YY 0290.6-1997
Intraocular Ienses.Part 6:Shelf-life and shipping testing (English Version)
- Standard No.
- YY 0290.6-1997
- Language
- Chinese, Available in English version
- Release Date
- 1997
- Published By
- Professional Standard - Medicine
- Status
- 2010-12
- Replace By
- YY 0290.6-2009
- Latest
- YY 0290.6-2009
- Scope
- This standard specifies the stability test of intraocular lenses. In the process of storing and selling sterile intraocular lenses, a stability test is required to determine the validity period of the lens. The purpose of the stability test is to determine the validity period of the lens under a specified series of environmental conditions. Under the influence, after a long enough time. The intraocular lens still retains its original properties. On the basis of the obtained information, corresponding transportation and storage conditions can be recommended to ensure the safety, effectiveness and acceptable performance of the intraocular lens during its validity period. It is also suitable for determining the expiration date of the intraocular lens. During the test period, the materials used to make the intraocular lens and the packaging used to ensure the environment required by the lens must be tested for stability. Intraocular lens stability testing is used to determine material properties and can be tested on a given intraocular lens material, packaging material and production process. Only one type of intraocular lens needs to be tested.
YY 0290.6-1997 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
