Aktívna norma | Vydaná: 27.04.2017

ISO/TR 22979:2017-ed.2.0

Ophthalmic implants — Intraocular lenses — Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
(Implants ophtalmiques — Lentilles intraoculaires — Directives relatives a l´évaluation de la nécessité d´investigation clinique pour les modifications de conception des lentilles intraoculaires)

Dostupné jazyky: Anglicky

Dostupné prevedenie: Elektronické PDF, Tlačené

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Podrobné informácie

Označenie: ISO/TR 22979:2017-ed.2.0

Dátum vydania: 27.04.2017

Stránok: 22

Krajina: Medzinárodná technická norma

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Anotácia

Description / Abstract: ISO/TR 22979:2017 provides guidance on the application of all parts of the ISO 11979 series of International Standards for intraocular lenses (IOLs).[1?9] It addresses factors to be considered in the risk management process of modifications to anterior and posterior chamber IOLs in accordance with ISO 14971.[11] It also suggests methods of data analysis and interpretation that can be used to determine the need for a clinical investigation and its design.

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