BS EN ISO 11980:2012:2013 Edition

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Ophthalmic optics. Contact lenses and contact lens care products. Guidance for clinical investigations

Published By	Publication Date	Number of Pages
BSI	2013	36

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Categories: 11.040.70 - Ophthalmic equipment, BSI

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Description

This International Standard gives guidelines for the clinical investigation (CI) of the safety and performance of contact lenses and contact lens care products.

NOTE This International Standard attempts to harmonize the recognized 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 International Standard.

Additional information

Status	Under Review
Pages	36
Publication Date	2013-10-31
ISBN	978 0 580 81665 9
Standard Number	BS EN ISO 11980:2012
Title	Ophthalmic optics. Contact lenses and contact lens care products. Guidance for clinical investigations
Corrects	BS EN ISO 11980:2012
Replaces	BS EN ISO 11980:2009
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
Publisher	BSI
Committee	CH/172/9
ICS Codes	11.040.70 - Ophthalmic equipment

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BS EN ISO 11980:2012:2013 Edition

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