BS EN ISO 11980:2025, 2025

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BSI

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

Edition: 2025

$495.05
/ user per year

Description
About BSI

Description of BS EN ISO 11980:2025 2025

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).

Standard Number	BS EN ISO 11980:2025
Title	Ophthalmic optics. Contact lenses and contact lens care products. Requirements and guidance for clinical investigations
Status	Definitive
Publication Date	2025-07-17
Replaces	BS EN ISO 11980:2012
Identical National Standard Of	EN ISO 11980:2025, ISO 11980:2025
Descriptors	Visual perception, Safety measures, Clinical testing, Tables (data), Optical properties of materials, Surface properties, Ophthalmic equipment, Diagnosis (medical), Reports, Contact lenses, Performance, Fitting, Classification systems, Ophthalmology, Eyes
ICS	11.040.70 Ophthalmic equipment
Committee	CH/172/9
ISBN	978 0 539 24586 8
Publisher	BSI
Pages	40

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.

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