Sky Bear Technical Standards - Home
Search
×
FR

Placeholder headline

This is just a placeholder headline

B51-14 (R2019) – Boiler, pressure vessel, and pressure piping code

$

362

BUY NOW

ISO 11980:2025

ISO 11980:2025 Ophthalmic optics — Contact lenses and contact lens care products — Requirements and guidance for clinical investigations

CDN $307.00

This publication was last reviewed and confirmed in 2025.

Ophthalmic optics — Contact lenses and contact lens care products — Requirements and guidance for clinical investigations

Description

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).

Edition

4

Published Date

2026-06-19

Status

PUBLISHED

Pages

30

Language Detail Icon

English

Format Secure Icon

Secure PDF

Abstract

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).

Previous Editions

Can’t find what you are looking for?

Please contact us at: