Telefon: (011) 7541-421, 3409-301, 3409-335, 6547-293, 3409-310
E-mail: Prodaja standarda: prodaja@iss.rs Seminari, obuke: iss-edukacija@iss.rs Informacije o standardima: infocentar@iss.rs
Stevana Brakusa 2, 11030 Beograd
Glavni meni

ISO/TR 22979:2017

Ophthalmic implants — Intraocular lenses — Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
27. 4. 2017.

Опште информације

90.92     14. 1. 2025.

ISO

ISO/TC 172/SC 7

Tehnički izveštaj

11.040.70  

engleski  

Kupovina

Objavljen

Jezik na kome želite da primite dokument.

Apstrakt

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.

Životni ciklus

PRETHODNO

POVUČEN
ISO/TR 22979:2006

TRENUTNO

OBJAVLJEN
ISO/TR 22979:2017
90.92 Odluka o izmeni ili reviziji standarda
14. 1. 2025.

REVIDIRAN OD

PROJEKAT
ISO/CD TR 22979