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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
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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

PUBLISH DATE 2025
PAGES 40
BSI BS EN ISO 11980:2025
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).
SDO BSI: British Standards Institution
Document Number ISO 11980
Publication Date July 17, 2025
Language en - English
Page Count 40
Revision Level
Supercedes
Committee CH/172/9
Publish Date Document Id Type View
July 17, 2025 BS EN ISO 11980:2025 Revision
Dec. 31, 2012 BS EN ISO 11980:2012 Revision
Nov. 30, 2009 BS EN ISO 11980:2009 Revision
Oct. 15, 1998 BS EN ISO 11980:1998 Revision
Oct. 31, 2013 BS EN ISO 11980:2012 Consolidated