NF EN ISO 11980

NF EN ISO 11980

January 2013
Standard Current

Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations

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

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Main informations

Collections

National standards and national normative documents

Publication date

January 2013

Number of pages

37 p.

Reference

NF EN ISO 11980

ICS Codes

11.040.70   Ophthalmic equipment

Classification index

S11-806

Print number

1 - 04/01/2013

International kinship

ISO 11980:2012

European kinship

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

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

Replaced standards (1)
NF EN ISO 11980
March 2010
Standard Cancelled
Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations

<p>ISO 11980:2009 gives guidelines for the clinical investigation of the safety and performance of contact lenses and contact lens care products.</p>

Table of contents
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  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    1
  • 4 Exigences relatives à l'investigation clinique
    1
  • 4.1 Généralités
    1
  • 4.2 Exigences supplémentaires
    1
  • 4.3 Autres éléments pris en considération
    5
  • Annexe A (informative) Éléments d'une investigation clinique
    6
  • Annexe B (informative) Modes opératoires d'évaluation de la sécurité, des performances physiologiques et des effets sur les tissus oculaires
    19
  • Annexe C (informative) Évaluation des performances visuelles et réfractives, de l'efficacité des lentilles et de leur degré de tolérance chez le sujet
    24
  • Bibliographie
    27
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