0 Stavka
Moj nalog
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 11980:2025

Ophthalmic optics — Contact lenses and contact lens care products — Requirements and guidance for clinical investigations
20. 6. 2025.

Опште информације

60.60     20. 6. 2025.

ISO

ISO/TC 172/SC 7

Međunarodni standard

11.040.70  

engleski   francuski  

Kupovina

Objavljen

Jezik na kome želite da primite dokument.

Apstrakt

This document gives requirements and guidelines for the clinical investigation (CI) to establish the safety and performance of contact lenses and contact lens care products.
NOTE 1        This document attempts to align the recognised regulatory requirements for the conduct of a CI to meet the marketing and labelling requirements for contact lenses and contact lens care products around the world. However, national requirements vary greatly. Wherever national practice or regulations dictate some legal requirement, this requirement takes precedence over this document.
NOTE 2        For indications beyond correction of refractive error, additional considerations for safety and performance are to be included in the clinical investigation plan (CIP).

Životni ciklus

PRETHODNO

POVUČEN
ISO 11980:2012

TRENUTNO

OBJAVLJEN
ISO 11980:2025
60.60 Standard objavljen
20. 6. 2025.

Nacionalna preuzimanja

dnaSRPS EN ISO 11980:2022  
ISS

Oftalmološka optika — Kontaktna sočiva i sredstva za održavanje kontaktnih sočiva — Smernice za klinička istraživanja

50.60   Završetak postupka odobravanja definitivnog teksta nacrta standarda

Z172 Saznaj više