Name: EN ISO 11980:2012
Brand: CEN

Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:2012)

Published date

11-15-2012

Publisher

Comite Europeen de Normalisation

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

ISO 11980:2012 gives guidelines for the clinical investigation of the safety and performance of contact lenses and contact lens care products.

Committee	CEN/TC 170
DocumentType	Standard
PublisherName	Comite Europeen de Normalisation
Status	Current

Standards	Relationship
BS EN ISO 11980:2012	Identical
SS-EN ISO 11980:2012	Identical
NF EN ISO 11980 : 2013	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
PN EN ISO 11980 : 2013	Identical
UNI EN ISO 11980 : 2013	Identical
ISO 11980:2012	Identical
DIN EN ISO 11980:2013-03	Identical
BS 7208-16(1998) : 1998	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