290.9-2010 Ophthalmic implants—Intraocular lenses—Part 9:Multifocal intraocular lenses YY 0290.10-2009 Intraocular lenses—Part 10:Phakic intraocular lenses 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 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

ISO 11979-8:2006