EN ISO 11980:2012
Current
The latest, up-to-date edition.
Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:2012)
11-15-2012
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
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 |
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