YY 0290.6-2009
Intraocular lenses.Part 6:Shelf-life and transport stability (English Version)
- Standard No.
- YY 0290.6-2009
- Language
- Chinese, Available in English version
- Release Date
- 2009
- Published By
- Professional Standard - Medicine
- Latest
- YY 0290.6-2009
- Replace
- YY 0290.6-1997
- Scope
- This part of YY 0290 specifies tests for determining the shelf life of sterile intraocular lenses in complete packaging. These trials included procedures to establish the stability of the intraocular lens during distribution and storage.
YY 0290.6-2009 Referenced Document
- GB/T 16886.12-2005 Biological evaluation of medical devices-Part 12:Sample preparation and reference materials
- GB/T 16886.5-2003 Biological evaluation of medical devices--Part 5: Test for in vitro cytotoxicity
- GB/T 19633 Packaging for terminally sterilized medical devices
- ISO/TR 22979:2006 Ophthalmic implants - Intraocular lenses - Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
- YY 0290.1 Ophthalmic implants.Intraocular lenses.Part 1:Terminology
- YY 0290.5 Ophthalmic implants.Intraocular lenses.Part 5:Biocompatibility
- YY/T 0316 Medical devices.Application of risk management to medical devices*， 2016-01-26 Update
YY 0290.6-2009 history
- 2009 YY 0290.6-2009 Intraocular lenses.Part 6:Shelf-life and transport stability
- 1997 YY 0290.6-1997 Intraocular Ienses.Part 6:Shelf-life and shipping testing
