2. Technical file for Intraocular lens
Intraocular lens are very common in the treatment of Cataract. An
Intraocular lens (IOL) is an artificial lens inserted during cataract
surgery to replace the natural lens. It also may be surgically inserted
as a method of vision correction that leaves the eye’s natural lens
intact. Surgery for cataracts involves removing the natural lens of the
eye that contains the cataract and either replacing it with an artificial
lens called an Intraocular lens implant (IOL) or compensating for its
absence with eyeglasses or contact lenses. Mainly two types of
Materials are used for the production of this artificial lens, PMMA &
PHEMA.
http://medicaldevicetrading.i3cglobal.com/iol.html
+91 9900 3218 14
3. In case of Technical file preparation for the Intraocular lens, consider
the requirements as per European Medical Device directive and the
standard applicable for the Intraocular lens including testing. File
should submitted to notified body for conformity assessment as per of
MDD 93/42/EEC. The technical file for IOLs, should consider the
following standards
ISO 15223-1.
ISO 17665-1
ISO 11135
ISO 14971
The Biocompatibility Test Reports of Intraocular lens includes
Cytotoxicity studies(ISO 10993-5) ,local effect on implantation(ISO
10993-6) ,ETO residue testing (ISO 10993-7)and systemic toxicity
(ISO 10993-11)
http://medicaldevicetrading.i3cglobal.com/iol.html
+91 9900 3218 14
