NF EN ISO 11979-7

NF EN ISO 11979-7

November 2008
Standard Cancelled

Ophthalmic implants - Intraocular lenses - Part 7 : clinical investigations

Le présent document spécifie les exigences particulières relatives aux investigations cliniques sur les lentilles intracculaires (LIO) monofocales de chambres antérieure et postérieure utilisées pour corriger l'aphakie.

See more
View the extract
Main informations

Collections

National standards and national normative documents

Publication date

November 2008

Number of pages

24 p.

Reference

NF EN ISO 11979-7

ICS Codes

11.040.70   Ophthalmic equipment

Classification index

S94-750-7

Print number

1 - 14/11/2008

International kinship

ISO 11979-7:2006

European kinship

EN ISO 11979-7:2006
Sumary
Ophthalmic implants - Intraocular lenses - Part 7 : clinical investigations

Le présent document spécifie les exigences particulières relatives aux investigations cliniques sur les lentilles intracculaires (LIO) monofocales de chambres antérieure et postérieure utilisées pour corriger l'aphakie.
Replaced standards (1)
NF EN 13503-7
February 2002
Standard Cancelled
Ophthalmic implants - Intraocular lenses - Part 7 : clinical investigations

Le présent document spécifie les exigences particulières s'appliquant aux protocoles d'investigation clinique pour les lentilles intraoculaires (LIO) monofocales de chambre antérieure et postérieure utilisées pour corriger l'aphaquie.

Standard replaced by (1)
NF EN ISO 11979-7
October 2014
Standard Cancelled
Ophthalmic implants - Intraocular lenses - Part 7 : clinical investigations

Le présent document spécifie les exigences particulières relatives aux investigations cliniques sur les lentilles intraoculaires (LIO) de chambres antérieure et postérieure.

Table of contents
View the extract
  • Avant-propos
    iv
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    1
  • 4 Justifications d'une investigation clinique
    1
  • 5 Considérations éthiques
    1
  • 6 Exigences générales
    2
  • 6.1 Généralités
    2
  • 6.2 Exigences supplémentaires
    2
  • Annexe A (informative) Éléments d'une investigation clinique
    4
  • Annexe B (informative) Évaluation des niveaux d'effet indésirables et des valeurs d'acuité visuelle postopératoire
    13
  • Bibliographie
    18
ZOOM ON ... the Requirements department
To comply with a standard, you need to quickly understand its issues in order to determine its impact on your activity.

The Requirements department helps you quickly locate within the normative text:
- mandatory clauses to satisfy,
- non-essential but useful clauses to know, such as permissions and recommendations.

The identification of these types of clauses is based on the document “ISO / IEC Directives, Part 2 - Principles and rules of structure and drafting of ISO documents ”as well as on a constantly enriched list of verbal forms.

With Requirements, quickly access the main part of the normative text!

With Requirements, quickly access the main part of the normative text!
Need to identify, monitor and decipher standards?

COBAZ is the simple and effective solution to meet the normative needs related to your activity, in France and abroad.

Available by subscription, CObaz is THE modular solution to compose according to your needs today and tomorrow. Quickly discover CObaz!

Request your free, no-obligation live demo

I discover COBAZ