Ophthalmic microsurgical knives are single-use devices intended for temporary use in ophthalmic surgery to make precise incisions for intraocular lens implantation. They are sterilized using ethylene oxide and come in various types depending on surgeon preference and the surgery. As class IIa medical devices for transient use, they require testing and certification according to European Medical Device Directive standards including ISO 15223-1, ISO 17665-1, ISO 11135, and ISO 14971.

1. TECHNICAL FILE FOR
OPHTHALMIC MICROSURGICAL KNIVES
Malesh M
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2. TECHNICAL FILE FOR OPHTHALMIC MICROSURGICAL KNIVES
Ophthalmic Microsurgical knives are designed to give incision of
required width for IOL Implant and Sterilized by ETO. Intended for
single use in ophthalmic surgery. The device is to be used by
qualified and trained ophthalmic surgeon only. Different types of
Ophthalmic Microsurgical knives are used based on the comfort
ability of the surgeons and required applicability in different types of
ophthalmic surgical interventions. Classification : Class IIa
Justification of Classification: As per section 2.2, Rule 6 of Annex IX
of MDD– All surgically invasive medical devices intended for transient
use are in Class IIa
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3. In case of CE Marking for the Ophthalmic Microsurgical knives are,
consider the requirements as per European Medical Device directive
and the standard applicable for the Ophthalmic Microsurgical knives
are including testing. File should submitted to notified body for
conformity assessment as per of MDD 93/42/EEC. The Ophthalmic
Microsurgical knives are technical file for CE Marking should consider
the following standards
ISO 15223-1
ISO 17665-1
ISO 11135
ISO 14971
The Biocompatibility Test Reports of Microsurgical blades are includes,
Cytotoxicity studies(ISO 10993-5)
ETO residue testing (ISO 10993-7)
systemic toxicity (ISO 10993-11)
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