ISO 11980:2012 PDF

Scope: 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.

ISO 11980:2012 Referenced Document

ISO 14155 Clinical investigation of medical devices for human subjects - Good clinical practice*， 2020-09-01 Update
ISO 14534 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements
ISO 18369-1 Ophthalmic optics — Contact lenses — Part 1: Vocabulary, classification system and recommendations for labelling specifications*， 2017-08-23 Update

2012 ISO 11980:2012 Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations
2009 ISO 11980:2009 Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations
1998 ISO 11980:1997/Cor 1:1998 Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations; Technical Corrigendum 1
1997 ISO 11980:1997 Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations