BS EN ISO 11980:2012

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Clinical investigational requirements
Annex A (informative) - Elements of a clinical
        investigation
Annex B (informative) - Procedures for the evaluation
        of safety, physiological
        performance and effect on
        ocular tissues
Annex C (informative) - The evaluation of visual,
        refractive and lens performance
        and subject acceptance
Bibliography

Provides guidelines for the clinical investigation (CI) of the safety and performance of contact lenses and contact lens care products.

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.