Name: UNI EN ISO 11980 : 2013
Brand: UNI

OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - GUIDANCE FOR CLINICAL INVESTIGATIONS

Published date

01-10-2013

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

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.

Committee	CT 44
DocumentType	Standard
PublisherName	Ente Nazionale Italiano di Unificazione (UNI)
Status	Current
Supersedes	UNI EN ISO 11980 : 2009

Standards	Relationship
BS EN ISO 11980:2012	Identical
EN ISO 11980:2012	Identical
NF EN ISO 11980 : 2013	Identical
ISO 11980:2012	Identical
NBN EN ISO 11980 : 2013	Identical
UNE-EN ISO 11980:2013	Identical
SN EN ISO 11980 : 2013	Identical
NS EN ISO 11980 : 2012	Identical
NEN EN ISO 11980 : 2012	Identical
I.S. EN ISO 11980:2012	Identical
DIN EN ISO 11980:2013-03	Identical

ISO 18369-1:2017	Ophthalmic optics — Contact lenses — Part 1: Vocabulary, classification system and recommendations for labelling specifications
ISO 14534:2011	Ophthalmic optics Contact lenses and contact lens care products Fundamental requirements
ISO 13485:2016	Medical devices Quality management systems Requirements for regulatory purposes
ISO 9001:2015	Quality management systems — Requirements
ISO 14155:2011	Clinical investigation of medical devices for human subjects Good clinical practice