ISO 11979-7

Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia

Body

ISO

Number

ISO 11979-7

Editions

2024

FDA recognition no.

10-135

Scope

Partial recognition. The following part(s) of the standard is (are) not recognized: Clause 6.2.2 Additional requirements for toric IOLs Clause 6.3.3 Additional characteristics to be studied for toric IOL Clause 6.4 Duration of the investigations - Paragraphs 4 and 5 Clause 6.10.3 Additional inclusion criteria for toric IOL Annex B - Additional elements for the clinical investigation of toric IOLs

Scope source: FDA 认可共识标准库

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