UNE-EN ISO 11980:2026
Current
The latest, up-to-date edition.
Ophthalmic optics - Contact lenses and contact lens care products - Requirements and guidance for clinical investigations (ISO 11980:2025)
Hardcopy , PDF
English, Spanish, Castilian
15-07-2026
This document gives guidelines for the clinical investigation (CI) to establish the safety and performance ofcontact 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 themarketing 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, thisrequirement takes precedence over this document.NOTE 2 For indications beyond correction of refractive error, additional considerations for safety and performanceshould be included in the clinical investigation plan (CIP).
| Committee |
CTN 45
|
| DocumentType |
Standard
|
| Pages |
40
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN ISO 11980:2025 | Identical |
| ISO 11980:2025 | Identical |
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