SS-EN 13503-7

Ögonimplantat - Intraokulära linser - Del 7: Klinisk prövning (ISO 11979-7:2001, modifierad)

Standard · Svensk standard
SS-EN 13503-7

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This part of EN 13503 specifies particular requirements for clinical investigation protocols for posterior and anterior chamber monofocal intraocular lenses (IOLs) for the correction of aphakia. NOTE Any other type of IOL not directly covered by EN 13503 and any IOL for which the sponsor wishes to investigate claims in addition to those defined in EN 13503 may be clinically evaluated by reference to EN 540.

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