GB 11533-1989
Replaced
YY/T 0290.6-2009
Replaced
Industry standards-Medicine
YY/T 0290.6-2009 Intraocular lenses—Part 6:Shelf-life and transport stability
YY/T 0290.6-2009 Intraocular lenses—Part 6:Shelf-life and transport stability
Basic Information
Standard Code:
YY/T 0290.6-2009
Standard Type:
Industry standards
Standard Status:
Replaced
is_force_gb:
no
CCS Name:
Medical optical instruments and equipment, and endoscopes
ICS Name:
Ophthalmic equipment
Publish Date:
2009-06-16
Implement Date:
2010-12-01
Pages:
11 pages
Scope
This part of YY 0290 specifies the tests for determining the shelf life of sterile intraocular lenses in complete packaging. These tests include procedures for establishing the stability of intraocular lenses during distribution and storage.
Development Information
Same series standard
Replace the following standards
Superseded by the following standards
Referenced Standards
GB/T 16886.5-2003 Biological evaluation of medical devices—Part 5:Test for in vitro cytotoxicity
GB/T 16886.12-2005 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials
ISO/TR 22979-2006
GB/T 19633-2005 Packaging for terminally sterilized medical devices
GB/T 19633.1-2015 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials, sterile barrier systems and packaging systems
GB/T 19633.1-2024 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials,sterile barrier systems and packaging systems
GB/T 19633.2-2015 Packaging for terminally sterilized medical devices—Part 2:Validation requirements for forming,sealing and assembly processes
GB/T 19633.2-2024 Packaging for terminally sterilized medical devices—Part 2:Validation requirements for forming,sealing and assembly processes
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 0290.5-1997 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/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
Adopt standards
ISO 11979-6:2007
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